OF M/s. ARCHIMEDIS LABORATORIES PVT. LTD. · Naresh Kumar E. V. Naresh Kumar P. Praveen Kumar the...

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ENVIRONMENTAL IMPACT ASSESSMENT REPORT & ENVIRONMENTAL MANAGEMENT PLAN OF M/s. ARCHIMEDIS LABORATORIES PVT. LTD. LOCATED AT Sy No: 108 & 109, Jayanthipuram (V) Jaggayyapet (M), Krishna District, Andhra Pradesh. FOR PROPOSED BULK DRUGS AND INTERMEDIATES MANUFACTURING UNIT Proposal for ENVIRONMENTAL CLEARANCE Industry falls under 5(f) ‘A’ Category as per the EIA Notification, 2006. Baseline Period March 2018 to May - 2018 Project Proponent Mr. Maddireddy Venkateswara Reddy, Managing Director, 5-163/1, 2 nd floor, Malleswari Nilayam, Chintalkunta, LB Nagar Post, Hyderabad Prepared by: Rightsource Industrial Solutions Pvt. Ltd Plot No: 203, H.No:5-36/203, Prashanthi Nagar, IDA, Kukatpally, Hyderabad 500072. Ph: 040-23070602, 23075699. 40126589. Email: [email protected]. NABET Accreditation No: NABET/EIA/1518/SA 038

Transcript of OF M/s. ARCHIMEDIS LABORATORIES PVT. LTD. · Naresh Kumar E. V. Naresh Kumar P. Praveen Kumar the...

Page 1: OF M/s. ARCHIMEDIS LABORATORIES PVT. LTD. · Naresh Kumar E. V. Naresh Kumar P. Praveen Kumar the project. Identified villages wise amenities and needs Period: Feb 2018 -Till date

ENVIRONMENTAL IMPACT ASSESSMENT REPORT

& ENVIRONMENTAL MANAGEMENT PLAN

OF

M/s. ARCHIMEDIS

LABORATORIES PVT. LTD.

LOCATED AT

Sy No: 108 & 109, Jayanthipuram (V) Jaggayyapet (M), Krishna District, Andhra Pradesh.

FOR

PROPOSED BULK DRUGS AND INTERMEDIATES

MANUFACTURING UNIT

Proposal for

ENVIRONMENTAL CLEARANCE Industry falls under 5(f) ‘A’ Category as per the EIA Notification, 2006.

Baseline Period – March – 2018 to May - 2018

Project Proponent

Mr. Maddireddy Venkateswara Reddy,

Managing Director,

5-163/1, 2nd

floor,

Malleswari Nilayam, Chintalkunta,

LB Nagar Post, Hyderabad

Prepared by:

Rightsource Industrial Solutions Pvt. Ltd Plot No: 203, H.No:5-36/203, Prashanthi Nagar, IDA, Kukatpally, Hyderabad – 500072. Ph: 040-23070602, 23075699. 40126589. Email: [email protected].

NABET Accreditation No: NABET/EIA/1518/SA 038

Page 2: OF M/s. ARCHIMEDIS LABORATORIES PVT. LTD. · Naresh Kumar E. V. Naresh Kumar P. Praveen Kumar the project. Identified villages wise amenities and needs Period: Feb 2018 -Till date

UNDERTAKING BY PROJECT

AUTHORITIES

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DISCLOSURE OF CONSULTANTS

ENGAGED

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s.

Annexure

Declaration by Experts contributing to the EIA of Archimedis Laboratories Pvt. Ltd ., Sy No:

108 & 109, Jayanthipuram (V) Jaggayyapet Mandai, Krishna District, Andhra Pradesh.

I, hereby, certify that I was a part of the EIA team in the following capacity that developed the

above EIA.

EIA coordinator:

Name: Yarlagadda V. Prasad

Signature: ;(-!'------.;o:r.-1 Period of involvement: Feb 2018 -Till date

Contact information: Rightsource Industrial Solutions Pvt. Ltd.

Plot No: 203, H.No:5-36/203, Prashanthi Nagar, IDA,

Kukatpally, Hyderabad - 500072. Ph: 040-23070602, 23075699.

[email protected] , [email protected]

Functional Area Experts:

Functional Name of Involvement No. areas the (period and task-) Signature

expertls

Period: Feb 2018 -Till date Task: Selecting ambient air monitoring sites

fl~ Yarlagadda based on IMD data, Review of the 1 AP V. Prasad meteorological data, Process emissions and

AAQ data, suggesting air pollution control measures.

Period: Feb 2018 - Till date

P.S.N. Task: Identification of water monitoring sites,

9 2 WP Murthy estimating water requirement, Suggesting Recycling of water, waste water treatment

,.,_ methods & disposal schemes.

Period: Feb 2018 - Till date

~~ P.S.N. Task: lnventorization of Hazardous waste, 3 SHW* Murthy Solid wastes, etc., suggesting treatment

options viz., landfill, incineration, recycling, and stabilization.

Setti VR Period: Feb 2018 -Till date y· 4 SE Bhaskara Task: Generating primary SE data, livestock

Rao inventory and impacts, conducted focused group discussions, taken public opinion on

DECLARATION OF ASSOCIATION IN THE EIA

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5 EB

6 HG

7 GEO

8 AQ

9 NV

10 LU

11 RH

G. Raja Reddy

E. V. Naresh Kumar

E. V. Naresh Kumar

P. Praveen Kumar

the project. Identified villages wise amenities and needs

Period: Feb 2018 - Till date Task: Collected secondary data from foresU agricultural/ fisheries department, generation of primary flora and fauna data from study area & core area, ground truthing for ecological assessment, development of status report, suggested species for greenbelt development.

Period: March 2018 -Till date Task: Measurement of ground water levels from the existing wells present in and around project site, observation of surface water bodies, establishing groundwater flow direction and its gradient and evaluation of rainfall data and suggesting suitable depth for secured land fill base, and identification of development of monitoring wells.

Period: March 2018 -Till date Task: Observations made towards the Identification of country rock, development of porosity, thickness and extent of weathered formations, area seismicity and evaluation of soil permeability for suggesting suitable civil structures.

Period: Feb 2018- Till date Task: Meteorological & Air Pollution dispersion studies, suggesting environmental management plan for air pollution control measures

Period: Feb 2018 - Till date Yarlagadda Task: Monitoring of noise I vibration levels v. Prasad using instrument, processing and analysis of

Data for suggesting suitable noise mitigating measures

Dr. Y. Ram a Mohan

P. Praveen Kumar

Period: March 2018 -Till date Task: Collection of GPS readings from the project site and prepared layout, preparation of TOPO map through SOl 1 :50,000 scale TOPO sheet. Collections of ground through data from the field. Preparation of LU map through Satellite imagery, SOl, Google map & Ground through data.

Period: Feb 2018 - Till date Task: Identification of Hazards and Hazardous substances from process &

DECLARATION OF ASSOCIATION IN THE EIA

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warehouse, storage tanks .Risks and consequence analysis using software and lethality damages, DMP and EPP for onsite & offsite were provided

S.No. Functional Name of the F AAs Involvement

Signature Areas Period

1 AP,AQ Y. Prathyusha Feb 2018- Till date R l..l~ho.

2 LU G. Sandeep Feb 2018- Till date ~·

S.No. Functional Name of the Team Involvement Signature Areas Members Period

1 sc G. Raja Reddy Feb 2018 -Till date ~

Declaration by the Head of the accredited consultant organization/ authorized person

I, Yarlagadda V . Prasad, hereby, confirm that the above mentioned experts prepared the EIA of

Archimedis Laboratories Pvt. Ltd., Sy No: 108 & 109, Jayanthipuram (V) Jaggayyapet Mandai,

Krishna District, Andhra Pradesh. I also confirm that the consultant organization shall be fully

accountable for any mis-leading information mentioned in this statement.

Signature: ~' Name: Yarlagadda V. Prasad

Designation: Managing Director

Name of the EIA consultant organization: Rightsource Industrial Solutions Pvt. Ltd.

NABET Certificate No. & Issue Date: NABET Accreditation No: NABET/EIA/1821/RA 0100

DECLARATION OF ASSOCIATION IN THE EIA

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COPY OF

TERMS OF REFERENCE [TOR]

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No.IA-J-11011/9/2018-IA-II(I)

Goverment of India

Minister of Enviroment,Forest and Climate Change

Impact Assessment Division

***

Indira Paryavaran Bhavan,

Vayu Wing,3rd Floor,Aliganj,

Jor Bagh Road,New Delhi-110003

05 Feb 2018

To,

         M/s ARCHIMEDIS LABORATORIES PRIVATE LIMITED

         5-163/1, 2 nd Floor, Malleswari Nilayam, Chintalkunta, LB Nagar Post Hyderabada,

         Rangareddi-500074

         Telangana

Tel.No.040-23070602; Email:[email protected]

Sir/Madam,

                      This has reference to the proposal submitted in the Ministry of Environment, Forest

and Climate Change to prescribe the Terms of Reference (TOR) for undertaking detailed EIA

study for the purpose of obtaining Environmental Clearance in accordance with the provisions of

the EIA Notification, 2006. For this purpose, the proponent had submitted online information in the

prescribed format (Form-1 ) along with a Pre-feasibility Report. The details of the proposal are

given below:

1. Proposal No.:                              IA/AP/IND2/72028/2018

2. Name of the Proposal:               Archimedis laboratories Private Limited

3. Category of the Proposal:         Industrial Projects - 2

4. Project/Activity applied for: 5(f) Synthetic organic chemicals industry (dyes

& dye intermediates; bulk

5. Date of submission for TOR:      03 Jan 2018

In this regard, under the provisions of the EIA Notification 2006 as amended, the Standard TOR

for the purpose of preparing environment impact assessment report and environment

management plan for obtaining prior environment clearance is prescribed with public consultation

as follows:

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STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

5(f):STANDARD TERMS OF REFERENCE FOR CONDUCTINGENVIRONMENT IMPACT ASSESSMENT STUDY FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES & DYEINTERMEDIATES; BULK DRUGS AND INTERMEDIATESEXCLUDING DRUG FORMULATIONS; SYNTHETIC RUBBERS;BASIC ORGANIC CHEMICALS, OTHER SYNTHETIC ORGANICCHEMICALS AND CHEMICAL INTERMEDIATES) ANDINFORMATION TO BE INCLUDED IN EIA/EMP REPORT

A. STANDARD TERMS OF REFERENCE

1) Executive Summary

2) Introduction

i. Details of the EIA Consultant including NABET accreditation

ii. Information about the project proponent

iii. Importance and benefits of the project

3) Project Description

i. Cost of project and time of completion.

ii. Products with capacities for the proposed project.

iii. If expansion project, details of existing products with capacities and whether adequate landis available for expansion, reference of earlier EC if any.

iv. List of raw materials required and their source along with mode of transportation.

v. Other chemicals and materials required with quantities and storage capacities

vi. Details of Emission, effluents, hazardous waste generation and their management.

vii. Requirement of water, power, with source of supply, status of approval, water balance diagram,man-power requirement (regular and contract)

viii. Process description along with major equipments and machineries, process flow sheet(quantative) from raw material to products to be provided

ix. Hazard identification and details of proposed safety systems.

x. Expansion/modernization proposals:

c. Copy of all the Environmental Clearance(s) including Amendments thereto obtained forthe project from MOEF/SEIAA shall be attached as an Annexure. A certified copy of thelatest Monitoring Report of the Regional Office of the Ministry of Environment and Forestsas per circular dated 30th May, 2012 on the status of compliance of conditions stipulatedin all the existing environmental clearances including Amendments shall be provided. In

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STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FORPROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

addition, status of compliance of Consent to Operate for the ongoing Iexisting operationof the project from SPCB shall be attached with the EIA-EMP report.

d. In case the existing project has not obtained environmental clearance, reasons for nottaking EC under the provisions of the EIA Notification 1994 and/or EIA Notification2006 shall be provided. Copies of Consent to Establish/No Objection Certificate andConsent to Operate (in case of units operating prior to EIA Notification 2006, CTE andCTO of FY 2005-2006) obtained from the SPCB shall be submitted. Further, compliancereport to the conditions of consents from the SPCB shall be submitted.

4) Site Details

i. Location of the project site covering village, Taluka/Tehsil, District and State, Justificationfor selecting the site, whether other sites were considered.

ii. A toposheet of the study area of radius of 10km and site location on 1:50,000/1:25,000 scaleon an A3/A2 sheet. (including all eco-sensitive areas and environmentally sensitive places)

iii. Details w.r.t. option analysis for selection of site

iv. Co-ordinates (lat-long) of all four corners of the site.

v. Google map-Earth downloaded of the project site.

vi. Layout maps indicating existing unit as well as proposed unit indicating storage area, plantarea, greenbelt area, utilities etc. If located within an Industrial area/Estate/Complex, layoutof Industrial Area indicating location of unit within the Industrial area/Estate.

vii. Photographs of the proposed and existing (if applicable) plant site. If existing, showphotographs of plantation/greenbelt, in particular.

viii. Landuse break-up of total land of the project site (identified and acquired), government/private - agricultural, forest, wasteland, water bodies, settlements, etc shall be included. (notrequired for industrial area)

ix. A list of major industries with name and type within study area (10km radius) shall beincorporated. Land use details of the study area

x. Geological features and Geo-hydrological status of the study area shall be included.

xi. Details of Drainage of the project upto 5km radius of study area. If the site is within 1 kmradius of any major river, peak and lean season river discharge as well as flood occurrencefrequency based on peak rainfall data of the past 30 years. Details of Flood Level of theproject site and maximum Flood Level of the river shall also be provided. (mega green fieldprojects)

xii. Status of acquisition of land. If acquisition is not complete, stage of the acquisition processand expected time of complete possession of the land.

xiii. R&R details in respect of land in line with state Government policy.

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STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

5) Forest and wildlife related issues (if applicable):

i. Permission and approval for the use of forest land (forestry clearance), if any, andrecommendations of the State Forest Department. (if applicable)

ii. Landuse map based on High resolution satellite imagery (GPS) of the proposed site delineatingthe forestland (in case of projects involving forest land more than 40 ha)

iii. Status of Application submitted for obtaining the stage I forestry clearance along with lateststatus shall be submitted.

iv. The projects to be located within 10 km of the National Parks, Sanctuaries, Biosphere Reserves,Migratory Corridors of Wild Animals, the project proponent shall submit the map dulyauthenticated by Chief Wildlife Warden showing these features vis-à-vis the project locationand the recommendations or comments of the Chief Wildlife Warden-thereon.

v. Wildlife Conservation Plan duly authenticated by the Chief Wildlife Warden of the StateGovernment for conservation of Schedule I fauna, if any exists in the study area.

vi. Copy of application submitted for clearance under the Wildlife (Protection) Act, 1972, to theStanding Committee of the National Board for Wildlife.

6) Environmental Status

i. Determination of atmospheric inversion level at the project site and site-specific micro-meteorological data using temperature, relative humidity, hourly wind speed and directionand rainfall.

ii. AAQ data (except monsoon) at 8 locations for PM10, PM2.5, SO2, NOX, CO and otherparameters relevant to the project shall be collected. The monitoring stations shall be basedCPCB guidelines and take into account the pre-dominant wind direction, population zoneand sensitive receptors including reserved forests.

iii. Raw data of all AAQ measurement for 12 weeks of all stations as per frequency given in theNAQQM Notification of Nov. 2009 along with - min., max., average and 98% values foreach of the AAQ parameters from data of all AAQ stations should be provided as an annexureto the EIA Report.

iv. Surface water quality of nearby River (100m upstream and downstream of discharge point)and other surface drains at eight locations as per CPCB/MoEF&CC guidelines.

v. Whether the site falls near to polluted stretch of river identified by the CPCB/MoEF&CC, ifyes give details.

vi. Ground water monitoring at minimum at 8 locations shall be included.

vii. Noise levels monitoring at 8 locations within the study area.

viii. Soil Characteristic as per CPCB guidelines.

ix. Traffic study of the area, type of vehicles, frequency of vehicles for transportation of materials,additional traffic due to proposed project, parking arrangement etc.

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STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FORPROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

x. Detailed description of flora and fauna (terrestrial and aquatic) existing in the study areashall be given with special reference to rare, endemic and endangered species. If Schedule-I fauna are found within the study area, a Wildlife Conservation Plan shall be prepared andfurnished.

xi. Socio-economic status of the study area.

7) Impact and Environment Management Plan

i. Assessment of ground level concentration of pollutants from the stack emission based onsite-specific meteorological features. In case the project is located on a hilly terrain, theAQIP Modelling shall be done using inputs of the specific terrain characteristics fordetermining the potential impacts of the project on the AAQ. Cumulative impact of all sourcesof emissions (including transportation) on the AAQ of the area shall be assessed. Details ofthe model used and the input data used for modelling shall also be provided. The air qualitycontours shall be plotted on a location map showing the location of project site, habitationnearby, sensitive receptors, if any.

ii. Water Quality modelling - in case of discharge in water body

iii. Impact of the transport of the raw materials and end products on the surrounding environmenthall be assessed and provided. In this regard, options for transport of raw materials andfinished products and wastes (large quantities) by rail or rail-cum road transport or conveyor-cum-rail transport shall be examined.

iv. A note on treatment of wastewater from different plant operations, extent recycled and reusedfor different purposes shall be included. Complete scheme of effluent treatment. Characteristicsof untreated and treated effluent to meet the prescribed standards of discharge under E(P)Rules.

v. Details of stack emission and action plan for control of emissions to meet standards.

vi. Measures for fugitive emission control

vii. Details of hazardous waste generation and their storage, utilization and management. Copiesof MOU regarding utilization of solid and hazardous waste in cement plant shall also beincluded. EMP shall include the concept of waste-minimization, recycle/reuse/recovertechniques, Energy conservation, and natural resource conservation.

viii. Proper utilization of fly ash shall be ensured as per Fly Ash Notification, 2009. A detailedplan of action shall be provided.

ix. Action plan for the green belt development plan in 33 % area i.e. land with not less than1,500 trees per ha. Giving details of species, width of plantation, planning schedule etc. shallbe included. The green belt shall be around the project boundary and a scheme for greeningof the roads used for the project shall also be incorporated.

x. Action plan for rainwater harvesting measures at plant site shall be submitted to harvestrainwater from the roof tops and storm water drains to recharge the ground water and also to

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STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

use for the various activities at the project site to conserve fresh water and reduce the waterrequirement from other sources.

xi. Total capital cost and recurring cost/annum for environmental pollution control measuresshall be included.

xii. Action plan for post-project environmental monitoring shall be submitted.

xiii. Onsite and Offsite Disaster (natural and Man-made) Preparedness and Emergency ManagementPlan including Risk Assessment and damage control. Disaster management plan should belinked with District Disaster Management Plan.

8) Occupational health

i. Plan and fund allocation to ensure the occupational health & safety of all contract and casualworkers

ii. Details of exposure specific health status evaluation of worker. If the workers' health is beingevaluated by pre designed format, chest x rays, Audiometry, Spirometry, Vision testing (Far& Near vision, colour vision and any other ocular defect) ECG, during pre placement andperiodical examinations give the details of the same. Details regarding last month analyzeddata of above mentioned parameters as per age, sex, duration of exposure and departmentwise.

iii. Details of existing Occupational & Safety Hazards. What are the exposure levels of hazardsand whether they are within Permissible Exposure level (PEL). If these are not within PEL,what measures the company has adopted to keep them within PEL so that health of the workerscan be preserved,

iv. Annual report of heath status of workers with special reference to Occupational Health andSafety.

9) Corporate Environment Policy

i. Does the company have a well laid down Environment Policy approved by its Board ofDirectors? If so, it may be detailed in the EIA report.

ii. Does the Environment Policy prescribe for standard operating process / procedures to bringinto focus any infringement / deviation / violation of the environmental or forest norms /conditions? If so, it may be detailed in the EIA.

iii. What is the hierarchical system or Administrative order of the company to deal with theenvironmental issues and for ensuring compliance with the environmental clearanceconditions? Details of this system may be given.

iv. Does the company have system of reporting of non compliances / violations of environmentalnorms to the Board of Directors of the company and / or shareholders or stakeholders atlarge? This reporting mechanism shall be detailed in the EIA report

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STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FORPROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

10) Details regarding infrastructure facilities such as sanitation, fuel, restroom etc. to be provided to thelabour force during construction as well as to the casual workers including truck drivers duringoperation phase.

11) Enterprise Social Commitment (ESC)

i. Adequate funds (at least 2.5 % of the project cost) shall be earmarked towards the EnterpriseSocial Commitment based on Public Hearing issues and item-wise details along with timebound action plan shall be included. Socio-economic development activities need to beelaborated upon.

12) Any litigation pending against the project and/or any direction/order passed by any Court of Lawagainst the project, if so, details thereof shall also be included. Has the unit received any noticeunder the Section 5 of Environment (Protection) Act, 1986 or relevant Sections of Air and WaterActs? If so, details thereof and compliance/ATR to the notice(s) and present status of the case.

13) 'A tabular chart with index for point wise compliance of above TOR.

B. SPECIFIC TERMS OF REFERENCEFOREIASTUDIES FOR SYNTHETICORGANIC CHEMICALS INDUSTRY (DYES & DYE INTERMEDIATES;BULK DRUGS AND INTERMEDIATES EXCLUDING DRUGFORMULATIONS; SYNTHETIC RUBBERS; BASIC ORGANICCHEMICALS, OTHER SYNTHETIC ORGANIC CHEMICALS ANDCHEMICAL INTERMEDIATES)

1. Detailsonsolvents to be used,measuresfor solventrecovery and for emissions control.

2. Details of process emissions from the proposed unit and its arrangement to control.

3. Ambient air quality data should include VOC, otherprocess-specificpollutants* like NH3*, chlorine*,HCl*, HBr*, H2S*, HF*,etc.,(*-asapplicable)

4. Work zone monitoring arrangements for hazardous chemicals.

5. Detailed effluent treatment scheme including ssegregation of effluent streams for units adopting'Zero' liquid discharge.

6. Action plan for odour control to be submitted.

7. A copy of the Memorandum of Understanding signed with cement manufacturers indicating clearlythat they co-process organic solid/hazardous waste generated.

8. Authorization/Membership for the disposal of liquid effluent in CETP and solid/hazardous waste inTSDF, if any.

9. Action plan for utilization of MEE/dryers salts.

10. Material Safety Data Sheet for all the Chemicals are being used/will be used.

11. Authorization/Membership for the disposal of solid/hazardous waste in TSDF.

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STANDARD TERMS OF REFERENCE (TOR) FOR EIA/EMP REPORT FOR PROJECTS/ACTIVITIES REQUIRING ENVIRONMENT CLEARANCE

12. Details of incinerator if to be installed.

13. Risk assessment for storage and handling of hazardous chemicals/solvents. Action plan for handling& safety system to be incorporated.

14. Arrangements for ensuring health and safety of workers engaged in handling of toxic materials.

***

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TOR COMPLIANCE

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TOR Compliance Archimedis Laboratories Pvt Ltd

Prepared By Rightsource Industrial Solutions Pvt. Ltd Page I

ToR COMPLIANCE

S. No Standard Terms of Reference Chapters Page Nos

1. Executive Summary Enclosed in EIA Report

2. Introduction

1. Details of the EIA Consultant including NABET accreditation

Enclosed as Enclosure - VI

2. Information about the project proponent Chapter - I 1

3. Importance and benefits of the project Chapter - VIII 430-433

3 Project Description

I. 1. Cost of project and time of completion Chapter - I Chapter - II

2 17-18

II. 2. Products with capacities for the proposed

project. Chapter - II 16-17

III.

3. If expansion project, details of existing products with capacities and whether adequate land is available for expansion, reference of earlier EC if any.

It is a Greenfield project

IV. 4. List of raw materials required and their source

along with mode of transportation. Chapter - II 226-239

V. 5. Other chemicals and materials required with

quantities and storage capacities. Chapter - VII 371

VI 6. Details of Emission, effluents, hazardous waste

generating and their management Chapter - X 438-451

VII.

7. Requirement of water, power, with source of supply, status of approval, water balance diagram, man-power requirement (regular and contract)

Chapter - II Chapter - VIII

209-210 430

VIII.

8. Process description along with major equipments and machineries, process flow sheet (quantities) from raw material to products to be provided.

Chapter - II 19-204

IX. 9. Hazard identification and details of proposed

safety systems. Chapter - VII 359-370

X.

X. Expansion/modernization proposals a. Copy of all Environmental Clearance (s)including Amendments thereto obtained for the project from MOEF/SEIAA shall be attached as an Annexure. A certified copy of the latest Monitoring report of the Regional Office of the Ministry of Environment and Forests as per circular dated 30th May, 2012 on the status of compliance of conditions stipulated in all the existing environmental clearances including Amendments shall be provided In addition, status of compliance of consent to operate for

It is a Greenfield Project

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TOR Compliance Archimedis Laboratories Pvt Ltd

Prepared By Rightsource Industrial Solutions Pvt. Ltd Page II

S. No Standard Terms of Reference Chapters Page Nos

the ongoing existing operation of the project from SPCB shall be attached with the EIA-EMP report.

d. In case the existing project has not obtainedenvironmental clearance, reasons for not taking EC under the provisions of the EIA Notification 2006 shall be provided. Copies of Consent to Establish /No Objection Certificate and Consent to Operate (in case of units operating prior to EIA Notification 2006, CTE and CTO of FY 2005-2006) obtained from the SPCB shall be submitted. Further, compliance report to the conditions of consents from the SPCB shall be submitted

4

Site Details i. Location of the project site covering village,

Taluka /Tehsil, District and State, Justification for selecting the site, whether other sites were considered.

ii. A toposheet of the study area of radius of 10 KMs and site location on 1:50,000/1:25,000 scale on an A3/A2 sheet. (including all eco-sensitive areas and environmentally sensitive places)

iii. Details w.r.t. option analysis for selection of site

iv. Co-ordinates (lat-long) of all four corners of the site.

v. Google map –Earth downloaded of the project site

vi. Layout maps indicating existing unit as well as proposed unit indicating storage area, plant area, greenbelt area, utilities etc. If located within an Industrial area/Estate /Complex, layout of Industrial Area indicating location of unit within the Industrial area/Estate.

vii. Photographs of the proposed and existing (if

Chapter - II Chapter - I

Chapter - II

Site is suitable for Industrial

Establishment & no need of

alternative site analysis.

Chapter - II

Chapter - II

Chapter - II

Chapter - II

9-10 4

14

14

12

15

13

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applicable) plant site. If existing, show photographs of plantation /greenbelt, in particular.

viii. Landuse break up of total land of the project site (identified and acquired), government/ private-agricultural, forest, wasteland, water bodies, settlement, etc shall be included. (not required for industrial area)

ix. A list of major industries with name and type within study area (10KMs radius) shall be incorporated. Land use details of the study area

x. Geological features and Geo-hydrological status of the study area shall be included.

xi. Details of Drainage of the project upto 5km radius of study area. If the site is within 1 km radius of any major river, peak and lean season river discharge as well as flood occurrence frequency based on peak rainfall data of thee past 30 years, Details of Flood Level of the project site and maximum Flood level of the river shall also be provided. (mega green field projects)

xii. Status of acquisition of land. If acquisition is not complete, stage of the acquisition process and expected time of complete possession of the land.

xiii. R&R details in respect of land in line with state Government policy.

Chapter - II

Chapter - I

Chapter - III

Proposed land for unit was acquired

by Proponent

The proposed unit is established in 11.62 Acres, so

R&R is applicable

9

5

248

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5

Forest and wildlife related issues (if applicable)

i. i. Permission and approval for the use of forest land (forestry clearance), if any, and recommendations of the State Forest Department (if applicable) ii. Landuse map base on High resolution satellite imagery (GPS) of the proposed site delineating the forestland (in case of projects involving forest land more than 40 ha) iii. Status of Application submitted for obtaining the stage I forestry clearance along with latest status shall be submitted. iv. The projects to be located within 10KMs of the National Parks, Sanctuaries, Biosphere Reserves, Migratory Corridors of Wild Animals, the project proponent shall submit the map duly authenticated by chief wildlife warden showing these features vis-à-vis the project location and the recommendations or comments of the Chief Wildlife Warden –there on. v. Wildlife Conservation plan duly authenticated by the chief wildlife warden of the state government for conservation of schedule 1 fauna, if any exists in the study area. vi. Copy of application submitted for clearance under the wildlife (Protection) Act, 1972, to be standing committee of the national board for wildlife.

The project area is non- forest land. Land use map based on satellite imaginary of the proposed site is presented in chapter - III, Page no: 294-295 Not applicable There are no National parks, Sanctuaries, Biosphere Reserves, Migratory corridors of Wild Animals, within the 10 Km buffer zone Not Applicable Not Applicable

6 Environmental Status

i. i) Determination of atmospheric inversion level at the project site and site-specific micro- meteorological data using temperature, relative humidity, hourly wind speed and direction and rainfall.

Chapter - III

249- 252

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ii) AAQ data (except monsoon) at 8 locations for PM10, PM2.5, SO2, NOX, CO and other parameters relevant to the project shall be collected. The monitoring stations shall be based CPCB guidelines and take into account the pre-dominant wind direction, population zone and sensitive receptors including reserved forests.

ii. iii) Raw data of all AAQ measurement for 12 weeks of al stations as per frequency given in the NAQQM Notification of Nov.2009 along with –min., max., average and 98% values for each of the AAQ parameters from data of all AAQ stations should be provided as an annexure to the EIA Report.

iii. iv. iv) Surface water quality of nearby River (100m

upstream and downstream of discharge point and other surface drains at eight locations as per CPCB / MoEF&CC guidelines. V) Whether the site falls near to polluted stretch of river identified by the CPCB/MoEFCC, if yes give details. Vi) Ground water monitoring at minimum at 8 locations shall be included vii) Noise levels monitoring at 8 locations within the study area. Viii) Soil characteristic as per CPCB guidelines. ix) Traffic study of the area, type of vehicles, frequency of vehicles for transportation of materials, additional traffic due to proposed project, parking arrangement etc. x) Detailed description of flora and fauna (terrestrial and aquatic) existing in the study area shall be given with special reference to rare, endemic and endangered species. If Schedule-I fauna are found within the study area, a wildlife conservation plan shall be prepared and furnished.

Chapter - III

Chapter - III

Chapter - III

Not Applicable

Chapter - III

Chapter - III

Chapter - III

Chapter - III

Chapter - III

254-255

259-267

269-270

269-270

277-278

283-284

280-282

296-307

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xi) Socio-economic status of the study area. Chapter - III 307-311

7 Impact and Environment Management Plan

i. i) Assessment of ground level concentration of pollutants from the stack emission based on site –specific meteorological features. In case the project is located on a hilly terrain, the AQIP Modelling shall be done using inputs of the specific terrain characteristics for determining the potential impacts of the project on the AAQ. Cumulative impact of all sources of emissions (including transportation) on the AAQ of the area shall be assessed. Details of the model used and the input data used for modeling shall also be provided. The air quality contours shall be plotted on a location map showing the location of project site, habitation nearby, sensitive receptors, if any.

ii. iii. ii) Water Quality modeling –in case of discharge

in water body iii) Impact of the transport of the raw materials and end products on the surrounding environment hall be assessed and provided. In this regard, options for transport of raw materials and finished products and wastes (large quantities) by rail or rail-cum road transport or conveyor- cum –rail transport shall be examined. iv) A note on treatment of wastewater from different plant operations, extent recycled and reused for different purposes shall be included. Complete scheme of effluent treatment, Characteristics of untreated and treated effluent to meet the prescribed standards of discharge under E (P) Rules. v) Details of stack emission and action plan for control of emissions to meet standards VI) Measures for fugitive emission control

Chapter - IV

The proposed unit is will employ ZLD

system

Chapter - X

Chapter - X

Chapter - X

Chapter - X

326-329

439

440-449

438

460-463

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VII) Details of hazardous waste generation and their storage, utilization and management. Copies of MOU regarding utilization of solid and hazardous waste in cement plant shall also be included. EMP shall include the concept of waste – minimization, recycle/reuse/ recover techniques, Energy conservation, and natural resource conservation. VIII) Proper utilization of fly ash shall be ensured as per fly ash notification, 2009. A detailed plan of action shall be provided. IX) Acton plan for the green belt development plan in 33% area i.e. land with not less than 1,500 trees per ha. Giving details of species, width of plantation, planning schedule etc. shall be included. The green belt shall be around the project boundary and a scheme for greening of the roads used for the project shall also be incorporated. X) Action plan for rainwater harvesting measures at plant site shall be submitted to harvest rainwater from the roof tops and storm water drains to recharge the ground water and also to use for the various activities at the project site to conserve fresh water and reduce the water requirement from other sources. XI) Total capital cost and recurring cost /annum for environmental pollution control measures shall be included. XII) Action plan for post –project environment monitoring shall be submitted. XIII) Onsite and offsite Disaster (natural and Man –made) Preparedness and Emergency Management Plan including Risk Assessment and damage control. Disaster management plan should be linked with District Disaster Management Plan.

Chapter - X

Chapter - X Chapter - IV

Chapter - X

Chapter - X

Chapter - X

Chapter - VI Chapter - X

Chapter - VII

465

465 336

455-456

466-467

468

347-350 456-458

413-429

8 Occupational health

i. Plan and fund allocation to ensure the occupational health & safety of all contract and

Chapter - VII 404-405

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casual workers ii. Details of exposure specific health status

evaluation of workers’ health is being evaluated by pre designed format, chest x rays, Audiometry, Spirometry, Vision testing (Far & Near vision, colour vision and any other ocular defect) EGG, during pre placement and periodical examinations give the details of the same details regarding last month analyzed data of above mentioned parameters as per age, sex, duration of exposure and department wise. Details of existing Occupational & safety Hazards. What are the exposure levels of hazards and whether they are within permissible Exposure level (PEL) If these are not within PEL, what measures the company has adopted to keep them within PEL so that health of the workers. Can be preserved, Annual report of heath status of workers with special reference to Occupational Health and safety.

9

Corporate Environment Policy i. Does the company have a well laid down Environment Policy approved by its Board of Directors? If so, it may be detailed in the EIA report. ii. Does the Environment Policy prescribe for standard operation process / procedures to bring into focus any infringement / deviation / violation of the environmental or forest norms/ conditions? If so, it may be detailed in the EIA. iii. What is the hierarchical system or Administrative order of the company to deal with the environmental issues and for ensuring compliance with the environmental clearance conditions? Details of this system may be given iv. Does the company have system of reporting of non compliance /violations of environmental norms to the Board of Directors of the company and / or shareholders or stakeholders at large? This reporting mechanism shall be detailed in the EIA report.

Chapter -VI - - -

344-345 - - -

10 Details regarding infrastructure facilities such as The proposed unit will provide

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sanitation, fuel, restroom etc. to be provided to the labour force during construction as well as to the casual workers including truck drivers during operation phase.

all the facilities for construction labour during construction phase and as well as the casual workers including truck drivers during operation phase

11

Enterprise Social Commitment(ESC) 1. Adequate funds (at least 2.5% of the project

cost) shall be earmarked towards the Enterprise social commitment based on public hearing issues and item –wise details along with time bound action plan shall be included socio-economic development activities need to be elaborated upon.

Chapter - VIII The fund allocated for Enterprise Social Commitment will be utilized as suggested during Public Hearing

431 - 432

12

Any litigation pending against the project and / or any direction/ order passed by any Court or law against the project, if so, details thereof shall also be included. Has the unit received any notice under the section 5 of environment (protection) Act 1986 or relevant sections of air and water acts? If so, details thereof and compliance /ATR to the notice (s) and present status of the case.

No Litigations against proposed project

13 A tabular chart with index for point wise compliance of above TOR.

Enclosed along with EIA & EMP Report

A Specific ToR

1 Details on solvents to be used, measures for solvent recovery and for emissions control.

Chapter - X 460-463

2 Details of process emissions from the proposed unit and its arrangement to control

Chapter - X 459-460

3 Ambient air quality data should include VOC, etc.,

Chapter - III 93-100

4 Work zone monitoring arrangements for hazardous chemicals

Chapter - VII 380-383

5 Detailed effluent treatment scheme including segregation of effluent streams for units adopting zero liquid discharge

NA NA

6 Action plan for odour control to be submitted; - -

7

A copy of the Memorandum of Understanding signed with cement manufactures indicating clearly that they co-process organic solid/hazardous waste generated.

Yet to make MOU with Cement Industries as it is a Greenfield Project

8 Authorization / Membership for the disposal of liquid effluent I CETP and solid/ hazardous waste in TSDF, If any.

Yet to take Membership of TSDS as it is a Proposed Project

9 Action plan for utilization of MEE/dryers salts. Chapter -X 465

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10 Material safety data sheet for all the chemicals are being used/ will be used.

MSDS for all the chemicals will be used and kept in plant for reference.

11 Authorization/ Membership for the disposal of solid/hazardous waste in TSDF are being used /will be used

Yet to take Membership of TSDF as it is a Proposed Project

12 Details of incinerator if to be installed No proposal for installation of Incinerator

13 Risk assessment for storage and hazardous chemicals/solvents, Action plan for handling & safety system to be incorporated.

Chapter - VII 380-383

14 Arrangements for ensuring health and safety of workers engaged in handling of toxic materials.

Chapter - VII 404-406

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LIST OF CONTENTS

[INDEX]

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LIST OF CONTENTS

CHAPTER - I INTRODUCTION

S. No Description Page No

1.1 Purpose of the Project 1

1.2 Identification of project & Project proponent 1

1.1.1 Identification of Project 1

1.1.2 About the Promoters 1

1.3 Objective and Scope of the Study 2

1.4 Brief Description of the Project 2

1.4.1 Nature of the Project 2

1.4.2 Size of the Project 2

1.4.3 Location of the Project 4

1.4.4 Project and its Importance to the Country & Region.

5

1.5 Scope of Study. 6

1.5.1 Environmental Impact Assessment 6

1.5.2 Socio-Economic Assessment 6

1.5.3 Regulatory Framework 6

1.5.4 Regulatory Scoping 6

1.6 Legal Policy and Institutional Frameworks 7-8

CHA PTER - II PROJECT DESCRIPTION

S. No Description Page No

2.1 Type of the project 9

2.2 Need For The Project 9

2.3 Location 9

2.4 Size and Magnitude of Operation 16

2.5 Proposed schedule for approval and implementation 17

2.6 Technology and process description 18

2.6.1 Manufacturing process of the Products 19-204

2.7 Pollution Load 204

2.8 Details of Process Emissions and its mitigation measures

207

2.9 Proposed Water Consumption Details 208

2.10 Expected Waste Water Generation Details 210

2.11 Waste Water Characteristics 214

2.12 Hazardous & Solid Waste Generation Details 214

2.13 Power(Energy) requirement 216

2.14 Utilities 216

2.15 Proposed Boilers & DG sets 216

2.16 Details Of Proposed Solvents Input, Recovery & Loss 218

2.17 List Of The Raw Materials Product Wise 226-239

2.18 Environmental aspects, impacts and mitigation measures of proposed industry

239-242

2.19 Assessment of new & untested technology for risk of technological failure

242

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CHAPTER - III DESCRIPTION OF THE ENVIRONMENT

S. No Description Page No

3.0 Introduction 243

3.1 Study Area 243

3.1.2 Study Period 243

3.2 Geological & Hydro geological Environment 243-244

3.2.1 Geomorphology and soil types 244

3.2.2 Geology 245

3.2.3 Hydrogeology 245

3.2.4 Ground water Conditions 245

3.2.5 Drainage Pattern of Study Area 245-246

3.2.6 Drainage Map 247

3.3 Micrometeorology And Climate 249-250

3.4 Air Environment 253

3.4.1 National Ambient Air Quality Standards (NAAQS) 256-257

3.4.2 Ambient Air Quality Data (AAQ) 257-258

3.5 Water Environment 268

3.5.1 Methodology For Water Quality Monitoring 268

3.6 Noise Environment 276

3.6.1 Noise Monitoring Stations 276-277

3.6.2 Traffic Study 280

3.7 Soil Environment 283

3.8 Land Use Pattern 287

3.8.1 Data Used 287

3.8.2 Land use / Land Cover Map 288

3.8.2.1 Basic concepts of land use 289

3.8.2.2 Methodology for land use / land cover mapping 289-291

3.9 Ecological Environment 296

3.9.1 Detailed Description of Flora and Fauna 296

3.9.2 Vegetation and Flora of the Buffer zone 298

3.9.3 Terrestrial fauna of the Core area and the Buffer zone

301

3.9.3.1 Methodology for Mammals study 302

3.9.3.2 Methodology for Herpeto-fauna 302

3.9.3.3 Methodology for Birds in Study Area 302

3.9.4 Aquatic flora and fauna 305

3.9.5 RET and Schedule I Fauna 307

3.10 Socio Economic Study 307

3.10.1 Methodology Adopted for the Study 307

3.10.2 Distribution of Population in the study area 308

3.10.3 Literacy & Illiteracy Rate 309

3.10.4 Occupational Structure 310

3.10.5 Civic Amenities Available In The Study Area 312

3.10.6 Corporate Social Responsibility of the Project Proponent

313

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CHAPTER - IV ANTICIPATED ENVIRONMENTAL IMPACTS & MITIGATION MEASURES

S. No Description Page No

4.1 Introduction 314

4.2 Investigated Environmental Impacts Due To Proposed Project

314

4.3 Construction Phase 315

4.3.1 Impact on Land Use 315

4.3.2 Impact on Land / Soil Environment 315

4.3.3 Impact on Topography 315

4.3.4 Impact on Air Quality 316

4.3.5 Impact on Water Environment 316

4.3.6 Impact on Noise Levels 317

4.3.7 Impact on Ecology 317

4.3.8 Impact on Socio-Economic Environment 317

4.4 Mitigative measures of impacts during construction phase

319-321

4.5 Prediction of Impacts During Operational Phase 321

4.6 Air Environment 322

4.6.1 Source of Air Pollution 322

4.6.2 Prediction of Impacts on Air Environment 324-332

4.7 Water Environment 332

4.8 Noise Environment 334

4.9 Impact on Land Use 334

4.9 Land/Soil Environment 334

4.10 Impact of Solid Waste 336

4.11 Impacts on Ecology 337

4.12 Impacts on Socio- Economy 339

4.13 Impacts on Hydrology and Geology 339

CHAPTER - V ANALYSIS OF ALTERNATIVES (TECHNOLOGY & SITE)

S. No Description Page No

5.0 Analysis Of Alternatives 340

5.1 Site Selection Criteria 340

5.2 Selection Of Process Technology 341

CHAPTER - VI ENVIRONMENTAL MONITORING PROGRAM

S. No Description Page No

6.1 Introduction 343

6.2 Environmental Management System 343-344

6.3 Environmental Management Cell Responsibilities 344-345

6.4 Environmental Monitoring and Reporting Procedure 346

6.4.1 Objectives of Monitoring 346

6.4.2 Monitoring Schedule for Construction and Operation Phases.

346-347

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6.5 Location of Monitoring Stations 350

6.6 Monitoring and Data Analysis 351

6.6.1 Air Quality Monitoring and Data Analysis 351

6.6.2 Water and Waste Water Quality Monitoring and Data Analysis.

351-352

6.6.3 Noise Levels 352

6.6.4 Soil Quality 352

6.7 Reporting Schedule of the Monitoring Data 353

6.8 Environmental Laboratory 353

6.8.1 Air Quality and Meteorology 353

6.9 Occupational Safety and Health aspects 354

CHAPTER -VII ADDITIONAL STUDIES, RISK ASSESSMENT & DISASTER MANAGEMENT REPORT

S. No Description Page No

7.1. Additional Studies 355

7.1.1 Scope of this Study 355

7.1.2 Methodology 355

7.2 Introduction to Risk Assessment 356

7.2.1 Objectives of Risk Assessment 356

7.2.2 Identification of Hazards 357-358

7.3 Solvents/Chemicals 371

7.4 Potential Hazards of solvents and chemicals 372-380

7.5 Safe practices [handling, storage, transportation and unloading of chemicals]

380

7.5.1 Measures to avoid Evaporation 380-381

7.5.2 Safety Systems 381

7.5.3 Transportation /unloading 381-382

7.5.4 Spill Control 382

7.5.5 Effect and Consequence Analysis 383

7.6 Inventory 383

7.7 Loss of Containment 383-385

7.8 Damage Criteria 385

7.9 Damages to human life due to heat radiation 388

7.10 Incidents Impact 390

7.11 Maximum credible loss accident scenarios 390-391

7.12 Risk Analysis 391

7.13 Risk Modeling Scenarios 391

7.14 Occupational Health 404-406

7.14.1 Sampling Devices 406-407

7.15 Chemical exposure limits & emp for the occupational safety & health hazards

407-409

7.16 Treatment of workers affected by accidental spillage of chemicals

410-412

7.17 Predictive and preventive maintenance 412-413

7.18 Onsite emergency plan 413

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CHAPTER - VIII PROJECT BENEFITS

S. No Description Page No

8.1 Employment Potential 430

8.2 Corporate Social Responsibility (CSR) & CER 430

8.3 Direct revenue earning to the National and State exchequer

433

8.4 Improvements in the Physical Infrastructure 433

8.5 Improvements in the Social Infrastructure 433

8.6 Other Tangible Benefits 433

7.19 Structure of emergency management system 413-414

7.20 Emergency Management system-Roles & Responsibilities

414

7.20.1 Site Main Controller (SMC) 414-415

7.21 Incident Controller/Deputy Incident Controller 415

7.22 Key Personnel’s 415-416

7.23 Essential workers 416-417

7.24 Other Elements of DMP 417

7.24.1 Assembly Point 417

7.24.2 Emergency Control Center 417-418

7.24.3 Fire Services 418-419

7.24.4 Medical Services 419

7.24.5 Security Services 419

7.24.6 Mutual Aid 420

7.25 Emergency Response 420-421

7.26 Emergency Capabilities 421

7.27 Emergency Handling Procedures 421-422

7.28 Mitigation of Environmental Impact during Fire Emergency

423

7.28.1 Raising the Alarm 423-424

7.29 Declaring Major Emergency 424

7.30 Transport and evacuation arrangements 424

7.31 Plant Operations 424-425

7.32 Telephone Messages 425

7.33 Mock Drill 425-426

7.34 Offsite emergency plan 426

7.35 Role of the factory management 428

7.35.1 Role of Local Authority 428

7.35.2 Role of Fire Authority 428

7.35.3 Role of Police 428

7.35.4 Role of Health Authorities 428

7.35.5 Role of the Mutual aid agencies 428

7.35.6 Role of the Factory Inspectorate 429

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CHAPTER - IX ENVIRONMENTAL COST BENEFIT ANALYSIS

S. No Description Page No

9.1 Cost benefit analysis 434

CHAPTER - X ENVIRONMENTAL MANAGEMENT PLAN

S. No Description Page No

10.1 Introduction 435

10.2 Pre-Project Environmental Management Plan 437

10.2.1 Site Preparation 437

10.2.2 Sanitation 437

10.2.3 Noise 437

10.2.4 Construction Equipment And Waste 437

10.2.5 Site Security 437

10.3 Environmental Management During Operation 438

10.3.1 Air Quality 438

10.3.1.1 Air Pollution Control / Management 438

A Stack Design 438

B Fugitive Emission from Solvents 438

C Expected Process Emission and Mitigation Measures 439

D Storage and Transportation of Raw Materials 439

E Storage and Transportation of Solvents 439

10.3.2 Noise Pollution 439

10.3.3 Water Quality 440

10.3.3.1 Details of ZLD system 445

10.3.3.2 The technical details of the systems are as follows 446

10.3.3.3 MEE plant configuration 446

10.3.3.4 Process description (Part - A) 446

10.3.3.5 Process description (Part - B) 447

10.3.3.6 Process description (Part - C) 448

10.4 Hazardous/ Solid Waste Management 450

10.5 EB [Ecology & Biodiversity 451

10.6 SE [Socio-Economic Aspects 451

10.7 HG [Hydrogeology, Ground Water & Water Conservation] 452

10.8 GEO [Geology] 453

10.9 SC [Soil Conservation] 453

10.10 RH [Risk & Hazards Management] 453

10.11 Greenbelt Development 454

10.11.1 Objective 454

10.11.2 Action Plan 455

10.12 Post Project Monitoring 456

10.12.1 Air Pollution Monitoring 457

10.12.2 Waste Water Monitoring 457

10.12.3 Ground Water Monitoring 457

10.12.4 Hazardous / Solid Waste Monitoring 457

10.13 Management of Public Interests 458

10.13.1 Objective 458

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10.13.2 Preference To Local Population 458

10.13.3 Health Camps 459

10.13.4 Public Amenities 459

10.13.5 Public Relations 459

10.14 Water Requirement 459

10.15 Process Emission Control System 459

10.16 Fugitive Emissions 460

10.17 Solvent Management Plan 460

10.18 Emissions – Utilities 463

10.19 Wastewater Loads 464

10.20 Stage wise Effluent Characteristics 465

10.21 Hazardous & Solid Waste details 465

10.22 Proposed Roof Water Harvesting 466

10.23 Investment 468

10.23.1 Budget allocation 468

10.24 Mitigation Plan 469

10.25 Socio-Economic development activities 470

10.26 Waste Minimization / Resource Conservation 5 r concept (Recycle / Refuse / Reduce / Reuse / Reform)

470

10.27 Conclusion 472

CHAPTER - XI SUMMARY & CONCLUSION (THIS WILL CONSTITUETE THE SUMMARY OF THE EIA REPORT)

S. No Description Page No

11.1 Salient features of the project 473

11.2 Conclusions 474

LIST OF TABLES

CHAPTER - I INTRODUCTION

Table No Description Page No

1.1 Proposed Products and Quantities 3

1.2 Proposed By-Products and Quantities 4

1.3 Project location and Compliance of site 4-5

1.4 Applicability of legal policies to the project 7-8

CHAPTER - II PROJECT DESCRIPTION

Table No Description Page No

2.1 Land use details 9

2.2 List of proposed products and Capacities 16-17

2.3 List of proposed By-Products and Capacities 17

2.4 Consolidated Pollution Load Of All Products In Per Day Quantities

205-206

2.5 Process Emission details and Its Mitigation 207

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measures

2.6 Process Emission Details Product wise 207-208

2.7 Proposed water consumption details 209

2.8 Proposed water consumption in process product wise

209-210

2.9 Expected Effluent Generation details 210

2.10 Expected HTDS & LTDS effluent details 210-211

2.11 Expected Waste water generation in Kg per day Product wise

212-213

2.12 Expected Hazardous/Solid Waste Generation, Disposal Details

214-215

2.13 Solid waste generation per day Product wise 215-216

2.14 Details Of Utilities 216

2.15 Emission characteristic details of proposed Boiler 217

2.16 Stack Emission Details for Thermic Fluid Heater 217

2.17 Stack Emission details of proposed DG Set 217

2.18 Details Of Proposed Solvent Input, Recovery & Loss [Product Wise]

218-225

CHAPTER - III DESCRIPTION OF THE ENVIRONMENT

Table No Description Page No

3.1 Showing drainage density based criteria by smith and strahler

247

3.2 Showing drainage density based criteria proposed by Long Bein

247

3.3 Showing Drainage Density Based Criteria Proposed by Horton

247

3.4 Frequency distribution wind directions and wind speed 251

3.5 Ambient air quality sampling locations 254

3.6 National ambient air quality standards 256-257

3.7 The maximum ,minimum & 98th percentile values for all the sampling locations

259

3.8 Ambient air quality, station : Project Site A1 260

3.9 Ambient air quality station : Jayanthipuram (A2) 261

3.10 Ambient air quality station : Dhramavarappadu tanda (A3) 262

3.11 Ambient air quality station : Bhimavaram (A4) 263

3.12 Ambient air quality station : Gauravaram (A5) 264

3.13 Ambient air quality station : Pochampalli (A6) 265

3.14 Ambient air quality station : Vedadri tanda (A7) 266

3.15 Ambient air quality station : Ravirala A8) 267

3.16 Ground water and Surface sampling locations 269

3.17 Ground water quality in the study area 270

3.18 Surface water quality the study area 272-274

3.19 Noise monitoring locations 277

3.20 Ambient noise levels within study area 279

3.21 Traffic Study 281-282

3.22 Soil sampling locations 283

3.23 Soil sampling analysis results 285

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3.24 Standard Soil Classification 286-287

3.25 Showing the Details of Sources & the Maps Prepared 287

3.26 Showing the Topographic Maps 287

3.27 Satellite Data of National Remote Sensing Center 288

3.28 Land Use / Land Cover Statistics of the Study Area 293

3.29 Sampling locations for flora and fauna study in study area 297

3.30 List of plants found in the project area 297-298

3.31 List of Trees, shrubs and perennial climbers Found the Buffer Zone

299-301

3.32 List of mammals observed in study area 303

3.33 List of reptiles and amphibians observed in study area 303

3.34 List of butterflies observed in study area 303-304

3.35 List of birds either spotted or reported from the areas in and around the project site

304-305

3.36 Aquatic ecological locations in study area 306

3.37 Check list of fishes found in Krishna River 306

3.38 List of aquatic flora species recorded in study area 306-307

3.39 Population Distribution 308

3.40 Distribution of Literacy Rate and Illiteracy Rate in the Study Area

311

3.41 Occupational Structure in Study Area 311

CHAPTER - IV ANTICIPATED ENVIRONMENTAL IMPACTS

& MITIGATION MEASURES

Table No Description Page No

4.1 Summary – Identification Of Impacts During Construction Phase

318

4.2 Mitigation Measures During Construction Phase 319-321

4.3 Emission Details from Proposed Boiler Stack 322

4.4 Emission Details from DG Set Stack 323

4.5 Predicted 24-Hourly Short Term Incremental Concentrations

326

4.6 Resultant Concentrations Due to Incremental GLC's 326

4.7 Process Emission details and mitigation measures 330

4.8 Hazardous & Solid Waste Disposal Details 337

CHAPTER - V ANALYSIS OF ALTERNATIVES (TECHNOLOGY & SITE)

Table No Description Page No

5.1 Site Description 340-341

CHAPTER - VI ENVIRONMENTAL MONITORING PROGRAM

Table No Description Page No

6.1 Post Project Environmental Monitoring schedule details

347

6.2 Environmental Monitoring Plan during Operation Phase

348-350

6.3 Details of Post Project Monitoring Locations 350

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CHAPTER -VII ADDITIONAL STUDIES, RISK ASSESSMENT & DISASTER MANAGEMENT REPORT

Table No Description Page No

7.1 Area Wise Identified Hazards, Precautions proposed With Mitigation Measures.

359-370

7.2 Solvent/ Chemicals 371

7.3 Severity Categories and Criteria 386

7.4 Heat flux Intensity and exposure time-Damage criteria for people

389

7.5 Damage due to overpressures 390

7.6 Chemical exposure limits 407

CHAPTER - X ENVIRONMENTAL MANAGEMENT PLAN

Table No Description Page No

10.1 List of Plants identified for Greenbelt 455

10.2 The details of the Monitoring Program 457-458

10.3 Proposed Water consumption details 459

10.4 Characteristics Details of proposed Boiler 463

10.5 Stack Emission Details for Thermic Fluid Heater 464

10.6 Stack Emission Details of proposed DG set 464

10.7 Effluent generation details 464

10.8 HTDs & LTDs effluent details 465

10.9 Hazardous / Solid waste generation, disposal Details 465-466

10.10 Available rain water (annual)for Harvesting 467

10.11 Proposed Budget for Environmental Management plan 468-469

LIST OF FIGURES

CHAPTER - II PROJECT DISCRIPTION

Figure No Description Page No

2.1 Location map 10

2.2 Google Earth Map Surrounding Of Project Area 11

2.3 Google Earth Map Showing Project Site 12

2.4 Latest photographs of Proposed site 13

2.5 Topomap showing 10km radius 14

2.6 Site plan details 15

CHAPTER - III DESCRIPTION OF THE ENVIRONMENT

Figure No Description Page No

3.1 Showing Drainage Map Of The Project Study Area

248

3.2 Windrose Diagram Period: March 2018 – May 2018

252

3.3 Ambient Air Quality Sampling Locations Map 255

3.4 Ground & Surface Water Sampling Locations Map 270

3.5 Noise Sampling Locations Map 278

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3.6 Soil Sampling Locations Map 284

3.7 Pie Diagram Showing Land Use The In Study Area

293

3.8 Satellite Image Of The Study Area 294

3.9 Land Use / Land Cover Map Of The Study Area 295

3.10 Diagram Showing Total Population Distribution in the Study Area

309

3.11 The Diagram Showing Literates and Illiterates in Study Area

310

3.12 The Diagram Showing Occupational Structure in Study Area

311

CHAPTER - IV ANTICIPATED ENVIRONMENTAL IMPACTS & MITIGATION MEASURES

Figure No Description Page No

4.1 Short term 24 hourly incremental GLCs of SPM 327

4.2 Short term 24 hourly incremental GLCs of SO2 328

4.3 Short term 24 hourly incremental GLCs of NOx 329

CHAPTER - VI ENVIRONMENTAL MONITORING PROGRAM

Figure No Description Page No

6.1 Organisational Structure of Environment Health & Safety

345

CHAPTER - X ENVIRONMENTAL MANAGEMENT PLAN

Figure No Description Page No

10.1 Flow chart of EMP 436

10.2 Schematic diagram of Proposed waste water treatment – ZLD System

442

10.3 Flow chart for effluent treatment HTDS 443

10.4 Flow chart for effluent treatment LTDS 444

10.5 Flow chart for effluent treatment 445

10.6 Schematic diagram of MEE system 449

10.7 Schematic diagram Emissions Control Scrubbing System

460

10.8 Roof water harvesting Structure 467

10.9 5 R concept 471

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EXECUTIVE SUMMARY OF

EIA REPORT

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EXECUTIVE SUMMARY OF

EIA REPORT

OF

ARCHIMEDIS LABORATORIES PVT. LTD

For

Proposed Bulk Drugs & Intermediates

Manufacturing Unit

AT

Sy No: 108 & 109, Jayanthipuram (V) Jaggayyapet (M),

Krishna District, Andhra Pradesh.

PREPARED BY

Rightsource Industrial Solutions Pvt. Ltd

Plot No: 203, H.No:5-36/203, Prashanthi Nagar,

IDA, Kukatpally, Hyderabad – 500072.

Ph: 040-65873137, 23070602, 23075699, 40126589.

Fax: 040-23070602. Mail: [email protected]

NABET Accreditation No. NABET/EIA/1518/SA 038

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1. INTRODUCTION

Archimedis Laboratories Pvt. Ltd proposed to establish a Bulk Drugs &

Intermediates manufacturing unit at Sy No: 108 & 109, Jayanthipuram (V)

Jaggayyapet (M), Krishna District, Andhra Pradesh.

The proposed project cost is about Rs. 30.0 Crores, which includes construction of

the buildings, equipment, machinery and greenbelt development.

The project proposal was appraised by the Expert Appraisal Committee (EAC) and

has issued Standard Terms of Reference vide F. No: J-11011/9144/2018-IA II (I)

Dated on 5th Feb 2018, to carryout EIA Study. The Environmental monitoring and

analysis was carried out during the period of March – 2018 to May– 2018 The

Environmental Public Hearing was conducted on 27/10/2018 in Jayanthipuram

village, Jaggayyapet Mandal, Krishna District, Andhra Pradesh. The Public Hearing

paper ads, PH Minutes and its compliance Report are enclosed as enclosures.

1.1. PROJECT DESCRIPTION

The salient features of the unit are furnished below.

TABLE-1: SALIENT FEATURES OF THE PROJECT

Project location Details

Latitude & Longitude Latitude: 16°50'51.19" North Longitude: 80°08'11.93" East

Climatic Conditions

Annual Max Temp is 47.1 0C Annual Min Temp is 9.3 0C Normal Annual Rainfall is 982 mm (Source: IMD Climatological Normals, 1981 - 2010)

Land acquired for the plant 11.62 Acres (47024.47 Sq.m)

Land use Industrial use

Nearest Habitation Jayanthipuram Village 1.80 km (WNW)

Major urban Settlements Vijayawada - 58 km (SE)

Nearest Highway Nearest Railway station Nearest Airport

National Highway No.65 – 4.45 km (N) Motumuri Railway Station – 22.7 km (NE) Vijayawada Airport - 77 km (SE)

Major Industries near the plant site

VBC Fertilizers & Chemicals Ltd

Amoda Iron & Steel Ltd

The Ramco Cements

Mine of VSP

Jaggayapeta Industrial Estate

CKS Laboratories Pvt Ltd

Mylan Laboratories Limited

RA Chem Pharma Pvt Ltd

National Parks None within 10 km radius

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2.0 PROCESS DESCRIPTION

The manufacturing process of Bulk Drugs & Intermediates consists of chemical

synthesis extending to stages of processing involving different type of chemical

reactions. Total production capacity of proposal will be 115 TPM. (Given in Table -2).

The unit will take adequate control measures for storage and handling of Raw

materials and cylinders with in factory premises.

TABLE- 2: PROPOSED PRODUCTS AND QUANTITIES

S No Product name Quantity in TPM

CAS NO Therapeutic

category

1 Itraconazole 4 84625-61-6 Anti fungal

2 Lansprazole 1 103577-45-3 Anti ulcerative

3 Pentaprazole Sodium 9 138786-67-1 Antiulcerative

4 Duloxetine Hydrochloride 2 136434-34-9 Antidepressant

5 Sumatriptan Succinate 1 103628-48-4 Anti migraine

6 Almotriptan Malate 1 181183-52-8 Anti migraine

7 Zolmitriptan 1 139264-17-8 Anti migraine

8 Ketorolac tromethamine 5 74103-07-4 Analgesic

9 Rosuvastatin 4 147098-20-2 Antilipemic

10 Mesalamine (or) Mesalazine 4 89-57-6 Anti-inflammatory

11 Imatinib Mesylate 2 220127-57-1 Anti neoplastic

12 Celecoxib 4 169590-42-5 Arthritis

13 Sitagliptin Phosphate Monohydrate 2 654671-77-9 Hypoglycemic

14 Dabigatran 2 211915-06-9 Anticoagulant

Wild life sanctuary None

Water Bodies within 10 km radius

Palleru River – 3.30 km (W) Krishna River – 3.30 km (SSW) Nagarjuna Sagar Left bank Canal- 2.50 km (E) Chillakallu Major canal - 2.10 km (WNW) Gauravaram Cheruvu – 5.40 km (E) Pochampalli Cheruvu – 3.38 km (ESE) Konakachi Cheruvu – 5.51 km (ESE) Nawabpeta Cheruvu – 9.53 km (ESE) Water body near Jaggayyapet – 5.54 km (NW) Tank Near Chillakallu – 4.57 km (N) Tank near Shermohammedpet – 8.55 km (NNW)

Reserve Forest within 10 km radius

Jaggayyapeta Extension R.F – 0.52 km (S),

0.39 km (N) of Project Site

Kuntimadi R.F- 5.12 km (SSW)

Ginjupalle R.F- 5.60 km (SSW)

Venkatayapalem R.F- 7.80 km (SSW)

Budavada R.F- 4.68 km (W)

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S No Product name Quantity in TPM

CAS NO Therapeutic

category

15 Velpatasvir 2 1377049-84-7 Antiviral

16 Emtricitabine 4 143491-57-0 Antiretroviral

17 Olmesartan medoxomil 4 144689-63-4 Anti hypertensive

18 Pregabalin 4 148553-50-8 Anticonvulsant

19 2,4- Dihydro-4-(4-4 hydroxy phenyl )-1-piperazinyl ) -2-(1-methyl propyl )-3H-1,2,4-Triazole-3-one(Itraconazole intermediate)

10 - Drug intermediate

20 Cis -2-[2,4-Di Chloro Phenyl] -2-[1H-1,2,4-Triazole -1-yl Methyl ]-1,3 Dioxalane -4 yl Methanol(Itraconazole intermediate)

4 - Drug intermediate

21

Cis -2-[2,4-Di chloro Phenyl]-2-[1H-1,2,4-Triazole -1-yl methyl]-1,3 Dioxalane-4yl Methyl ] Methane Sulfonate (Itraconazole intermediate)

5 - Drug intermediate

22

2-[3-methyl -4-(2,2,2-trifluoroethoxy)-2-pyridinyl ] 5methylthio -1H-benzimidazole(Lansoprazole Sulfide Intermediate )

5 - Drug intermediate

23 Pentaprazole chloro compound (2-Chloromethyl-3,4-Dimethoxy-Pyridine)

10 72830-09-02 Drug intermediate

24 (S)-(-)-3-(Dimethyl amino )-1-(2-Thienyl)-1-praponal

10 13233-44-5 Drug intermediate

25 4-Chloro-1 hydroxy butane sulphonic acid sodium salt

5 54322-20-2 Drug intermediate

26 4-Chloro Butyralde Diethyl acetal 5 6139-83-9 Drug intermediate

27 4-Dimethyl amino butytalde diethyl acetal 5 1116-77-4 Drug intermediate

Total 115

2.1 RESOURCE REQUIREMENT & INFRASTRUCTURE FACILITIES

A) Land Use Details:

The proposed unit is in an area of 11.62 Acres (47024.47 SQM), the usage details

are given table 3.

TABLE- 3: PROPOSED LAND USE DETAILS

S. No. DESCRIPTION AREA IN SQM AREA IN ACRES AREA IN %

1 Total Built up Area 11536.00 2.85 24.5

2 Green Belt Area 17287.11 4.27 36.8

3 Roads & Open Area 18201.36 4.50 38.7

TOTAL 47024.47 11.62 100

36.8 % of Land is allotted For Green Belt Development

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B) Proposed Water Consumption Details

TABLE- 4: PROPOSED WATER CONSUMPTION DETAILS

S.No Purpose Water

input KLD

1 Process 59

2 Washings 10

3 Boiler make up 71

4 Cooling towers make up 104

5 Scrubbing system 5

6 Domestic 4

7 Gardening 6

Total 259

The fresh water of 175 KLD will be met from Ground Water source.

Recovered water 84 KLD from ZLD system is reused.

The permission to draw ground water for industrial and drinking water purpose was

obtained for 269 KLD from AP Ground Water & Water Audit Department and the

same has been enclosed.

C) Energy Requirement

Power requirement of proposed project will be made available through Andhra

Pradesh Southern Power Distribution Corporation Limited [APSPDCL]. The power

requirement of project will be 2000 KVA.

D) Utilities:

For generation of Steam, the industry proposed to install 8 TPH & 4 TPH coal fired

boilers. The coal requirement will be met from government allocation or from local

authorized sources.

The unit is proposing a 500 KVA & 1000 KVA DG set, for usage during the power

failures.

The emission details are presented in table No.6, 7 & 8.

TABLE- 5: DETAILS OF UTILITIES

S. No Description Capacity

1 Coal fired boiler 8 TPH & 4 TPH

2 Thermic Fluid Heater

200000 kcal/hr

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TABLE- 6: EMISSION CHARACTERISTIC DETAILS OF PROPOSED BOILER

Particulars Units 8.0 TPH Coal fired

Boiler 4.0 TPH Coal fired

Boiler

Type of Fuel -- Indian Coal with CV of 4000 kcal/kg to

5000 kcal/kg

Indian Coal with CV of 4000 kcal/kg to

5000 kcal/kg

Coal Consumption TPD 32 16

Ash Content % 35 35

Sulphur Content % 0.4 0.4

No. of Stacks No 1 1

Height of stack M 34 30

Diameter of Stack M 0.50 0.40

Temperature of Flue Gas oC 200 180

Velocity of Flue Gas m/s 16 14

Particulate Matter gm/sec 0.26 0.13

Sulphur dioxide emission gm/sec 2.95 1.48

Oxides of Nitrogen emission gm/sec 9.70 4.86 Note: 5 TPH Coal fired Boiler is kept as standby.

TABLE- 7: Stack Emission Details for Thermic Fluid Heater

Particulars Units 2,00,000 kcal/hr.

Thermic fluid heater

Thermo pack Boiler Capacity Kcal/hr. 2,00,000

Type of Fuel -- Diesel

Stack Temperature Before Air preheater

oC 200

Stack Temperature After Air preheater oC 130

Stack Height m 15

Fuel Consumption per Day TPD 0.57

Diameter m 0.3

3 D.G. Set 500 KVA & 1000

KVA

4 Cooling Towers 2x200 TR, 250 TR

& 300 TR

5 Electricity supply from APSPDCL.

2000 KVA

Fuel

6 Coal 48 TPD

7 Diesel 300 Liters/Day

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TABLE- 8: STACK EMISSION DETAILS OF PROPOSED DG SET

Capacity In KVA

Emission of SPM in mg/Nm3

Emission Of SO2 in mg/Nm3

Emission of NOx

in mg/Nm3

Stack dia. in m

Flue Gas Temp. in

OC

Stack Height in m

Flue gas Velocity in m/sec.

500 KVA (Proposed)

80 150 180 0.30 220 10 16

1000 KVA (Proposed)

120 170 200 0.35 280 10 18

E) Pollution Control Equipment:

i) Cyclone separator: The denser particles which are carried away by boiler flue

gases will get separated in the cyclone separator and collected in the bottom of the

cyclone separator at a definite interval.

ii) Bag Filter: The boiler flue gases from cyclone separator enter into pack of bag

filters, where particulate matter will be separated leaving as cake on bags surface.

They are cleared by shaking or vibrating by pulse jet causing the filter cake to be

loosened and to fall in the Hopper.

iii) Boiler Stack: The adequate stacks of height 34 mtrs & 30 mtrs will be provided

for pollutants (SO2, NOx, PM & CO) dispersed in a very large area so that ground

level concentration is within CPCB permissible limits.

iv) Scrubbers: Two scrubbers of 2-Stage are proposed to scrub the HCl & SO2. The

packing media in the scrubber is 25mm poly propylene rings.

3. BASELINE ENVIRONMENTAL STATUS

3.1 Study Area Included In Environmental Setting

Studies were carried out in about 10 km radius area from the site with respect to

meteorology, flora, fauna, land and socio-economies of the area. Further sampling

and analysis of air quality, water quality, noise level and soil quality were carried out.

The air quality, water quality, noise level and soil quality in the study area is

evaluated based on this physical sampling and analysis.

The base line data were monitored during the study period of March 2018 – May

2018. The study team conducted site surveys and field experiments for gathering the

information on air quality, water quality, noise quality and soil quality.

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3.2 CLIMATE OF THE STUDY AREA

A. Temperature:

During the study period the minimum and maximum temperatures were recorded as

22.1°C and 45.2°C respectively.

B. Relative Humidity:

During study period at project site during study period, the relative humidity was

recorded as 79.1%

C. Wind Pattern during Study Period

Dispersion of different air pollutants released into the atmosphere has significant

impacts on neighborhood air environment. The dispersion/dilution of the released

pollutant over a large area will result in considerable reduction of the concentration of

a pollutant. The dispersion in turn depends on the weather conditions like the wind

speed, wind direction, temperature, relative humidity, mixing height, cloud cover and

also the rainfall in the area.

Wind speed and direction data recorded during the study period is useful in

identifying the influence of meteorology on the air quality of the area. Wind roses on

sixteen sector basis have been drawn. Wind directions and wind speed frequency

observed during study period is given in Table 3.5 and wind rose diagrams are given

in Figure 3.7

The following observations can be made from the collected data;

Calm period is observed to be 16.9 % during the time of monitoring.

The predominant wind direction is S & SSW.

Other than predominant wind directions wind was blowing in ESE direction.

Average wind speed 3.7 m/s.

Mostly the wind speeds are observed to be in the range of 5.7 – 8.8 m/sec,

0.5 – 2.1 m/Sec, 3.6 - 5.7 m/Sec, with frequency of distribution percentages

ranges from 27.5, 21.1, & 16.2.

D. Rainfall

No rainfall during the Study Period at the Project Site. Average annual rainfall is 982

mm. (Source: IMD Climatatological Normals, Nandigama 1981 - 2010)

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3.3 SAMPLING LOCATION DETAILS

Total eight locations were selected for Base line status. Air, Water & Noise results

are presented in Table 10, 11 & 12 respectively.

3.4 AMBIENT AIR QUALITY

The ambient air monitoring was carried out for 24 hours a day, twice a week for 12

week per location in the study area. Ambient Air Quality Monitoring (AAQM) was

carried out at eight locations during period of March 2018 – May 2018.

1. Particulate Matter (PM10)

The maximum and minimum concentrations for PM10 were recorded in the study

area showed 98th percentile values in the range of 55.46 – 68.88 μg/ m3. The

maximum concentration 68.88 μg/ m3 were recorded at sampling locations at

Dhramavarappadu Tanda. The concentrations of PM10 are well below the CPCB

standard of 100 μg/ m3.

2. Particulate Matter (PM2.5)

The CPCB Standard for concentration of PM2.5 is 60 μg/ m3. The maximum and

minimum 98th percentile concentrations for Particulate Matter (PM2.5) monitored

in the study area were 18.02 – 28.92 μg/m3 respectively. Highest value of 28.92

μg/ m3 was at Dhramavarappadu Tanda. The concentration of PM2.5 is well

below the prescribed limit of 60 μg/ m3

3. Sulphur Dioxide (SO2)

98th percentile value of Sulphur dioxide in the study area from the monitored data

was in the range of 11.44 – 15.15 μg/ m3. Maximum value of Sulpur dioxide of

15.15 μg/ m3 obtained at Dhramavarappadu Tanda. The concentration of SO2 is

well below the prescribed limit of 80 μg/ m3

4. Oxides of Nitrogen (NOx)

Ambient air quality status monitored for oxides of nitrogen in the study area were

in the range with 98th percentile values between 17.10 – 22.33 μg/ m3. A

maximum value of 22.33 μg/ m3 was prevailing at the time of sampling at

Bhimavaram. The concentration of NOX is well below the prescribed limit of 80

μg/ m3

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5. Carbon Monoxide (CO)

The maximum and minimum 98th percentile concentrations for Carbon Monoxide

(CO) monitored in the study area were 0.34 – 0.74 mg/m3 respectively. Highest

value of 0.74 mg/ m3 was at the Dhramavarappadu Tanda. The concentration of

CO is well below the prescribed limit of 2 mg/ m3

6. Ammonia (NH3)

The maximum and minimum 98th percentile concentrations for Ammonia (NH3)

monitored in the study area were 12.91 – 32.75 μg/m3 respectively. Highest value

of 32.75 μg/ m3 was at Dhramavarappadu Tanda. The concentration of NH3 is

well below the prescribed limit of 400 μg/ m3

7. Volatile Organic Compounds (VOCs)

Volatile Organic Compounds (VOCs) concentration in study area was found to be

Below Detectable Limit of 1 ppm.

The ambient air quality monitoring results indicates that the overall air quality in the

study area is within permissible standards prescribed by NAAQ Standards.

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TABLE- 9: THE MAXIMUM, MINIMUM & 98TH PERCENTILE VALUES FOR ALL THE

SAMPLING LOCATIONS

Code Name of Sampling Location

PM 10(µg/M3) PM 2.5(µg/M

3) SO2(µg/M

3) NOX(µg/M

3) CO (mg/M

3) NH3 (µg/M

3)

Min Max 98th

Min Max 98th

Min Max 98th

Min Max 98th

Min Max 98th

Min Max 98th

A1 Project Site 53.69 62.35 61.68 18.62 22.60 22.17 10.50 14.31 13.93 13.78 21.93 20.84 0.22 0.41 0.40 20.98 30.25 29.97

A2 Jayanthipuram 56.51 61.44 60.93 17.05 21.31 20.97 11.21 16.30 15.07 15.42 22.51 20.79 0.42 0.67 0.65 20.49 27.63 27.61

A3 Dhramavarappadu Tanda

59.89 70.15 68.88 18.07 30.59 28.92 11.29 15.19 15.15 15.93 19.46 19.45 0.45 0.76 0.74 28.35 32.87 32.75

A4 Bhimavaram 56.29 64.29 62.46 19.42 25.18 25.18 12.37 15.06 15.04 15.49 23.19 22.33 0.24 0.45 0.44 18.29 22.46 22.33

A5 Gauravaram 58.09 60.31 60.24 18.09 21.47 21.45 11.04 14.83 14.26 15.89 20.18 19.94 0.24 0.41 0.40 12.58 15.73 15.59

A6 Pochampalli 55.19 60.39 60.34 17.42 24.87 24.85 10.34 13.84 13.74 14.25 19.27 19.00 0.23 0.39 0.38 10.23 13.31 12.91

A7 Vedadri Tanda 49.30 55.73 55.46 14.52 18.06 18.02 10.08 12.89 12.85 15.24 17.39 17.36 0.20 0.34 0.34 12.38 15.09 15.05

A8 Ravirala 48.23 59.68 58.13 15.00 19.63 19.10 9.58 11.49 11.44 13.82 17.25 17.10 0.19 0.35 0.35 10.48 14.00 13.97

NAAQ Standards’ 100 60 80 80 2 400

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3.5 WATER QUALITY

Water sampling and subsequent analysis was carried out to determine both the

groundwater and surface water quality of the study area.

Ground water & Surface water samples were collected at 8 locations in the study

area. These samples were analyzed for physical and chemical parameters to

ascertain the Baseline status in the existing surface water and ground water bodies.

TABLE-10: WATER ANALYSIS RESULTS

S. No Parameters Ground water Surface water

Min Max Min Max 1 pH 7.32 8.37 7.54 8.51 2 Total dissolved solids (mg/l) 467.5 983.4 401 905 3 Total hardness (mg/l) 295 670 210 455

4 Chlorides (mg/l) 94.2 310 34 148

5 Fluoride (mg/l) <0.5 <0.5 <0.5 <0.5

6 Sulphates (mg/l) 25 96 2.5 64.2

Ground water samples collected was analyzed as per the Standard methods

and the water quality of the study area is found to be above the acceptable

limits of IS-10500, for parameters TDS, Total hardness, Total Alkalinity,

Calcium, Magnesium and Chloride.

3.6 NOISE ENVIRONMENT

Noise level monitoring was carried out at eight locations during the period of March

2018 – May 2018.

Daytime Noise Levels (Lday)

Industrial Zone: The day time noise level at the Project site was 55.0 dB(A), which

is well below the permissible limits of 75 dB(A).

Commercial Zone: The daytime noise levels in all the commercial locations were

observed to be in the range of 59.5 dB (A) to 62.3 dB(A). The noise levels at all the

locations were below the permissible limits of 65 dB(A).

Residential Zone: The daytime noise levels in all the residential locations were

observed to be in the range of 46.5 dB (A) to 53.2 dB(A). The noise levels at all the

locations were below the permissible limits of 55 dB(A).

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Night time Noise Levels (Lnight)

Industrial Zone: The night time noise level in the Project site was observed be 43.8

dB(A), which is well below the permissible limits of 70 dB (A).

Commercial Zone: The night time noise levels in all the commercial locations were

observed to be in the range of 46.2 dB (A) to 52.1 dB(A). The noise levels at all the

locations were below the permissible limits of 55 dB(A).

Residential Zone: The nighttime noise levels in all the residential locations were

observed to be in the range of 38.9 dB(A) to 42.6 dB(A). The noise levels were

below the permissible limits of 45 dB(A) in nighttime at all the locations.

TABLE-11: NOISE LEVELS OF THE STUDY AREA

S.No

Name of the

Location

Category of Area/zone

Day Time in Leq dB (A)

CPCB Standard Day Time

Night Time in Leq dB (A)

CPCB Standard

Night time

1. Project site Industrial 55.0 75dB (A) 43.8 70dB (A)

2. Jayanthipuram Residential 53.2 55dB (A) 40.4 45dB (A)

3. Chillakallu Commercial 62.3 65dB (A) 52.1 55dB (A)

4. Bhimavaram Residential 50.6 55dB (A) 42.6 45dB (A)

5. Konakanchi Residential 48.7 55dB (A) 39.2 45dB (A)

6. Vedadri Tanda Residential 50.0 55dB (A) 38.9 45dB (A)

7. Mukteswarapuram Residential 46.5 55dB (A) 39.1 45dB (A)

8. Jaggayyapeta Commercial 59.5 65dB (A) 46.2 55dB (A)

3.7 SOIL ENVIRONMENT

On data obtained, the soil quality at around the site is appropriate and normal in

terms of soil contaminants.

3.8 LAND USE/ LAND COVER OF THE STUDY AREA

Land use / Land cover map is prepared by visual interpretation of high-resolution

satellite data (Satellite Imagery Acquisition: 11-Nov-2016) and with the help of

Survey of India Topographic maps on 1: 50,000 scale. Two seasons’ data (Rabi year

2017) is used for the delineation of different units. The units are confirmed by the

ground truth/field visits.

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TABLE-12: LAND USE / LAND COVER OF THE STUDY AREA

S. No LANDUSE Area in SQ.KM

Area in Percentage (%)

1 Built Up Land 22.3 7.1

2 Water Bodies 23.2 7.4

3 Forest 36.4 11.6

4 Crop Land 172.1 54.8

5 Waste Lands 60.0 19.1

Total 314 100

3.9 DEMOGRAPHIC AND SOCIO-ECONOMIC PROFILE

The total population of the study area is 2,04,510 in which male and female

population constitutes about 49.75 % and 50.25 % in the study area

respectively.

The literate male and female in the study area are 68,273 and 55,524 which

implies that the percentage of literacy rate is 67.06% with male and 54.06%

with female respectively.

In the study area the main and marginal workers are 86,663 (42.3%) and

13,633 (6.7%) respectively of the total population while the remaining

1,04,214 (51.0%) constitutes non-workers

All the Villages, in the study area, are electrified – both for Domestic Purpose and

common facilities like, Street Lights, Public Water Pumping, etc. and also are

provided with Domestic Water.

4.0 IDENTIFICATION, PREDICTION & MITIGATION MEASURES

4.1 Expected Air Environment

A. PROCESS EMISSIONS DETAILS

The Predicted Process emissions are O2, CO2, (CH3)2NH, HF, CH4, H2, NH3 & HCl

which are liberated from manufacturing process of proposed products.

TABLE-13: PROCESS EMISSION DETAILS

S. No Name of the Gas Quantity

in Kg/Day Treatment Method

1 Carbon dioxide 270 Dispersed into the atmosphere

2 Oxygen 224 Dispersed into the atmosphere

3 Ammonia 9 Scrubbed by using Chilled water media

4 Hydrogen chloride 426 Scrubbed by using Chilled water media

5 Sulfur dioxide 312 Scrubbed by using C.S.Lye Solution

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6 Dimethylamine 8 Scrubbed by using chilled water media

7 Hydrogen fluoride 5 Scrubbed by using C.S.Lye Solution

8 Hydrogen 35 Diffused by using Nitrogen through

Flame arrestor

9 Methane 15 Dispersed into the atmosphere

4.2 PROPOSED PROCESS EMISSION CONTROL SYSTEM

Scrubbers with 300 mm (Diameter) X 3 meters (Height) & 300mm (Diameter) X 3

meters (Height) capacities will be installed for control of process emissions. The

Schematic diagram of emission control system is given below.

FIGURE-1: SCHEMATIC DIAGRAM OF PROPOSED EMISSION CONTROL

SYSTEM

B. EMISSIONS FROM BOILER

The Particulate matter generated from 8 TPH &4 TPH Boilers will be controlled by

using cyclone separator followed by bag filters. The sulphur dioxide (SO2) and

oxides of nitrogen (NOX) from boiler will be dispersed in to atmosphere by providing

adequate stacks of height 34 mtrs & 30 mtrs for effective dispersion and dilution.

The predicted ground level concentrations when added to Baseline scenario, the

overall scenario levels of PM, SO2 and NOX are well within the permissible limits as

specified by NAAQ Standards.

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TABLE 14: RESULTANT CONCENTRATIONS DUE TO

INCREMENTAL GLC's

Pollutant Maximum Baseline

Concentration

(μg/m3)

Incremental

Concentrations due to

Proposed Project (μg/m3)

Resultant

Concentration

(μg/m3)

NAAQ

Standards

(μg/m3)

PM 68.88 0.759 69.639 100

SO2 15.15 4.694 19.844 80

NOx 22.33 9.47 31.80 80

4.3 Expected Effluent Water Details

The waste water generation will be 105.8 KLD which is from process, floor & reactor

washes, cooling tower blow down, boiler blow down, scrubber, DM plant and

domestic usage. The effluent generation and its HTDS & LTDS effluent details are

given below.

TABLE-15: EXPECTED EFFLUENT GENERATION DETAILS

S.No. Purpose Effluent

Details KLD

1 Process 66

2 Washings 10

3 Boiler Blow down 10

4 Cooling towers Blow down 12

5 Scrubbing system 5.00

6 Domestic 2.80

Total 105.8

TABLE-16: EXPECTED HTDS & LTDS EFFLUENT GENERATION DETAILS

S. No Purpose HTDS In KLD

LTDS In KLD

Effluent In KLD

Disposal Method

1 Process 47 19 66 HTDS Effluent sent to MEESystem.MEE Condensate sent to Biological treatment. LTDS Effluents along with Domestic sewage sent to ETP, treated effluent sent to RO followed by MEE & ATFD. RO Permeate and MEE

2 Washings 0 10 10

3 Boiler Blow down 0 10 10

4 Cooling towers bleed off

0 12 12

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5 Scrubbing system 5 0 5.00 Condensate water recovered for reuse MEE Salts collected and disposed to TSDF. 6 Domestic 0 2.8 2.80

Total 52 53.8 105.8

Effluent Treatment / Disposal: Zero Liquid Discharge (ZLD) concept consisting of

steam stripper, MEE system, ATFD, Biological Treatment and RO will be installed to

treat the effluents generated from plant and to reuse the treated water.

The MEE System with 85 KLD Capacity & RO system with 100 KLD Capacity will be

installed for treatment of effluents generated from plant operations.

4.4 Noise Environment

The main sources of noise pollution in the plant operations are Boiler, Reactors, DG

Set, compressors and other Noise generating units. Vehicular movements during

operation phase for loading / unloading of raw materials and finished products and

transporting activity may also increases the noise levels.

All the noise generating equipments like motors, gear boxes and compressors will be

regularly maintained with lubricating material to avoid noise generation. DG set will

be provided with acoustic enclosures. A thick greenbelt will be developed along the

periphery of the plant boundaries to minimize the noise pollution from the source.

4.5 Land Environment

The plant activities are unlikely to alter the land-use pattern in the project site. The

unit will take adequate measures for storage, handling and disposal of hazardous

waste. Hence, there will be no significant adverse impact on land environment.

4.6 Ecological Environment

Detailed flora and fauna studies were carried in the study area. As per baseline

studies, there are no endangered, threatened & protected plants and animal species

were recorded in the study area. Hence, no significant adverse impact is envisaged

on ecology.

4.7 Expected Hazardous and Solid Waste Details

The Hazardous / Solid waste generated and disposal methods from proposed project

are given below.

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TABLE- 17: EXPECTED HAZARDOUS/SOLID WASTE GENERATION, DISPOSAL

DETAILS

S. No Name of the

Hazardous Waste Quantity Disposal Method

1 Organic Solid Waste 3757 Kg/Day

Sent to Cement Industries

2 Spent Carbon 108 Kg/Day

3 Solvent distillation residue 1174 Kg/Day

4 Organic Evaporate liquid from

MEE stripper 1040 Kg/Day

5 Mixed Solvents 3933 Kg/Day

6 ETP Sludge 1000 Kg/Day

Sent to TSDF 7 Inorganic solid waste 366 Kg/Day

8 MEE Salts 4954 Kg/Day

9 Used Oils 1000

Ltrs/Annum

SPCB Authorized Agencies

for Reprocessing/Recycling

10 Detoxified Containers 1000

No’s/Month

After Detoxification sent back

to suppliers/sent to outside

Parties

11 Used Lead Acid Batteries 9 No’s/Year Send back to suppliers for

buyback of New Batteries

Solid Waste Details

12 Ash from boiler 16800

Kg/Day Sent to Brick Manufacturers

4.8. Risk Assessment and Disaster Management Plan

The Risk assessment studies have been conducted for identification of hazards, to

calculate damage distances and to spell out risk mitigation measures. The details

are discussed in detail in Chapter – 7 of EIA Report.

5.0 ENVIRONMENTAL MANAGEMENT PLAN

5.1 ENVIRONMENT MANAGEMENT PLAN FOR CONSTRUCTION PHASE

Adequate and effective environment protection measures will be planned and

designed to minimize the impacts due to activities related to pre-construction

(preparatory phase) of the project, machinery installation and commissioning stages

and end with the induction of manpower and start up. The impacts identified during

the construction phase are mainly due to site preparation, foundation work, material

handling, and construction of buildings and installation of the machinery.

All possible care will be taken to reduce the noise levels due to construction activity.

Also, noise prone activities shall be restricted to the extent possible during night

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particularly during the period of 10 PM to 6 AM in order to have minimum

environmental impact.

5.2 ENVIRONMENT MANAGEMENT PLAN FOR OPERATIONAL PHASE

A) Air Pollution Management

The industry will take measures for reduction of fugitive emissions emanating

out of process reactions by providing vent condensers.

Good ventilation will be provided to reduce the workroom concentrations.

Fugitive emissions will be reduced by providing vent condensers to the all the

reactors.

Adequate stacks of height of 34 Mtrs & 30 Mtrs will be provided to the 8 TPH

& 4 TPH coal fired boilers.

Stack monitoring facilities for the periodic monitoring of the stack to verify the

compliance of the stipulated norms. Apart from this Cyclone Separator, Bag

filters will be provided to the boiler.

In order to minimize the air pollution, unit will develop greenbelt in and around

its premises.

B) Water Pollution Management

Effluent generated in the plant will be treated in Proposed ZLD system.

The industry is proposing to install a MEE System with 85 KLD capacity,

Biological Treatment system of 110 KLD and RO system with 100 KLD

capacities for treatment of 105.8 KLD effluents generated from plant

operations.

Total Water requirement is 259 KLD out of which 84 KLD recycled water

recovered from ZLD system. The fresh water of 175 KLD will be met from

Ground Water source.

Unit is proposed to recharge ground water through roof water harvesting pits

in the project area and rain water harvesting pits outside plant area wherever

possible to balance the water table.

Use of high-pressure hoses for cleaning the floor and process equipment to

reduce the amount of wastewater generated during washings.

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C) Noise Pollution Management

Noise suppression measures such as enclosures, buffers and / or protective

measures will be provided, if required.

Extensive oiling, lubrication and preventive maintenance will be carried out for

the machineries and equipments to reduce noise generation.

Greenbelt Development.

D) Hazardous & Solid Waste Management

To reduce the quantity of solid / hazardous waste generation as well as possible

contamination of land (soil) due to spillages / leaks from the plant operations,

following Mitigation measures are proposed:

There will not be any leakages / spillage from the raw-materials storage.

The generated Hazardous waste will be stored on floor with suitable packing

and this dedicated area will be covered with the roof.

The records on quantity of hazardous waste generation and disposal will be

maintained for each category and possibilities will be explored for

minimization and reuse.

E) Green Belt

Greenbelt will be developed in an area of 4.27 Acres (17287.11 Sq.m). The industry

will spend 5 Lakhs as capital cost for planting of samplings. Lists of plants suitable

for greenbelt as per the local agro climatic conditions are given in the EIA Report.

F) Solvent Recovery

Solvents will be recovered upto 95% using distillation column and necessary cooling

condensers.

5.3 ENVIRONMENT MANAGEMENT CELL

Archimedis Laboratories Pvt. Ltd. will have a dedicated Environmental

Management Cell with experienced staff to look after the proper environmental

management of the plant including operation & maintenance of all pollution control

facilities.

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5.4 ENVIRONMENT MONITORING PROGRAM

Regular monitoring of environmental parameters is of immense importance to

assess the status of environment during project operation. The regular monitoring

will be carried out with the MoEF&CC Registration / NABL Accredited Laboratory.

6. PROPOSED ROOF WATER HARVESTING

Roof top rainwater harvesting is one of the appropriate options for augmenting

ground water recharge/ storage in this industry.

The following table gives expected quantity of rain water harvesting using buildings

Roof top.

TABLE- 18: AVAILABLE RAINWATER (ANNUAL) FOR HARVESTING

Description Area (m2) Rainfall

(m/Annum) Runoff

coefficient Total Rainwater

(m3/Annum)

Roof Area 11536 0.98 0.8 9044.224

Total available rainwater (in m3/annum) 9044

FIGURE-2: PROPOSED ROOF WATER HARVESTING STRUCTURE

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7. EMP BUDGET

The unit has proposed for 110 Lakhs as capital cost and 20 Lakhs as recurring cost

for environment pollution control measures.

TABLE- 19: PROPOSED BUDGET FOR ENVIRONMENTAL MANAGEMENT

PLAN [EMP]

S. No Particulars

Proposed

Capital Cost

(Rs. Lakhs)

Recurring

Cost

(Rs. Lakhs)

1

Pollution Control Equipment

(Scrubbers, Cyclone separator, Bag filter,

Sampling port arrangements etc.,)

30.0 2.0

2 ZLD System

(MEE, RO, ETP system) 70.0 12.0

3

Rain Water Harvesting

(Roof top water collection pit and Roof top water

towards the rain water harvesting pit)

3.0 0.5

4 Green Belt Development

(Plantation and Maintenance) 5.0 2.0

5 Health & Safety

(PPEs, Medical Surveillances Expenses etc.,) 2.0 1.0

6

Environmental Monitoring

(Air, Water, Noise, VOCs, Boiler Stack flue

gases, DG sets stack monitoring expenses etc.,)

0.0 2.5

Total 110.0 20.0

8.0 SOCIO-ECONOMIC DEVELOPMENT

It is predicted that socio-economic impact due to this project will positively increase

the chance of more employment opportunities for local people. There are no

Resettlement and Rehabilitation issues involved in this project. The project

infrastructures will be of use to people of the area. The revenue of the village will be

definitely increased due to the proposed project.

9.0 PROJECT BENEFITS

Proposed project will result in considerable growth and upliftment of local community

in the nearby villages by providing the employment. The project will generate direct

and indirect employment to the nearby villages and the unavailable technical

persons will be recruited from outside.

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10.0 CONCLUSION

Archimedis laboratories Pvt. Ltd. has committed to implement all the pollution

control measures to protect the surrounding environment – adapting Zero-Liquid-

Discharge System for all its Effluents, by controlling process emissions and Safe-

Disposal of all Solid Wastes – generated either as process wastes or packing

wastes.

The project can definitely improve the regional, state and national economy.

Industrial growth is an indication of all-round Socio-Economic Development – by

generating local Employment and Business Opportunities. The implementation of

this project will definitely improve the physical and social infrastructure of the

surrounding area.

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CHAPTER -I

INTRODUCTION

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EIA Report Archimedis Laboratories Pvt. Ltd.

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CHAPTER- I

INTRODUCTION

1.1 PURPOSE OF THE REPORT

As per the EIA Notification dated 14th September 2006 and its amendments from time to

time, the project falls under 5(f) “A” category and require Environmental Clearance. The

industry engaged the services of Rightsource Industrial Solutions Pvt. Ltd, Hyderabad to

prepare and submit the necessary documents. The consulting firm has submitted an

application in prescribed FORM-I along with necessary enclosures for obtaining Terms of

Reference to IA – II Division, MoEF&CC GOI, New Delhi. The project proposal was

appraised by the Expert Appraisal Committee (EAC) and has given Standard Terms of

Reference vide F. No: J-11011/9/2018-IA II (I) Dated on 05th Feb 2018, to carryout EIA

Study. The Environmental monitoring and analysis were carried out during the period of

March – 2018 to May – 2018. The Environmental Public Hearing was conducted on

27/10/2018 in Jayanthipuram village, Jaggayyapet Mandal, Krishna District, Andhra

Pradesh. The Public Hearing paper ads, PH Minutes and its compliance Report are

enclosed as enclosures.

1.2 IDENTIFICATION OF PROJECT & PROJECT PROPONENT

1.1.1 IDENTIFICATION OF THE PROJECT

Archimedis Laboratories Pvt. Ltd. was incorporated on 24th Dec, 2004. Its registered

office is at 5-163/1, 2nd floor, Malleswari Nilayam, Chintalkunta, LB Nagar Post, Hyderabad

– 500074. Industry proposed to set up a new Bulk Drugs & Intermediates Manufacturing

Unit at Sy No: 108 & 109, Jayanthipuram (V) Jaggayyapet (M), Krishna District, Andhra

Pradesh.

1.1.2 ABOUT THE PROMOTERS

Mr. Maddireddy Venkateswara Reddy is the Managing Director of the company. He has

done Master of Technology and has 15 years of manufacturing experience in Bulk Drugs

and Drug Intermediates and overall 27 years of Industrial experience.

Mr. Maddireddy Kesava Reddy is the Director of the company having bachelors of

Engineering. He worked as a Govt. Civil Engineer for 28 years and has 12 years of

manufacturing experience of Bulk Drugs and Intermediates.

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1.3 OBJECTIVE OF THE STUDY

The objective of the study is to carry out Environmental Impact Assessment (EIA) for the

proposed project to meet the Environmental compliances laid down by the Ministry of

Environment, Forest and Climate Change (MoEF&CC) Government of India. Ministry

issued a circular making it mandatory to obtain Environment Clearance for 65 categories of

industries. Bulk Drugs & Intermediates is one of them, occupying 5th place.

The study would include the description of project setting, appraisal of project activities and

assessment of adverse impacts related to the location, design, construction and operation

of the project. Environmental Management Plan (EMP) will be prepared that includes

mitigation measures, including evaluation of alternatives to reduce or mitigate/eliminate the

impacts that likely to cause most significant environmental burdens. As per the above

notification the industry seeks Environment Clearance from MoEF&CC, GOI, New Delhi,

Preparation of Environmental Impact Assessment Report (EIA) based on one season

(Three Months) data, which would be used as management planning tool for better

Environmental Management by suggesting control measures to avoid pollution problems

arising out of the project. The report will include a detailed Environmental Management

Plan (EMP). The study will be carried out incorporating all the details and requirements of

State Pollution Control (SPCB) and Ministry of Ministry of Environment, Forest and Climatic

Change as per their requirements.

1.4 BRIEF DESRIPTION OF THE PROJECT

1.4.1 NATURE OF THE PROJECT

Archimedis Laboratories Pvt. Ltd proposed to establish a Bulk Drugs & Intermediates

manufacturing unit. The proposed project falls under 5(f) “A” category of Synthetic Organic

Chemicals Industry of EIA Notification-2006 and its amendment thereof and requires

Environmental Clearance.

1.4.2 SIZE OF THE PROJECT

The industry proposed to establish the unit in an area of 11.62 Acres (47024.47 SQM). The

proposed project cost is about Rs. 30 Crores, which includes construction of the buildings,

equipment, machinery and greenbelt development.

Archimedis Laboratories Pvt. Ltd to produce below mention products with Manufacturing

Capacity of 115 TPM. The list of products is shown in Table 1.1.

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Table 1.1: Proposed Products and Quantities

S No Product name Quantity in TPM

CAS NO Therapeutic

category

1 Itraconazole 4 84625-61-6 Anti fungal

2 Lansprazole 1 103577-45-3 Anti ulcerative

3 Pentaprazole Sodium 9 138786-67-1 Antiulcerative

4 Duloxetine Hydrochloride 2 136434-34-9 Antidepressant

5 Sumatriptan Succinate 1 103628-48-4 Anti migraine

6 Almotriptan Malate 1 181183-52-8 Anti migraine

7 Zolmitriptan 1 139264-17-8 Anti migraine

8 Ketorolac tromethamine 5 74103-07-4 Analgesic

9 Rosuvastatin 4 147098-20-2 Antilipemic

10 Mesalamine (or) Mesalazine 4 89-57-6 Anti-inflammatory

11 Imatinib Mesylate 2 220127-57-1 Anti neoplastic

12 Celecoxib 4 169590-42-5 Arthritis

13 Sitagliptin Phosphate Monohydrate 2 654671-77-9 Hypoglycemic

14 Dabigatran 2 211915-06-9 Anticoagulant

15 Velpatasvir 2 1377049-84-7 Antiviral

16 Emtricitabine 4 143491-57-0 Antiretroviral

17 Olmesartan medoxomil 4 144689-63-4 Anti hypertensive

18 Pregabalin 4 148553-50-8 Anticonvulsant

19

2,4- Dihydro-4-(4-4 hydroxy phenyl )-1-piperazinyl ) -2-(1-methyl propyl )-3H-1,2,4-Triazole-3-one(Itraconazole intermediate)

10 - Drug intermediate

20 Cis -2-[2,4-Di Chloro Phenyl] -2-[1H-1,2,4-Triazole -1-yl Methyl ]-1,3 Dioxalane -4 yl Methanol(Itraconazole intermediate)

4 - Drug intermediate

21

Cis -2-[2,4-Di chloro Phenyl]-2-[1H-1,2,4-Triazole -1-yl methyl]-1,3 Dioxalane-4yl Methyl ] Methane Sulfonate (Itraconazole intermediate)

5 - Drug intermediate

22

2-[3-methyl -4-(2,2,2-trifluoroethoxy)-2-pyridinyl ] 5methylthio -1H-benzimidazole(Lansoprazole Sulfide Intermediate )

5 - Drug intermediate

23 Pentaprazole chloro compound (2-Chloromethyl-3,4-Dimethoxy-Pyridine)

10 72830-09-02 Drug intermediate

24 (S)-(-)-3-(Dimethyl amino )-1-(2-Thienyl)-1-praponal

10 13233-44-5 Drug intermediate

25 4-Chloro-1 hydroxy butane sulphonic acid sodium salt

5 54322-20-2 Drug intermediate

26 4-Chloro Butyralde Diethyl acetal 5 6139-83-9 Drug intermediate

27 4-Dimethyl amino butytalde diethyl acetal 5 1116-77-4 Drug intermediate

Total 115

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Table 1.2: Proposed By-Products and Quantities

S. No Name of the Product Name of the By-Product Quantity in Kg/Day

1

Lansprazole

Ammonium sulphate 698.00

2[4-(2,2,2-Tri Fluoro Ethoxy)-3-Methyl Pyridinyl]Methyl Thio]-1h-Benzimidazole

Zolmitriptan

Imitinib mesylate

2

Lansprazole

Acetic acid (70%) 414.00 2[4-(2,2,2-Tri Fluoro Ethoxy)-3-Methyl Pyridinyl]Methyl Thio]-1h-Benzimidazole

3

Dabigartan

Hydrobromic acid (20%) 4552.00

Velpatasvir

2, 4-Di Hydro-4-[4-[4-(4hydroxy Phenyl)-1-Piperazinyl]-2-(1-Methylpropyl)-3h-1, 2, 4-Triazole-3-One (Itraconazole Intermediate)

Olmesartan Medoxomil

4 Pentaprazole chlorocompound (2-Chloromethyl-3,4-Dimethoxy-Pyridine)

Potassium carbonate 167

Phosphoric acid 472

5 Emtricitabine L-Menthol 105.00

1.4.3 LOCATION OF THE PROJECT

Archimedis Laboratories Pvt. Ltd proposed to set up a new Bulk Drugs & Intermediates

Manufacturing Unit at Sy No: 108 & 109, Jayanthipuram (V) Jaggayyapet Mandal, Krishna

District, Andhra Pradesh.

TABLE 1.3: PROJECT LOCATION AND COMPLIANCE OF SITE.

Project location Details

Latitude & Longitude Latitude: 16°50'51.19"N Longitude: 80°08'11.93"E

Climatic Conditions

Annual Max Temp is 47.10C Annual Min Temp is 9.3 0C Normal Annual Rainfall is 982 mm (Source: IMD Climatalogical Normals, Nandigama 1981 - 2010)

Land acquired for the plant 11.62 Acres (47024.47 Sq.m)

Land use Industrial use

Nearest Habitation Jayanthipuram Village 1.80 km (WNW)

Major urban Settlements Vijayawada - 58 km (SE)

Nearest Highway National Highway No.65 – 4.45 km (N)

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1.4.4 PROJECT AND ITS IMPORTANCE TO THE COUNTRY, REGION

Archimedis Laboratories Pvt. Ltd. is a Greenfield project intended to start a

manufacturing unit of Bulk Drugs & Intermediates.

Availability of the well-connected road and railway network for easy transportation of

the construction equipments and materials, Raw materials and finished products.

Easy availability of skilled and unskilled labor for construction of Plant and its

operation.

India’s pharmaceutical sector accounts for about 2.4 per cent of the global pharmaceutical

industry in terms of value and 10 per cent in terms of volume. India accounted for about 20

per cent of the global exports in generics. In FY16, India exported pharmaceutical products

worth USD$16.89 billion, with the number expected to reach USD$40 billion by 2020.

India’s healthcare sector, one of the fastest growing sectors, is expected to advance at a

CAGR of 17 per cent to reach USD$250 billion by 20. The generics market stood at

Nearest Railway station Nearest Airport

Motumuri Railway Station – 22.6 km (NE) Vijayawada Airport - 77 km (SE)

Major Industries near the plant site

VBC Fertilizers & Chemicals Ltd Amoda Iron & Steel Ltd The Ramco Cements Mine of VSP Jaggayapeta Industrial Estate CKS Laboratories Pvt Ltd Mylan Laboratories Limited RA Chem Pharma Pvt Ltd

National Parks None within 10 km radius

Wild life sanctuary None

Historical Places Buddhist Stupa near Jaggayyapet - 5.17 km (NW)

Water Bodies within 10 km radius

Palleru River – 3.30 km (W) Krishna River – 3.30 km (SSW) Nagarjuna Sagar Left bank Canal- 2.50 km (E) Chillakallu Major canal - 2.10 km (WNW) Gauravaram Cheruvu – 5.40 km (E) Pochampalli Cheruvu – 3.38 km (ESE) Konakachi Cheruvu – 5.51 km (ESE) Nawabpeta Cheruvu – 9.53 km (ESE) Water body near Jaggayyapet – 5.54 km (NW) Tank Near Chillakallu – 4.57 km (N) Tank near Shermohammedpet – 8.55 km (NNW)

Reserve Forest within 10 km radius

Jaggayyapeta Extension R.F – 0.52 km (S), 0.39 km (N) of Project Site Kuntimadi R.F- 5.12 km (SSW) Ginjupalle R.F- 5.60 km (SSW) Venkatayapalem R.F- 7.80 km (SSW) Budavada R.F- 4.68 km (W)

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USD$26.1 billion in 2016 from USD$21 billion in 2015. India’s generics market has shown

an immense potential for future growth.

1.5 SCOPE OF STUDY

1.5.1 ENVIRONMENTAL IMPACT ASSESSMENT

To assess the impact of the project on Land use, Ambient Air Quality, Water

Quality, Noise levels, Ecology & Biodiversity, Hydrology & Geology, and Socio-

economic status of area.

To prepare Environmental Management Plan (EMP) for mitigating adverse

impacts due to proposed project.

Collection and testing of water sources and soil.

To prepare environmental monitoring plan for operational phase.

Greenbelt development.

1.5.2 SOCIO-ECONOMIC ASSESSMENT

This Study Report covers Population, Gender Ratio, Rural & Semi-Urban Demographic

Distribution, Literacy Rate and Social Amenities available in the study Area like, Transport,

Sanitation, Drinking Water, Medical & Health Facilities, Employment Rate and other

Developmental Indices of Villages falling within the 10 km radius of the Proposed Project

site.

1.5.3 REGULATORY FRAMEWORK

The MoEF&CC, CPCB and SPCBs together form the regulatory and administrative core of

the sector. Legislation for environmental protection in India for chemical industry is mainly

EIA Notification- 2006, Water (Prevention & Control of Pollution) Act -1974, Air (Prevention

& Control of Pollution) Act, 1981, Water (Prevention and Control of Pollution) Cess Act,

1977 Hazardous Waste (Management, Handling and Transboundary Movement) Rules,

2016, amended time to time etc are major Act/rules/notification applicable to industry.

1.5.4 REGULATORY SCOPING

Obtaining Consent for Establishment & Consent for Operation from State

Pollution control board.

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1.6 LEGAL POLICY AND INSTITUTIONAL FRAMEWORKS

The principal environmental regulatory authority is the Ministry of Environment, Forest and

Climatic Change (MoEF&CC), New Delhi which formulates environmental policies and

accords environmental clearances for different projects. Table 1.2 highlights the relevant

environmental legislations applicable to this project.

TABLE 1.4: APPLICABILITY OF LEGAL POLICIES TO THE PROJECT

S. No Legal frame work coordinating

authority Objectives of the policy

Applicability to the

project

Environmental Legality

1 Water (Prevention and Control of pollution) Act, 1974

CPCB

Prohibits the discharge of pollutants into water bodies beyond a given standard, and lays down penalties for non-compliance

Applicable

2

Water (Prevention and Control of Pollution) Cess Act, 1977

SPCB Provides for a levy and collection of a cess on water consumed by industries and local authorities

Applicable

3 Air (Prevention and Control of Pollution) Act, 1981

CPCB Provides means for the control and abatement of air pollution.

Applicable

4

The Air(Prevention and Control of Pollution) Rules, 1982

CPCB

Defined the procedures for conducting meetings of the boards, the powers of the presiding officers, decision-making etc

Applicable

5 Public Liability Insurance Act, 1991

Director of Factories

An act to provide for public liability insurance for the purpose of providing immediate relief to the persons affected by accident occurring while handling any hazardous substance and for matters connected herewith or incidental thereto

Applicable

6

Environment (Protection) Act, 1986 (EPA) followed by amendment in May1994 (Schedule-I)

Ministry of Environment, Forest and Climatic Change (MoEF&CC)

Ensure that appropriate measures are taken to conserve and protect the Environment before commencement of operations.

Applicable

7

Environmental Impact Assessment Notification no. S.O. 1533

MoEF&CC

Under its ambit, 32 types of industries are liable to opt for Environmental clearance from MoEF&CC by providing adequate

Applicable

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EIA report

8 The Environment (Protection) Rules, 1986

CPCB

Lay down the procedures for setting standards of emission or discharge of environmental pollutants

Applicable

9

The Hazardous Wastes management (Management and Handling) Rules, 1989 and amended in 2000

SPCB

Procedure for inventory, control, handling and disposal of hazardous waste. Provide for setting up of disposal sites/landfill sites design, operation and closure

Applicable

10 Solid Waste Management Rules, 2016

SPCB Procedure for management and handling of solid wastes

Applicable

11

Batteries (Management and Handling) Amendment Rules, 2010

SPCB To ensure that the used batteries are collected back as per the schedule against new batteries

Applicable

12 E- Waste (Management Rules), 2016

SPCB

Procedure to recovery/and/or reuse of useful material from waste electrical and electronic equipment

Applicable

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PROJECT DESCRIPTION

CHAPTER -II

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CHAPTER-II

PROJECT DESCRIPTION

2.1 TYPE OF THE PROJECT

Archimedis Laboratories Pvt. Ltd. is a Greenfield project, which proposed to

establish a Bulk Drugs & Intermediates manufacturing unit.

2.2 NEED FOR THE PROJECT

India’s healthcare sector, one of the fastest growing sectors, is expected to advance

at a compounded annual growth rate (CAGR) of 17 per cent to reach USD$250

billion by 2020. The generics market stood at USD$26.1 billion in 2016 from USD$21

billion in 2015. India’s generics market has shown an immense potential for future

growth. Hence, the proponent has decided to set up a Bulk drugs industry in this

location keeping in view of Low cost manpower, Semi–skilled and un-skilled labor

availability.

2.3 LOCATION

The proposed site is located at Sy No: 108 & 109, Jayanthipuram (V) Jaggayyapet

(M), Krishna District, Andhra Pradesh. It has good connectivity and infrastructure

availability. National Highway No.65 is at a distance of 4.45 km (N); the proposed

site is located about 5.7 km from Jaggayyapet. The Nearest Railway Station

Motumuri is at distance of 22.7 km (NE). Vijayawada Airport is about 224 km from

the project site.

The industry proposes to establish unit in an area of 11.62 Acres (47024.47 SQM).

The co-ordinates of the Project site are Latitude: 16°50'51.19"N, Longitude:

76°50'36.3" East. The land usage details are given in Table 2.1.

TABLE 2.1: LAND USE DETAILS

S. No. DESCRIPTION AREA IN SQM AREA IN ACRES AREA IN %

1 Total Built up Area 11536.00 2.85 24.5

2 Green Belt Area 17287.11 4.27 36.8

3 Roads & Open Area 18201.36 4.50 38.7

TOTAL 47024.47 11.62 100

36.8% of Land Allotted For Green Belt Development

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FIGURE 2.1: LOCATION MAP

ARCHIMEDIS LABORATORIES PVT

LTD

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FIGURE 2.2: GOOGLE EARTH MAP SURROUNDING OF PROJECT AREA

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FIGURE 2.3: GOOGLE EARTH MAP SHOWING PROJECT SITE

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FIGURE 2.4: LATEST PHOTOGRAPHS OF PROJECT SITE

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FIGURE 2.5: TOPO MAP SHOWING 10KM RADIUS

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FIGURE 2.6: SITE PLAN

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2.4 SIZE AND MAGNITUDE OF OPERATION

Total production capacity of proposal is 115 TPM.

TABLE 2.2: List Of Proposed Products And Capacities

S No Product name Quantity in Kg/Month

CAS No Therapeutic

category

1 (S)-(-)-3-(Dimethyl amino )-1-(2-Thienyl)-1-praponal

10000 13233-44-5 Drug

intermediate

2

2,4- Dihydro-4-(4-4 hydroxy phenyl )-1-piperazinyl ) -2-(1-methyl propyl )-3H-1,2,4-Triazole-3-one(Itraconazole intermediate)

10000 - Drug

intermediate

3

2-[3-methyl -4-(2,2,2-trifluoroethoxy)-2-pyridinyl ] 5methylthio -1H-benzimidazole(Lansoprazole Sulfide Intermediate )

5000 - Drug

intermediate

4 4-Chloro Butyralde Diethyl acetal 5000 6139-83-9 Drug

intermediate

5 4-Chloro-1 hydroxy butane sulphonic acid sodium salt

5000 54322-20-2 Drug

intermediate

6 4-Dimethyl amino butytalde diethyl acetal 5000 1116-77-4 Drug

intermediate

7 Almotriptan Malate 1000 181183-52-8 Anti migraine

8 Celecoxib 4000 169590-42-5 Arthritis

9

Cis -2-[2,4-Di Chloro Phenyl] -2-[1H-1,2,4-Triazole -1-yl Methyl ]-1,3 Dioxalane -4 yl Methanol(Itraconazole intermediate)

4000 - Drug

intermediate

10

Cis -2-[2,4-Di chloro Phenyl]-2-[1H-1,2,4-Triazole -1-yl methyl]-1,3 Dioxalane-4yl Methyl ] Methane Sulfonate (Itraconazole intermediate)

5000 - Drug

intermediate

11 Dabigatran 2000 211915-06-9 Anticoagulant

12 Duloxetine Hydrochloride 2000 136434-34-9 Antidepressant

13 Emtricitabine 4000 143491-57-0 Antiretroviral

14 Imatinib Mesylate 2000 220127-57-1 Anti neoplastic

15 Itraconazole 4000 84625-61-6 Anti fungal

16 Ketorolac tromethamine 5000 74103-07-4 Analgesic

17 Lansprazole 1000 103577-45-3 Anti ulcerative

18 Mesalamine (or) Mesalazine 4000 89-57-6 Anti-

inflammatory

19 Olmesartan medoxomil 4000 144689-63-4 Anti

hypertensive

20 Pentaprazole chloro compound (2-Chloromethyl-3,4-Dimethoxy-Pyridine)

10000 72830-09-02 Drug

intermediate

21 Pentaprazole Sodium 9000 138786-67-1 Antiulcerative

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22 Pregabalin 4000 148553-50-8 Anticonvulsant

23 Rosuvastatin 4000 147098-20-2 Antilipemic

24 Sitagliptin Phosphate Monohydrate 2000 654671-77-9 Hypoglycemic

25 Sumatriptan Succinate 1000 103628-48-4 Anti migraine

26 Velpatasvir 2000 1377049-84-

7 Antiviral

27 Zolmitriptan 1000 139264-17-8 Anti migraine

Total 115000

Table 2.3: Proposed By-Products and Quantities

S. No Name of the Product Name of the By-Product Quantity in Kg/Day

1

Lansprazole

Ammonium sulphate 698.00

2[4-(2,2,2-Tri Fluoro Ethoxy)-3-Methyl Pyridinyl]Methyl Thio]-1h-Benzimidazole

Zolmitriptan

Imitinib mesylate

2

Lansprazole

Acetic acid (70%) 414.00 2[4-(2,2,2-Tri Fluoro Ethoxy)-3-Methyl Pyridinyl]Methyl Thio]-1h-Benzimidazole

3

Dabigartan

Hydrobromic acid (20%) 4552.00

Velpatasvir

2, 4-Di Hydro-4-[4-[4-(4hydroxy Phenyl)-1-Piperazinyl]-2-(1-Methylpropyl)-3h-1, 2, 4-Triazole-3-One (Itraconazole Intermediate)

Olmesartan Medoxomil

4 Pentaprazole chlorocompound (2-Chloromethyl-3,4-Dimethoxy-Pyridine)

Potassium carbonate 167

Phosphoric acid 472

5 Emtricitabine L-Menthol 105.00

The required raw materials & solvents will be procured indigenously. In case any raw

material is un-available the same will be imported. The proponent is committed to

manufacture products as per current Good Manufacturing Practices.

2.5 PROPOSED SCHEDULE FOR APPROVAL AND IMPLEMENTATION

The industry intends to obtain approval within one year and to implement the

recommendations. The industry proposes to implement the recommendations of the

Authorities from construction stage. The MoEF&CC has given Terms of Reference

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vide F. No: J-11011/9/2018-IA II (I) Dated on 05th Feb 2018, to carryout EIA Study.

The Environmental monitoring and analysis were carried out during the period of

March – 2018 to May – 2018. The Environmental Public Hearing was conducted on

27/10/2018 in Jayanthipuram village, Jaggayyapet Mandal, Krishna District, Andhra

Pradesh. The Public Hearing paper ads, PH Minutes and its compliance Report are

enclosed as enclosures.

The proponent after receiving the EC will approach SPCB to get CFE/CFO and other

statutory approvals from respective authorities for plant operations.

2.6 TECHNOLOGY AND PROCESS DESCRIPTION

The manufacturing process of Bulk Drug Intermediates consists of chemical

synthesis extending to stages of processing involving different types of chemical

reactions. The unit will take adequate control measures for storage and handling of

Raw materials, solvents and gas cylinders within factory premises. The proponent is

having proven technology to manufacture the proposed products.

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2.6.1 MANUFACTURING PROCESS OF THE PRODUCTS

1. (S)-(-)-3-(DIMETHYLAMINO)-1-(2-THIENYL)-1-PROPANOL

Process description:

Stage-1

2-Acetylthiophene reacts with Dimethylamine hydrochloride and Formaldehyde in

presence of Isopropylalcohol to give Stage-1Product

Stage-2

Step-A

Stage-1 product undergoes reduction with Sodium borohydride inpresence of Water,

Methanol and n-Hexane to give Step-A Product

Step-B

Step-A Product undergoes resolution with (S)-(+)-Mandelic acid in presence of

Methanol and n-Hexane to give Stage-2Product

Stage-3

Stage-2Product undergoes Hydrolysis with Sodium hydroxide and Hydrochloric acid

in presence of methanol, Toluene & Petroleum ether to give (S)-(-)-3-

(Dimethylamino)-1-(2-Thienyl)-1-Propanol product

Route of synthesis:

Stage-1

S

O

2-Acetyl thiophene

C6H6OS

126.18

+

Para formaldehyde

Dimethyl amine Hydrochloride

C2H8ClN

81.54

Isopropyl alcohol

HN H

Cl+

+

C9H14ClNOS

219.73

. HCl

CH2O

H2O

18.02

30.03

S

O

NCH3

H3C

3-Dimethylamino-1-thiophen-2-yl-propan-1-one;Hydrochloride

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Stage-2

Step-A

NaBH4

37.83

3-Dimethylamino-1-thiophen-2-yl-propan-1-ol

C9H15NOS

185.29

+ NaCl

58.44

+

+

H3BO3

3 H2O

54.06

61.83

+ 3H2

6.05

C9H14ClNOS

219.73

. HCl

S

O

NCH3

H3C

3-Dimethylamino-1-thiophen-2-yl-propan-1-one;Hydrochloride

+

SN

CH3

H3C

OH

n-Hexane Methanol

Step-B

3-Dimethylamino-1-thiophen-2-yl-propan-1-ol

C9H15NOS

185.29 X 2=370.40

SN

CH3

H3C

OH

+

(S)-(+)-mandelic acid

OH

O

OH

C8H8O3

152.15

+

185.29

Acetone

Isomer

SN

CH3

H3C

OH

HO

O

HO

3-Dimethylamino-1-thiophen-2-yl-propan-1-ol Mandalate salt

C17H23NO4S

337.43

2

C9H15NOS

SN

CH3

H3C

OH

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Stage-3

SN

CH3

H3C

OH

HO

O

HO

3-Dimethylamino-1-thiophen-2-yl-propan-1-ol Mandalate salt

C17H23NO4S

337.43

+ NaOH

40.00

+ HCl

36.46

Methanol , Toluene & Petroleum ether

SN

CH3

H3C

OH

(S)-(-)-3-(DIMETHYLAMINO)-1-(2-THIENYL)-1-PROPANOL

+

HO

O

HO

Mandelic acid

C8H8O3

152.15C9H15NOS

185.29

+NaCl

58.44

+ H2O

18.02

FLOW CHART:

2-Acetylthiophene Dimethylamine hydrochlorideFormaldehyde Isopropyl alcohol Water

Isopropyl alcohol RecoveryEffluent Waterstage-1

Methanol Recoveryn-Hexane RecoveryAcetone RecoveryEffluent Water

stage-2

Toluene recoveryMethanol Recovery Petroleum ether Recovery

stage-3

Stage-1Sodium borohydride S-(+) -mandelic acid Methanoln-Hexane Acetone Water

Stage-3Sodium hydroxideHydrochloric acid Toluene Methanol Petroleum etherWater

(S)-(-)-3-(Dimethylamino)-1-(2-Thienyl)-1-Propanol

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Material Balance:

Material Balance of (S)-(-)-3-(Dimethylamino)-1-(2-Thienyl)-1-Propanol

Stage-1 Batch Size:100.00Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

2-Acetylthiophene 152.00 Stage-1 260.00

Dimethylamine hydrochloride 98.50 Isopropyl alcohol Recovery 95.00

Formaldehyde 37.00 Isopropyl alcohol Loss 2.00

Isopropyl alcohol 100.00 Effluent Water (Water-300, Generated water-21.70,)

321.70

Water 300.00 Organic Residue Process residue-5.8 Distillation Residue-3 (IPA)

8.80

Total 687.50 Total 687.50

Material Balance of (S)-(-)-3-(Dimethylamino)-1-(2-Thienyl)-1-Propanol Stage-2

Batch Size:100.00Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Stage-1 260.00 Stage-2 190.00

Sodium borohydride 45.00 Mixed Solvents (n-Hexane +Methanol )Recovery

494.00

S-(+) –mandelic acid 87.00 Methanol Loss 13.00

Methanol 260.00 n-Hexane loss 13.00

n-Hexane 260.00 Acetone Recovery 190.00

Acetone 200.00 Acetone loss 4.00

Water 300.00 Effluent Water (Water-236 Sodium chloride-69.13, Boric acid-73.06)

378.19

Process emission (Hydrogen)

7.15

Isomer Recovery/Reuse 107.00

Organic Residue Process residue-9.66 Distillation Residue-6 (Acetone)

15.66

Total 1412 Total 1412

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Material Balance of (S)-(-)-3-(Dimethylamino)-1-(2-Thienyl)-1-Propanol Stage-3

Batch Size:100.00Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Stage-3 190.00 (S)-(-)-3-(Dimethylamino)-1-(2-Thienyl)-1-Propanol

100.00

Sodium hydroxide 23.00 Toluene recovery 190.00

Hydrochloric acid 21.00 Toluene loss 4.00

Toluene 200.00 Methanol Recovery 190.00

Methanol 200.00 Methanol loss 4.00

Petroleum ether 200.00 Petroleum ether Recovery 190.00

Water 300.00 Petroleum ether loss 4.00

Mandelic acid Recovery /Reuse 85.00

Effluent Water (Water-300,Sodium chloride-33, Generated Water-10.14, Toluene-6)

349.14

Organic Residue Process residue-5.86 Distillation Residue-12 (Methanol-6, Petroleum Ether-6)

17.86

Total 1134 Total 1134

2. 2, 4 –DIHYDRO-4-(4-[4-(4-HYDOXY PHENYL)-1-PIPERZINYL]-2-(1- METHYLPROPYL)-3H-1, 2, 4-TRIAZOLE -3-ONE

(Itraconazole intermediate)

Process Description

Stage-1

Step-A

1-(4-methoxy-phenyl)-4-(4-nitro-phenyl)-piperazine under goes Hydrogenation with

Hydrogen in presence of Palladium Carbon and Di methyl formamide to give Step-

A product

Step-B

Step-A product reacts with Phenyl chloroformate in presence of Pyridine and Di

methyl foramamide to give Step-B product

Step-c

Step –B reacts with hydrazine hydrate in presence of Acetic acid in presence of Di

Methyl formamide to give step –C product

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Step-D

Step-c product reacts with Formamidine and Acetic acid in presence of Di Methyl

formamide to give Stage-1 product

Stage-2

Stage-1 product reacts with 2-Bromo butane in presence Potassium hydroxide,

Dimethyl sulfoxide and Acetone to give stage-2 product

Stage-3

Stage-2 product reacts with Hydro bromic acid in presence of Acetic Acid

,Chloroform Sodium carbonate , Methanol and water to give 2,4 –DIHYDRO-4-(4-

[4-(4-Hydoxy phenyl)-1-Piperzinyl]-2-(1- methylpropyl)-3H-1,2,4-Triazole -3-one

(Itraconazole intermediate)

Route of synthesis

Stage-1

Step-A

N N NO2H3CO

1-(4-Methoxy-phenyl)-4-(4-nitro-phenyl)-piperazine

C17H19N3O3

313.36

+N N NH2H3CO

1-(4-Methoxy-phenyl)-4-(4-amino-phenyl)-piperazine

C17H21N3O

283.37

Palladium carbon,Dimethylformamide

+H2

2.02

O2

32.00

Step-B

N N NH2H3CO

1-(4-Methoxy-phenyl)-4-(4-amino-phenyl)

-piperazineC17H21N3O

283.37

+

COOCl

phenylchloroformate

C7H5ClO2

156.57

DimethylformamidePyridine

N N NHCOOH3CO

{1-4[4-(4-Methoxy-phenyl)-piperazinyl]-phenyl}phenyl carbonate

403.48

C24H25N3O3

+ HCl

36.46

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Step-C

N N NHCOOH3CO

{1-4[4-(4-Methoxy-phenyl)-piperazinyl]-phenyl}phenyl carbonate

403.48

C24H25N3O3

HydrazineHydrate

+

50.06

Dimethylformamide

N N NHCONH NH2H3CO

{1-4[4-(4-Methoxy-phenyl)-piperazinyl]-phenyl}Hydrazinecarboximide

C18H23N5O2

341.41

N2H6O

OH

Phenol

+

C6H6O

94.11

+ H2O

18.02

NH2-NH2.H2O

Step-D

H3CO N N NHCONHNH2

C18H23N5O2

341.41

+ H2N NH + 2CH3COOH

Formamidine

CH4N2

44.07

120.10

H3CO N N N

N

NH

O

C19H21N5O2

351.40

+

Ammonium acetate

2CH3COONH4

154.16

1,3-Dimethyl-7-{2-[(1-phenyl-2-propanyl)amino]ethyl}-3,7-dihydro-1H-purine-2,6-dione

2,4- Dihydro-4-(4-4 hydroxy phenyl )-1-piperazinyl ) -2-(1-methyl propyl )-3H-1,2,4-Triazole-3-one

Dimethylformamide

Water

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Stage-2

H3CO N N N

N

NH

O

C19H21N5O2

351.40

2,4- Dihydro-4-(4-4 hydroxy phenyl )-1-piperazinyl ) -2-(1-methyl propyl )-3H-1,2,4-

Triazole-3-one

2-Bromobutane

Br

C4H9Br

137.02

H3CO N N NN

N

OCH3

C2H5

4-{4[4-(4-Methoxy-phenyl)-piperazinyl]-phenyl}2,4-Dihydro2-(1-methyl propyl )-3H-1,2,4-

Triazole-3-one

C23H29N5O2

407.51

+

+ KBr

119.00

+ H2O

18.02

+ KOH

56.11

AcetoneDimethyl sulfoxide

Water

Stage-3

H3CO N N NN

N

OCH3

C2H5

4-{4[4-(4-Methoxy-phenyl)-piperazinyl]-phenyl}2,4-Dihydro2-(1-methyl propyl )-3H-1,2,4-

Triazole-3-one

C23H29N5O2

407.51

+ 2 HBr

161.82

HO N N NN

N

OCH3

C2H5

2, 4-Di hydro-4-[4-[4-(4Hydroxy phenyl)-1-piperazinyl]-2-(1-Methylpropyl)-3h-1, 2, 4-triazole-3-one

C22H27N5O2

393.48

+ 2 NaBr

205.79

Acetic acidChloroform

Methanol, Water

+ Na2CO3

105.99

+ CO2

44.01

CH3OH+

32.03

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Flow chart:

1-(4-Methoxy-phenyl)-4- (4-nitro-phenyl)-piperazineHydrogen Palladium on carbon DimethylformamidePhenyl chloroformate Formamidine Hydrazine hydrate Acetic acid Water

Dimethylformamide RecoveryPalladium on carbon Recovery Effluent waterstage-1

Dimethylsulfoxide RecoveryAcetone RecoveryEffluent water

stage-2

Acetic acid RecoveryChloroform Recovery Methanol RecoveryEffluent water

stage-3

Stage-12-Bromo butane Dimethylsulfoxide Acetone Potassium hydroxide Water

Stage-2Sodium carbonate Hydrobromic acid Acetic acid Chloroform MethanolWater

2, 4-di hydro-4-[4-[4-(4hydroxy phenyl)-1-piperazinyl]-2-(1-methylpropyl)-3h-1, 2, 4-triazole-3-one

Material Balance

Material Balance of 2, 4-di hydro-4-[4-[4-(4hydroxy phenyl)-1-piperazinyl]-2-(1-methylpropyl)-3h-1, 2, 4-triazole-3-one (Itraconazole Intermediate)

Stage-1 Batch Size: 100Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

1-(4-Methoxy-phenyl)-4- (4-nitro-phenyl)-piperazine

185.00 Stage-1 140.00

Hydrogen 1.20 Dimethylformamide Recovery 285.00

Palladium on carbon 10.00 Dimethylformamide Loss 6.00

Dimethylformamide 300.00 Palladium on carbon Recovery 10.00

Phenyl chloroformate 87.00 Effluent water 730.45

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Formamidine 20.00 (water-610, Phenol-43.85 Generated Water-8.40, Ammonium acetate-68.2 )

Hydrazine hydrate 24.00 Process emission (Oxygen-18.88 Hydrogen chloride-20.19)

39.07

Acetic acid 54.00 Organic Residue 80.68

Water 610.00 Process residue-71.68 Distillation residue -9 (Dimethylformamide -9)

Total 1291.2 Total 1291.2

Material Balance of 2, 4-di hydro-4-[4-[4-(4hydroxy phenyl)-1-piperazinyl]-2-(1-methylpropyl)-3h-1, 2, 4-triazole-3-one (Itraconazole Intermediate)

Stage-2 Batch Size: 100Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-1 140.00 Stage-2 126.00

2-Bromo butane 55.00 Dimethylsulfoxide Recovery 190.00

Dimethylsulfoxide 200.00 Dimethylsulfoxide loss 4.00

Acetone 200.00 Acetone Recovery 190.00

Potassium hydroxide 23.00 Acetone Loss 4.00

Water 600.00 Effluent water 654.57

(water-600, Generated Water-7.17 Potassium bromide-47.4 )

Organic Residue 49.43

Process residue-37.43 Distillation residue -12 (Acetone-6, Dimethylsulfoxide-6)

Total 1218 Total 1218

Material Balance of 2, 4-di hydro-4-[4-[4-(4hydroxy phenyl)-1-piperazinyl]-2-(1-methylpropyl)-3h-1, 2, 4-triazole-3-one (Itraconazole Intermediate)

Stage-3 Batch Size: 100Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-2 126.00 2, 4-di hydro-4-[4-[4-(4hydroxy phenyl)-1-piperazinyl]-2-(1-methylpropyl)-3h-1, 2, 4-triazole-3-one

100.00

Sodium carbonate 42.00 Acetic acid Recovery 392.00

Hydrobromic acid 750.00 Acetic acid loss 9.00

Acetic acid 412.00 Chloroform Recovery 1045.00

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Chloroform 1100.00 Chloroform loss 55.00

Methanol 300.00 Methanol Recovery 285.00

Water 2239.00 Methanol loss 6.00

(By-Product Hydrobromic acid )

1350.00

Effluent water 1673.90

(water-1600.38, Sodium bromide-63.62 Methanol-9.9 )

0

Process emission (Carbon dioxide)

13.60

Organic Residue 39.50

Process residue-19.5 Distillation residue -20 (Acetic acid-11 Methanol-9)

Total 4969 Total 4969

3. 2-[3-METHYL-4-(2, 2, 2-TRIFLUOROETHOXY) METHYLTHIO-1H-

BENZIMIDAZOLE

Process Description

Stage-1

2, 3 –Lutidine reacts with Hydrogen Peroxide in presence of Acetic acid to give

stage-1 product

Stage-2

Stage-1 product reacts with Sulphuric acid, nitric acid and Ammonia to give stage-2

product

Stage-3

Stage-2 product reacts with trifuloro ethanol, Potassium carbonate ,Acetic anhydride

in presence of Tetra –n-butyl Ammonium bromide (TBAB),Sodium hydroxide ,

Methyl isobutyl ketone (MIBK),Isopropyl alcohol, Toluene and Acetone to give

stage-3 product

Stage-4

Stage-3 product reacts with Thionyl chloride in presence of DiChloro methane,

Acetone and Methanol to give stage-4 product

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Stage-5

Stage-4 Product reacts with 2-mercapto benimidazole in presence of Sodium

hydroxide and Acetone to give product 2-[3-methyl-4-(2, 2, 2-trifluoroethoxy)

methylthio-1h-benzimidazole

Route of Synthesis:

Stage-1

N

CH3

CH3

C7H9N

+ H2O2

34.00

N+

CH3

CH3

O-

C7H9NO

+ H2O

18.02

Aceticacid

107.16

123.15

2,3-Lutidine2,3-Dimethyl-4-nitro

-pyridine N-oxide

Stage-2

N+

CH3

CH3

O-

C7H9NO

123.15

2,3-Dimethyl-4-nitro-pyridine N-oxide

+ H2SO4 + HNO3

63.00

N

NO2

CH3

CH3

98.08

+ 2 NH3

34.062,3-Dimethyl-

4-nitro-pyridine-N-Oxide

Ammonium sulphate

(NH4)2SO4

132.12

+ + H2O

18.02

MethanolSodium hydroxide

methylenedichloride

O

C7H8N2O3

168.15

Water

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Stage-3

N

NO2

CH3

CH3

O+

4-Nitro-2,3-Dimethyl pyridine-N-Oxide

168.15

CF3CH2OH + K2CO3 + (CH3CO)2O + NaoH + HCl

Trifluoro ethanol

Acetic anhydride

100.04

138.21

102.09

40.00 36.46

N

OCH2CF3

CH3

CH2OH

. HCl

2-Hydroxy methyl-3-methyl pyridine hydrochloride

257.64

+ KHCO3

Potassium bicarbonate

100.12

+ KNO2

Potassium nitrite

85.10

+ CH3COONa

82.03

+ CH3COOH

60.05

C7H8N2O3

C9H11ClF3NO2

Tetra-n-butylammonium bromide(TBAB)Methylisobutylketone(MIBK)Isopropyl alcoholTolueneAcetone

Water

Stage-4

N

OCH2CF3

CH3

CH2OH

. HCl

2-Hydroxy methyl-3-methyl pyridine hydrochloride

257.64

+ SOCl2

118.97N

OCH2CF3

CH3

CH2Cl

. HCl

276.08

+ SO2

64.06

+ HCl

36.46

C9H11ClF3NO2

C9H10Cl2F3NO

MethylenedichlorideAcetonemethanol

2-Chloromethyl-3-methyl-4-(2,2,2-trifluoro-ethoxy)-pyridine

hydrochloride

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Stage-5

N

OCH2CF3

CH3

CH2Cl

. HCl

276.08

C9H10Cl2F3NO

2-Chloromethyl-3-methyl-4-(2,2,2-trifluoro-ethoxy)-pyridine

hydrochloride

+

HN

N

HS

2-Mercaptobenimidazole

C7H6N2S

150.22

Acetone, methylene di chloride

N

HN

SN

O

FF

F

H3C

2-[3-Methyl-4-(2,2,2-trifluoro-ethoxy)-pyridin-2-ylmethylsulfanyl]-

1H-benzoimidazole

C16H14F3N3OS

353.36

+ 2NaCl

116.88

+ 2H2O

36.02

+ 2NaOH

79.99

Water

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FLOW CHART:

2,3-LutidineHydrogen peroxide (50%)Acetic acid Water

Acetic acid recoveryEffluent water

stage-1

Methanol RecoveryMethylene di chloride recoveryEffluent water

stage-2

stage-3

Stage-1Sulphuric acid Nitric acidAmmoniaSodium hydroxide MethanolMethylene di chloride Water

Stage-2Trifluoroethanol Potassium carbonate Acetic anhydrideSodium hydroxideHydrochloric acid Tetra-n-butylammonium bromide(TBAB)Methyl isobutyl ketoneIsopropyl alcoholTolueneAcetone Water

2[4-(2,2,2-Tri Fluoro Ethoxy)-3-Methyl Pyridinyl]Methyl Thio]-1h-Benzimidazole

Methylene dichloride RecoveryMethanol RecoveryAcetone RecoveryEffluent water

stage-4

Stage-3Thionyl chlorideMethylene dichlorideMethanolAcetoneWater

Isopropyl alcohol RecoveryMethyl isobutyl ketone recoveryToluene RecoveryAcetone RecoveryEffluent water

Stage-52-MercaptobanzimidazoleSodium hydroxideAcetoneWater

Acetone RecoveryEffluent water

stage-5

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Material Balance:

Material Balance of 2[4-(2,2,2-Tri Fluoro Ethoxy)-3-Methyl Pyridinyl]Methyl Thio]-1h-Benzimidazole

Stage-1 Batch Size: 500Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

2,3-Lutidine 400.00 Stage-1(With Acetic acid) 645.00

Hydrogen peroxide (50%) 360.00 (By Product Acetic acid + Water)

495.00

Acetic acid 380.00

Total 1140 Total 1140

Material Balance of 2[4-(2,2,2-Tri Fluoro Ethoxy)-3-Methyl Pyridinyl]Methyl Thio]-1h-Benzimidazole

Stage-2 Batch Size: 500Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-1(With Acetic acid) 645.00 Stage-2 375.00

Sulphuric acid 1390.00 Methanol Recovery 741.00

Nitric acid 740.00 Methanol Loss 16.00

Ammonia 700.00 Methylene di chloride recovery 1520.00

Sodium hydroxide 25.00 Methylene di chloride loss 32.00

Methanol 780.00 Effluent water 1200.00

Methylene di chloride 1600.00 (Generatedwater-1175, Sodium hydroxide-25)

0

Water 3000.00 By-Product (Ammonium sulphate)

1850.00

Ammonium sulphate Water Distillation loss

200.00

Generated Ammonium sulphate water distillation for water reuse

2800.00

Organic Residue 146.00

Process residue-75 Distillation residue -71 ( Methanol-23, Methylene dichloride-48)

Total 8880 Total 8880

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Material Balance of 2[4-(2,2,2-Tri Fluoro Ethoxy)-3-Methyl Pyridinyl]Methyl Thio]-1h-Benzimidazole

Stage-3 Batch Size: 500Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-2 375.000 Stage-3 393.00

Trifluoroethanol 223.00 Isopropyl alcohol Recovery 570.00

Potassium carbonate 309.00 Isopropyl alcohol Loss 12.00

Acetic anhydride 750.00 Methyl isobutyl ketone recovery 570.00

Sodium hydroxide 90.00 Methyl isobutyl ketone loss 30.00

Hydrochloric acid 82.00 Toluene Recovery 570.00

Tetra-n-butylammonium bromide(TBAB)

10.00 Toluene loss 12.00

Methyl isobutyl ketone 600.00 Acetone Recovery 570.00

Isopropyl alcohol 600.00 Acetone loss 12.00

Toluene 600.00 By product (Acetic acid )

500.00

Acetone 600.00 Effluent water 1424.03

Water 800.00 (water-800, Potassium bicarbonate-223.30, Potassium nitrite-189.8, Sodium acetate-182.93 , Toluene-18, TBAB-10)

0

Organic Residue 375.97

Process residue-339.97 Distillation residue -36 (Isopropyl alcohol-18, Acetone-18 )

Total 5039 Total 5039

Material Balance of 2[4-(2,2,2-Tri Fluoro Ethoxy)-3-Methyl Pyridinyl]Methyl Thio]-1h-Benzimidazole

Stage-4 Batch Size: 500Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-3 393.00 Stage-4 393.00

Thionyl chloride 182.00 Methylene dichloride Recovery 1425.00

Methylene dichloride 1500.00 Methylene dichloride Loss 30.00

Methanol 1000.00 Methanol Recovery 950.00

Acetone 1000.00 Methanol Loss 20.00

Water 1000.00 Acetone Recovery 950.00

Acetone Loss 20.00

Effluent water 1000.00

(water-1000) 0

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Process emission (Sulphur dioxide-97.70 Hydrogen chloride-55.60

153.30

Organic Residue 133.70

Process residue-28.7 Distillation residue -105 (Methanol-30, Methylene dichloride -45, Acetone-30)

Total 5075 Total 5075

Material Balance of 2[4-(2,2,2-Tri Fluoro Ethoxy)-3-Methyl Pyridinyl]Methyl Thio]-1h-Benzimidazole

Stage-5 Batch Size: 500Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-4 393.00 2[4-(2,2,2-Tri Fluoro Ethoxy)-3-Methyl Pyridinyl]Methyl Thio]-1h-Benzimidazole

500.00

2-Mercaptobanzimidazole 214.00 Acetone Recovery 1900.00

Sodium hydroxide 114.00 Acetone Loss 40.00

Acetone 2000.00 Effluent water 1717.47

Water 1500.00 (water-1500,Sodium chloride-166.3 Generated Water -51.17

0

Organic Residue 63.53

Process residue-3.53 Distillation residue -60 ( Acetone-60)

Total 4221 Total 4221

4. 4-CHLOROBUTYRALDEHYDE DIETHYL ACETAL

Process description:

Stage-1

Tetrahydrofuran reacts with Hydrochloric acid and Sodium hydroxide in presence of

Water to give stage-1 product

Stage-2

Stage-1 product reacts with Sodium hypo chlorite in presence of Methylene

dichloride,TEMPO , Potassium bromide, Sodium thiosulphate , Sodium bicarbonate&

Water to give Stage-2 Product.

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Stage-3

Stage-2 product reacts with Triethylorthoformate and water in presence of Para

toluene sulfonic acid , Methylene dichloride and Sodium carbonate to give 4-

Chlorobutyraldehyde Diethyl Acetal

Route of synthesis:

Stage-1

O

Tetrahydro-furan

C4H8O

72.11

+ 2 HCl

72.92

HOCl

4-Chloro-butanol

C4H9OCl

108.57

+ NaOH

40.00

+ 2 NaCl

116.89

+ H2O

18.02

Water

Stage-2

HOCl

4-Chloro-butanolC4H9OCl108.57

+ NaOCl

Sodium hypochlorite

74.44

ClH

O

4-Chloro-butyraldehydeC4H7OCl

106.55

+ NaCl +

TEMPO, Potassium bromide, Sodium bicarbonate,Sodium thiosulphate,

Sodium chloride, Methylene dichloride & Water

58.44

H2O

18.02

Stage-3

ClH

O

4-Chloro-butyraldehyde

C4H7OCl

106.55

+

Triethyl orthoformate

C7H16O3

C8H17ClO2

180.67

4-Chlorobutyraldehyde Diethyl Acetal

+

O

O

O

+

C2H5OH

46.07

148.20

Paratoluenesoulphonic acid,

Sodium carbonate,Methylene dichloride

+

18.02

CO2 +

44.01

H2O

2.02

H2

Cl

O

O

H3C

CH3

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Flow chart:

Tetra hydrofuran Sodium hydroxide Hydrochloric acid Water

Effluent waterStage-1

MDC RecoveryMixed Solvent s(Methanol+Toluene)Recovery Effluent water

Stage-2

Stage-1Sodium hypochlorite Sodium bicarbonate Sodium thiosulphate Potassium bromide Sodium chloride MDCTEMPOMethanol Toluene Water

MDC RecoveryEffluent water

Stage-3

Stage-2Triethylorthoformate Sodium carbonate MDCPara toluene sulfonic acid Water

4-Chlorobutyraldehyde Diethyl Acetal

Material balance:

Material Balance of 4-Chlorobutyraldehyde Diethyl Acetal

Stage-1 Batch Size:100Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Tetra hydrofuran 47.00 Stage-1 66.00

Sodium hydroxide 26.10 Effluent water (Water-500, Sodium chloride-38.10, Generated water-11.74

549.84

Hydrochloric acid 47.60 Organic Residue 4.860

Water 500.0

Total 620.70 Total 620.70

Material Balance of 4-Chlorobutyraldehyde Diethyl Acetal

Stage-2 Batch Size:100Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-1 66.00 Stage-2 61.00

Sodium hypochlorite 45.25 MDC Recovery 380.00

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Sodium bicarbonate 50.00 MDC Loss 8.00

Sodium thiosulphate 3.25 Mixed Solvent s (Methanol+Toluene)Recovery

980.00

Potassium bromide 5.00 Toluene loss 10.00

Sodium chloride 3.25 Methanol loss 10.00

MDC 400.00 Effluent water (Water-300, Sodium chloride-35.55 Generated water-10.95, Sodium thio sulphate-3.25, TEMPO-20)

369.75

TEMPO 20.00 Inorganic solid waste (Sodium chloride-3.25, Sodium bicarbonate-50, Potassium bromide-5)

58.25

Methanol 500.00 Organic Residue Process residue-3.75 Distillation Residue-12 (MDC)

15.75

Toluene 500.00

Water 300.00

Total 1892.75 Total 1892.75

Material Balance of 4-Chlorobutyraldehyde Diethyl Acetal Stage-3

Batch Size:100Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-2 61.00 4-Chlorobutyraldehyde Diethyl Acetal

100.00

Triethylorthoformate 84.85 MDC Recovery 380.00

Sodium carbonate 5.00 MDC Loss 8.00

MDC 400.00 Effluent water (Water-289.65 Ethanol-26.4, Para toluene sulfonic acid-5, Sodium carbonate-5)

326.05

Para toluene sulfonic acid 5.00 Process emission (Carbon dioxide-25.19, Hydrogen-1.15)

26.34

Water 300.00 Organic Residue Process residue-3.46 Distillation Residue-12 (MDC)

15.46

Total 855.85 Total 855.85

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5. 4-CHLORO 1-HYDROXY BUTANE SULPHONIC ACID SODIUM SALT

Process description:

Stage-1

Tetrahydrofuran reacts with Hydrochloric acid and Sodium hydroxide in presence of Water to

give stage-1 product

Stage-2

Stage-1 product reacts with Sodium hypo chlorite in presence of Methylene dichloride,

TEMPO, Potassium bromide, Sodium thiosulphate, Sodium chloride, Water and Sodium

bicarbonate to give Stage-2 Product.

Stage-3

Stage-2 Product reacts with Sodium met bisulphate and Hydrochloric acid in presence of

methanol and Methylenedichoride to give 4-Chloro 1-Hydroxy Butane Sulphonic Acid

Sodium Salt

Route of Synthesis

Stage-1

O

Tetrahydro-furan

C4H8O

72.11

+ 2 HCl

72.92

HOCl

4-Chloro-butanol

C4H9OCl

108.57

+ NaOH

40.00

+ 2 NaCl

116.89

+ H2O

18.02

Water

Stage-2

HOCl

4-Chloro-butanolC4H9OCl108.57

+ NaOCl

Sodium hypochlorite

74.44

ClH

O

4-Chloro-butyraldehydeC4H7OCl

106.55

+ NaCl +

TEMPO, Potassium bromide, Sodium bicarbonate,Sodium thiosulphate,

Sodium chloride, Methylene dichloride & Water

58.44

H2O

18.02

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Stage-3

ClH

O

4-Chloro-butyraldehyde

C4H7OCl

106.55

+ Na2S2O5

190.11

4-Chloro-1-Hydroxy Butane Sulphonic Acid Sodium Salt

Na+ S

O

O-O

OH

Cl

C4H8O4SNaCl

210.61

+

+ NaCl

58.44

sodium metabisulfite

HCl

36.46

+ SO2

64.06

WaterMethylenedichloride

Methanol

Flow chart:

Tetra hydrofuran Sodium hydroxide Hydrochloric acid Water

Effluent waterStage-1

MDC RecoveryEffluent waterStage-2

Stage-1Sodium hypochlorite Sodium bicarbonate MDC(2,2,6,6-Tetramethylpiperidin-1-yl)oxyl or (2,2,6,6-tetramethylpiperidin-1-yl)oxidanyl,(TEMPO)Potassium bromide Sodium thio sulphate Sodium chloride Water

MDC RecoveryMethanol RecoveryEffluent water

Stage-3

Stage-2Hydrochloric acid Sodium metabisulphateMDCMethanol Water

4-Chloro 1-Hydroxy Butane

Sulphonic Acid Sodium Salt

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Material balance:

Material Balance Of 4-Chloro 1-Hydroxy Butane Sulphonic Acid Sodium Salt Stage-1

Batch Size:100Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Tetra hydrofuran 40.00 Stage-1 57.00

Sodium hydroxide 22.20 Effluent water (Water-300, Sodium chloride-32.41, Generated water-9.99

342.40

Hydrochloric acid 40.50 Organic Residue 3.30

Water 300.00

Total 402.7 Total 402.7

Material Balance Of 4-Chloro 1-Hydroxy Butane Sulphonic Acid Sodium Salt Stage-2

Batch Size:100Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-1 57.00 Stage-2 53.00

Sodium hypochlorite 39.10 MDC Recovery 380.00

Sodium bicarbonate 50.00 MDC Loss 8.00

MDC 400.00 Effluent water (Water-300, Sodium chloride-30.7 Generated water-9.45, Sodium thio sulphate-3.25 TEMPO-20)

363.40

(2,2,6,6-Tetramethylpiperidin-1-yl)oxyl or (2,2,6,6-tetramethylpiperidin-1-yl)oxidanyl,(TEMPO)

20.00 Inorganic solid waste (Sodium chloride-3.25, Sodium bicarbonate-50, Potassium bromide-5)

58.25

Potassium bromide 5.00 Organic Residue Process residue-2.95 Distillation Residue-12 (MDC)

14.95

Sodium thio sulphate 3.25

Sodium chloride 3.25

Water 300.00

Total 877.6 Total 877.6

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Material Balance Of 4-Chloro 1-Hydroxy Butane Sulphonic Acid Sodium Salt Stage-3

Batch Size:100Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-2 53.00 4-Chloro 1-Hydroxy Butane Sulphonic Acid Sodium Salt

100.00

Hydrochloric acid 18.15 MDC Recovery 380.00

Sodium metabisulphate 94.60 MDC Loss 8.00

MDC 400.00 Methanol Recovery 190.00

Methanol 200.00 Methanol loss 4.0

Water 300.00 Effluent water (Water-300 Sodium chloride-29.1)

329.10

Process emission (Sulphur dioxide)

31.86

Organic Residue Process residue-4.79 Distillation Residue-18 (MDC-12, Methanol,-6)

22.79

Total 1065.75 Total 1065.75

6. 4- DIMETHYLAMINOBUTYRALDEHYDE DIETHYL ACETAL

Process Description

Stage-1

1-Bromo -3-chloro –propane reacts with Dimethyl amine in presence of Sodium

hydroxide, water and Cyclohexane to give stage-1 product

Stage-2

Stage-1 product reacts with Triethyl orthoformate in presence of Magnesium, Iodine,

Hydrochloric acid and Cyclohexane to give 4-Dimethylamino butyraldehyde Diethyl

acetal product.

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Route of Synthesis:

Stage- 1

Cl Br

1-Bromo-3-chloro-propane

C3H6BrCl

157.44

+

C2H7N

45.08

Cl N

CH3

CH3

C5H12NCl

3-Dimethylamino,1-Chloropropone

121.61

cyclohexane+ NaOH

40.00

NaBr+ + H2O

18.02102.89

HN

CH3H3C

Dimethyl-amine

Water

Stage-2

Cl N

CH3

CH3

C5H12NCl

3-Dimethylamino,1-Chloropropone

121.61

+

C7H16O3

148.20

O

ON

CH3

CH3

C10H23NO2

189.30

4- Dimethylaminobutyraldehyde Diethyl Acetal

+ Mg

24.31

+

Triethyl orthoformate

O

OO

MgCl(C2H5O)

104.82

IodineCyclohexane

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Flow chart:

1-Bromo-3-chloro-propane Dimethylamine Sodium hydroxide Cyclo hexane Water

Cyclo hexane RecoveryEffluent waterStage-1

Cyclo hexane RecoveryEffluent water

Stage-2

Stage-1Triethylorthoformate Magnesium Hydrochloric acid Iodine Cyclo hexane Water

4- Dimethylaminobutyraldehyde Diethyl Acetal

Material Balance:

Material Balance Of 4- Dimethylaminobutyraldehyde Diethyl Acetal Stage-1

Batch Size:100Kg

Name of the input Quantity

in Kg

Name of the out put Quantity

in Kg

1-Bromo-3-chloro-propane 93.00 Stage-1 68.00

Dimethylamine 26.70 Cyclo hexane Recovery 285.00

Sodium hydroxide 23.65 Cyclo hexane loss 6.00

Cyclo hexane 300.00 Effluent water

(Water-300, Sodium bromide-

60.80, Generated water-10.65,

Cyclo hexane-4)

375.45

Water 300.00 Organic Residue

Process residue-3.9

Distillation Residue-5

(Cyclohexane)

8.90

Total 743.35 Total 743.35

Material Balance Of 4- Dimethylaminobutyraldehyde Diethyl Acetal Stage-2

Batch Size:100Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-1 68.00 4- Dimethylaminobutyraldehyde Diethyl Acetal

100.00

Triethylorthoformate 81.50 Cyclo hexane Recovery 285.00

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Magnesium 14.00 Cyclo hexane loss 6.00

Iodine 20.00 Effluent water (Water-300, Iodine-20, Magnesium salt of Ethnocide-58.61 )

378.61

Cyclohexane 300.00 Organic Residue Process residue-4.89 Distillation Residue-9 (Cyclohexane)

13.89

Water 300.00

Total 783.5 Total 783.5

7. ALOMOTRIPTAN MALATE

Process Description

Stage-1

(4- Nitro –phenyl)-Methane sulfonyl Chloride reacts in presence of Chloroform and

Methanol to stage-1 product Process Description

Stage-2

Stage-1 Product under goes hydrogenation with hydrogen gas in presence of Raney

nickel, Di methyl formamide and Di Isopropyl ether to give stage-2 product

Stage-3

Stage-2 reacts with Sodium Nitrite and Stannous chloride in presence of liquid

Ammonia, water, Hydrochloric acid, Di chloro methane, Methanol and, Isopropyl

Alcohol to give stage -3 product

Stage-4

Stage-3 product reacts with 4- Chloro -1,1-dimethoxy –butane in presence of Di

chloro methane , methanol , Hydrochloric acid and water to give stage -4 product

Stage-5

Stage-4 product reacts with Sodium boro hydride and Formaldehyde in presence of

Di chloro methane, Ethyl acetate and Oxalic acid to given Stgae-5 product

Stage-6

Stgae-5 product under goes Salt formation with Malic acid in presence of Methanol

and Ethyl acetate to give Almotriptan malate product

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Route of Synthesis:

Stage-1

SCl

O

O

NO2

(4-Nitro-phenyl)-methanesulfonyl chloride

C7H6ClNO4S

235.64

+

N

H

Pyrrolidine

C4H9N

71.12

Chloroform

S

O

O

NO2

N

1-(4-Nitro-phenylmethanesulfonyl)-pyrrolidine

C11H14N2O4S

270.30

+ HCl

36.46

Methanol

Stage -2

Raney NickelDimethylformamide,

Diisopropylether

S

O

O

NO2

N

1-(4-Nitro-phenylmethanesulfonyl)-pyrrolidine

C11H14N2O4S

270.30

+

O2

32.00

H2

2.02

S

O

O

NH2

N

4-(Pyrrolidine-1-sulfonylmethyl)-phenylamine

C11H16N2O2S

240.32

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Stage-3

S

O

O

NH2

N

4-(Pyrrolidine-1-sulfonylmethyl)-phenylamine

C11H16N2O2S

240.32

+ NaNO2

69.00

+ SnCl2

189.62

+ 2 NH4OH

70.09

Dichloromethane, Methanol & Isopropylalcohol

S

O

O

HN

N

NH2 . HCl

[4-(Pyrrolidine-1-sulfonylmethyl)-phenyl]-hydrazine

Hydrochloride

C11H18ClN3O2S

291.80

+

Ammonium Stannate

(NH4)2SnO3

202.79

+

58.44

NaCl + 0.5 O2

16.00

HCl+Water

Stage-4

Dichloromethane, Methanol, HCl+Water

S

O

O

HN

N

NH2. HCl

[4-(Pyrrolidine-1-sulfonylmethyl)-phenyl]-hydrazine

Hydrochloride

C11H18ClN3O2S

291.80

+

4-Chloro-1,1-dimethoxy-butane

O

O

Cl

C6H13ClO2

152.62

SO

O

N

NH

2-[5-(Pyrrolidine-1-sulfonylmethyl)-1H-indol-3-yl]-ethylamine

NH2

C15H21N3O2S

307.41

+ 2 CH3OH

64.08

+ 2 HCl

72.92

Disodiumorthophosphate

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Stage-5

Dichloromethane, Methanol, Ethyl acetate & Oxalic acid

SO

O

N

NH

2-[5-(Pyrrolidine-1-sulfonylmethyl)-1H-indol-3-yl]-ethylamine

NH2

C15H21N3O2S

307.41

+ NaBH4

37.83 Formaldehyde

H2C O+

CH2O

2 X30.03=60.06

Almotriptan

NH

N(CH3)2S

O

N

O

C17H25N3O2S

335.46

2

+ NaBO2

Sodium meta borate

65.80

+ 2 H2

4.02

Stage-6

Methanol, Ethyl acetateAlmotriptan

NH

N(CH3)2S

O

N

O

C17H25N3O2S

335.46

Malic acid

OH

O

HO

O

OH

+

C4H6O5

158.28

NH

N(CH3)2S

O

N

O

OH

O

HO

O

OH

.

Almotriptan malate

C21H31N3O7S

469.55

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Flow Chart: (4-Nitro-phenyl)-methane sulfonyl chloridePyrrolidine Chloroform MethanolWater

Stage-1

Chloroform RecoveryMethanol RecoveryEffluent water

Stage-2

Diisopropylether RecoveryDimethyl formamide RecoveryEffluent water

Stage-1Hydrogen Raney nickel Dimethyl formamide Diisopropylether Water

Stage-3

Isopropyl alcohol RecoveryMethanol RecoveryDichloromethane RecoveryEffluent water

Stage-2Sodium nitrite Ammonium hydroxide Tin(II) chlorideHydrochloric acid Dichloromethane MethanolIsopropyl alcohol Water

ALMOTRIPTAN MALATE

Stage-4

Methanol RecoveryDichloromethane RecoveryEffluent water

Stage-34-Chloro-1,1-dimethoxy-butane Disodium orthophosphate Hydrochloric acid Dichloromethane MethanolWater

Stage-5

Methanol RecoveryDichloromethane RecoveryEthyl acetate RecoveryEffluent water

Stage-4Sodium borohydride Formaldehyde Ethyl acetate Oxalic acid Dichloromethane MethanolWater

Stage-5Malic acid Ethyl acetate MethanolWater

Stage-6

Methanol RecoveryEthyl acetate RecoveryEffluent water

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Material Balance:

Material balance of Almotriptan Malate Stage-1

Batch Size:100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

(4-Nitro-phenyl)-methane sulfonyl chloride

73.00 Stage-1 79.00

Pyrrolidine 22.00 Chloroform Recovery 190.00

Chloroform 200.00 Chloroform Loss 10.00

Methanol 200.00 Methanol Recovery 190.00

Water 200.00 Methanol Loss 4.00

Effluent water 200.00

(Water-200)

Process emission

(Hydrogen chloride) 11.29

Organic Residue Process residue-4.71 Distillation Residue-6 (Methanol-6)

10.71

Total 695 Total 695

Material balance of Almotriptan Malate Stage-2

Batch Size:100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Stage-1 79.00 Stage-2 66.00

Hydrogen 0.60 Diisopropylether Recovery 190.00

Raney nickel 10.00 Diisopropylether Loss 10.00

Dimethyl formamide 200.00 Dimethyl formamide Recovery 190.00

Diisopropylether 200.00 Dimethyl formamide Loss 4.00

Water 200.00 Effluent water 200.00

(Water-200)

Spent Raney Nickel recovery /Reuse

10.00

Process emission

(Oxygen) 9.34

Organic Residue Process residue-4.26 Distillation Residue-6 (Dimethyl formamide -6)

10.26

Total 689.6 Total 689.6

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Material balance of Almotriptan Malate Stage-3 Batch Size:100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Stage-2 66.00 Stage-3 76.00

Sodium nitrite 19.00 Isopropyl alcohol Recovery 190.00

Ammonium hydroxide 52.00 Isopropyl alcohol Loss 4.00

Tin(II) chloride 20.00 Methanol Recovery 190.00

Hydrochloric acid 20.00 Methanol Loss 4.00

Dichloromethane 200.00 Dichloromethane Recovery 190.00

Methanol 200.00 Dichloromethane loss 4.00

Isopropyl alcohol 200.00 Effluent water 242.05

Water

200.00 (Water-200, Isopropyl alcohol-6 Sodium chloride-16.05, Hydrochloric acid -20)

Inorganic solid waste (Ammonium stannate)

55.70

Process emission (Oxygen)

4.38

Organic Residue Process residue-4.87 Distillation Residue-12 (Methanol -6,Dichloromethane-6 )

16.87

Total 977 Total 977

Material balance of Almotriptan Malate Stage-4

Batch Size:100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Stage-3 76.00 Stage-4 75.00

4-Chloro-1,1-dimethoxy-butane

40.00 Methanol Recovery 190.00

Disodium orthophosphate 20.00 Methanol Loss 4.00

Hydrochloric acid 20.00 Dichloromethane Recovery 190.00

Dichloromethane 200.00 Dichloromethane loss 4.00

Methanol 200.00 Effluent water 256.70

Water

200.00 (Water-200, Methanol-16.7, Hydrochloric acid -20, Disodium orthophosphate-20)

Process emission (hydrogen chloride)

18.98

Organic Residue Process residue-5.32 Distillation Residue-12 (Methanol -6,Dichloromethane-6 )

17.32

Total 756 Total 756

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Material balance of Almotriptan Malate Stage-5

Batch Size:100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Stage-4 75.00 Stage-5 76.00

Sodium borohydride 10.00 Methanol Recovery 190.00

Formaldehyde 15.00 Methanol Loss 4.00

Ethyl acetate 200.00 Dichloromethane Recovery 190.00

Oxalic acid 20.00 Dichloromethane loss 4.00

Dichloromethane 200.00 Ethyl acetate Recovery 190.00

Methanol 200.00 Ethyl acetate loss 4.00

Water 200.00 Effluent water 242.05

(Water-200, Sodium meta borate-16.05, Oxalic acid-20, Ethyl acetate--6)

Process emission

(hydrogen) 0.97

Organic Residue Process residue-6.98 Distillation Residue-12 (Methanol -6,Dichloromethane-6 )

18.98

Total 920 Total 920

Material balance of Almotriptan Malate Stage-6

Batch Size:100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Stage-5 76.00 Almotriptan Malate 100.00

Malic acid 36.00 Methanol Recovery 190.00

Ethyl acetate 200.00 Methanol Loss 4.00

Methanol 200.00 Ethyl acetate Recovery 190.00

Water 200.00 Ethyl acetate loss 4.00

Effluent water 206.00

(Water-200, Ethyl acetate--6)

Organic Residue Process residue-12 Distillation Residue-6 (Methanol -6)

18.00

Total 712 Total 712

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8. CELECOXIB

Process Description

Stage-1

Trifluro acetic acid reacts with Methanol in presence of Methanol to give stage-1

product

Stage-2

Stage -1 reacts with 4-Methyl Acetophenone in presence of Sodium methoxide,

Hydrochloric acid and Methanol to give stage-2 product

Stage-3

4-Aminobenzene sulphonamide reacts with Sodium nitrite, Hydrochloric acid and

Sodium metabisulfite in presence of Sodium hydrochloride and Methanol to give

stage-3 product

Stage-4

Stage-3 product reacts with 4, 4, 4, - Trifluoro 1-p-tolyl butane-1, 3-dione in presence

of Methanol to give Celecoxib product

Stage-5

Celecoxib Crude under goes Purification in Methanol and Toluene to give Celecoxib

product

Route of Synthesis:

Stage-1

OHF3C

O + CH3OH

OF3C

O

CH3

+ H2O

Trifluro Acetic Acid Methanol

114.00

32.04

128.00

C2HF3O2

Trifluoro-acetic acid methyl ester

C3H3F3O2

18.00

Methanol

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Stage-2

OF3C

O

CH3

128.00

+

CH3

O

H3C + CH3ONa + HCl

4-Methyl Acetophenone

134.00

54.00 36.50

O

H3C

230.18

O

CF3

+ 2CH3OH + NaCl

64.00 58.50

Trifluoro-acetic acid methyl ester

C3H3F3O2

C9H10O

4,4,4-Trifluoro-1-p-tolyl-butane-1,3-dione

C11H9F3O2

Methanol

Stage-3

H2NS

O O

NH2 + NaNO2 + 2HCl + 2NaOH Na2S2O5+

4-Aminobenzene sulfonamide Sodium metabisulfite

69.00 72.92

190.00

H2NS

O O

NH

NH2.HCl+ NaCl + H2O+2 Na2SO4

4-Sulfonamido Phenyl Hydrazine HCl

223.68

58.50

C6H8N2O2S

172.00

80.00

C6H10ClN3O2S

142.04X2=284.08 18.02

Methanol

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Stage-4

H2NS

O O

NH

NH2.HCl

4-Sulfonamido Phenyl Hydrazine HCl

223.68

+ H3C

O O

CF3

(Stage-2)

230.18

(Stage-3)

+ 2H2O + HCl

C6H10ClN3O2S

4,4,4-Trifluoro-1-p-tolyl-butane-1,3-dione

C11H9F3O2

H3C

NN

SH2N

OO

CF3

C17H14F3N3O2S

381.37

Celecoxib Crude 36.03 36.46

Methanol

Stage-5

H3C

NN

SH2N

OO

CF3

H3C

NN

SH2N

OO

CF3

Celecoxib

C17H14F3N3O2S

381.37

Celecoxib Crude

C17H14F3N3O2S

381.37

TolueneMethanol

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Flow Chart:

Trifluoro acetic acid Methanol Water

Methanol RecoveryEffluent waterStage-1

Methanol RecoveryEffluent water

Stage-2

Stage-14-methyl acetophenone Sodium methoxideHydrochloric acidMethanolWater

4-amino benzene sulfonamideSodium nitrite Hydrochloric acidSodium chlorideSodiummeta bi sulphate MethanolWater

Stage-34,4,4,-Trifluooro-1-p-toly-utane -1,3-dione MethanolWater

Methanol RecoveryEffluent waterStage-3

Methanol RecoveryEffluent water

Stage-4

Toluene RecoveryMethanol RecoveryEffluent waterStage-5

Stage-4Toluene MethanolWater

Celecoxib

Material Balance:

Material balance of Celecoxib Stage-1

Batch Size: 100.0Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Trifluoro acetic acid 36.00 Stage-1 38.00

Methanol 210.20 Methanol Recovery 190.00

Water 200.00 Methanol Loss 4.00

Effluent water 205.70

(Water-200 Generated water-5.7)

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Organic Residue 8.50

Process residue -2.5 Distillation Residue-6 (Methanol)

Total 446.2 Total 446.2

Material balance of Celecoxib Stage-2

Batch Size: 100.0Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Stage-1 38.00 Stage-2 66.00

4-methyl acetophenone 39.80 Methanol Recovery 190.00

Sodium methoxide 16.05 Methanol Loss 4.00

Hydrochloric acid 10.85 Effluent water 236.40

Methanol 200.00 (Water-200, Methanol-19, Sodium chloride-17.4)

Water 200.00 Organic Residue 8.30

Process residue -2.30 Distillation Residue-6 (Methanol)

Total 504.7 Total 504.7

Material balance of Celecoxib Stage-3

Batch Size: 100.0Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

4-amino benzene sulfonamide 51.00 Stage-3 64.00

Sodium nitrite 20.50 Methanol Recovery 190.00

Hydrochloric acid 21.65 Methanol Loss 4.00

Sodium chloride 23.75 Effluent water 307.15

Sodiummeta bi sulphate 56.60 (Water-200, Generated Water-5.55, Sodium chloriode-17.35, Sodium sulphate-84.25)

Methanol 200.00 Organic Residue 8.35

Water 200.00 Process residue -2.35 Distillation Residue-6 (Methanol)

Total 573.5 Total 573.5

Material balance of Celecoxib Stage-4

Batch Size: 100.0Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

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Stage-3 64.00 Stage-4 105.00

Stage-2 66.00 Methanol Recovery 190.00

Methanol 200.00 Methanol Loss 4.00

Water 200.00 Effluent water 210.30

(Water-200, Generated Water-10.30)

Process emission (Hydrogen chloride)

10.45

Organic Residue 10.25

Process residue – 4.25 Distillation Residue-6 (Methanol)

Total 530.00 Total 530.00

Material balance of Celecoxib Stage-5

Batch Size: 100.0Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Stage-4 105.00 Celecoxib 100.00

Toluene 200.00 Toluene Recovery 190.00

Methanol 200.00 Toluene loss 4.00

Water 300.00 Methanol Recovery 190.00

Methanol Loss 4.00

Effluent water 300.00

(Water-300)

Organic Residue 17.00

Process residue – 5 Distillation Residue-12 (Toluene -6, Methnol-6)

Total 805.00 Total 805.00

9. CIS -2-[2, 4-DI CHLORO PHENYL] -2-[1H-1, 2,4-TRIAZOLE -1-YL METHYL

]-1,3 DIOXALANE -4 YL METHANOL

Process description:

Stage-1

Cis Bromo benzoate undergoes condensation with 1,2,4 triazole in presence of

Potassium carbonate, Sodium hydroxide, Dimethyl sulfoxide Toluene & methanol to

give Cis -2-[2, 4-Di Chloro Phenyl] -2-[1h-1, 2,4-Triazole -1-Yl Methyl ]-1,3

Dioxalane -4 Yl Methanol product

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Route of Synthesis:

Stage-1

ClCl

O

O

Br

OOCC6H5

+ NN

HN

+ 1/2 K2CO3 + NaOH

Cis-bromo benzoate

C18H15BrCl2O4

446.12

1,2,4-Triazole

C2H3N3

69.1

Potassium carbonate

69.0

Sodium hydroxide

40.0

+

C13H13Cl2N3O3

330.17

COONa

Sodium benzoate

144.10

+ KBr + 1/2 CO2 +

119.0 22.0 9.01

O

OHO

NN

N

Cl Cl

Cis -2-[2,4-Di Chloro Phenyl] -2-[1h-1,2,4-Triazole -1-Yl Methyl ]-

1,3 Dioxalane -4 Yl Methanol C7H5NaO2

1/2 H2O

DimethylsulfoxideToluene,Methanol

Water

Flow chart:

Cis bromo benzoate 1,2,4-Trazole Potassium carbonate Sodium hydroxide Dimethylsulfoxide Toluene MethanolWater

Stage-1

Toluene RecoveryMethanol RecoveryDimethylsulfoxide Recovery

Cis -2-[2,4-Di Chloro Phenyl] -2-[1h-1,2,4-Triazole -1-Yl Methyl ]-1,3 Dioxalane -4 Yl Methanol

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Material balance:

Material Balance of Cis -2-[2,4-Di Chloro Phenyl] -2-[1h-1,2,4-Triazole -1-Yl Methyl ]-1,3 Dioxalane -4 Yl Methanol

Stage-1 Batch Size: 100Kgs

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Cis bromo benzoate 159.00 Cis -2-[2,4-Di Chloro Phenyl] -2-

[1h-1,2,4-Triazole -1-Yl Methyl ]-

1,3 Dioxalane -4 Yl Methanol

100.00

1,2,4-Trazole 24.50 Toluene Recovery 190.00

Potassium carbonate 24.50 Toluene Loss 4.00

Sodium hydroxide 15.00 Methanol Recovery 190.00

Dimethylsulfoxide 200.00 Methanol Loss 4.00

Toluene 200.00 Dimethylsulfoxide Recovery 190.00

Methanol 200.00 Dimethylsulfoxide Loss 4.00

Water 200.00 Effluent water 302.82

(Water-200,generated water-3.18, Sodium benzoate-51.35, Potassium bromide-42.29, Toluene-6)

Process emission (Carbon dioxide )

7.79

Organic Residue (Process residue-18.39 Distillation Residue-12 (Methanol-6, DMSO-6)

30.39

Total 1023 Total 1023

10. CIS -2-[2, 4-DI CHLORO PHENYL]-2-[1H-1, 2, 4-TRIAZOLE -1-YL

METHYL]-1, 3 DIOXALANE-4YL METHYL] METHANE SULFONATE

Process description:

Stage-1

Cis Bromo benzoate undergoes condensation with 1,2,4 triazole in presence of

Potassium carbonate, Sodium hydroxide, Dimethyl sulfoxide Toluene & methanol to

give Stage-1 product

Stage-2

Stage-1 product react with Methane sulfonyl chloride in presence of Triethyl amine ,

Dicholoro methane ,methanol & Water to give Cis -2-[2, 4-Di Chloro Phenyl]-2-[1h-

1,2,4-Triazole -1-Yl Methyl]-1,3 Dioxalane-4yl Methyl ] Methane Sulfonate product

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Route of Synthesis:

Stage-1

ClCl

O

O

Br

OOCC6H5

+ NN

HN

+ 1/2 K2CO3 + NaOH

Cis-bromo benzoate

C18H15BrCl2O4

446.12

1,2,4-Triazole

C2H3N3

69.1

Potassium carbonate

69.0

Sodium hydroxide

40.0

+

C13H13Cl2N3O3

330.17

COONa

Sodium benzoate

144.10

+ KBr + 1/2 CO2 +

119.0 22.0 9.01

O

OHO

NN

N

Cl Cl

Cis -2-[2,4-Di Chloro Phenyl] -2-[1h-1,2,4-Triazole -1-Yl Methyl ]-

1,3 Dioxalane -4 Yl Methanol C7H5NaO2

1/2 H2O

DimethylsulfoxideToluene,Methanol

Water

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Stage-2

ClCl

O

O

N

HO

N

N

C13H13Cl2N3O3

330.17

+ CH3SO2Cl + (C2H5)3N

C14H15Cl2N3O5S

408.26

+ (C2H5)3N.HCl

Methane sulfonyl chloride

114.55

Triethyl amine

101.19

Triethyl amine hydrochloride

137.65

[2-(2,4-Dichloro-phenyl)-2-[1,2,4]triazol-1-ylmethyl-[1,3]dioxolan-4-yl]-methanol

ClCl

O

O

N

O3SH3C

N

N

Cis -2-[2,4-Di chloro Phenyl]-2-[1H-1,2,4-Triazole -1-yl methyl]-1,3 Dioxalane-

4yl Methyl ] Methane Sulfonate

DichloromethaneMethanol

Water

Flow chart;

Cis bromo benzoate 1,2,4-Trazole Potassium carbonate Sodium hydroxide Dimethylsulfoxide Toluene MethanolWater

Stage-1

Stage-2

Dichloromethane RecoveryMethanol RecoveryEffluent water

Stage-1 Methane sulfonyl chloride Triethylamine Dichloromethane MethanolWater

Toluene RecoveryMethanol RecoveryDimethylsulfoxide Recovery

Cis -2-[2,4-Di Chloro Phenyl]-2-[1h-1,2,4-Triazole -1-Yl Methyl]-1,3 Dioxalane-4yl Methyl ]

Methane Sulfonate

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Material balance:

Material Balance of Cis -2-[2,4-Di Chloro Phenyl]-2-[1h-1,2,4-Triazole -1-Yl Methyl]-1,3 Dioxalane-4yl Methyl ] Methane Sulfonate

Stage-1 Batch Size: 100Kgs

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Cis bromo benzoate 137.00 Stage-1 86.00

1,2,4-Trazole 22.00 Toluene Recovery 190.00

Potassium carbonate 22.00 Toluene Loss 4.00

Sodium hydroxide 13.00 Methanol Recovery 190.00

Dimethylsulfoxide 200.00 Methanol Loss 4.00

Toluene 200.00 Dimethylsulfoxide Recovery 190.00

Methanol 200.00 Dimethylsulfoxide Loss 4.00

Water 200.00 Effluent water 289.55

(Water-200,generated water-2.75, Sodium benzoate-44.25 Potassium bromide-36.55, Toluene-6)

Process emission (Carbon dioxide )

6.75

Organic Residue (Process residue-17.7 Distillation Residue-12 (Methanol-6, DMSO-6)

29.70

Total 994 Total 994

Material Balance of Cis -2-[2,4-Di Chloro Phenyl]-2-[1h-1,2,4-Triazole -1-Yl Methyl]-1,3 Dioxalane-4yl Methyl ] Methane Sulfonate

Stage-2 Batch Size: 100Kgs

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-1 86.00 Cis -2-[2,4-Di Chloro Phenyl]-2-[1h-1,2,4-Triazole -1-Yl Methyl]-1,3 Dioxalane-4yl Methyl ] Methane Sulfonate

100.00

Methane sulfonyl chloride 30.00 Dichloromethane Recovery 190.00

Triethylamine 27.00 Dichloromethane Loss 4.00

Dichloromethane 200.00 Methanol Recovery 190.00

Methanol 200.00 Methanol Loss 4.00

Water 200.00 Effluent water 235.85

(Water-200,Triethylamine hydrochloride-35.85)

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Organic Residue (Process residue-7.15 Distillation Residue-12 (Methanol-6, Dichloromethane -6)

19.15

Total 743 Total 743

11. DABIGARTAN

Process Description

Stage-1

Pyridin-2-ylamine reacts with Ethyl acrylate, Ammonia and Hydrochloric acid in

presence of n-Hexane to give stage-1 product

Stage-2

Step-A

4-Chloro -3-nitro benzoic acid reacts with Methyl amine in presence of Isopropyl

Alcohol and Acetic to give step –A product

Step-B

Step-A product reacts with thinly chloride in presence of Methanol to give step-B of

stage of state-2 product

Stage-3

Stage-2 and Stage-1 condensed in presence of Tri ethyl amine, Toluene and Ethanol

to give stage-3product

Stage-4

Stage-3 product undergoes reduction with Iron powder in presence of Ammonium

formate, Toluene, Ethanol, Tetra hydro furan to give stage-3 product

Stage-5

4-Amino benzonitrile reacts with 2- Bromo acetic acid in presence of water to give

stage-5 product

Stage-6

Stage-4 product reacts with stage -5 products in presence of DiChloro methane and

ethyl acetate to give stage-6 product

Stage-7

Stage-6 product reacts with Ammonium carbonate in presence of Ethanol and

Isopropyl Alcohol give stage-7 product

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Stage-8

Stage-7 product reacts with Hexylchloroformate in presence of potassium carbonate

and Tetra hydro furan to give Dibgatran product

Route of Synthesis:

Stage-1

N NH2

Pyridin-2-ylamine

C5H6N2

94.11

+

Ethyl acrylate

O

O

C5H8O2

100.12

N NH

O

O

3-(Pyridin-2-ylamino)-propionic acid ethyl ester

C10H14N2O2

194.23

n-Hexane+ NH3

17.03

+ HCl

36.46

+ NH4Cl

53.49

Stage-2

Step-A

OH

O

O2N

Cl

4-Chloro-3-nitro-benzoic acid

C7H4ClNO4

201.56

+

Methyl Amine

H2N

CH5N

31.06

Acetic acid , Isopropylalcohol

OH

O

O2N

NH

4-Methylamino-3-nitro-benzoic acid

C8H8N2O4

196.16

+ HCl

36.46Water

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Step-B

OH

O

O2N

NH

4-Methylamino-3-nitro-benzoic acid

C8H8N2O4

196.16

+ HCl

36.46+ SOCl2

118.97

Methanol

Cl

O

O2N

NH

C8H7ClN2O3

+

4-Methylamino-3-nitro-benzoyl chloride

214.61SO2

64.06

Stage-3

Toluene , Ethanol

Cl

O

O2N

NH

C8H7ClN2O3

+4-Methylamino-3-nitro-

benzoyl chloride

214.61

N NH

O

O

3-(Pyridin-2-ylamino)-propionic acid ethyl ester

C10H14N2O2

194.23

+

Triethylamine

N

C6H15N

101.19

O

O2N

NH N

N O

O

3-[(4-Methylamino-3-nitro-benzoyl)-pyridin-2-yl-amino]-propionic acid ethyl ester

C18H20N4O5

372.38

+

Triethylamine hydrochloride

N

C6H16NCl

137.65

. HCl

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Stage-4

Ammonium formate Toluene , Ethanol ,Tetrahydrofuran & Water

O

O2N

NH N

N O

O

3-[(4-Methylamino-3-nitro-benzoyl)-pyridin-2-yl-amino]-propionic acid ethyl ester

C18H20N4O5

372.38

+ Fe

55.84

O

H2N

NH N

N O

O

C18H22N4O3

342.39

+

3-[(3-Amino-4-methylamino-benzoyl)-pyridin-2-yl-amino]-propionic acid ethyl ester

Fe

55.84

+ O2

32.00

Stage-5

4-Amino benzonitrile

N NH2

C7H6N2

118.14

2-bromoacetic acid

O

OHBr

+

C2H3BrO2

138.95

NHN

O

OH

Water

(4-Cyano-phenylamino)-acetic acid

C9H8N2O2

176.17

+ HBr

80.91

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STAGE-6

Dichloromethane, Ethyl acetate

O

H2N

NH N

N O

O

C18H22N4O3

342.39

3-[(3-Amino-4-methylamino-benzoyl)-pyridin-2-yl-amino]-propionic acid ethyl ester

+N

HN

O

OH

(4-Cyano-phenylamino)-acetic acid

C9H8N2O2

176.17

N NH

O

N

N O

O

N

N

3-({2-[(4-Cyano-phenylamino)-methyl]-1-methyl-1H-benzoimidazole-5-carbonyl}-pyridin-2-yl-amino)-propionic acid ethyl ester

C27H26N6O3

482.53

+ 2 H2O

36.03

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STAgE-7

N N O

O

O

N

N

HN

N N O

O

O

N

N

HN CN (NH4)2CO3

NH2

NH

C27H26N6O3

Mol. Wt.: 482.53

Ethyl 3-(2-((4-cyanophenylamino)methyl)-1-methyl-N-(pyridin-2-yl)-

1H-benzo[d]imidazole-5-carboxamido)propanoate

C27H29N7O3

Mol. Wt.: 499.56

Ethyl 3-(2-((4-amidinophenylamino)methyl)-1-methyl-N-(pyridin-2-

yl)-1H-benzo[d]imidazole-5-carboxamido)propanoate

CO2+

Ethano, IPA+

Ammonium carbonate

96.09

44.0

+ NH3

17.03

+ H2O

18.0

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Stage-8

N N O

O

O

N

N

HNNH2

NH

N N O

O

O

N

N

HNN

NH2

O

O

Dabigatran

Hexyl chloroformate

499.56

O

O

Cl

+

164.63

C34H41N7O5

627.73

C7H13Cl O2

3-({2-[(4-Carbamimidoyl-phenylamino)-methyl]-1-methyl-1H-benzoimidazole-5-

carbonyl}-pyridin-2-yl-amino)-propionic acid ethyl ester

C27H29N7O3

THF

+ K2CO3

138.21

+ KCl

74.55

CHKO2

84.12

+

Potassium formate

+ 0.5 O2

16.00

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Flow chart:

(pyridine-2-ylamine Ethyl acrylate Ammonia Hydrochloric acid n-Hexane Water

Stage-1

n-Hexane RecoveryEffluent water

Stage-2

Acetic acid RecoveryIsopropyl alcohol RecoveryMethanol RecoveryEffluent water

4-chloro-3-nitro-benzoic acid Methyl amine Acetic acid Isopropyl alcohol Thionyl chloride Methanol Water

Stage-3

Toluene RecoveryEthanol RecoveryEffluent water

Stage-1Stage-2Triethylamine Toluene Ethanol Water

Stage-4

Toluene RecoveryEthanol RecoveryTetra hydrofuran RecoveryEffluent water

Stage-3Iron Ammonium formate Toluene Ethanol Tetra hydrofuran Water

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Dabigartan

Stage-5 Effluent water

4-amino benzonitrile 2-bromoacetic acid Water

Stage-4Stage-5Dichloromethane Ethyl acetate Water

Stage-6

Dichloromethane RecoveryEthyl acetate RecoveryEffluent water

Stage-6Ammonium carbonate Ethanol Isopropyl alcohol Water

Stage-7

Ethanol RecoveryIsopropyl alcohol RecoveryEffluent water

Stage-7Hexyl chloro formate Potassium carbonate Tetrahydrofuran Water

Stage-8

Tetrahydrofuran RecoveryEffluent water

Material balance:

Material balance of Dabigartan Stage-1

Batch Size: 100.0Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

(pyridine-2-ylamine 23.00 Stage-1 45.00

Ethyl acrylate 25.00 n-Hexane Recovery 190.00

Ammonia 5.00 n-Hexane loss 4.00

Hydrochloric acid 9.00 Effluent water 313.10

n-Hexane 200.00 (Water-300 Ammonium chloride-13.10)

Water 300.00 Organic Residue 9.90

Process residue -3.9 Distillation Residue-6 (n-Hexane )

Total 562 Total 562

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Material balance of Dabigartan Stage-2

Batch Size: 100.0Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

4-chloro-3-nitro-benzoic acid 55.00 Stage-2 49.00

Methyl amine 9.00 Acetic acid Recovery 190.00

Acetic acid 200.00 Acetic acid loss 4.00

Isopropyl alcohol 200.00 Isopropyl alcohol Recovery 190.00

Thionyl chloride 31.00 Isopropyl alcohol loss 4.00

Methanol 200.00 Methanol Recovery 190.00

Water 300.00 Methanol loss 4.00

Effluent water 306.00

(Water-300 Isopropyl alcohol -6)

Process emission (Hydrogen chloride-19.04 Sulphur dioxide-16.25,

35.29

Organic Residue 22.71

Process residue -10.71 Distillation Residue-12 (Methanol-6, Acetic acid-6 )

Total 995 Total 995

Material balance of Dabigartan Stage-3

Batch Size: 100.0Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Stage-1 45.00 Stage-3 78.00

Stage-2 49.00 Toluene Recovery 190.00

Triethylamine 24.00 Toluene loss 4.00

Toluene 200.00 Ethanol Recovery 190.00

Ethanol 200.00 Ethanol loss 4.00

Water 300.00 Effluent water 337.45

(Water-300 Toluene -6, Triethylamine hydrochloride-31.45)

Organic Residue 14.55

Process residue -8.55 Distillation Residue-6 (Ethanol -6)

Total 818 Total 818

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Material balance of Dabigartan Stage-4

Batch Size: 100.0Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Stage-3 78.00 Stage-4 68.00

Iron 12.00 Toluene Recovery 190.00

Ammonium formate 20.00 Toluene loss 4.00

Toluene 200.00 Ethanol Recovery 190.00

Ethanol 200.00 Ethanol loss 4.00

Tetra hydrofuran 200.00 Tetra hydrofuran Recovery 190.00

Water 300.00 Tetra hydrofuran loss 4.00

Effluent water 337.70

(Water-300 Toluene -6, Iron -11.70, Ammonium formate-20)

Process emission (oxygen)

6.70

Organic Residue 15.6

Process residue -3.6 Distillation Residue-12 (Ethanol -6, Tetra hydrofuran-6)

Total 1010 Total 1010

Material balance of Dabigartan Stage-5

Batch Size: 100.0Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

4-amino benzonitrile 25.00 Stage-5 35.00

2-bromoacetic acid 30.00 Effluent water 300.00

Water 300.00 (Water-300)

Byproduct (Hydrobromic acid)

17.15

Organic Residue 2.85

Total 355 Total 355

Material balance of Dabigartan Stage-6

Batch Size: 100.0Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Stage-4 68.00 Stage-6 89.00

Stage-5 35.00 Dichloromethane Recovery 190.00

Dichloromethane 200.00 Dichloromethane loss 4.00

Ethyl acetate 200.00 Ethyl acetate Recovery 190.00

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Water 300.00 Ethyl acetate loss 4.00

Effluent water 313.15

(Water-300 Ethyl acetate -6, Generated water -7.15

Organic Residue 12.85

Process residue -6.85 Distillation Residue-6 (Dichloromethane -6)

Total 803 Total 803

Material balance of Dabigartan Stage-7

Batch Size: 100.0Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Stage-6 89.00 Stage-7 87.00

Ammonium carbonate 18.00 Ethanol Recovery 190.00

Ethanol 200 Ethanol loss 4.00

Isopropyl alcohol 200.00 Isopropyl alcohol Recovery 190.00

Water 300.00 Isopropyl alcohol loss 4.00

Effluent water 303.25

(Water-300 Generated water -3.35)

Process emission (Carbon dioxide-8.10, Ammonia-3.13),

11.23

Organic Residue 17.52

Process residue -5.52 Distillation Residue-12 (ethanol-6, Isopropyl alcohol-6 )

Total 807 Total 807

Material balance of Dabigartan Stage-8

Batch Size: 100.0Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Stage-7 87.00 Dabigartan 100.00

Hexyl chloro formate 29.00 Tetrahydrofuran Recovery 190.00

Potassium carbonate 25.00 Tetrahydrofuran loss 4.00

Tetrahydrofuran 200.00 Effluent water 327.63

Water 300.00 (Water-300 , Potassium formate-14.65, potassium chloride-12.98)

Process emission (Oxygen)

2.78

Organic Residue 16.59

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Process residue -10.59 Distillation Residue-6 (THF )

Total 641 Total 641

12. DULOXETIN HYDROCHLORIDE

Process Description

Stage-1

(S)-3-Dimethyl amino -1-thiophen -2-yl-propan-1-ol reacts with in presence of DMSO

and Potassium hydroxide to give stage -1 product

Stage-2

Stage-1 product reacts with oxalic acid, Phenyl chloro formate and Sodium

hydroxide in presence of Di isopropyl ethyl amine to give stage-2 product

Stage-3

Stage-2 product reacts with Hydrochloric acid in presence of Ethyl acetate to give

stage-3 product

Stage-4

Stage-3 product undergoes purification in Ethyl acetate and Methanol to give

Duloxetin Hydrochloride product

Route of synthesis

Stage-1 OH

NCH3

CH3

S

C9H15NSO185.29

+

(S)-3-Dimethylamino-1-thiophen-2-yl-propan-1-ol

F

1-fluoronaphthalene

C10H7F

145.15

O

NCH3

CH3

S

(S)-N,N-Dimethyl-[3-(naphthalen-1-yloxy)-3-thiophen-2-yl)-

propan-1-amineC19H21NSO

311.44

+ HF

20.01

DMSO, Potassium hydroxide, toluene & Water

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Stage-2

O

NCH3

CH3

S

(S)-N,N-Dimethyl-[3-(naphthalen-1-yloxy)-3-thiophen-2-yl)-

propan-1-amine

C19H21NOS

311.44

+

diisopropylethylamine

O OH

OHOOxalicacid

C2H2O4

90.03

O

NHCH3

SO OH

OHO.

(S)-N-N-Dimethyl-[3-(naphthalen-1-yloxy)-3-thiophen-2-yl-propan-1-oxalate]

C20H21NSO5

387.45

+

+

Phenylchloroformate

O

OCl

C7H5ClO2156.57

+ NaOH

40.00

Methyl benzoate

136.15

O O

C8H8O2

+ NaCl

58.44

+ O2

32.00

Water

Stage-3

O

NH

CH3

SO OH

OHO.

(S)-N-N-Dimethyl-[3-(naphthalen-1-yloxy)-3-thiophen-2-yl-propan-1-oxalate]

C20H21NSO5

387.45

+ HCl

36.46

Ethylacetate

O

HNCH3

S. HCl

C18H20ClNOS

338.88

O OH

OHO+

Oxalic acid

C2H2O4

90.03

Duloxetin hydrochlorideCrude

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Stage-4

EthylacetateMethanol

O

NHCH3

S. HCl

C18H20ClNOS

338.88

O

HN

CH3

S. HCl

C18H20ClNOS

338.88

Duloxetin hydrochloride pureDuloxetin hydrochloride Crude

Flow chart:

(S)-3-Dimethylamino-1-thiophen -2-yl-propan-1-ol1-fluoronaphthalenePotassium hydroxide DMSOToluene Water

Stage-1

Toluene RecoveryDMSO RecoveryEffluent water

Stage-2Diisopropyl ethylamine RecoveryEffluent water

Stage-1Oxalic acidPhenyl chloro formate Sodium hydroxide Diisopropyl ethylamine Water

Stage-3Ethyl acetate RecoveryEffluent water

Stage-2Hydrochloric acid Ethyl acetate Water

Stage-4Methanol RecoveryEthyl acetate Recover

Stage-3Methanol Ethyl acetate

Duloxetin Hydrochloride

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Material Balance:

Material balance of Duloxetin Hydrochloride Stage-1

Batch Size: 100.0Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

(S)-3-Dimethylamino-1-thiophen -2-yl-propan-1-ol

74.00 Stage-1 118.00

1-fluoronaphthalene 58.00 Toluene Recovery 190.00

Potassium hydroxide 10.00 Toluene loss 4.00

DMSO 200.00 DMSO Recovery 190.00

Toluene 200.00 DMSO loss 4.00

Water 300.00 Effluent water 316.00

(Water-300 DMSO-6, Potassium hydroxide-10)

Process emission (Hydrogen Fluoride)

7.98

Organic Residue 12.02

Process residue -6.02 Distillation Residue-6 (Toluene)

Total 842 Total 842

Material balance of Duloxetin Hydrochloride Stage-2

Batch Size: 100.0Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Stage-1 118.00 Stage-2 135.00

Oxalic acid 35.00 Diisopropyl ethylamine Recovery 190.00

Phenyl chloro formate 60.00 Diisopropyl ethylamine loss 4.00

Sodium hydroxide 16.00 Effluent water 373.75

Diisopropyl ethylamine 200.00 (Water-300 Methyl benzoate -51.60, Sodium chloride-22.15)

Water 300.00 Process emission (Oxygen)

12.11

Organic Residue 14.14

Process residue -8.14 Distillation Residue-6 (Diisopropyl ethylamine)

Total 729 Total 729

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Material balance of Duloxetin Hydrochloride Stage-3

Batch Size: 100.0Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Stage-2 135.00 Stage-3 106.00

Hydrochloric acid 13.00 Ethyl acetate Recovery 190.00

Ethyl acetate 200.00 Ethyl acetate loss 4.00

Water 300.00 Effluent water 334.40

(Water-300 Oxalic acid-31.40, Ethyl acetate-3)

Organic Residue 13.60

Process residue -10.60 Distillation Residue-3 (Ethyl acetate)

Total 648 Total 648

Material balance of Duloxetin Hydrochloride Stage-4

Batch Size: 100.0Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Stage-3 106.00 Duloxetin Hydrochloride 100.00

Methanol 200.00 Methanol Recovery 190.00

Ethyl acetate 200.00 Methanol loss 4.00

Ethyl acetate Recovery 190.00

Ethyl acetate loss 4.00

Organic Residue 18.00

Process residue -6 Distillation Residue-12 (Ethyl acetate-6, Methanol-6)

Total 506 Total 506

13. EMTRICITABINE

Process Description: Stage-1 5-(4-Amino-5-fluoro-2-oxo-2H-pyrimidin-1-yl)-[1,3]Oxa thiolane-2-carboxylic acid-2-

isopropyl-5-methyl cyclo hexyl ester undergoes reduction with Sodium borohydride

in presence of Ethanol , Toluene and Isopropyl alcohol to give stage -1 product.

Stage-2

Stage-1 undergoes neutralization with Tri ethylamine in the presence of Methanol

and MDC to give stage -2 product.

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Stage-3

Stage-2 undergoes purification in Isopropyl alcohol and activated carbon to give

Emtricitabine.

Route of synthesis: Stage-1:

O

O

S

O

N

NF

NH2

O

CH3

CH3H3C

5-(4-Amino-5-fluoro-2-oxo-2H-pyrimidin-1-yl)-[1,3]oxathiolane-2-carboxylic acid 2-isopropyl

-5-methyl-cyclohexyl ester

C18H26FN3O4S

399.48

+ NaBH4 +

O

S

N

NF

NH2

O

HO

CH3

CH3H3C

OH

4X18=72.0

H3BO3

+

37.83

4 H2O

36.46

+ 2 H2

C10 H20O

156.26

Menthol4-Amino-5-fluoro-1-(2-hydroxy

methyl-[1,3]oxathiolan-5-yl)-1H-pyrimidin-2-one 4.00

+ +

C8H11ClFN3O3S

283.70

EthanolToluene, IPA

HCl

58.44

NaCl +

Boric acid

61.83

HCl

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Stage-2:

O

S

N

NF

NH2

O

HO

4-Amino-5-fluoro-1-(2-hydroxymethyl-[1,3]oxathiolan-5-yl)-1H-

pyrimidin-2-one

C8H11ClFN3O3S

283.70

+

Triethyl amine

C6H15N

101.19

O

S

N

NF

NH2

O

HO(C2H5)3N

+ (C2H5)3N.HCl

4-Amino-5-fluoro-1-(2-hydroxymethyl-[1,3]oxathiolan-5-yl)-1H-pyrimidin-2-one

C8H10FN3O3S

247.25

137.65

Triethyl amine Hydrochloride

Methanol

MDC

H

Cl

Stage-3:

O

S

N

NF

NH2

O

HO

Emtricitabine(Crude)

C8H10FN3O3S

247.25

Purification

IPA

O

S

N

NF

NH2

O

HO

Emtricitabine(Pure)

C8H10FN3O3S

247.25

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Flow chart:

5-(4-Amino-5-fluoro-2-oxo-2H-pyrimidin-1-yl)-[1,3]Oxa thiolane-2-carboxylic acid-2-isopropyl-5-methyl cyclo hexyl esterIPA.HCl (25%)Dipotassium hydrogen phosphateSodium Hydroxide EthanolSodium borohydrideTolueneActivated carbonIsopropyl alcoholHydrochloric AcidWater

Stage-1

Isopropyl alcohol RecoveryToluene RecoveryEthanol RecoveryEffluent Water

Methanol RecoveryMDC Recovery

Stage-2Isopropyl alcoholActivated carbonHyflow

IPA RecoverySpent Carbon & Hyflow

Stage-2

Stage-3

EMTRICITABINE

Stage-1Tri ethylamineActivated carbonMethanolMDCHyflow

Material Balance:

Material Balance Of Emtricitabine Stage-1

Batch Size:100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

5-(4-Amino-5-fluoro-2-oxo-2H-pyrimidin-1-yl)-[1,3]Oxa thiolane-2-carboxylic acid-2-isopropyl-5-methyl cyclo hexyl ester

200.00 Stage-1 130.00

IPA.HCl (25%) 73.20 Isopropyl alcohol Recovery 145.90

Dipotassium hydrogen 10.00 Isopropyl alcohol Loss 2.00

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phosphate

Sodium Hydroxide 11.00 Toluene Recovery 95.00

Ethanol 200.00 Toluene Loss 2.00

Sodium borohydride 19.00 Ethanol Recovery 190.00

Toluene 100.00 Ethanol Loss 4.00

Activated carbon 13.00 Effluent Water 1069.78

Isopropyl alcohol 100.00 (Water-982, Sodium borate-32.9, Dipotassium hydrogen phosphate-10 Sodium chloride-32.02, Generated water-9.86, Toluene-3,)

Hydrochloric Acid 20.00 Spent Carbon 13.00

Water 1000.00 By-Product (L-Menthol )

78.23

Process Emission 2.00

(Hydrogen) 0

Organic residue 14.29

Process residue-5.29 Distillation Resideu-9 (Ethanol-6 IPA-3)

Total 1746.20 Total 1746.20

Material Balance Of Emtricitabine Stage-2

Batch Size: 100.0 Kg/Day

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-1 130.00 Stage-2 105.00

Tri ethylamine 47.00 Methanol Recovery 95.00

Activated carbon 5.00 Methanol Loss 2.00

Methanol 100.00 MDC Recovery 95.00

MDC 100.00 MDC Loss 2.00

Hyflow 5.00 Spent Carbon & Hyflow 10.00

Organic Residue 78.00

(Process residue-72 (Triethylamine-63.93, Organioc impurities-8.07) Distillation Residue-6 (MDC-3,Methanol-3

Total 387 Total 387

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Material Balance Of Emtricitabine Stage-3

Batch Size:100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-2 105.00 Emtricitabine 100.00

Isopropyl alcohol 100.00 IPA Recovery 95.00

Activated carbon 5.00 IPA Loss 2.00

Hyflow 5.00 Spent Carbon & Hyflow 10.00

Organic Residue 8.00

Process Residue-5 Distillation Residue-3 (IPA-3)

Total 215.00 Total 215.00

14. IMATINIB MESYLATE

Process Description:

Stage-1

O-Toluidine undergoes nitration with Nitric acid in presence of Sulphuric acid and

IPA to give Stage-1 product

Further Spent Nitration MLs (H2SO4) neutralization with ammonia gas to give

Ammonia sulphate as by product

Stage-2

Stage-1 product reacts with cyanamide in the presence of nitric acid and n-Butanol ,

IPE & Methanol to give stage-2 product.

Stage-3

Stage-2 product undergoes Condensation with 2-Dimethylamino-1-(3-pyridyl)-2-

propen-1-one in the presence of n-Butanol, Methanol & 2-Propanol to give stage-3

as product.

Stage-4

Stage-3 product undergoes reduction with Tin (II) chloride in presence of Chloroform

& Ethyl acetate to give stage-4 product.

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Stage-5

Stage-4 product undergoes condensation with 4-(4-methyl piperazino methyl)

benzoyl chloride in presence of Chloroform, DMF & Ethyl acetate to give stage-5 as

product.

Stage-6

Stage-5 product undergoes Condensation with Methane sulfonic acid in presence

of Methanol to give Imatinib Mesylate as product.

Route of synthesis:

Stage-1: CH3

NH2

+ HNO3

CH3

NH2

NO2

IPA

+ H2O

O-Toluidine

C7H9N

107.1563.01

Nitric acid

5-Nitro Toluidine

C7H8N2O2

160.21

18.00

+ H2SO4

98.08

+ 2 NH3

34.06

+(NH4)2SO4

132.14

Stage-2:

CH3

NH2

NO2

5-Nitro Toluidine

C7H8N2O2

152.15

+ NH2CN

Cyanamide

42.03

CH3HN

NO2

NH

NH2

HNO3

+ HNO3

63.01

N-Butanol, Methanol & IPE

2-Methyl-5-nitro-phenyl-guanidine Nitrate

C8H11N5O5

257.20

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Stage-3:

CH3HN

NO2

NH

NH2

HNO3

2-Methyl-5-nitro-phenyl-guanidine

Nitrate

C8H11N5O5

257.20

+

N

O

N

CH3

CH3

3-Dimethylamino-1-pyridin-3-yl-propenone

C10H12N2O

176.21

CH3

NO2

HN

N

N

N + 2H2O NaNO3+

(2-Methyl-5-nitro-phenyl)-(4-pyridin-3-yl-pyrimidin-2-yl)-amine

C16H13N5O2

307.31

+

Dimethyl amine

C2H7N

45.08

36.02

n-Butanol, Methanol+ NaOH

40.0

84.99

H3C

HN

CH3

Stage-4:

CH3

NO2

HN

N

N

N

(2-Methyl-5-nitro-phenyl)-(4-pyridin-3-yl-pyrimidin-2-yl)-amine

C16H13N5O2

307.30

+3H2

Hydrogen

3X2=6.00

CH3

NH2

HN

N

N

N

(N-(5-Amino-2-Methyl phenyl)-4-

(3-Pyridyl)-2-pyrimidine Amine

C16H15N5

277.32

+ 2H2O

2X18=36.00

Palladium on Carbon

Tin(II) chloride, Chloroform & Ethylacetate

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Stage-5: Step-A:

H2C

COOH

N N CH3 H2C

COCl

N N CH3

2HCl 2HCl

4-(4-Methyl-piperazin-1-ylmethyl)-benzoyl chloride Dihydrochloride

4-(4-Methyl-piperazin-1-ylmethyl)-benzoic acid Dihydrochloride

C13H20Cl2N2O2

307.22C13H19Cl3N2O

325.66

+ SOCl2

118.97

Dimethylformamide

+ SO2

64.06

+ HCl

36.45 Step-B

CH3

NH2

HN

N

N

N

(N-(5-Amino-2-Methyl phenyl)-4-(3-Pyridyl)-2-pyrimidine Amine

C16H15N5

277.32

+ COCl

N N CH3

2 HCl

4-(4-Methyl-piperazin-1-ylmethyl)-benzoyl chloride Hydrochloride

C13H17ClN2O.2HCl

325.66

3 HCl

N

NHN

HN

O

N

NCH3

N

CH3

4-(4-Methyl-piperazin-1-ylmethyl)-N-[4-methyl-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-phenyl]-

benzamide(Imatinib)

C29H31N7O

493.60

+

109.38

Chloroform, DMF & Ethylaceate

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Stage-6:

N

NHN

HN

O

N

NCH3

N

CH3

4-(4-Methyl-piperazin-1-ylmethyl)-N-[4-methyl-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-phenyl]-

benzamide(Imatinib)

C29H31N7O

493.60

+

Methane Sulphonic acid

CH3

SO O

OH

96.10

Methanol

N

NHN

HN

O

N

NCH3

N

CH3

CH3

SO O

OH

Imatinib Methane Sulfonate

C29H31N7O.CH4O3S

CH4O3S

589.71

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Flow Chart:

Stage-1

Stage-2

Stage-3

O-ToludineNitric acidSulfuric acidIPAWater

IPA RecoveryEffluent water

Stage-1Nitric acidCyanamideN-ButanolMethanolIPEWater

N-Butanol RecoveryIPE RecoveryMethanol RecoveryEffluent water

Stage-23-dimethylamino-1-(pyridyl0-2-propan-1-oneSodium hydroxideN-ButanolMethanol2-PropanolWater

N-Butanol RecoveryMethanol Recovery2-Propanol RecoveryEffluent water

IMATINIB MESYLATE

Stage-4

Stage-5

Stage-6

Stage-3Stannous chlorideHydrogen Chloroform Ethyl acetatePalladium on carbon Water

Chloroform RecoveryEthyl acetate RecoverySpent Palladium on carbon Recovery Effluent water

Stage-44-(4-methylpiperazine mono methyl)benzoic acid di HClThionyl chlorideChloroform DMFEthyl acetateWater

Chloroform RecoveryDMF RecoveryEthyl acetate RecoveryEffluent water

Stage-5Methane sulfonic acidMethanol

Methanol Recovery

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Material Balance:

Material Balance of Imatinib mesylate

Stage-1 Batch Size: 100Kgs

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

O-Toludine 31.00 Stage-1 42.00

Nitric acid 18.25 IPA Recovery 285.00 Sulfuric acid 28.50 IPA Loss 6.00 Ammonia 10.00 Effluent water 405.20

IPA 300.00 (Water-400, Generated Water-5.2)

Water 400.00 By products (Ammonium sulphate)

38.50

Organic residue Process residue-2.05 Distillation Residue-9 (IPA)

11.05

Total 787.75 Total 787.75

Material Balance of Imatinib mesylate

Stage-2 Batch Size: 100Kgs

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-1 42.00 Stage-2 69.00

Nitric acid 17.40 N-Butanol Recovery 285.00 Cyanamide 11.60 N-Butanol Loss 6.00 N-Butanol 300.00 IPE Recovery 190.00 Methanol 300.00 IPE Loss 10.00 IPE 200.00 Methanol Recovery 285.00 Water 300.00 Methanol Loss 6.00

Effluent water 300.00

(Water-300)

Organic residue (Process residue-2 Distillation Residue-18 (Methanol-9, n-Butanol-9)

20.00

Total 1171.00 Total 1171

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Material Balance of Imatinib mesylate

Stage-3 Batch Size: 100Kgs

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-2 69.00 Stage-3 80.00

3-dimethylamino-1-(pyridyl0-2-propan-1-one

47.30 N-Butanol Recovery 190.00

Sodium hydroxide 10.75 N-Butanol Loss 10.00 N-Butanol 200.00 Methanol Recovery 190.00 Methanol 200.00 Methanol Loss 4.00

2-Propanol 200.00 2-Propanol Recovery 190.00 Water 300.00 2-Propanol Loss 10.00 Effluent water

(Water-300, Generated Water-9.70, Sodium nittate-22.8)

332.80

Process emission (Dimethylamine)

12.08

Organic residue- (Process residue-2.17 Distillation Residue-6 (Methanol)

8.17

Total 1027.05 Total 1027.05

Material Balance of Imatinib mesylate

Stage-4 Batch Size: 100Kgs

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-3 80.00 Stage-4 70.00

Tin(II) chloride 10.00 Chloroform Recovery 190.00 Hydrogen 1.56 Chloroform Loss 4.00 Chloroform 200.00 Ethyl acetate Recovery 285.00

Ethyl acetate 300.00 Ethyl acetate Loss 6.00 Palladium on carbon 10.00 Spent Palladium on carbon

Recovery 10.00

Water 400.00 Effluent water 423.40

(Water-400, Generated Water-9.40, Ethyl acetate-4, Stannous chloride-10 )

Organic Residue (Process residue-2.16 Distillation Residue-11 (Chloroform -6,Ethyl acetate-5)

13.16

Total 1001.56 Total 1001.56

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Material Balance of Imatinib mesylate

Stage-5 Batch Size: 100Kgs

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-4 70.00 Stage-5 87.00

4-(4-methylpiperazine mono methyl)benzoic acid di HCl

57.00 Chloroform Recovery 190.00

Thionyl chloride 22.10 Chloroform Loss 4.00 Chloroform 200.00 DMF Recovery 285.00 DMF 300.00 DMF Loss 6.00

Ethyl acetate 300.00 Ethyl acetate Recovery 285.00 Water 300.00 Ethyl acetate Loss 6.00 Effluent water 309.00 (Water-300,Ethyl acetate-9)

Process Emission 38.45 (Sulphur dioxide-11.88,

Hydrogen chloride-26.57)

Organic residue (Process Residue-23.65 Distillation Residue-15 (Chloroform-6, DMF-9)

38.65

Total 1249.1 Total 1249.1

Material Balance of Imatinib mesylate

Stage-6 Batch Size: 100Kgs

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-5 87.00 Imatinib mesylate 100.00

Methane sulfonic acid 16.95 Methanol Recovery 285.00 Methanol 300.00 Methanol Loss 6.00 Organic residue

(Process residue-3.95 Distillation Residue-9 (Methanol)

12.95

Total 403.95 Total 403.95

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15. ITRCONAZOLE

Process Description

Stage-1

1-[2,(2,4-Dichloro-phenyl)-4-ethyl-[1,3] dioxolan-2-ylmethyl]-1H-[1,2,4] triazole reacts

with 2-{4-(4-hydroxy –phenyl)-piperazin -1-yl ]-4-isobutyl-2,4-di hydro-[1,2,4] triazol-

3-one in presence of sodium hydroxide , Toluene and Methanol to give

Itraconazole product

Route of Synthesis

Stage-1

ClCl

O

O

N

O3SH3C

N

N

C14H15Cl2N3O5S

408.26

C22H27N5O2

393.48

+ NaOH

40.00

Touene, Methanol

CH3O2SONa + H2O

Methane sulfonate Sodium

118.09

18.02

1-[2-(2,4-Dichloro-phenyl)-4-ethyl-[1,3]dioxolan

-2-ylmethyl]-1H-[1,2,4]triazole;

+ HO N N NN

NO

CH3

CH3

2-{4-[4-(4-Hydroxy-phenyl)-piperazin-1-yl]-phenyl}-4-isobutyl-2,4-dihydro

-[1,2,4]triazol-3-one

O N N NN

N

O

CH3

CH3Cl Cl

O

O

NN

N

+

C35H38Cl2N8O4

705.63

ITRACONAZOLE

MDC, Water

Flowchart:

1-[2-(2,4-Dichloro-phenyl)-4-ethy l-[1,3]dioxolan -2-ylmethyl]-1H-[1,2,4]triazole2-{4-[4-(4-Hydroxy-phenyl)-piperazin- 1-yl]-phenyl}-4-isobutyl-2,4-dihydro -[1,2,4]triazol-3-oneSodium hydroxideToluene MethanolDichloro methane Water

Stage-1

Toluene RecoveryMethanol RecoveryDichloro methane RecoveryEffluent Water

Itraconazole

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Material Balance:

Material Balance of Itraconazole Stage-1

Batch Size:100.00Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

1-[2-(2,4-Dichloro-phenyl)-4-ethy l-[1,3]dioxolan -2-ylmethyl]-1H-[1,2,4]triazole

65.00 Itraconazole 100.00

2-{4-[4-(4-Hydroxy-phenyl)-piperazin- 1-yl]-phenyl}-4-isobutyl-2,4-dihydro -[1,2,4]triazol-3-one

63.00 Toluene Recovery 190.00

Sodium hydroxide 7.00 Toluene loss 4.00

Toluene 200.00 Methanol Recovery 190.00

Methanol 200.00 Methanol Loss 4.00

Dichloro methane 200.00 Dichloro methane Recovery 190.00

Water 500.00 Dichloro methane loss 4.00

Effluent Water (Water-500, Generated Water-2.9 Sodium Methane Sulfonate-18.80, Toluene-6

527.70

Organic residue 25.30

Process residue-13.3 Distillation Residue-12 (Methanol-6, Dichloro methane -6)

Total 1235 Total 1235

16. KETORLAC TROMETHAMINE

Process Description

Stage-1

Step-A

Benzoyl chloride reacts with Morpholine in presence of Sodium hydroxide and

Toluene to give step-A product

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Step-B

Step-A product reacts with pyrrole and phosphorus oxy chloride in presence of

Sodium hydroxide and water to give stage-1 product

Stage-2

Di ethyl malonate reacts with Ethyl chloroforate in presence of Magnesium oxide,

Hydrochloric acid, Toluene and water to give stage-2 product

Stage-3

Stage-1 product reacts with stage-2 product in presence of Potassium

permanngate, Manganesactate, Acetic acid and acetic anhydride to give stage-3

product

Stage-4

Stage-3 product reacts with Dichloro ethane in presence of water, Tetra-n-butyl

ammonium bromide (TBAB) and Ethylene Dichloride (EDC) to give stage -4 products

Stage-5

Stage-4 product undergoes hydrolysis with Sodium hydroxide, water and

Hydrochloric acid in presence of Ethyl acetate to give Ketorolac product

Stage-6

Ketorolac Crude reacts with Tromethamine in presence of Acetone and Ethyl acetate

to give Ketorolac Tromethamine

Route of synthesis

Stage-1

Step-A

Cl

O

Benzoyl chloride

C7H5ClO

140.57

+

Morpholine

HN

O

C4H9NO

87.12

+ NaOH

40.00

TolueneO

N

O

Morpholin-4-yl-phenyl-methanone

C11H13NO2

191.23

+ NaCl

58.44

+ H2O

18.02

Water

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Step-B

Water

+ 3 NaCl

175.33

+ H3PO4

O

N

O

Morpholin-4-yl-phenyl-methanone

C11H13NO2

191.23

+

Pyrrole

NH

C4H5N

67.09

+ POCl3

153.33

+ 3 NaOH

119.99

HN

O

Phenyl-(1H-pyrrol-2-yl)-methanone

C11H9NO

171.20

97.99

HN

O

Morpholine

C4H9NO

87.12

Stage -2

O O

O O

Diethyl malonate

C7H12O4

160.17

+ MgO

40.30 Ethylchloroformate

+

C3H5ClO2

O

O Cl

108.52

Toluene , Water

O O

O O

O O

Triethyl methane tricarboxylate

C10H16O6

232.23

+ HCl

36.46

+ MgCl2

95.21

+ H2O

18.02

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Stage-3

Manganesactate,Potassium per mamganate , Acetic acid & Acetic anhydride

+ H2

HN

O

Phenyl-(1H-pyrrol-2-yl)-methanone

C11H9NO

171.20

O O

O O

O O

2-Ethoxycarbonyl-malonic acid diethyl ester

+

C10H16O6

232.23HN

O O OO

O

OO

2-(5-Benzoyl-1H-pyrrol-2-yl)-2-ethoxycarbonyl-malonic acid diethyl ester

C21H23NO7

401.41

2.02

water

Stage-4

TBAB, EDC+

HN

O O OO

O

OO

2-(5-Benzoyl-1H-pyrrol-2-yl)-2-ethoxycarbonyl-malonic acid diethyl ester

C21H23NO7

401.41

Dichloroethane

Cl

Cl

C2H4Cl2

98.96

N

OO

O

OO

5-Benzoyl-2,3-dihydro-pyrrolizine-1,1-dicarboxylic acid diethyl ester

C20H21NO5

355.38

+ 2 HCl

72.92

+ C2H5OH

46.07

+ H2O

18.02

+ CO2

44.01

Water

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Stage-5

N

OO

O

OO

5-Benzoyl-2,3-dihydro-pyrrolizine-1,1-dicarboxylic acid diethyl ester

C20H21NO5

355.38

+ NaOH

40.00

+ HCl

36.46

Ethyl acetate

O

O

H

Formic acid ethyl ester

C3H6O2

74.08

+ NaCl

58.44

+ H2O

18.02

N

O

OHO

Ketorolac

C15H13NO3

255.27

+ + C2H5OH

46.07

+ 0.5 O2

16.00

Water

Stage-6

Ethyl acetate

N

O

OHO

Ketorolac

C15H13NO3

255.27

+

Tromethamine

NH2HO

HOOH

C4H11NO3

121.14 N

O

OHO .

NH2HO

HOOH

Ketorolac Tromethamine

C19H24N2O6

376.40

Acetone

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Flow chart:

Benzoyl chloride Morpholine Sodium hydroxide Toluene Pyrrole Phosphoryl chlorideWater

Stage-1Toluene RecoveryEffluent water

Stage-2Toluene RecoveryEffluent water

Diethylmalonate Magnesium oxideEthylchloroformate Hydrochloric acid Toluene Water

Stage-3Acetic acid RecoveryEffluent water

Stage-1Stage-2Manganese acetate potassium permanganateAcetic acidAcetic anhydride Water

Stage-4 EDC RecoveryEffluent water

Stage-3Dichloroethane (EDC)TBAB Water

Stage-4Sodium hydroxideHydrochloric acid Ethyl acetate Water

Stage-5Ethyl acetate RecoveryEffluent water

Stage-5Tromethamine Acetone Ethyl acetate

Stage-6Ethyl acetate RecoveryAcetone Recovery

Ketorolac Tromethamine

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Material Balance

Material Balance of Ketorolac Tromethamine Stage-1

Batch Size: 100Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Benzoyl chloride 71.00 Stage-1 73.00

Morpholine 44.00 Toluene Recovery 190.00

Sodium hydroxide 77.30 Toluene Loss 4.00

Toluene 200.00 Effluent water 713.12

Pyrrole 32.00 (water-500,Sodium chloride-112.94, Generated water-9.10, Toluene-3, Phosphoric acid-46.63, Morpholine-41.45)

Phosphoryl chloride 73.00 Organic Residue 17.18

Water 500.00 Process residue-14.18 Distillation residue -3 (Toluene -3)

Total 997.3 Total 997.3

Material Balance of Ketorolac Tromethamine Stage-2

Batch Size: 100Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Diethylmalonate 71.00 Stage-2 99.00

Magnesium oxide 18.00 Toluene Recovery 190.00

Ethylchloroformate 48.00 Toluene Loss 4.00

Hydrochloric acid 16.20 Effluent water 550.20

Toluene 200.00 (water-500, Magnesium chloride-42.20, Generated Water-8)

Water 500.00 Organic Residue 10.00

Process residue-4 Distillation residue -6 (Toluene -6)

Total 853.2 Total 853.2

Material Balance of Ketorolac Tromethamine Stage-3

Batch Size: 100Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-1 73.00 Stage-3 152.00

Stage-2 99.00 Acetic acid Recovery 190.00

Manganese acetate 10.00 Acetic acid Loss 4.00

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potassium permanganate 10.00 Effluent water 754.00

Acetic acid 200.00 (water-500, Manganese acetate -10, potassium permanganate -10, Acetic anhydride-234)

Acetic anhydride 234.00 Process emission (Hydrogen)

0.86

Water 500.00 Organic Residue 25.14

Process residue-19.14 Distillation residue -6 (Acetic acid -6)

Total 1126 Total 1126

Material Balance of Ketorolac Tromethamine Stage-4

Batch Size: 100Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-3 152.00 Stage-4 118.00

Dichloroethane (EDC) 238.00 EDC Recovery 190.00

TBAB 10.00 EDC Loss 4.00

Water 500.00 Effluent water 527.45

(water-500, TBAB-10, Ethanol-17.45)

Process emission (Hydrogenchloride-27.61 Carbon dioxide-16.66)

44.27

Organic Residue 16.28

Process residue-10.28 Distillation residue -6 (EDC)

Total 900 Total 900

Material Balance of Ketorolac Tromethamine Stage-5

Batch Size: 100Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-4 118.00 Stage-5 76.00

Sodium hydroxide 13.50 Ethyl acetate Recovery 190.00

Hydrochloric acid 12.00 Ethyl acetate Loss 4.00

Ethyl acetate 200.00 Effluent water 562.40

Water 500.00 (water-500, Sodium chloride-19.5, Ethanol-15.30, Formic acid ethyl ester-24.6, Ethyl acetate -3)

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Process emission (Oxygen)

5.31

Organic Residue 5.79

Process residue-2.79 Distillation residue -3 (Ethyl acetate)

Total 843.5 Total 843.5

Material Balance of Ketorolac Tromethamine Stage-6

Batch Size: 100Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-5 76.00 Ketorolac Tromethamine 100.00

Tromethamine 36.00 Ethyl acetate Recovery 190.00

Acetone 200.00 Ethyl acetate Loss 4.00

Ethyl acetate 200.00 Acetone Recovery 190.00

Acetone Loss 4.00

Organic Residue 24.00

Process residue-12 Distillation residue -12 (Ethyl acetate-6, Acetone-6)

Total 512 Total 512

17. LANSPRAZOLE

Process Description

Stage-1

2, 3 –Lutidine reacts with Hydrogen Peroxide in presence of Acetic acid to give

stage-1 product

Stage-2

Stage-1 product reacts with Sulphuric acid, nitric acid and Ammonia to give stage-2

product

Stage-3

Stage-2 product reacts with trifuloro ethanol, Potassium carbonate ,Acetic anhydride

in presence of Tetra –n-butyl Ammonium bromide (TBAB),Sodium hydroxide ,

Methyl isobutyl ketone (MIBK),Isopropyl alcohol, Toluene and Acetone to give

stage-3 product

Stage-4

Stage-3 product reacts with Thionyl chloride in presence of DiChloro methane,

Acetone and Methanol to give stage-4 product

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Stage-5

Stage-4 Product reacts with 2-mercapto benimidazole in presence of Sodium

hydroxide and Acetone to give Stage-5 product

Stage-6

Stage-5 Product reacts with Sodium hypochlorite in presence of Ammonium sulphate

and Acetone to give Lansprazole product

Route of Synthesis:

Stage-1

N

CH3

CH3

C7H9N

+ H2O2

34.00

N+

CH3

CH3

O-

C7H9NO

+ H2O

18.02

Aceticacid

107.16

123.15

2,3-Lutidine2,3-Dimethyl-4-nitro

-pyridine N-oxide

Stage-2

N+

CH3

CH3

O-

C7H9NO

123.15

2,3-Dimethyl-4-nitro-pyridine N-oxide

+ H2SO4 + HNO3

63.00

N

NO2

CH3

CH3

98.08

+ 2 NH3

34.062,3-Dimethyl-

4-nitro-pyridine-N-Oxide

Ammonium sulphate

(NH4)2SO4

132.12

+ + H2O

18.02

MethanolSodium hydroxide

methylenedichloride

O

C7H8N2O3

168.15

Water

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Stage-3

N

NO2

CH3

CH3

O+

4-Nitro-2,3-Dimethyl pyridine-N-Oxide

168.15

CF3CH2OH + K2CO3 + (CH3CO)2O + NaoH + HCl

Trifluoro ethanol

Acetic anhydride

100.04

138.21

102.09

40.00 36.46

N

OCH2CF3

CH3

CH2OH

. HCl

2-Hydroxy methyl-3-methyl pyridine hydrochloride

257.64

+ KHCO3

Potassium bicarbonate

100.12

+ KNO2

Potassium nitrite

85.10

+ CH3COONa

82.03

+ CH3COOH

60.05

C7H8N2O3

C9H11ClF3NO2

Tetra-n-butylammonium bromide(TBAB)Methylisobutylketone(MIBK)Isopropyl alcoholTolueneAcetone

Water

Stage-4

N

OCH2CF3

CH3

CH2OH

. HCl

2-Hydroxy methyl-3-methyl pyridine hydrochloride

257.64

+ SOCl2

118.97N

OCH2CF3

CH3

CH2Cl

. HCl

276.08

+ SO2

64.06

+ HCl

36.46

C9H11ClF3NO2

C9H10Cl2F3NO

MethylenedichlorideAcetonemethanol

2-Chloromethyl-3-methyl-4-(2,2,2-trifluoro-ethoxy)-pyridine

hydrochloride

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Stage-5

N

OCH2CF3

CH3

CH2Cl

. HCl

276.08

C9H10Cl2F3NO

2-Chloromethyl-3-methyl-4-(2,2,2-trifluoro-ethoxy)-pyridine

hydrochloride

+

HN

N

HS

2-Mercaptobenimidazole

C7H6N2S

150.22

Acetone

N

HN

SN

O

FF

F

H3C

2-[3-Methyl-4-(2,2,2-trifluoro-ethoxy)-pyridin-2-ylmethylsulfanyl]-

1H-benzoimidazole

C16H14F3N3OS

353.36

+ 2NaCl

116.88

+ 2H2O

36.02

+ 2NaOH

79.99

Stage-6

N

HN

SN

O

FF

F

H3C

2-[3-Methyl-4-(2,2,2-trifluoro-ethoxy)-pyridin-2-ylmethylsulfanyl]-

1H-benzoimidazole

C16H14F3N3OS

353.36

+ NaOCl

Sodium hypochlorite

74.44

AcetonewaterAmmonium Sulphate

N

HN

S N

O

FF

F

H3C

C16H14F3N3O2S

O

369.36

Lansprazole

+ NaCl

58.44

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Flow chart:

Stage-1

Stage-2

Stage-3

Stage-4

2,3-LutidineHydrogen peroxide (50%)Acetic acid

By-products(Acetic acid+Generated Water)

Stage-1Sulphuric acid Nitric acidAmmoniaSodium hydroxide MethanolMethylene di chloride Water

Methanol RecoveryMethylene di chloride recoveryEffluent water

Isopropyl alcohol RecoveryMethyl isobutyl ketone recoveryToluene RecoveryAcetone RecoveryEffluent water

Stage-2Trifluoroethanol Potassium carbonate Acetic anhydrideSodium hydroxideHydrochloric acid Tetra-n-butylammonium bromide(TBAB)Methyl isobutyl ketoneIsopropyl alcoholTolueneAcetone Water

Methylene dichloride RecoveryMethanol RecoveryAcetone RecoveryEffluent water

Lansprazole

Stage-3Thionyl chlorideMethylene dichlorideMethanolAcetoneWater

Stage-42-MercaptobanzimidazoleSodium hydroxideAcetoneWater

Stage-5Acetone RecoveryEffluent water

Stage-5Sodium hypo chlorite Acetone Ammonium sulphate Water

Stage-6Acetone RecoveryEffluent water

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Material Balance:

Material Balance of Lansprazole Stage-1

Batch Size: 100Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

2,3-Lutidine 47.00 Stage-1 51.00

Hydrogen peroxide (50%) 30.00 By-products (Acetic acid+ Water)

222.90

Acetic acid 200.00 Organic Residue Process Residue-3.10

3.10

Total 277.00 Total 277.00

Material Balance of Lansprazole Stage-2

Batch Size: 100Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-1 51.00 Stage-2 63.00

Sulphuric acid 41.00 Methanol Recovery 190.00

Nitric acid 27.00 Methanol Loss 4.00

Ammonia 15.00 Methylene di chloride recovery 285.00

Sodium hydroxide 5.00 Methylene di chloride loss 6.00

Methanol 200.00 Effluent water 512.50

Methylene di chloride 300.00 (water-500, Generatedwater-7.50, Sodium hydroxide-5)

Water 500.00 By-Product (Ammonium sulphate)

55.00

Organic Residue 23.50

Process residue-8.5 Distillation residue -15 ( Methanol-6, Methylene dichloride-9)

Total 1139 Total 1139

Material Balance of Lansprazole Stage-3

Batch Size: 100Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-2 63.00 Stage-3 88.00

Trifluoroethanol 38.00 Isopropyl alcohol Recovery 190.00

Potassium carbonate 52.00 Isopropyl alcohol Loss 4.00

Acetic anhydride 39.00 Methyl isobutyl ketone recovery 190.00

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Sodium hydroxide 15.00 Methyl isobutyl ketone loss 10.00

Hydrochloric acid 14.00 Toluene Recovery 190.00

Tetra-n-butylammonium bromide(TBAB)

10.00 Toluene loss 4.00

Methyl isobutyl ketone 200.00 Acetone Recovery 190.00

Isopropyl alcohol 200.00 Acetone loss 4.00

Toluene 200.00 By product (Acetic acid)

22.50

Acetone 200.00 Effluent water 616.20

Water 500.00 (water-500, Potassium bicarbonate-37.55, Potassium nitrite-31.90,Sodium acetate-30.75 , Toluene-6, TBAB-10)

Organic Residue 22.30

Process residue-10.3 Distillation residue -12 (Isopropyl alcohol-6, Acetone-6 )

Total 1531 Total 1531

Material Balance of Lansprazole Stage-4

Batch Size: 100Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-3 88.00 Stage-4 89.00

Thionyl chloride 41.00 Methylene dichloride Recovery 190.00

Methylene dichloride 200.00 Methylene dichloride Loss 4.00

Methanol 200.00 Methanol Recovery 190.00

Acetone 200.00 Methanol Loss 4.00

Water 500.00 Acetone Recovery 190.00

Acetone Loss 4.00

Effluent water 500.00

(water-500)

Process emission (Sulphur dioxide-21.82 Hydrogen chloride-12.45)

34.27

Organic Residue 23.73

Process residue-5.73 Distillation residue -18 (Methanol-6, Methylene dichloride -6, Acetone-6)

Total 1229 Total 1229

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Material Balance of Lansprazole Stage-5

Batch Size: 100Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-4 89.00 Stage-5 104.00

2-Mercaptobanzimidazole 49.00 Acetone Recovery 285.00

Sodium hydroxide 26.00 Acetone Loss 6.00

Acetone 300.00 Effluent water 549.30

Water 500.00 (water-500,Sodium chloride-37.7 Generated Water -11.6)

Organic Residue 19.70

Process residue-10.7 Distillation residue -9 ( Acetone-9)

Total 964 Total 964

Material Balance of Lansprazole Stage-6

Batch Size: 100Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-5 104.00 Lansprazole 100.00

Sodium hypo chlorite 22.00 Acetone Recovery 190.00

Acetone 200.00 Acetone Loss 4.00

Ammonium sulphate 25.00 Effluent water 542.00

Water 500.00 (water-500,Sodium chloride-17, Ammonium sulphate-25)

Organic Residue 15.00

Process residue-9 Distillation residue -6 ( Acetone)

Total 851 Total 842

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18. MESALAMINE

Process Description

Stage-1

2-Chloro benza ldehyde under goes nitration with Nitric acid in presence of

Sulphuric acid and water to give stage -1 product

Stage-2

Stage-1 reacts with Potassium permanganate and water in presence of Acetone to

give stage-2 product

Stage-3

Stage-2 undergoes Hydrolysis with Potassium hydroxide in presence of Acetone and

Ethyl acetate to give stage-3 product

Stage-4

Stage-3 product undergoes Hydrogenation with Hydrogen in presence of Raney

nickel and Methanol to give Mesalamine product

Route of synthesis:

Stage-1

Cl O

2-Chloro-benzaldehyde

C7H5ClO

140.57

+ H2SO4

98.08

+ HNO3

63.01

Cl O

NO2Water

2-Chloro-5-nitro-benzaldehyde

C7H4ClNO3

185.56

+ SO2

64.06

+ 0.5 O2

16.00

+ 2 H2O

36.03

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Stage-2

AcetoneH2

2.02

+

Cl O

NO2

2-Chloro-5-nitro-benzaldehyde

C7H4ClNO3

185.56

+ 2 KMnO4

potassium permanganate

316.07

Cl O

NO2

OH

2-Chloro-5-nitro-benzoic acidC7H4ClNO4

201.56

+H2O

18.02

+ K2MnO4

potassium manganate

197.13

+ MnO2

86.94

+ O2

32.00

Stage-3

Acetone & Ethyl acetate +KOHKCl

74.55

+

Cl O

NO2

OH

2-Chloro-5-nitro-benzoic acidC7H4ClNO4

201.56

56.11

OH O

NO2

OH

2-Hydroxy-5-nitro-benzoic acid

C7H5NO5

183.12

Stage-4

Raney Nickel,Methanol

+ H2

OH O

NO2

OH

2-Hydroxy-5-nitro-benzoic acid

C7H5NO5

183.12

2.02

+

OH O

NH2

OH

Mesalamine

C7H7NO3

153.14

O2

36.00

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Flowchart:

Mesalamine

Stage-1 Effluent water

2-chloro-benzaldehyde Sulphuric acid Nitric acid Water

Stage-1Potassium permanganate Acetone Water

Stage-2

Acetone RecoveryEffluent water

Stage-2Potassium hydroxide Acetone Ethyl acetate Water

Stage-3

Acetone Recovery Ethyl acetate Recovery Effluent water

Stage-3Raney Nickel Hydrogen Methanol

Stage-4

Methanol Recovery Raney nickel Recovery/Reuse

Material Balance:

Material Balance of Mesalamine Stage-1

Batch Size:100kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

2-chloro-benzaldehyde 138.00 Stage-1 164.00

Sulphuric acid 96.50 Effluent Water 335.40

Nitric acid 62.00 (Water-300, Generated Water -35.40)

Water 300.00 Process Emission 78.58

(Oxygen-15.70, Sulphur dioxide-62.88))

Organic Residue 18.52

Total 596.5 Total 596.5

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Material Balance of Mesalamine Stage-2

Batch Size:100kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-1 164.00 Stage-2 160.00

Potassium permanganate 279.50 Acetone Recovery 190.00

Acetone 200.00 Acetone loss 4.00

Water 300.00 Effluent Water 535.10

(Water-284,Potassium manganate-174.25, Manganese dioxide-76.85)

Process Emission 28.27

(Oxygen-28.27

Organic Residue Process Residue-20.13 Distillation Residue-6 (Acetone)

26.13

Total 943.5 Total 943.5

Material Balance of Mesalamine Stage-3

Batch Size:100kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-2 160.00 Stage-3 133.00

Potassium hydroxide 45.00 Acetone Recovery 190.00

Acetone 200.00 Acetone loss 4.00

Ethyl acetate 200.00 Ethyl acetate Recovery 190.00

Water 300.00 Ethyl acetate loss 4.00

Effluent water (Water-300,Potassium Chloride-59.20, Ethyl acetate-6)

365.20

Organic Residue Process Residue-12.8 Distillation Residue-6 (Acetone, )

18.80

Total 905 Total 905

Material Balance of Mesalamine Stage-4

Batch Size:100kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-3 133.00 Mesalamine 100.00

Raney Nickel 10.00 Methanol Recovery 190.00

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Hydrogen 1.50 Methanol loss 4.00

Methanol 200.00 Raney nickel Recovery/Reuse

10.00

Process emission (Oxygen

26.13

Organic Residue Process Residue-8.37 Distillation Residue-6 (Methanol)

14.37

Total 344.5 Total 344.5

19. OLEMESARTAN MEDOXOMIL

Process Description

Stage-1

Diamino maleonitrile reacts with Tri methyl orthobutarate in presence of Acetonitrile

to give stage-1 product

Stage-2

Stage-1 product reacts with Hydrochloric acid in presence of water to give stage-2

product

Stage-3

Step-A

Stage-2 product reacts undergoes Thionyl chloride in presence of Ethyl Acetate to

give step-a product

Step-B

Step-A product under goes Esterification with ethanol in presence of n-Hexane to

give stage-3 product

Stage-4

Stage-3 product reacts with Methyl magnesium chloride, water and Hydrochloric acid

in presence of Toluene, Di isopropyl ether and Acetone to give stage-4 product

Stage-5

Stage-4 product reacts with 4-[2-(Trityltetrazole)-5yl) phenyl] benzyl bromide (5-(4-

bromo methyl-biphenyl-2-yl)-2-trityl-2, 5-dihydro-1H-tetrazole in presence of Ethyl

acetate to give stage-5 product

Stage-6

Stage-5 product reacts with Lithium hydroxide mono hydrate in presence of Dioxane,

Ethyl acetate to give stage-6 product

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Stage-7

Stage-6 reacts with 4-Chloromethyl-5-methyl-[1,3]dioxol-2-one in presence of Ethyl

acetate and Di methyl acetamide to give stage-7 product

Stage-8

Stage-7 product reacts with water in presence of Acetic acid and Toluene to give

Olmesartan medoxomil

Route of Synthesis:

Stage-1

DiaminoMaleonitrile

CN

NH2H2N

NC

C4H4N4

120.20

+

Tri methyl orthobutarate

OCH3

OCH3

OCH3

C2H5

(1,1,1-Trimethoxy-butane)

C7H16O3

148.20

Acetonitrile NH

N

NC

NC

CH3

2-Propyl-1H-imidazole-4,5-dicarbonitrile

C8H8N4

160.18

3 CH3OH+

96.13

Stage-2

WaterNH

N

NC

NC

CH3

2-Propyl-1H-imidazole-4,5-dicarbonitrile

C8H8N4

160.18

+ HCl + 4 H2O

72.0636.46

NH

N

CH3

O

HO

HO

O + NH4Cl

53.492-Propyl-1H-imidazole-

4,5-dicarboxylic acid

C8H10N2O4

198.18

+ NH3

17.03

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Stage-3

Step-A

NH

N

CH3

O

HO

HO

O

2-Propyl-1H-imidazole-4,5-dicarboxylic acid

C8H10N2O4

198.18

+ SOCl2

118.97

Ethyl acetate

NH

N

CH3

O

Cl

Cl

O +

2-Propyl-1H-imidazole-4,5-dicarbonyl dichloride

C8H8Cl2N2O2

235.07

SO2

64.06

+ H2O

18.02

Step-B

+ 2 C2H5OH

92.14

n-Hexane

NH

N

CH3

O

Cl

Cl

O

+

2-Propyl-1H-imidazole-4,5-dicarbonyl dichloride

C8H8Cl2N2O2

235.07

2 HCl

72.92

NH

N

CH3

O

C2H5O

C2H5O

O

2-Propyl-1H-imidazole-4,5-dicarboxylic acid diethyl ester

C12H18N2O4

254.28

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Stage-4

Toluene , Di isopropyl ether & Acetone

+

NH

N

CH3

O

C2H5O

C2H5O

O

2-Propyl-1H-imidazole-4,5-dicarboxylic acid diethyl ester

C12H18N2O4

254.28

+ CH3MgCl

74.79

NH

N

CH3

CH3

H3C

C2H5O

O

HO

5-(1-Hydroxy-1-methyl-ethyl)-2-propyl-3H-imidazole-4-carboxylic acid ethyl ester

C12H20N2O3

240.30

CH3OH

+ H2O

18.02

+

32.04

+MgCl2

16.00

+ HCl

95.21

36.46

0.5 O2

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Stage-5

Ethyl acetate, Sodium sulphate

NH

N

CH3

CH3

H3C

C2H5O

O

HO

5-(1-Hydroxy-1-methyl-ethyl)-2-propyl-3H-imidazole-4-carboxylic acid ethyl ester

C12H20N2O3

240.30

+

Br

NN

N

N

Ph

Ph

Ph

(5-(4'-Bromomethyl-biphenyl-2-yl)-2-trityl-2,5-dihydro-1H-tetrazole)

4-[2-(TRITYLTETRAZOLE)-5YL)PHENYL]BENZYL BROMIDE

C33H25BrN4

557.48

NN

N

N

Ph

Ph

Ph

N

N

CH3

CH3

H3C

C2H5O

O

HO

5-(1-Hydroxy-1-methyl-ethyl)-2-propyl-3-[2'-(2-trityl-2H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-

3H-imidazole-4-carboxylic acid ethyl esterC45H44N6O3

716.87

+ HBr

80.91

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Stage-6

Dioxan, Ethyl acetate, Sodium sulphate

NN

N

N

Ph

Ph

Ph

N

N

CH3

CH3

H3C

C2H5O

O

HO

5-(1-Hydroxy-1-methyl-ethyl)-2-propyl-3-[2'-(2-trityl-2H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-

3H-imidazole-4-carboxylic acid ethyl esterC45H44N6O3

716.87

+ LiOH .H2O

41.96

Lithium hydroxide monohydrate

NN

N

N

Ph

Ph

Ph

N

N

CH3

CH3

H3C

HO

O

HO

. 2 H2O

5-(1-Hydroxy-1-methyl-ethyl)-2-propyl-3-[2'-(2-trityl-2H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-3H-

imidazole-4-carboxylic acid hydrate

C43H44N6O5

724.85

+ C2H5OH

+ H2O

18.02

46.07

+

+ HCl

36.46

LiCl

42.39

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Stage-7

Ethyl acetate, Dimethylacetamide

NN

N

N

Ph

Ph

Ph

N

N

CH3

CH3

H3C

HO

O

HO

. 2 H2O

5-(1-Hydroxy-1-methyl-ethyl)-2-propyl-3-[2'-(2-trityl-2H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-3H-

imidazole-4-carboxylic acid hydrate

C43H44N6O5

724.85

O O

O

H3C Cl

4-Chloromethyl-5-methyl-[1,3]dioxol-2-one

C5H5ClO3

148.54

+

NN

N

N

Ph

Ph

Ph

N

N

CH3

CH3

H3C

O

O

HO

.

2 H2O

O O

O

H3C

5-(1-Hydroxy-1-methyl-ethyl)-2-propyl-3-[2'-(2-trityl-2H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-

3H-imidazole-4-carboxylic acid 5-methyl-2-oxo-[1,3]dioxol-4-ylmethyl ester

C48H44N6O6

800.90

+

36.03

+ HCl

36.46

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Stage-8

NN

N

N

Ph

Ph

Ph

N

N

CH3

CH3

H3C

O

O

HO

O O

O

H3C

5-(1-Hydroxy-1-methyl-ethyl)-2-propyl-3-[2'-(2-trityl-2H-tetrazol-5-yl)-biphenyl-4-ylmethyl]-

3H-imidazole-4-carboxylic acid 5-methyl-2-oxo-[1,3]dioxol-4-ylmethyl ester

C48H44N6O6

800.90

Ph

Ph

Ph

OH

Triphenyl-methanol

+ H2O

18.02

Acetic acid,Toluene

NHN

NN

N

N

CH3

CH3

H3C

O

O

HOO O

O

H3C

Olmesartan Medoxomil

C29H30N6O6

558.59

+

C19H16O

260.33

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Flow chart:

DiaminoMaleonitrileTrimethyl ortho butyrateAcetonitrile

Stage-1 Acetonitrile Recovery

Stage-2 Effluent waterStage-1Hydrochloric acidWater

Stage-3

Ethyl acetate Recovery n-hexane RecoveryEffluent water

Stage-2Thionyl chloride Ethyl acetate Ethanol n-hexane Water

Stage-4

Toluene Recovery Diisopropyl ether RecoveryAcetone Recovery Effluent water

Stage-3Methyl magnesium chlorideHydrochloric acid Toluene Diisopropyl ether Acetone Water

Stage-44-[2-(trityltetrazole)-5yl)phenyl] benzyl bromideSodium sulphateEthyl acetate Water

Stage-5Ethyl acetate RecoveryEffluent water

Stage-5Lithium hydroxide mono hydrate Hydrochloric acid Ethyl acetate Dioxane Sodium sulphateWater

Stage-6

Ethyl acetate Recovery Dioxane Recovery Effluent water

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Stage-7

Ethyl acetate Recovery Dimethylacetamide Recovery Effluent water

Stage-64-Chloromethyl-5-methyl-[1,3]diooxol-2-oneEthyl acetate Dimethylacetamide Water

Stage-7Acetic acid Toluene Water

Stage-8Toluene RecoveryEffluent water

Olmesartan Medoxomil

Material Balance:

Material Balance of Olmesartan Medoxomil Stage-1

Batch Size:100.00Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

DiaminoMaleonitrile 41.00 Stage-1 51.00

Trimethyl ortho butyrate 51.00 Acetonitrile Recovery 190.00

Acetonitrile 200.00 Acetonitrile Loss 4.00

Generated Methanol 32.80

Organic Residue Process residue-8.20 Distillation Residue-6 (Acetonitrile)

14.20

Total 292 Total 292

Material Balance of Olmesartan Medoxomil Stage-2

Batch Size:100.00Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Stage-1 51.00 Stage-2 58.00

Hydrochloric acid 12.00 Effluent water (Water-277, Ammonium chloride-17.05)

294.05

Water 300.00 Process emission (Ammonia)

5.42

Organic Residue 5.53

Total 363 Total 363

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Material Balance of Olmesartan Medoxomil Stage-3

Batch Size:100.00Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Stage-2 58.00 Stage-3 64.00

Thionyl chloride 35.00 Ethyl acetate Recovery 190.00

Ethyl acetate 200.00 Ethyl acetate loss 4.00

Ethanol 26.00 n-hexane Recovery 190.00

n-hexane 200.00 n-hexane loss 4.00

Water 300.00 Effluent water (Water-300, Generated water-5.30)

305.30

Process emission (Sulphur dioxide-18.74, Hydrochloric acid-20.16))

38.90

Organic Residue Process residue-10.8 Distillation Residue- (Ethyl acetate-6, N-Hexane-6)

22.80

Total 819 Total 819

Material Balance of Olmesartan Medoxomil Stage-4

Batch Size:100.00Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Stage-3 64.00 Stage-4 55.00

Methyl magnesium chloride 19.00 Toluene Recovery 190.00

Hydrochloric acid 10.00 Toluene loss 4.00

Toluene 200.00 Diisopropyl ether Recovery 190.00

Diisopropyl ether 200.00 Diisopropyl ether loss 4.00

Acetone 200.00 Acetone Recovery 190.00

Water 300.00 Acetone loss 4.00

Effluent water (Water-295 Methanol-8.10, Magnesium chloride-23.96, Toluene-6)

333.06

Process emission (Oxygen)

4.02

Organic Residue Process residue-6.92 Distillation Residue-12 (Acetone -6, Diisopropyl ether -6)

18.92

Total 993 Total 993

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Material Balance of Olmesartan Medoxomil Stage-5

Batch Size:100.00Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Stage-4 55.00 Stage-5 155.00

4-[2-(trityltetrazole)-5yl)phenyl] benzyl bromide((5-(4'-Bromomethyl-Biphenyl-2-Yl)-2- Trityl-2,5-Dihydro-1H-Tetrazole))

128.00 Ethyl acetate Recovery 190.00

Sodium sulphate 75.00 Ethyl acetate loss 4.00

Ethyl acetate 200.00 Effluent water (Water-300)

300.00

Water 300.00 By product (Hydrobromic acid)

18.55

Inorganic solid waste (Sodium sulphate)

75.00

Organic Residue Process residue-9.45 Distillation Residue-6 (Ethyl acetate)

15.45

Total 758 Total 758

Material Balance of Olmesartan Medoxomil Stage-6

Batch Size:100.00Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Stage-5 155.00 Stage-6 144.00

Lithium hydroxide mono hydrate

10.00 Ethyl acetate Recovery 190.00

Hydrochloric acid 8.00 Ethyl acetate loss 4.00

Ethyl acetate 200.00 Dioxane Recovery 190.00

Dioxane 200.00 Dioxane loss 4.00

Sodium sulphate 75.00 Effluent water (Water-296,Ethyl acetate-6, Ethanol-9.95, Lithium chloride-9.20)

321.15

Water 300.00 Inorganic solid waste (Sodium sulphate)

75.00

Organic Residue Process residue-13.85 Distillation Residue-6 (Dioxane)

19.85

Total 948 Total 948

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Material Balance of Olmesartan Medoxomil Stage-7

Batch Size:100.00Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Stage-6 144.00 Stage-7 151.00

4-Chloromethyl-5-methyl-[1,3]diooxol-2-one

30.00 Ethyl acetate Recovery 190.00

Ethyl acetate 200.00 Ethyl acetate loss 4.00

Dimethylacetamide 200.00 Dimethylacetamide Recovery 190.00

Water 300.00 Dimethylacetamide loss 4.00

Effluent water (Water-300,Ethyl acetate-6, Generated water -7.15)

313.15

Process emission (Hydrogen chloride)

7.29

Organic Residue Process residue-8.56 Distillation Residue-6 (Dimethylacetamide)

14.56

Total 874 Total 874

Material Balance of Olmesartan Medoxomil Stage-8

Batch Size:100.00Kg

Name of the input Quantity in Kg

Name of the out put Quantity In Kg

Stage-7 151.00 Olmesartan Medoxomil 100.00

Acetic acid 200.00 Acetic acid Recovery 190.00

Toluene 200.00 Acetic acid loss 4.00

Water 300.00 Toluene Recovery 190.00

Toluene loss 4.00

Effluent water (Water-296, Toluene -6, Triphenylmethanol-49.10)

351.10

Organic Residue Process residue-5.9 Distillation Residue-6 (Acetic acid)

11.90

Total 851 Total 851

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20. PENTAPRAZOLE CHLORO COMPOUND

(2-CHLOROMETHYL-3, 4-DIMETHOXY-PYRIDINE)

Process Description Stage-1: Maltol undergoes Methylation with Dimethyl sulphate in presence of Potassium

carbonate IPA , Acetone and Toluene to give Stage-1product.

Stage-2: Stage-1 product reacts with Ammonium in presence of Toluene to give Stage-2

product.

Stage-3: Stage-2 product. reacts with Phosphorous oxy chloride in presence of MDC to give

Stage-3 product.

Stage-4

Stage-3 product undergoes oxidation with Hydrogen peroxide in presence of

Methanol and MDC to give Stage-4 product.

Stage-5

Stage-4 product reacts with Sodium Methoxide in presence of Methanol to give

stage-5 product.

Stage-6

Step-A:

Stage-5 product undergoes Acetylation with Acetic anhydride in presence of MDC to

give Step-A product.

Step-B:

Step-A product undergoes Hydrolysis with Sodium Hydroxide in presence of

Methanol to give Stage-6 product.

Stage-7

Stage-6 product undergoes condensation with Hydrochloric acid in presence of

Methanol and MDC to give Pentaprazole Chloro Compound (2-Chloromethyl-3, 4-

Dimethoxy-Pyridine) product.

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Route of Synthesis:

Stage-1

O

O

OH

CH3

Maltol

C6H6O3

2X126.11=252.22

Dimethyl sulphate

(CH3)2SO4

126.13

K2CO3

138.21

O

O

OCH3

CH3

C7H8O3

2x140.14=280.28

K2SO4

174.26

CO2

44.0

+ +

+ + + H2O

18.0

2 2

3-Methoxy-2-methyl-pyran-4-one

IPA , Toluene&Acetone

Stage-2

O

O

OCH3

CH3

C7H8O3

140.14

NH

O

OCH3

CH3

C7H9NO2

139.15

++ H2O

18.0

NH3

17.033-Methoxy-2-methyl-

pyran-4-one 3-Methoxy-2-methyl-

1H-pyridin-4-one

Water

Stage-3

NH

CH3

OCH3

O

3-Methoxy-2-methyl-1H-pyridin-4-one

C7H9NO2

139.15

+ + POCl3N CH3

OCH3

Cl

4-Chloro-3-methoxy-2-methyl-pyridine

C7H8ClNO

157.60

153.3336.03

+ H3PO4

98.00

+

72.92

water2 H2O

2 HCl

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Stage-4

N

Cl

OCH3

CH3

C7H8ClNO

157.60

+ H2O2

34.01

Acetic acid, Methanol

N

Cl

OCH3

CH3

O

C7H8ClNO

173.60

+ H2O

18.04-Chloro-3-methoxy-2-methyl-pyridine

4-Chloro-3-methoxy-2-methyl-pyridin-1-ol

Stage-5

N

Cl

OCH3

CH3

O

C7H8ClNO

173.60

+ CH3OH + NaOH Methanol

32.0 40.0

N

OCH3

OCH3

CH3

O

C8H11NO3

169.18

4-Chloro-3-methoxy-2-methyl-pyridin-1-ol 3,4-Dimethoxy-2-

methyl-pyridin-1-ol

+ NaCl

58.5

+ H2O

18.0

Stage-6

Step-A

N

OCH3

OCH3

CH3

O

C8H11NO3

169.18

+ (CH3CO)2O

Acetic anhydride

102.09

Chloroform N

OCH3

OCH3

CH2OCOCH3

C10H13NO4

211.21

+ CH3COOH

60.03,4-Dimethoxy-2-methyl-pyridin-1-ol

Acetic acid 3,4-dimethoxy-pyridin-2-ylmethyl ester

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Step-B

N

OCH3

OCH3

CH2OCOCH3

C10H13NO4

211.21

+ NaOHMDC , Water

N

OCH3

OCH3

CH2OH

C8H11NO3

169.18

+ CH3COONa

82.0340.0Acetic acid 3,4-dimethoxy-pyridin-2-ylmethyl ester

(3,4-Dimethoxy-pyridin-2-yl)-methanol

Stage-7

N

OCH3

OCH3

CH2OH

C8H11NO3

169.18

+

118.97

MDC,MethanolN

OCH3

OCH3

CH2Cl

C8H11Cl2NO2

224.08

SOCl2 + SO2

64.06(3,4-Dimethoxy-pyridin-

2-yl)-methanol

. HCl

2-Chloromethyl-3,4-dimethoxy-pyridineHydrochloride

(Pantaprazole chloro compound)

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Flow chart:

Stage-1

Stage-2

Stage-3

Maltol Dimethyl sulphatePotassium carbonateToluene IPA Acetone Water

Mixed Solvents (IPA+Toluene ) RecoveryAcetone RecoveryEffluent water

Stage-1AmmoniaWater

Effluent water

Stage-2Phosphorous oxy chlorideSodium hydroxideWater

Effluent Water

Stage-3Hydrogen peroxide MethanolAcetic acid Water

Acetic acidRecoveryMethanol RecoveryEffluent Water

Stage-4

Stage-5

Stage-6

Stage-4MethanolSodium HydroxideWater

Methanol RecoveryEffluent Water

Stage-5Acetic AnhydrideChloroformSodium hydroxideMDCWater

Chloroform RecoveryMDC RecoveryEffluent Water

Pentaprazole chloro compound (2-Chloromethyl-3,4-Dimethoxy-Pyridine)

Stage-6Hydrochloric acid MethanolMDCWater

Stage-7

Methanol RecoveryMDC RecoveryEffluent water

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Material Balance:

Material Balance of Pentaprazole chloro compound (2-Chloromethyl-3,4-Dimethoxy-Pyridine)

Stage-1 Batch Size: 500 Kg

Name of the input Quantity in Kg

Name of the output Quantity in Kg

Maltol 411.00 Stage-1 447.00

Dimethyl sulphate 206.00 Mixed Solvents (IPA+Toluene ) Recovery

980.00

Potassium carbonate 359.00 Toluene Loss 10.00

Toluene 500.00 IPA loss 10.00

IPA 500.00 Acetone recovery 95.00

Acetone 100.00 Acetone loss 2.00

Water 100.00 Effluent water 266.36

(Water-100, Generated water -29.36, Potassium sulphate-137)

By-products (Potassium carbonate)

250.00

Process Emission 71.69

(Carbon dioxide)

Organic residue- (Process residue-40.95 Distillation Residue-3 (Acetone)

43.95

Total 2176 Total 2176

Material Balance of Pentaprazole chloro compound (2-Chloromethyl-3,4-Dimethoxy-Pyridine)

Stage-2 Batch Size: 500Kg

Name of the input Quantity in Kg

Name of the output Quantity in Kg

Stage-1 447.00 Stage-2 432.00

Ammonia 54.50 Effluent water (Water-300, Generated water-57.47)

357.47

Water 300.00 Organic residue- (Process residue-12.03

12.03

Total 801.5 Total 801.5

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Material Balance of Pentaprazole chloro compound (2-Chloromethyl-3,4-Dimethoxy-Pyridine)

Stage-3 Batch Size: 500Kg

Name of the input Quantity in Kg

Name of the output Quantity in Kg

Stage-2 432.00 Stage-3 474.00

Phosphorous oxy chloride 476.00 By product (Phosphoric acid Water )

707.62

Water 500.00 Process Emission (Hydrogen Chloride)

226.38

Total 1408 Total 1408

Material Balance of Pentaprazole chloro compound (2-Chloromethyl-3,4-Dimethoxy-Pyridine)

Stage-4 Batch Size: 500Kg

Name of the input Quantity in Kg

Name of the output Quantity in Kg

Stage-3 474.00 Stage-4 509.00

Hydrogen peroxide (50%) 205.00 Acetic acid Recovery 95.00

Methanol 100.00 Acetic acid Loss 2.00

Acetic acid 100.00 Methanol Recovery 95.00

Water 300.00 Methanol Loss 2.00

Effluent Water 456.63

(Water-300, generated Waetre-54.13, Water from Hydrogen peroxide-102.50)

Organic residue Process Residue-13.37 Distillation Residue-6 (Acetic acid -3 Methanol-3

19.37

Total 1179 Total 1179

Material Balance of Pentaprazole chloro compound (2-Chloromethyl-3,4-Dimethoxy-Pyridine)

Stage-5 Batch Size: 500 Kg

Name of the input Quantity in Kg

Name of the output Quantity in Kg

Stage-4 509.00 Stage-5 481.00

Methanol 194.00 Methanol Recovery 95.00

Sodium Hydroxide 117.50 Methanol Loss 2.00

Water 500.00 Effluent Water 724.35

(Water-500, Sodium Chloride-171.52, Generated water -52.83)

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Organic Residue Process residue-15.15 Distillation Residue-3 (Methanol)

18.15

Total 1320.50 Total 1320.50

Material Balance of Pentaprazole chloro compound (2-Chloromethyl-3,4-Dimethoxy-Pyridine)

Stage-6 Batch Size: 500Kg

Name of the input Quantity in Kg

Name of the output Quantity in Kg

Stage-5 481.00 Stage-6 461.00

Acetic Anhydride 290.50 Chloroform Recovery 190.00

Chloroform 200.00 Chloroform Loss 10.00

Sodium hydroxide 111.40 MDC Recovery 95.00

MDC 100.00 MDC loss 2.00

Water 200.00 Effluent Water (Water-200, Acetic acid-170.58,Sodium acetate-228.36)

598.94

Organic residue- (Process residue-22.96 Distillation Residue-3 (MDC)

25.96

Total 1382.90 Total 1382.9

Material Balance of Pentaprazole chloro compound (2-Chloromethyl-3,4-Dimethoxy-Pyridine)

Stage-7 Batch Size: 500Kg

Name of the input Quantity in Kg

Name of the output Quantity in Kg

Stage-6 461.00 Pentaprazole chloro compound (2-Chloromethyl-3,4-Dimethoxy-Pyridine)

500.00

Hydrochloric acid 99.50 Methanol Recovery 95.00

Methanol 100.00 Methanol Loss 2.00

MDC 100.00 MDC Recovery 95.00

Water 200.00 MDC Loss 2.00

Effluent water (Water-200, Generated water -49.10)

249.10

Organic residue (Process residue-11.4 Distillation residue-6 (MDC-3 Methanol-3)

17.40

Total 960.5 Total 960.5

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21. PANTOPRAZOLE SODIUM

Process Description

Stage-1

2-Chloromethyl -3, 4-dimethoxy pyridine hydrochloride reacts with 5-

Difuloromethoxy-2-mercatobenzimidazole in presence of Acetone, Di chloro

methane and Isopropyl Alcohol to give stage-1 product

Stage-2

Stage-1 product undergoes oxidation with Sodium hydroxide in presence of Acetone

Di chloro methane to give Pantoprazole sodium

Route of Synthesis:

Stage-1:

N

OCH3

OCH3

CH2Cl

HCl

C8H10ClNO2.HCl

224.12

+

NHN

O

F

F

SH

5-Difluoromethoxy-2-mercaptobenzimidazole

C8H6F2N2OS

216.21

+

Toluene, Acetone , Isopropylalcohol & Dichloromethane

N

OCH3

OCH3

CH2 SN

HN

OF

F

C16H15F2N3O3S

367.37

+ 2 NH4Cl + 2 H2O

106.98 36.045-Difluoromethoxy-2-(3,4-dimethoxy-

pyridin-2-ylmethylsulfanyl)-1H-benzoimidazole

2-Chloromethyl-3,4-dimethoxy-pyridine

Hydrochloride

2 NH4OH

70.08

Water

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Stage-2

N

OCH3

OCH3

CH2 SN

HN

O

F

F

C16H15F2N3O3S

367.37

+ NaOCl + NaOHDichloromethane

Acetone

N

OCH3

OCH3

CH2 SN

N

OF

F

O

+ NaCl +Na H2O

Pantoprazole sodium

C16H14F2N3NaO4S

405.35

58.5 18.0

Sodium hypochlorite

74.44

Sodium hydroxide

40.0

5-Difluoromethoxy-2-(3,4-dimethoxy-pyridin-2-ylmethylsulfanyl)-

1H-benzoimidazole

Flow Chart

Stage-1

Acetone RecoveryDichloromethane RecoveryIsopropylacohol RecoveryEffluent water

2-Chloromethyl-3,4-dimethoxy-pyridine Hydrochloride5-Difluoromethoxy-2- mercaptobenzimidazoleAmmonium hydroxide Dichloromethane AcetoneIsopropylacohol Water

Stage-1Sodium hypochlorite Sodium hydroxide DichloromethaneAcetone Water

Stage-2

Acetone RecoveryDichloromethane RecoveryEffluent water

Pantoprazole Sodium

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Material Balance:

Material Balance of Pantoprazole Sodium Stage-1

Batch Size: 100 Kg

Name of the input Quantity in Kg

Name of the output Quantity in Kg

2-Chloromethyl-3,4-dimethoxy-pyridine Hydrochloride

68.00 Stage-1 99.00

5-Difluoromethoxy-2- mercaptobenzimidazole

66.00 Acetone Recovery 190.00

Ammonium hydroxide 22.00 Acetone Loss 4.00

MDC 200.00 MDC Recovery 190.00

Acetone 200.00 MDC Loss 4.00

Isopropylacohol 200.00 Isopropylacohol Recovery 190.00

Water 500.00 Isopropylacohol Loss 4.00

Effluent water 543.50

(Water-500, Generated water-11 Ammonium chloride-32.5

Organic residue 31.50

Process residue-13.50 Distillation residue-18 (MDC-6, Acetone-6, Isopropyl alcohol-6 )

Total 1256 Total 1256

Material Balance of Pantoprazole Sodium Stage-2

Batch Size: 100 Kg

Name of the input Quantity in Kg

Name of the output Quantity in Kg

Stage-1 99.00 Pantoprazole Sodium 100.00

Sodium hypochlorite 20.00 Acetone Recovery 190.00

Sodium hydroxide 11.00 Acetone Loss 4.00

Dichloromethane 200.00 Dichloromethane Recovery 190.00

Acetone 200.00 Dichloromethane Loss 4.00

Water 500.00 Effluent water 520.80

(Water-500, Generated water-5 Sodium chloride-15.80

Organic residue 21.20

Process residue-9.20 Distillation residue-12 (MDC-6, Acetone-6)

Total 1030 Total 1030

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22. PREGABALIN

Process Description

Stage-1

Iso valeraldehyde Reacts with Diethylmalonate in presence of Water to give stage-1

product

Stage-2

Stage-1 reacts with Sodium cyanide and Acetic acid in presence of Ethanol to give

stage-2 product

Stage-3

Stage-2 product undergoes Hydrolysis with Potassium hydroxide in presence of

methanol to give salt formation of stage-3 product

Stage-4

Stage-3 undergoes Hydrogenation with hydrogen in presence of Acetic acid, Raney

nickel and methanol to give stage-4 product

Stage-5

Stage-4 product under goes with tartaric acid in presence of Acetone to give stage-5

product

Stage-6

Stage-5 product reacts undergoes Hydrolysis with Sodium hydroxide in presence

of Toluene ,water and Hydrochloric acid to give stage-6(Pregabalin crude)

Product

Stage-7

Sdtage-6 (Pregabalin crude) product undergoes purification in Acetone, Activated

carbon and Isopropyl Alcohol to give Pregabalin product

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Route of Synthesis:

Stage-1

Iso valeraldehyde

CH3

CH3O

C5H10O

86.13

+

Diethylmalonate

O O

O O

H3C CH3

C7H12O4

160.17

O O

O O

H3C CH3

CH3H3C

2-(3-Methyl-butyl)-malonic acid diethyl ester

C12H20O4

228.28

+ H2O

18.02

Stage-2

O O

O O

H3C CH3

CH3H3C

2-(3-Methyl-butyl)-malonic acid diethyl ester

C12H20O4

228.28

+ NaCN

49.01

+ CH3COOH

60.05

Ethanol

O O

O O

H3C CH3

CH3H3C

NC

2-(1-Cyano-3-methyl-butyl)-malonic acid diethyl ester

C13H21NO4

255.31

+ CH3COONa

Sodium acetate

82.03

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Stage-3

Methanol

O O

O O

H3C CH3

CH3H3C

NC

2-(1-Cyano-3-methyl-butyl)-malonic acid diethyl ester

C13H21NO4

255.31

+ KOH

56.11

H3C

CH3

O-

CN O

K+

Potassium; 3-cyano-5-methyl-hexanoate

C8H12KNO2

193.28

O

O

H3CO

C5H10O3

118.13

+ CH3

Ethyl methoxyacetate

Stage -4

H3C

CH3

O-

CN O

K+

Potassium; 3-cyano-5-methyl-hexanoate

C8H12KNO2

193.28

+ 2 H2

4.03

Raney NickelMethanol

H3C

CH3

OH

O

C8H17NO2

159.23

+ CH3COOH

60.05

CH3COOK+

98.14

H2N

3-Aminomethyl-5-methyl-hexanoic acid

water

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Stage –5

H3C

CH3

OH

O

C8H17NO2

2 x 159.23=318.46

H2N

3-Aminomethyl-5-methyl-hexanoic acid

+

Tartaric acid

OH

OHO

HO

O

OH

C4H6O6

150.09

H3C

CH3

OH

O

H2N

.

OH

OHO

HO

O

OH

Acetone

3-Aminomethyl-5-methyl-hexanoic acid ,2,3-dihydroxy-succinic acid

C12H23NO8

309.31

2

+ Isomer

159.23

Stage –6

H3C

CH3

OH

O

H2N

.

OH

OHO

HO

O

OH

3-Aminomethyl-5-methyl-hexanoic acid ,2,3-dihydroxy-succinic acid

C12H23NO8

309.31

+ NaOH

40.00

+ HCl

36.46

H3C

CH3

OH

O

H2N

Pregabalin Crude

C8H17NO2

159.23

+

OH

OHO

HO

O

OH

Tartaric acid

C4H6O6

150.09

Toluene

+ NaCl

58.44

+ H2O

18.02

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Stage-7

H3C

CH3

OH

O

H2N

Pregabalin Crude

C8H17NO2

159.23

Activated Carbon Acetone& IPA H3C

CH3

OH

O

H2N

Pregabalin

C8H17NO2

159.23

Flow Chart:

Iso valeraldehyde Diethylmalonate Water

Stage-1

Stage-2Ethanol RecoveryEffluent water

Stage-1Sodium cyanideAcetic acid Ethanol Water

Stage-3Methanol Recovery Effluent water

Stage-2Potassium hydroxideMethanol Water

Stage-4 Methanol Recovery Effluent water

Stage-3Acetic acid HydrogenRaney Nickel Methanol Water

Stage-4Tartric acid Acetone Water

Stage-5

Acetone Recovery Effluent water

Stage-5Sodium hydroxide Hydrochloric acid Toluene Water

Stage-6Toluene Recovery Effluent water

Effluent water

Stage-6Activated carbon Acetone IPA

Stage-7Acetone Recovery IPA Recovery

Pregabalin

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Material Balance:

Material Balance of Pregabalin Stage-1

Batch Size: 100.0Kgs

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Iso valeraldehyde 553.00 Stage-1 1172.00

Diethylmalonate 1028.50 Effluent water (Water-500, Generated water-115.70)

615.70

Water 500.00 Organic Residue 293.80

Total 2081.5 Total 2081.5

Material Balance of Pregabalin Stage-2

Batch Size: 100.0Kgs

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-1 1172.00 Stage-2 1114.00

Sodium cyanide 252.00 Ethanol Recovery 190.00

Acetic acid 309.00 Ethanol loss 4.00

Ethanol 200.00 Effluent water (Water-500, Sodium acetate- 421.10)

921.10

Water 500.00 Organic Residue Process residue-197.9 Distillation Residue- (Ethanol-6)

203.90

Total 2433 Total 2433

Material Balance of Pregabalin Stage-3

Batch Size: 100.0Kgs

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-2 1114.00 Stage-3 759.00

Potassium hydroxide 245.00 Methanol Recovery 190.00

Methanol 200.00 Methanol loss 4.00

Water 500.00 Effluent water (Water-500

500.00

Organic residue (Process Residue-600 (Ethylmethoxyacetate-515.35, Organic impurities-84.65) Distillation Residue-6

606.00

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(Methanol)

Total 2059 Total 2059

Material Balance of Pregabalin Stage-4

Batch Size: 100.0Kgs

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-3 759.00 Stage-4 594.00

Acetic acid 236.00 Methanol Recovery 190.00

Hydrogen 16.00 Methanol loss 4.00

Raney Nickel 10.00 Effluent water (Water-500 Potassium acetate-385.35)

885.35

Methanol 200.00 Spent Raney nickel Recovery/reuse

10.00

Water 500.00 Organic residue (Process Residue-31.65 Distillation Residue-6 (Methanol)

37.65

Total 1721 Total 1721

Material Balance of Pregabalin Stage-5

Batch Size: 100.0Kgs

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-4 594.00 Stage-5 530.00

Tartric acid 280.00 Acetone Recovery 190.00

Acetone 200.00 Acetone loss 4.00

Water 500.00 Effluent water (Water-500 )

500.00

Isomer Recovery /reuse for product

297.00

Organic residue (Process Residue-47 Distillation Residue-6 (Acetone)

53.00

Total 1574 Total 1574

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Material Balance of Pregabalin Stage-6

Batch Size: 100.0Kgs

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-5 530.00 Stage-6 109.00

Sodium hydroxide 69.00 Toluene Recovery 190.00

Hydrochloric acid 63.00 Toluene loss 4.00

Toluene 200.00 Effluent water (Water-500 , Sodium chloride-100.15, Generated Water-30.85)

631.00

Water 500.00 Tartaric acid Recovery 257.15

Organic residue (Process Residue-164.85 Distillation Residue-6 (Toluene)

170.85

Total 1362 Total 1362

Material Balance of Pregabalin Stage-7

Batch Size: 100.0Kgs

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-6 109.00 Pregabalin 100.00

Activated carbon 30.00 Acetone Recovery 190.00

Acetone 200.00 Acetone loss 4.00

IPA 200.00 IPA Recovery 190.00

IPA loss 4.00

Spent carbon 30.00

Organic residue (Process Residue-9 Distillation Residue-12 (IPA-6, Acetone-6)

21.00

Total 539 Total 539

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23. ROSUVASTATIN

Process Description

Stage-1

4-Fluoro-Benzadehyde reacts with Methylisobutyrylacetate in presence of Piperadine

& Isopropyl Alcohol to give Stage-1 as product.

Stage-2

Stage-1 product reacts with 2-Methyl iso thio urea and Sodoium hydroxide & Hydrochloric acid in presence of Water to give stage-2 as product. Stage-3 Stage-2 product reacts with Manganese dioxide in presence of Dichloromethane &Water to give Stage-3 product Stage-4 Stage-3 product reacts with Sodium hypochlorite in presence of TEMPO, Sodium bi carbonate & Dichloromethane to give Stage-4 as product. Stage-5 Stage-4 product reacts with Methane amine in presence of Toluene to give Stage-5 as product. Stage-6 Stage-5 product reacts with Methane sulfonic acid in presence of Toluene to give Stage-6 as product. Stage-7 Stage-6 product reacts with Sodium boro hydride in presence of Methanol to give Stage-7 Product Stage-8 Stage-7 product reacts with Hydrogen bromide in presence of Sodium bi carbonate & Water to give Stage-8 as product. Stage-9 Stage-8 product reacts with Triphenylphosphine in presence of Toluene to give Sage-9 product. Stage-10

Step-A

(6-Acetoxy-2,2-dimethyl-[1,3] dioxan-4-yl)-acetic acid tert-butyl ester reacts with

potassium carbonate & hydrochloric acid I presence of Methanol to give Step-A

product

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Step-B

Step-A product reacts with Sodium hypo chlorite in presence of Methanol to give

Stage-10 product

Stgae-11

Stage-10 undergoes condensation with Stage-9 Product in presence of Potassium

carbonate , DMSO , Dichloromethane & Methanol to give Stage-11 product

Stage-12

Stage-11 product undergoes condensation with Dicyclohexylamine in presence of

Water to give Stage-12 Product

Stage-13

Stage-12 Product reacts with Water to give Rosuvastatin product

Route of Synthesis:

Stage-1

O

F

4-Fluoro-benzaldehyde

C7H5FO

124.11

+

O

O O

methyl isobutyryl acetate

C7H12O3

144.17

Piperadine, Iso propylalcohol

F

O O

O

2-(3-Fluoro-benzylidene)-4-methyl-3-oxo-pentanoic acid methyl ester

C14H15FO3

250.27

+ H2O

18.02

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Stage-2

Water

O O

O

C14H15FO3

250.27

+

2 H2O

36.04

H2N S

NH

2-Methyl-isothiourea

C2H6N2S

90.15

+ NaOH

40.00

+ HCl

36.46

F

2-(4-Fluoro-benzylidene)-4-methyl-3-oxo-pentanoic acid

methyl ester

N

N

O

O

S

F6-(4-Fluoro-phenyl)-4-isopropyl-2-

methylsulfanyl-4,5-dihydro-pyrimidine-5-carboxylic acid methyl ester

C16H19FN2O2S

322.40

+ NaCl

58.44

+

Stage-3

Water, Dichloromethane

N

N

O

O

S

F6-(4-Fluoro-phenyl)-4-isopropyl-2-

methylsulfanyl-4,5-dihydro-pyrimidine-5-carboxylic acid methyl ester

C16H19FN2O2S

322.40

+ MnO2

86.94

N

N

O

O

S

F

4-(4-Fluoro-phenyl)-6-isopropyl-2-methylsulfanyl-pyrimidine-5-carboxylic

acid methyl ester

C16H17FN2O2S

320.38

MnO2+

86.94

+ H2

2.02

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Stage-4

TEMPO, Sodium bicarbonate, Dichloromethane

N

N

O

O

S

F

4-(4-Fluoro-phenyl)-6-isopropyl-2-methylsulfanyl-pyrimidine-5-carboxylic

acid methyl esterC16H17FN2O2S

320.38

+

+ 2 NaOCl

148.88

N

N

O

O

S

FO

O

4-(4-Fluoro-phenyl)-6-isopropyl-2-methanesulfonyl-pyrimidine-5-carboxylic

acid methyl esterC16H17FN2O4S

352.38

2 NaCl

116.89

Stage-5

Toluene+

N

N

O

O

S

FO

O

4-(4-Fluoro-phenyl)-6-isopropyl-2-methanesulfonyl-pyrimidine-5-carboxylic acid methyl ester

C16H17FN2O4S

352.38

Methyl amine

H2N CH3

31.06

N

N

O

O

NH

F

4-(4-Fluoro-phenyl)-6-isopropyl-2-methylamino-pyrimidine-5-carboxylic acid methyl ester

C16H18FN3O2

303.33

CH4 + SO2

64.0616.04

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Stage-6

Toluene

H2O

18.02

N

N

O

O

NH

F

4-(4-Fluoro-phenyl)-6-isopropyl-2-methylamino-pyrimidine-5-carboxylic acid methyl ester

C16H18FN3O2

303.33

CH3SHO3

Methane sulfonic acid

SO O

OH

+

96.11

N

N

O

O

N

F

S

O

O

4-(4-Fluoro-phenyl)-6-isopropyl-2-(methanesulfonyl-methyl-amino)-pyrimidine-

5-carboxylic acid methyl ester

C17H20FN3O4S

381.42

+

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Stage-7

Methanol

N

N

O

O

N

F

S

O

O

4-(4-Fluoro-phenyl)-6-isopropyl-2-(methanesulfonyl-methyl-amino)-pyrimidine-

5-carboxylic acid methyl ester

C17H20FN3O4S

381.42

+ NaBH4

37.83

N

N

OH

N

F

S

O

O

N-[4-(4-Fluoro-phenyl)-5-hydroxymethyl-6-isopropyl-pyrimidin-2-yl]-N-methyl

-methanesulfonamide

C16H20FN3O3S

353.41

NaBO2+

65.80

+ CH4

16.04

+ H2O

18.02

+ H2

2.02

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Stage-8

Sodium bicarbonate

N

N

OH

N

F

S

O

O

N-[4-(4-Fluoro-phenyl)-5-hydroxymethyl-6-isopropyl-pyrimidin-2-yl]-N-methyl

-methanesulfonamide

C16H20FN3O3S

353.41

HBr+

+

18.02

80.91

N

N

Br

N

F

S

O

O

N-[5-Bromomethyl-4-(4-fluoro-phenyl)-6-isopropyl-pyrimidin-2-yl]-N-methyl-

methanesulfonamide

C16H19BrFN3O2S

416.31

H2O

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Stage-9

Toluene

262.29

N

N

Br

N

F

S

O

O

N-[5-Bromomethyl-4-(4-fluoro-phenyl)-6-isopropyl-pyrimidin-2-yl]-N-methyl-

methanesulfonamide

C16H19BrFN3O2S

416.31

+

Triphenylphosphine

P

Ph

Ph

Ph

C18H15P

N

N

Br

N

F

S

O

O

.

P

Ph

Ph

Ph

N-[5-Bromomethyl-4-(4-fluoro-phenyl)-6-isopropyl-pyrimidin-2-yl]-N-methyl-

methanesulfonamide; triphenyl-phosphane

C34H34BrFN3O2PS

678.59

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Stage-10

Step-A

O

O O O O

O

(6-Acetoxy-2,2-dimethyl-[1,3]dioxan-4-yl)-acetic acid tert-butyl ester

C14H24O6

288.34

+ K2CO3

138.21

Methanol

HO

O O O

O

(6-Hydroxymethyl-2,2-dimethyl-[1,3]dioxan-4-yl)-acetic acid tert-butyl ester

C13H24O5

260.33

+ +

88.01

2 CO2

+

+ H2

2.02

2 HCl

72.92

2 KCl

149.10

Step-B

MethanolHO

O O O

O

(6-Hydroxymethyl-2,2-dimethyl-[1,3]dioxan-4-yl)-acetic acid tert-butyl ester

C13H24O5

260.33

+ NaOCl

74.44

H

O O O

O

O

(6-Formyl-2,2-dimethyl-[1,3]dioxan-4-yl)-acetic acid tert-butyl ester

C13H22O5

258.31

+ NaCl

58.44

+ H2O

18.02

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Stage-11

+

N

N

Br

N

F

S

O

O

.

P

Ph

Ph

Ph

N-[5-Bromomethyl-4-(4-fluoro-phenyl)-6-isopropyl-pyrimidin-2-yl]-N-methyl-

methanesulfonamide; triphenyl-phosphane

C34H34BrFN3O2PS

678.59

H

O O O

O

O

(6-Formyl-2,2-dimethyl-[1,3]dioxan-4-yl)-acetic acid tert-butyl ester

C13H22O5

258.31

+ K2CO3

138.20

DMSO, Dichloromethane & Methanol

N

NN

F

SO

O

O O

O

O

(6-{2-[4-(4-Fluoro-phenyl)-6-isopropyl-2-(methanesulfonyl-methyl-amino)-pyrimidin-5-yl]

-vinyl}-2,2-dimethyl-[1,3]dioxan-4-yl)-acetic acid tert-butyl ester

C29H40FN3O6S

577.71

+ 2 KCl

149.10

+ CO2

44.01

+

Triphenylphosphine

P

Ph

Ph

Ph

C18H15P

262.29

HBr+

80.91

+

16.00

+ 2 HCl

72.92

0.5O2 + H2O

18.02

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Stage-12

HN

Dicyclohexyl-amine

C12H23N

181.32

+ 2 H2O

+

OH

CH3H3CCH3

2-Methyl-propan-2-ol

C3H8O

Propanol

60.10

74.12

+

36.03

N

NN

F

S

O

O

O O

O

O

(6-{2-[4-(4-Fluoro-phenyl)-6-isopropyl-2-(methanesulfonyl-methyl-amino)-pyrimidin-5-yl]

-vinyl}-2,2-dimethyl-[1,3]dioxan-4-yl)-acetic acid tert-butyl ester

C29H40FN3O6S

577.71

+

N

NN

F

S

O

O

OH OH

O

O

7-[4-(4-Fluoro-phenyl)-6-isopropyl-2-(methanesulfonyl-methyl-amino)-pyrimidin-

5-yl]-3,5-dihydroxy-hept-6-enoic acid Dicyclohexyl-amine

C34H49FN4O6S

660.84

C4H10O

N

HO

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Stage-13

+

N

NN

F

SO

O

OH OH

O

O

7-[4-(4-Fluoro-phenyl)-6-isopropyl-2-(methanesulfonyl-methyl-amino)-pyrimidin-

5-yl]-3,5-dihydroxy-hept-6-enoic acid Dicyclohexyl-amine

C34H49FN4O6S

660.84

N

H2O

18.02

N

NN

F

S

O

O

OH OH

OH

O

+

N

Rosuvastatin

C22H28FN3O6S

481.54 C12H23NO

197.32

HO

N,N-Dicyclohexyl-hydroxylamine

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ROSUVASTATIN CALCIUM Flow-Chart:

4-Fluoro benzaldehydeMethyl isobutyryl acetate Piperidine Isopropyl alcohol Water

Stage-1

Stage-2Effluent water

Stage-12-Methyl iso thio ureaSodium hydroxide Hydrochloric acid Water

Stage-3MDC Recovery Effluent water

Stage-2Manganese dioxideMDCWater

Stage-4Dichloromethane Recovery Effluent water

Stage-3Sodium hypo chlorite TEMPO Dichloro methane Water

Stage-4Methyl Amine Toluene Water

Stage-5

Toluene RecoveryEffluent water

Stage-5Methane sulfonic acid TolueneWater

Stage-6Toluene Recovery Effluent water

Isopropyl alcohol RecoveryEffluent water

Stage-6Sodium boro hydride Methanol Water

Stage-7Methanol RecoveryEffluent water

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Stage-8 Effluent water

Stage-7Hydrobromic acidSodium bicarbonate Water

Stage-8Triphenylphosphine Toluene Water

Stage-9Toluene RecoveryEffluent water

(6-Acetoxy-2,2-dimethyl-[1,3] dioxan-4-yl)-acetic acid tert-butyl esterPotassium carbonate Methanol Sodium hypo chlorite Water

Stage-10Methanol RecoveryEffluent water

Stage-9Stage-10Potassium carbonate DMSO Dichloromethane Methanol Water

Stage-11

Methanol RecoveryDichloromethane RecoveryDMSO RecoveryEffluent water

Stage-11Dicyclohexylamine Water

Stage-12 Effluent water

Rosuvastatin

Stage-12Water Stage-13 Effluent water

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Material Balance:

Material Balance of Rosuvastatin Stage-1

Batch Size: 100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

4-Fluoro benzaldehyde 62.00 Stage-1 114.00

Methyl isobutyryl acetate 72.00 Isopropyl alcohol Recovery 190.00

Piperidine 5.00 Isopropyl alcohol Loss 4.00

Isopropyl alcohol 200.00 Effluent water 514.25

Water 500.00 (Water-500 Generated water-9.25, Piperidine-5)

Organic Residue (Process residue-10.75 Distillation Residue-6 (Isopropyl alcohol)

16.75

Total 839 Total 839

Material Balance of Rosuvastatin Stage-2

Batch Size: 100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-1 114.00 Stage-2 139.00

2-Methyl iso thio urea 41.00 Effluent water 543.10

Sodium hydroxide 19.00 (Water-500,gen water-16.45, Sodium chloride-26.65)

Hydrochloric acid 17.0 Organic Residue 8.90

Water 500.00

Total 691 Total 691

Material Balance of Rosuvastatin Stage-3

Batch Size: 100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-2 139.00 Stage-3 127.00

Manganese dioxide 10.00 MDC Recovery 190.00

MDC 200.00 MDC Loss 4.00

Water 500.00 Effluent water 510.00

(Water-500, Manganese dioxide-10)

Process emission (Hydrogen)

0.86

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Organic Residue 17.14

Process residue-11.14 Distillation Residue-6 (MDC)

Total 849 Total 849

Material Balance of Rosuvastatin Stage-4

Batch Size: 100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-3 127.00 Stage-4 131.00

Sodium hypo chlorite 59.00 Dichloro methane Recovery 190.00

TEMPO 5.00 Dichloro methane Loss 4.00

Dichloro methane 200.00 Effluent water 551.35

Water 500.00 (Water-500,Sodium chloride-46.35, TEMPO-5)

Organic Residue Process residue-8.65 Distillation Residue-6 (Dichloro methane)

14.65

Total 891 Total 891

Material Balance of Rosuvastatin Stage-5

Batch Size: 100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-4 131.00 Stage-5 103.00

Methyl Amine 12.00 Toluene Recovery 190.00

Toluene 200.00 Toluene Loss 4.00

Water 500.00 Effluent waters (Water-500)

500.00

Process Emissions 29.76

(Methane-5.96, Sulphur dioxide-23.8))

Organic Residue (process residue-10.24 Distillation Residue-6 (Toluene)

16.24

Total 843 Total 843

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Material Balance of Rosuvastatin Stage-6

Batch Size: 100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-5 103.00 Stage-6 123.00

Methane sulfonic acid 33.00 Toluene Recovery 190.00

Toluene 200.00 Toluene Loss 4.00

Water 500.00 Effluent water (Water-500, Generated Water-6.15)

506.15

Organic Residue 12.85

Process residue-6.85 Distillation residue-6 (Toluene)

Total 836 Total 836

Material Balance of Rosuvastatin Stage-7

Batch Size: 100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-6 123.00 Stage-7 102.00

Sodium boro hydride 13.00 Methanol Recovery 190.00

Methanol 200.00 Methanol Loss 4.00

Water 500.00 Effluent water 515.38

(Water-494.18, Sodium meta borate-21.2)

Process emission (Hydrogen-0.65, Methane-5.17)

5.82

Organic Residue 18.80

Process residue-12.8 Distillation Residue-6 (Methanol)

Total 836 Total 836

Material Balance of Rosuvastatin Stage-8

Batch Size: 100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-7 102.00 Stage-8 108.00

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Hydrobromic acid 24.00 Effluent water (Water -500, Generated water-5.20, Sodium bicarbonate-5)

510.20

Sodium bicarbonate 5.00 Organic Residue 12.80

Water 500.00

Total 631 Total 631

Material Balance of Rosuvastatin Stage-9

Batch Size: 100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-8 108.00 Stage-9 166.00

Triphenylphosphine 68.00 Toluene Recovery 190.00

Toluene 200.00 Toluene Loss 4.00

Water 500.00 Effluent water 506.00

(water-500 Toluene-6)

Organic Residue 10.00

Total 876 Total 876

Material Balance of Rosuvastatin Stage-10

Batch Size: 100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

(6-Acetoxy-2,2-dimethyl-[1,3] dioxan-4-yl)-acetic acid tert-butyl ester

81.00 Stage-10 63.00

Potassium carbonate 39.00 Methanol Recovery 190.00

Methanol 200.00 Methanol Loss 4.00

Sodium hypo chlorite 20.00 Effluent water 562.16

Hydrochloric acid 21.00 (Water-500, Potassium chloride-41.88, Sodium chloride-15.48, Generated water-4.80)

Water 500.00 Process emission (Carbon dioxide-24.72, Hydrogen-0.56)

25.28

Organic Residue 16.56

(Process residue-10.56 Distillation Residue-6 (Methanol -6)

Total 861 Total 861

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Material Balance of Rosuvastatin Stage-11

Batch Size: 100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-9 166.00 Stage-11 132.00

Stage-10 63.00 Methanol Recovery 190.00

Potassium carbonate 34.00 Methanol Loss 4.00

DMSO 200.00 Dichloromethane Recovery 190.00

Dichloromethane 200.00 Dichloromethane Loss 4.00

Methanol 200.00 DMSO Recovery 190.00

Hydrochloric acid 18.00 DMSO Loss 4.00

Water 500.00 Effluent water (Water-500, Potassiumchloride-36.47 Triphenyl phosohine-63.97, DMSO-6, generated water-4.4)

610.84

By-product (Hydrogen bromide)

19.73

Process emission (Carbon dioxide-10.76, Oxygen-3.91)

14.67

Organic Residue 21.76

(Process residue-9.76 Distillation Residue-12 (Dichloromethane-6, Methanol-6)

Total 1381 Total 1381

Material Balance of Rosuvastatin Stage-12

Batch Size: 100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-11 132.00 Stage-12 145.00

Dicyclohexylamine 42.00 Effluent water (Water-491.7, 2-Methyl-propanol-16.95, Propanol-13.72)

522.37

Water 500.00 Organic Residue 6.63

Total 674 Total 674

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Material Balance of Rosuvastatin Stage-13

Batch Size: 100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-12 145.00 Rosuvastatin 100.00

Water 500.00 Effluent water (Water-496,

496.00

Organic Residue (N,N-Dicyclohexylhydroxylamie-43.3), Organivc impurities-5.70)

49.00

Total 645 Total 645

24. SITAGLIPTIN PHOSPHATE MONOHYDRATE

Process Description

Stage-1

Step-A

(2, 4, 5-Trifluoro-phenyl) acetic acid reacts with Thionyl chloride and Meldrum acid

in presence of Sodium Hydroxide, Methylene dichloride, Methanol and Ethyl acetate

to give Step-A product

Step-B

Step-A product reacts with 3-(Trifluoro methyl) 5, 6, 7, 8-tetra hydro-[1,2,4]triazolo (4,

3-a) pyrazine hydrochloride in presence of Methane sulphonic acid , Sodium

carbonate, Methanol, Toluene and IPA to give Stage-1 product

Stage-2

Stage-1 produc reacts with Hydroxyl-phenyl acetic acid and sodium borohydride in

presence of Toluene, Methylene dichloride and Isopropylalcohol to give stage-2

product

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Stage-3

Stage-2 compound reacts with sodium hydroxide, phosphoric acid and water in

presence of Methylene dichloride and Isopropyl alcohol to give Sitagliptin Phosphate

Monohydrate.

Route of synthesis

Stage-1

Step-A

F

F

F

OH

O

(2,4,5-Trifluoro-phenyl)-acetic acid

C8H5F3O2

190.12

+ SOCl2

118.97

+

O O

OO

CH3H3C

Meldrums acid

C6H8O4

144.13

+ 2 NaOH

80.00

F

F

FOH

O

O

O

OCH3

C14H11F3O5

316.23

+ SO2 + 2 NaCl

64.06 2X58.4=116.8

+ 2H2O

36.02

CH3

5-[1-Hydroxy-2-(2,4,5-trifluoro-phenyl)-ethylidene]-2,2-dimethyl-[1,3]

dioxane-4,6-dione

Methylenedichloride Methanol, Ethyl acetate

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Step-B

F

F

FOH

O

O

O

OCH3

C14H11F3O5

316.23

CH3

5-[1-Hydroxy-2-(2,4,5-trifluoro-phenyl)-ethylidene]-2,2-dimethyl-[1,3]

dioxane-4,6-dione

+

HN

NN

N

CF3

HCl

C6H8ClF3N4

228.60

+

3-Trifluoromethyl-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]

pyrazine Hydrochloride

+CH3SO3H

96.11

NaHCO3

+ NH3

17.03

84.01

F

F

FNH2 O

N

NN

N

CF3

3-Amino-1-(3-trifluoromethyl-5,6-dihydro-8H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl)-4-(2,4,5-

trifluoro-phenyl)-but-2-en-1-one

C16H13F6N5O

405.30

+

NaCl

58.44

+ SO2

64.06

+ O2

32.00

Propanetriol

OHHO

HO

C3H8O3

92.09

+

Lactic acid

OH

OOH

C3H6O3

90.08

+

Methanol, Toluene, IPA

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Stage-2

F

F

FNH2 O

N

NN

N

CF3

3-Amino-1-(3-trifluoromethyl-5,6-dihydro-8H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl)-4-(2,4,5-

trifluoro-phenyl)-but-2-en-1-one

C16H13F6N5O

405.30

+ NaBH4

37.83

+ CH3COOH

60.05

+

O

OH

OH

Hydroxy-phenyl-acetic acid

C8H8O3

152.15

F

F

FNH2 O

N

NN

N

CF3

O

OH

OH

3-Amino-1-(3-trifluoromethyl-5,6-dihydro-8H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl)-4-

(2,4,5-trifluoro-phenyl)-but-2-en-1-one Hydroxy phenyl acetate

C24H23F6N5O4

559.46

+ CH3COONa

82.03

+

+ H3BO3

61.83

3 H2O

54.05

+ 4 H2

8.00

Methylene dichloride, Toluene & Isopropylalcohol

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Stage-3

F

F

FNH2 O

N

NN

N

CF3

O

OH

OH

3-Amino-1-(3-trifluoromethyl-5,6-dihydro-8H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl)-4-

(2,4,5-trifluoro-phenyl)-but-2-en-1-one Hydroxy phenyl acetate

C24H23F6N5O4

559.46

+ NaOH

40.00

+ H3PO4

98.00

H3PO4 H2O

Sitagliptin Phosphate monohydrate

C16H20F6N5O6P

523.32

O

OH

ONa

+

Sodium mandelate

C8H7NaO3

174.13

F

F

F

NH2

N

N

NN

CF3

O

Methylenedichloride, Isopropylalcohol

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SITAGLIPTIN PHOSPHATE MONOHYDRATE

Flow Chart

2,4,5-Trifluro phenyl acetic acid3-(trifluoromethyl)-5,6,7,8-tetrahydro(1,2,4)triazole(4,3,-a)Pyrazine hydrochlorideMethane sulfonic acidThionyl chlorideMeldrum acidSodium hydroxideSodium bicarbonateAmmoniaMethylene dichlorideEthyl acetateMethanolIPAToluene Water

Stage-1Sodium borohydrateHydroxyl phenyl acetic acidAcetic acidIsopropyl alcoholTolueneMethylene chlorideWater

Methylene dichloride RecoveryToluene RecoveryIsopropyl alcohol RecoveryEffluent water

Methylene dichloride recoveryIsopropyl alcohol RecoverySodium mandelate recoveryEffluent water

Stage-1

Stage-2

Stage-3

Methylene dichloride RecoveryToluene RecoveryEthyl acetate RecoveryMethanol RecoveryIPA RecoveryEffluent water

Stage-2Sodium hydroxidePhosphoric acidMethylene chlorideIsopropyl alcoholWater

Sitagliptin Phosphate Monohydrate

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Material Balance

Material balance of Sitagliptin Phosphate Monohydrate Stage-1 Batch size : 100kg

Name of the input Quantity In kg

Name of the out put Quantity In kg

2,4,5-Trifluro phenyl acetic acid 95.00 Stage-1 180.00

3-(trifluoromethyl)-5,6,7,8-tetrahydro(1,2,4)triazole(4,3,-a)Pyrazine hydrochloride

109.00 Methylene dichloride Recovery

95.00

Methane sulfonic acid 46.00 Methylene dichloride Loss

2.00

Thionyl chloride 60.00 Toluene Recovery 95.00

Meldrum acid 72.00 Toluene Loss 2.00

Sodium hydroxide 40.00 Ethyl acetate Recovery 95.00

Sodium bicarbonate 40.00 Ethyl acetate Loss 2.00

Ammonia 8.00 Methanol Recovery 95.00

Methylene dichloride 100.00 Methanol Loss 2.00

Ethyl acetate 100.00 IPA Recovery 95.00

Methanol 100.00 IPA Loss 2.00

IPA 100.00 Effluent water 996.48

Toluene 100.00 (Water-800, Generated water-17.99, Sodium chloride-86.08, Lactic acid-42.73, Ethyl acetate-3 Propanetriol-43.68, Toluene-3)

Water 800.00 Process emission 77.54

(Sulphur dioxide-62.37, Oxygen-15.17)

0

Organic residue 30.98

Process residue -21.98 Distillation residue- 9 (MDC-3, Methanol-3, IPA-3)

Total 1770.00 Total 1770.00

Material balance of Sitagliptin Phosphate Monohydrate Stage-2 Batch size : 100kg

Name of the input Quantity In kg

Name of the out put Quantity In kg

Stage-1 180.00 Stage-2 115.00

Sodium borohydrate 8.50 Methylene dichloride Recovery

95.00

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Hydroxyl phenyl acetic acid 34.00 Methylene dichloride Loss 2.00

Acetic acid 15.00 Toluene Recovery 95.00

Isopropyl alcohol 100.00 Toluene Loss 2.00

Toluene 100.0 Isopropyl alcohol Recovery 95.00

Methylene chloride 100.00 Isopropyl alcohol Loss 2.00

Water 800.00 Effluent water 822.93

(Water-788, Sodium acetate-18.21, Boric acid-13.72, Toluene-3)

Process emission 1.77

(Hydrogen-1.77)

Organic residue 106.80

Process residue-100.8, (R-Isomer-90, Organic impuritises-10.8) Distillation residue - 6 ( MDC-3, IPA-3)

Total 1337.50 Total 1337.50

Material balance of Sitagliptin Phosphate Monohydrate Stage-3 Batch size : 100kg

Name of the input Quantity In kg

Name of the out put Quantity In kg

Stage-2 115.00 Sitagliptin Phosphate Monohydrate

100.00

Sodium hydroxide 8.50 Methylene dichloride Recovery

95.00

Phosphoric acid 20.50 Methylene dichloride Loss 2.00

Methylene chloride 100.00 Isopropyl alcohol Recovery 95.00

Isopropyl alcohol 100.00 Isopropyl alcohol Loss 2.00

Water 700.00 Sodium mandelate recovery

35.79

Effluent water 700.00

(Water-700)

Organic residue 14.21

Process residue -8.21 Distillation residue-6 (MDC-3, IPA-3)

Total 1044.00 Total 1044.00

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25. SUMATRIPTAN SUCCINATE

Process Description

Stage-1

Para nitro benzyl bromide reacts with Sodium sulphite in presence of water to give

stage-1 product

Stage-2

Stage -1 product reacts with Phosphorus oxy chloride and Methyl amine in presence

of water and Toluene to give stage-2 product

Stage-3

Stage-2 undergoes Hydrogenation in presence of Raney nickel, Methanol and

Toluene to give stage-3 product

Stage-4

Stage-3 product reacts with Sodium nitrite and Hydrochloric acid in presence of

water Sodium dithionite, Methanol and Sodium hydroxide to give stage-4 product

Stage-5

Stage-5 reacts with 4-Chloro-1-hydroxy –butane – sodium sulfonic acid in presence

of Disodium hydrogen ortho phosphate, Dichloro methane and Methanol to give

stage-5 product

Stage-6

Stage-5 product reacts with Formaldehyde and Sodium borohydride in presence of

water and Methanol ethyl acetate to give stage-6 product

Stage-7

Stage-6 product with Succinic acid in presence of methanol to give Sumatriptan

succinate

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Route of Synthesis

Stage-1 CH2Br

NO2

Para nitro benzyl bromide

C7H6BrNO2

216.03

+ Na2SO3

Sodiumsulphite

126.04

CH2SO3Na

NO2

Sodium salt of (4-Nitro-phenyl)-methanesulfonic acid

C7H6NNaO5S

239.18

NaBr+

102.89

Water

Stage-2

CH2SO3Na

NO2Sodium salt of (4-Nitro-phenyl)

-methanesulfonic acid

C7H6NNaO5S

239.18

+ POCl3

153.33

CH3NH2+

Monomethyl amine

31.06

Toluene

CH2SO2NHCH3

NO2

4-nitro-Methayl benzene methene sulfonamide

C8H10N2O4S230.24

H3PO4+

2H2O

36.03

+

98.00

+ 2HCl NaCl+

58.4472.92

Stage-3

CH2SO2NHCH3

NO24-nitro-Methayl benzene

methene sulfonamide

C8H10N2O4S

230.24

+

2.02

CH2SO2NHCH3

NH2

(4-Amino)-N-methylbenzene-

methanesulfonamide

C8H12N2O2S

200.26

raney NickelNi,MethanolToluene

H2+ O2

32.00

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Stage-4

(4-Amino)-N-methylbenzene-methanesulfonamide

C8H12N2O2S

200.26

CH2SO2NHCH3

NH2 + NaNO2

sodium nitrite

69.00CH2SO2NHCH3

NHNH2

4-Hydrazino-N-methyl- benzenemethane

sulfonamide hydrochloride

.HCl

C8H14N3O2SCl

251.73

2 HCl

72.92

+

+ NaCl

58.44

+ O2

32.00

Sodium hydroxideMethanol

water Sodium dithionite

Stage-5

NH

S

O

O

HNH3C

NH2

C-(4-Hydrazino-phenyl)-N-methyl-methanesulfonamide

Hydrochloride

H

Cl

C8H14ClN3O2S

251.73

+

ClOH

SO3Na

4-Chloro-1-hydroxy-butane-1-Sodium sulfonic acid

C4H8ClNaO4S

210.61

Methanol,Disodiumhydrogen orthophosphate,Dichloromethane

NH

S

O

O

HNH3C

NH2

C-[3-(2-Amino-ethyl)-1H-indol-5-yl]-N-methyl-methanesulfonamide

C12H17N3O2S

267.35

+ HCl+NaCl + 2 H2O

36.4658.44 36.03

+ SO2

64.06

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Stage-6

NH

S

O

O

HNH3C

NH2

C-[3-(2-Amino-ethyl)-1H-indol-5-yl]-N-methyl-methanesulfonamide

C12H17N3O2S

267.35

+ 2 CH2O

60.05

+ NaBH4

37.83

Methanol Ethyl acetaeWater

NH

S

O

O

HNH3C

N

H3C

CH3

C-[3-(2-Dimethylamino-ethyl)-1H-indol-5-yl]-N-methyl

-methanesulfonamide Oxalate

Formaldehyde

295.40

C14H21N3O2S

+

Sodium metaborate

NaBO2

65.80

+ 2H2

4.03

Stage-7

NH

S

O

O

HNH3C

N

H3C

CH3

C-[3-(2-Dimethylamino-ethyl)-1H-indol-5-yl]-N-methyl-methanesulfonamide

C14H21N3O2S

295.40

+

COOH

COOH

Succinic acid

C4H6O4

118.09

Methanol

NH

S

O

O

HNH3C

N

H3C

CH3

Sumatriptan succinate

C18H27N3O6S

413.49

COOH

COOH

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SUMATRIPTAN SUCCINATE Flow Chart

Stage-1

Stage-2

Stage-3

Stage-4

Para Nitrobenzyl Bromide Sodium Sulphite Water

Effluent water

Stage-1Phosphoryl chlorideMono methyl amine Toluene Water

Toluene RecoveryEffluent water

Stage-3Sodium nitrite Hydrochloric acid Sodium dithionate Sodium hydroxide Methanol Water

Toluene RecoveryMethanol RecoveryEffluent water

Stage-2Hydrogen Raney Nickel Methanol Toluene Water

Methanol RecoveryEffluent water

Stage-44-Chloro-1-hydroxy butane-1-sodium sulfonic acidDisodium hydrogen orthophosphateDichloromethane Methanol Water

Stage-5Methanol recoveryDichloromethane RecoveryEffluent water

Stage-5Formaldehyde (50%)Sodium borohydrideMethanolEthyl acetateWater

Stage-6Methanol RecoveryEthyl acetate RecoveryEffluent water

Stage-6Succinic acidMethanolWater

Stage-7Methanol RecoveryEffluent water

Sumatriptan Succinate

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SUMATRIPTAN SUCCINATE

Material Balance

Material Balance of Sumatriptan Succinate

Stage-1 Batch Size: 100.0Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Para Nitrobenzyl Bromide 372.00 Stage-1 288.00

Sodium Sulphite 217.00 Effluent water 417.15

Water 300.00 (Water-300, Sodium bromide-117.15)

Organic Residue 183.85

Total 889.0 Total 889.00

Material Balance of Sumatriptan Succinate

Stage-2 Batch Size: 100.0Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-1 288.00 Stage-2 166.00

Phosphoryl chloride 185.00 Toluene Recovery 190.00 Mono methyl amine 38.00 Toluene loss 4.00

Toluene 200.00 Effluent water 444.35

Water 300.00 (Water-256,

Phosphoric acid-118 Sodium chloride-70.35)

Process emission (Hydrogen chloride)

87.78

Organic Residue Process residue-112.87 Distillation Residue-6.00 (Toluene )

118.87

Total 1011 Total 1011

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Material Balance of Sumatriptan Succinate

Stage-3 Batch Size: 100.0Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-2 166.00 Stage-3 115.00

Hydrogen 1.50 Toluene Recovery 190.00 Raney Nickel 10.00 Toluene loss 4.00

Methanol 200.00 Methanol Recovery 190.00

Toluene 200.00 Methanol loss 4.00

Water 300.00 Effluent water 306.00

(Water-300 Toluene-6)

Process emission (Oxygen)

23.05

Spent Raney Nickel Recovery/Reuse

10.00

Organic Residue Process residue-29.45 Distillation Residue-6.00 (Methanol)

35.45

Total 877.5 Total 877.5

Material Balance of Sumatriptan Succinate Stage-4

Batch Size: 100.0Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-3 115.00 Stage-4 108.00

Sodium nitrite 40.00 Methanol Recovery 190.00

Hydrochloric acid 42.00 Methanol loss 4.00

Sodium dithionate 15.00 Effluent water 358.55

Sodium hydroxide 10.00

(Water-300 Sodium hydroxide-10, Sodium chloride-33.55, Sodium dithionate-15)

Methanol 200.00 Process emission

(Oxygen) 18.36

Water 300.00

Organic Residue Process residue-37.09 Distillation Residue-6.00 (Methanol)

43.09

Total 722 Total 722

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Material Balance of Sumatriptan Succinate

Stage-5 Batch Size: 100.0Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-4 108.00 Stage-5 91.00

4-Chloro-1-hydroxy butane-1-sodium sulfonic acid

91.00 Methanol recovery 190.00

Disodium hydrogen orthophosphate 10.00 Methanol loss 4.00

Dichloromethane 200.00 Dichloromethane Recovery 190.00

Methanol 200.00 Dichloromethane Loss 4.00

Water 300.00 Effluent water 350.60

(Water-300, Generated water-15.50 Sodium chloride -25.10, Disodium hydrogen orthophosphate-10)

Process emission

(Hydrogen chloride-16.07, Sulphur dioxide-27.47)

43.54

Organic Residue 35.86

(Process residue-23.86 Distillation Residue-12 (Dichloromethane-6, Methanol-6)

Total 909 Total 909

Material Balance of Sumatriptan Succinate

Stage-6 Batch Size: 100.0Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-5 91.00 Stage-6 80.00

Formaldehyde (50%) 42.00 Methanol Recovery 190.00

Sodium borohydride 13.00 Methanol Loss 4.00

Methanol 200.00 Ethyl acetate Recovery 190.00

Ethyl acetate 200.00 Ethyl acetate Loss 4.00

Water 300.00 Effluent water 349.40

(Water-300 Water from Formaldehyde-21, Sodium meta borate-22.40, Ethyl acetate -6)

Process Emissions 1.36

(Hydrogen)

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Organic residue- (Process residue-21.24 Distillation Residue-6 (Methanol-6)

27.24

Total 846 Total 846

Material Balance of Sumatriptan Succinate

Stage-7 Batch Size: 100.0Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-6 80.00 Sumatriptan Succinate 100.00

Succinic acid 32.00 Methanol Recovery 190.00

Methanol 200.00 Methanol Loss 4.00

Water 300.00 Effluent water 300.00

(Water-300)

Organic Residue Process residue-12 Distillation Residue-6 (Methanol)

18.00

Total 612 Total 612

26. VELPATASVIR

Process description:

Stage-1

9-Bromo-3-(2-bromo-acetyl)-10,11-dihydro-5H,9H-6-oxa-benzo[a]anthracen-8-one reacts with 4-Methoxymethyl-pyrrolidine -1,2-dicarboxylic acid 1-tert-butyl ester in presence of MDC and Water to give Stage-1 product

Stage-2

Stage-1 product reacts with 1-(2-Methoxycarbonylamino-3-methyl -butyryl)-5-methyl-pyrrolidine- 2-carboxylic acid and Ammonia in presence of THF and Caesium Carbonate to give Stage-2 product

Stage-3

Stage-2 product reacts with Ammonium acetate in presence fo IPA and Toluene to give Stage-3 product

Stage-4

Stage-3 product undergoes Dehydrogenation with DDQ in presence of THF and Methanol to give Stage-4 product

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Stage-5

Stage-4 product reacts with Water in presence of Methanol, Phosphoric acid & Hydrochloric acid to give Stage-5 product

Stage-6

Stage-5 product reacts with Acetyl amino-phenyl-acetic acid in presence of CDMT and Methanol to give Velptasvir product.

Route of Synthesis

Stage-1

O

O

Br

Br

O

9-Bromo-3-(2-bromo-acetyl)-10,11-dihydro-5H,9H-6-oxa-benzo[a]anthracen-8-one

C19H14Br2O3

450.12

+

N

O

O

O

CH3

CH3

CH3

OH3C

OH

4-Methoxymethyl-pyrrolidine-1,2-dicarboxylic acid 1-tert-butyl ester

C12H21NO5

259.30

+ H2O

18.02

MDC

NO

H3C

O

O

CH3

H3C CH3

O

O

O

O

O

Br

2-(9-Bromo-8-oxo-8,9,10,11-tetrahydro-5H-6-oxa-benzo[a]anthracene-3-carbonyloxycarbonyl)-4-methoxymethyl

-pyrrolidine-1-carboxylic acid tert-butyl ester

C30H32BrNO8

614.48

+

80.91

CH3OHHBr +

32.04

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Stage-2

NOH3C

O

OCH3

H3C CH3

O

O

O

O

O

Br

2-(9-Bromo-8-oxo-8,9,10,11-tetrahydro-5H-6-oxa-benzo[a]anthracene-3-carbonyloxycarbonyl)-

4-methoxymethyl-pyrrolidine-1-carboxylic acid tert-butyl ester

C30H32BrNO8

614.48

+

NH3C

ONH

H3C CH3

O

OHO

H3C

O

1-(2-Methoxycarbonylamino-3-methyl-butyryl)-5-methyl-pyrrolidine-

2-carboxylic acid

C13H22N2O5

286.32

THF, Caesium carbonate

NO

H3C

O

OCH3

H3C CH3

O

O

O

O N

HN

NH3C

OCH3

H3C

HN

O

CH3

O

(2s,4s)-1-(TERT-BUTOXYCARBONYL)-4--(METHOXYMETHYL)PYRROLIDINE-2-CARBOXYLIC2-(2s, 5s)-1((S)-2-(METHOXYCARBONYL)AMINO)-3-

METHYLBUTANOYL)5-METHYLPYRROLIDINE-2-YL)-1,4,511-TETRAHYDROISOCHROMENO[4,3,6,7]NAPTHOL [1,2d]IMIAZOLE-9-CARBOXYLIC

ANHYDRIDE

C43H53N5O10

799.91

+

+ 2 NH3

34.06

HBr

80.91

3 H2O+

54.05

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Stage-3

IPA,Toluene

NO

H3C

O

OCH3

H3C CH3

O

O

O

O N

HN

NH3C

OCH3

H3C

HN

O

CH3

O

(2s,4s)-1-(TERT-BUTOXYCARBONYL)-4--(METHOXYMETHYL)PYRROLIDINE-2-CARBOXYLIC2-(2s, 5s)-1((S)-2-(METHOXYCARBONYL)AMINO)-3-

METHYLBUTANOYL)5-METHYLPYRROLIDINE-2-YL)-1,4,511-TETRAHYDROISOCHROMENO[4,3,6,7]NAPTHOL [1,2d]IMIAZOLE-9-

CARBOXYLIC ANHYDRIDE

C43H53N5O10

799.91

+

Ammonium acetate

NH4+

O

-O

C2H7NO2

77.08 X2=154.16

2

O N

HN

NH3C

OCH3

H3C

HN

O

CH3

O

N

OH3C

O

O

CH3

H3C CH3

N

HN

2-(5-{2-[1-(2-Methoxycarbonylamino-3-methyl-butyryl)-5-methyl-pyrrolidin-2-yl]-1,4,5,11-tetrahydro-12-oxa-1,3-diaza-

benzo[a]cyclopenta[h]anthracen-9-yl}-1H-imidazol-2-yl)-4-methoxymethyl-pyrrolidine-1-carboxylic acid tert-butyl ester

C44H55N7O7

793.95

CH3COOH+

60.05

CH3OH+

32.04

+ 2 H2O

36.02

+ O2

32.00

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Stage-4

O N

HN

NH3C

OCH3

H3C

HN

O

CH3

O

N

OH3C

O

O

CH3

H3C CH3

N

HN

2-(5-{2-[1-(2-Methoxycarbonylamino-3-methyl-butyryl)-5-methyl-pyrrolidin-2-yl]-1,4,5,11-tetrahydro-12-oxa-1,3-diaza-

benzo[a]cyclopenta[h]anthracen-9-yl}-1H-imidazol-2-yl)-4-methoxymethyl-pyrrolidine-1-carboxylic acid tert-butyl ester

C44H55N7O7

793.95

2,3-Dichloro-5,6-dicyano-1,4-benzoquinone(DDQ), Acetic acid ,

THF, Methanol

O N

HN

NH3C

OCH3

H3C

HN

O

CH3

O

N

OH3C

O

O

CH3

H3C CH3

N

HN

2-(5-{2-[1-(2-Methoxycarbonylamino-3-methyl-butyryl)-5-methyl-pyrrolidin-2-yl]-1,11-dihydro-12-oxa-1,3-

diaza-benzo[a]cyclopenta[h]anthracen-9-yl}-1H-imidazol-2-yl)-4-methoxymethyl-pyrrolidine-1-carboxylic acid tert-butyl ester

C44H53N7O7

791.93

+H2

2.02

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Stage-5

O N

HN

NH3C

OCH3

H3C

HN

OCH3

O

NO

H3C

O

O

CH3

H3C CH3

N

HN

2-(5-{2-[1-(2-Methoxycarbonylamino-3-methyl-butyryl)-5-methyl-pyrrolidin-2-yl]-1,11-dihydro-12-oxa-1,3-

diaza-benzo[a]cyclopenta[h]anthracen-9-yl}-1H-imidazol-2-yl)-4-methoxymethyl-pyrrolidine-1-carboxylic acid tert-butyl ester

C44H53N7O7

791.93

+

O N

HN

NH3C

OCH3

H3C

HN

OCH3

O

NHO

H3C

N

HN

+

O

O

CH3

H3C CH3

H

[1-(2-{9-[2-(4-Methoxymethyl-pyrrolidin-2-yl)-3H-imidazol-4-yl]-1,4,5,11-tetrahydro-12-oxa-1,3-diaza-

benzo[a]cyclopenta[h]anthracen-2-yl}-5-methyl-pyrrolidine-1-carbonyl)-2-methyl-propyl]-carbamic acid methyl ester

Acetic acid tert-butyl ester

C39H47N7O5

693.83

C5H10O2

102.13

2 H2O

36.03

O2

32.00

+

Phospohric acid, Hydrochloric acid &Methanol

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Stage-6

O N

HN

NH3C

OCH3

H3C

HN

O

CH3

O

NH

OH3C

N

HN

+[1-(2-{9-[2-(4-Methoxymethyl-pyrrolidin-2-yl)

-3H-imidazol-4-yl]-1,4,5,11-tetrahydro-12-oxa-1,3-diaza-benzo[a]cyclopenta[h]anthracen-2-yl}-5-methyl-pyrrolidine-1-carbonyl)-2-methyl-propyl]-carbamic acid methyl ester

C39H47N7O5

693.83

HN CH3

O

O

HO

Acetylamino-phenyl-acetic acid

C10H11NO3

193.20

CDMT,Methanol

O N

HN

NH3C

OCH3

H3C

HN

OCH3

O

NO

H3C

N

HN

O

NH

O

O

H3C

C49H54N8O8

Velpatasvir

883.0

+ 2 H2

4.03

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Flow chart:

9-Bromo-3-(2-bromo-acetyl)-10,11 -dihydro-5H,9H-6-oxa-benzo[a]anthracen-8-one4-Methoxymethyl-pyrrolidine -1,2-dicarboxylic acid 1-tert-butyl esterMDCWater

MDC RecoveryEffluent waterStage-1

THF RecoveryEffluent water

Stage-2

Stage-11-(2-Methoxycarbonylamino-3-methyl -butyryl)-5-methyl-pyrrolidine- 2-carboxylic acidAMMONIA Caesium carbonate THF Water

IPA RecoveryToluene RecoveryEffluent water

Stage-3

Stage-2Ammonium acetate IPAToluene Water

Methanol RecoveryTHF RecoveryEffluent water

Stage-4

Stage-3DDQ THFMethanolWater

Methanol RecoveryEffluent waterStage-5

Stage-4Phosphoric acid MethanolWater

Velpatasvir

Methanol RecoveryEffluent waterStage-5

Stage-5Acetylamino-phenyl-acetic acidCDMT(2-Chloro-4,6-dimethoxy-1,3,5-triazine)MethanolWater

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Material balance:

Material Balance of Velpatasvir

Stage-1 Batch Size: 100Kgs

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

9-Bromo-3-(2-bromo-acetyl)-10,11 -dihydro-5H,9H-6-oxa-benzo[a]anthracen-8-one

61.00 Stage-1 80.00

4-Methoxymethyl-pyrrolidine -1,2-dicarboxylic acid 1-tert-butyl ester

35.15 MDC Recovery 190.00

MDC 200.00 MDC Loss 4.0

Water 100.00 Effluent water (water-97.55, Methanol-4.35 )

101.90

By product Hydrogen bromide

10.96

Organic residue Process residue -3.29 Distillation Residue-6 (MDC)

9.29

Total 396.15 Total 396.15

Material Balance of Velpatasvir

Stage-2 Batch Size: 100Kgs

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-1 80.00 Stage-2 102.00

1-(2-Methoxycarbonylamino-3-methyl -butyryl)-5-methyl-pyrrolidine- 2-carboxylic acid

37.30 THF Recovery 190.00

AMMONIA 4.50 THF Loss 4.0

Caesium carbonate 5.00 Effluent water (water-100, generated water-7.05, Caesium carbonate-5 )

112.05

THF 200.00 By product (Hydrogen bromide)

10.52

Water 100.00 Organic residue Process residue -2.23 Distillation Residue-6 (THF)

8.23

Total 426.80 Total 426.8

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Material Balance of Velpatasvir

Stage-3 Batch Size: 100Kgs

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-2 102.00 Stage-3 98.00

Ammonium acetate 19.70 IPA Recovery 190.00

IPA 200.00 IPA Loss 4.0

Toluene 200.00 Toluene Recovery 190.00

Water 100.00 Toluene loss 4.00

Effluent water (water-100, generated water-4.6, Acetic acid-7.65, Methanol-4.10)

116.35

Process emission (Oxygen)

4.08

Organic residue Process residue -3.27 Distillation Residue-12 (PA-6, Toluene-6)

15.27

Total 621.70 Total 621.7

Material Balance of Velpatasvir

Stage-4 Batch Size: 100Kgs

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-3 98.00 Stage-4 95.00

DDQ 5.00 Methanol Recovery 285.00

THF 200.00 Methanol Loss 6.00

Methanol 300.00 THF Recovery 190.00

Acetic acid 200.00 THF loss 4.00

Water 100.00 Acetic acid Recovery 190.00

Acetic acid loss 4.00

Effluent water (water-100, DDQ -5)

105.00

Process emission (Hydrogen)

0.24

Organic residue Process residue -2.76 Distillation Residue-21 (Methanol-9, THF-6, Acetic acid-6)

23.76

Total 903 Total 903

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Material Balance of Velpatasvir

Stage-5 Batch Size: 100Kgs

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-4 95.00 Stage-5 81.00

Phosphoric acid 5.00 Methanol Recovery 285.00

Hydrochloric acid 5.00 Methanol Loss 6.00

Methanol 300.00 Effluent water (water-95.65, Phosphoric acid -5, Hydrochloric acid -5)

105.65

Water 100.00 Process emission (Oxygen)

3.83

Organic residue Process residue -14.52 (Acetic acid tert butylester-12.25, Organic imipurities-2.27) Distillation Residue-9 (Methanol)

23.52

Total 505 Total 505

Material Balance of Velpatasvir

Stage-6 Batch Size: 100Kgs

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-5 81.00 Velpatasvir 100.00

Acetylamino-phenyl-acetic acid 22.60 Methanol Recovery 285.00

CDMT(2-Chloro-4,6-dimethoxy-1,3,5-triazine)

5.00 Methanol Loss 6.00

Methanol 300.00 Effluent water (water-100, CDMT(2-Chloro-4,6-dimethoxy-1,3,5-triazine)-5)

105.00

Water 100.00 Process emission (Hydrogen)

0.46

Organic residue (Process residue-3.14 Distillation Residue-9 (Methanol)

12.14

Total 508.6 Total 508.6

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27. ZOLMITRIPTAN

Process Description

Stage-1

L-Phenylalanine undergoes nitration with nitric acid in presence of Sulphuric acid,

Ammonia and Sodium hydroxide to give stage-1 product

Stage-2

Stage-2 product reacts with Thionyl chloride and Methanol in presence of Methanol

to give stage-2 product

Stage-3

Stage-2 reacts with Ethyl chloroforamate in presence of Ethyl acetate Sodium

Hydroxide, n-hexane and methanol to give stage-3 product

Stage-4

Stage-3 product reacts with sodium borohydride, sodium Ethyl acetate and n-

Hexane to give stage-4 product

Stage-5

Stage-4 product reacts with Sodium methoxide, Hydrochloric acid ,water in

presence of Ethyl acetate , Methanol , and n-Hexane to give stage-5 product

Stage-6

Stage-5 product undergoes Hydrogenation with Hydrogen gas in presence of Raney

nickel, Methanol, Ethyl acetate and Isopropyl alcohol to give stage-6 product

Stage-7

Stage-6 product reacts with 4, 4 –Diethoxy –butyl –dimethyl amine in presence of

Methanol to give Zolmitriptan

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Route of synthesis:

Stage-1:

C9H11NO2

165.18

+ HNO3

63.01

C9H10N2O4

210.18

+ H2O

18.02

+ H2SO4

98.08

+ 2 NH3

34.06

+ (NH4)2SO4

132.14

HO

O

NH2

L-Phenylalanine

HO

O

NH2NO2

L-Paranitro phenyl alanine

Sodium hydroxide,methanol

water

Stage-2:

+ SOCl2

118.97

+ CH3OH

32.04

C10H12N2O4.HCl260.67

+ SO2 + HCl

64.06 36.45

C9H10N2O4

210.18

HO

O

NH2NO2

L-Paranitro phenyl alanine

OH3C

O

NH2NO2

. HCl

L-Paranitro phenyl alanine hydrochloride

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Stage-3

C10H12N2O4.HCl260.67

OH3C

O

NH2NO2

. HCl

L-Paranitro phenyl alanine hydrochloride

+

Ethyl Chloroformate

Ethylacetaten-hexaneMethanol

Sodium sulfate

OH3C

O

NO2

NHO

O4-Nitrobenzene-S-(Ethyl carbamate)

methyl propanonate

C13H16N2O6

296.28

+

+ 2 NaCl

2 NaOH

79.99

O

O Cl

C3H5ClO2

108.52

116.88

+ 2H2O

36.03

Stage-4

OH3C

O

NO2

NHO

O4-Nitrobenzene-S-(Ethyl carbamate)

methyl propanonate

C13H16N2O6

296.28

+ NaBH4

38.03

OH

NO2

NHO

O

4-Nitrobenzene-2-S-(Ethyl carbamate)-1-

propanolC12H16N2O5

268.27

+ HCl

36.46

+ NaCl

58.44

3 H2O+

+ H3BO3

61.83

54.05

+ CH3OH

32.04

+ 2H2

4.03

Sodium bicarbonateEthyl acetaten-HexaneSodium sulfateCarbon,Hi-flow

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Stage-5

OH

NO2

NHO

O

4-Nitrobenzene-2-S-(Ethyl carbamate)-1-

propanolC12H16N2O5

268.27

+ CH3ONa

54.02

NO2

HNO

O

S-(4)-(4-Nitro-benzyl)-2-oxazolidinone

C10H10N2O4

222.20

+ HCl

36.46

+ NaCl

58.44

+ H2O

18.02

C2H5OH+

46.07

+ CO2

44.01

MethanolEthyl acetate

n-HexaneSodiumsulfateCarbon,Hiflow

3H2

6.05

+

Stage-6:

NO2

HNO

OS-(4)-(4-Nitro-benzyl)

-2-oxazolidinone

C10H10N2O4

222.20

+ H2

2.02

NH2

HNO

O

Raney Ni,Methanol

Ethyl acetate,Isopropyl alocholActivated carbon

(S)-4-(4-Amino-benzyl)-oxazolidin-2-one

C10H12N2O2

192.21

+ O2

32.00

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Stage-7

NH2

HNO

O

(S)-4-(4-Amino-benzyl)-oxazolidin-2-one

C10H12N2O2

192.21

(4,4-Diethoxy-butyl)-dimethyl-amine

NO

CH3

H3C

O

CH3

CH3

+

C10H23NO2

189.30

HN

(H3C)2N

O

HN

O

C16H21N3O2

287.35

Zolmitrptan

2C2H5OH+

92.12

+ H2

2.00

Methanol

water/HCl

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Flow chart:

L-Phenylalanine Nitric acidSulphuric acidAmmonia Methanol Sodium hydroxide Water

Methanol Recovery Effluent waterstage-1

Methanol Recovery Effluent waterstage-2

Ethyl acetate Recoveryn-Hexane RecoveryMethanol Recovery Effluent water

stage-3

Stage-1Thionyl chloride Methanol Water

Stage-2Ethyl chloroformate Hydrochloric acid Methanol Sodium sulphate n-HexaneEthyl acetate Water

Ethyl acetate Recoveryn-Hexane RecoveryEffluent water

stage-4

Ethyl acetate Recoveryn-Hexane RecoveryMethanol RecoveryEffluent water

stage-5

Stage-3Sodium boro hydride Hydrochloric acid Sodium bicarbonateSodium sulphate Activated carbon Hyflown-HexaneEthyl acetate Water

Stage-4Sodium methoxide Hydrochloric acid Sodium sulphate Activated carbon HyflowMethanol n-HexaneEthyl acetate Water

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Ethyl acetate RecoveryIsopropyl alcohol RecoveryMethanol RecoveryEffluent water

stage-6

Methanol RecoveryEffluent water

stage-7

Stage-5Hydrogen Raney Nickel Ethyl acetate Isopropyl alcohol Activated Carbon Methanol Water

Stage-6(4,4-Diethoxy-butyl) -dimethyl-amineMethanol Hydrochloric acid Water

Zolmitriptan

Material Balance

Material Balance of Zolmitriptan Stage-1

Batch Size: 100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

L-Phenylalanine 132.00 Stage-1 151.00

Nitric acid 51.00 Methanol Recovery 190.00

Sulphuric acid 79.00 Methanol loss 4.00

Ammonia 28.00 Effluent water 524.40

Methanol 200.00 (Water-500, generated water -14.40, Sodium hydroxide-10)

0

Sodium hydroxide 10.00 By product (Ammonium sulphate)

105.60

Water 500.00 Organic Residue 25.00

(Process residue-19 Distillation Residue-6 (Methanol-6)

Total 1000

Total 1000

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Material Balance of Zolmitriptan Stage-2

Batch Size: 100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-1 151.00 Stage-2 164.00

Thionyl chloride 86.00 Methanol Recovery 190.00

Methanol 223.00 Methanol loss 4.00

Water 500.00 Effluent water 500.00

(Water-500)

Process emission (Sulphur dioxide-46, Hydrogen chloride-26.18

72.18

Organic Residue 29.82

(Process residue-23.82 Distillation Residue-6 (Methanol-6)

Total 960

Total 960

Material Balance of Zolmitriptan Stage-3

Batch Size: 100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-2 164.00 Stage-3 167.00

Ethyl chloroformate 69.00 Ethyl acetate Recovery 190.00

Hydrochloric acid 51.00 Ethyl acetate Loss 4.00

Methanol 200.00 n-Hexane Recovery 190.00

Sodium sulphate 50.00 n-Hexane loss 4.00

n-Hexane 200.00 Methanol Recovery 190.00

Ethyl acetate 200.00 Methanol loss 4.00

Water 500.00 Effluent water 602.25

(Water-500,Generated Water-22.70, Sodium chloride-73.55, Ethyl acetate-6)

Inorganic solid waste (Sodium sulphate)

50.00

Organic Residue 32.75

(Process residue-20.75 Distillation Residue-12 (n-Hexane -6, Methanol-6)

Total 1434

Total 1434

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Material Balance of Zolmitriptan Stage-4

Batch Size: 100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-3 167.00 Stage-4 133.00

Sodium boro hydride 22.00 Ethyl acetate Recovery 190.00

Hydrochloric acid 21.00 Ethyl acetate Loss 4.00

Sodium bicarbonate 20.00 n-Hexane Recovery 190.00

Sodium sulphate 50.00 n-Hexane loss 4.00

Activated carbon 20.00 Effluent water 580.83

Hyflow 5.00 (Water-469 Ethyl acetate-6, Sodium chloride-32.93, Boric acid-34.85, Methanol-18.05, Sodium bicarbonate-20 )

n-Hexane 200.00 Process emission (Hydrogen)

2.27

Ethyl acetate 200.00 Spent carbon & Hyflow 25.00

Water 500.00 Inorganic solid waste (Sodium sulphate)

50.00

Organic Residue 25.90

(Process residue-19.9 Distillation Residue-6 (n-Hexane -6)

Total 1205 Total 1205

Material Balance of Zolmitriptan Stage-5

Batch Size: 100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-4 133.00 Stage-5 99.00

Sodium methoxide 27.00 Ethyl acetate Recovery 190.00

Hydrochloric acid 18.00 Ethyl acetate Loss 4.00

Sodium sulphate 50.00 n-Hexane Recovery 190.00

Activated carbon 20.00 n-Hexane loss 4.00

Hyflow 5.00 Methanol Recovery 190.00

Methanol 200.00 Methanol loss 4.00

n-Hexane 200.00 Effluent water 548.79

Ethyl acetate 200.00 (Water-491,Ethyl acetate-6, Sodium chloride-28.96, Ethanol-22.83, )

Water 500.00 Process emission (Carbon dioxide-21.81, Hydrogen -2.99)

24.80

Spent carbon & Hyflow 25.00

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Inorganic solid waste (Sodium sulphate)

50.00

Organic Residue 23.41

(Process residue-11.41 Distillation Residue-12 (Methanol-6, n-Hexane -6)

Total 1353 Total 1353

Material Balance of Zolmitriptan Stage-6

Batch Size: 100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-5 99.00 Stage-6 75.00

Hydrogen 0.90 Ethyl acetate Recovery 190.00

Raney Nickel 10.00 Ethyl acetate Loss 4.00

Ethyl acetate 200.00 Isopropyl alcohol Recovery 190.00

Isopropyl alcohol 200.00 Isopropyl alcohol loss 4.00

Activated Carbon 20.00 Methanol Recovery 190.00

Methanol 200.00 Methanol loss 4.00

Water 500.00 Effluent water 506.00

(Water-500 Ethyl acetate-6)

Process emission (Oxygen)

14.25

Spent carbon 20.00

Spent Reney Nickel Recovery/Reuse

10.00

Organic Residue 22.65

(Process residue-10.65 Distillation Residue-12 (Methanol-6, Isopropyl alcohol-6)

Total 1229.9 Total 1229.9

Material Balance of Zolmitriptan Stage-7

Batch Size: 100.0 Kg

Name of the input Quantity in Kg

Name of the out put Quantity in Kg

Stage-6 75.00 Zolmitriptan

100.00

(4,4-Diethoxy-butyl) -dimethyl-amine

74.00 Methanol Recovery 190.00

Methanol 200.00 Methanol Loss 4.00

Hydrochloric acid 10.00 Effluent water 546.00

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Water 500.00 (Water-500 ,ethanol-36, Hydrochloric acid-10)

Process emission (Hydrogen)

0.78

Organic Residue 18.22

(Process residue-12.22 Distillation Residue-6 (Methanol)

Total 859.00 Total 859.00

2.7 POLLUTION LOAD

Pollution load and generation of waste per day from all the proposed products is

given in below table 2.4

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TABLE 2.4: CONSOLIDATED POLLUTION LOAD OF ALL PRODUCTS IN PER DAY QUANTITES

S.No.

Product Name Production

Capacity Kg/Month

Production

Capacity

Kg/Day

Kg Per Day

Water Input

Water In

effluent

Organics

In

Effluent

In Organics

In

Effluent

TDS COD(Mg/L) COD HTDS LTD

S

Total Efflue

nt

Organic

Inorganic

Spent

Carbon

Total

solid

waste

Distillation Resid

ue

Process

Fugitive

1 (S)-(-)-3-(Dimethylamino)-1-(2-Thienyl)-1-Propanol

10000 333.33 3000.0

0 2892.

80 20.00

583.97

583.97 179297.70 62.60 3496.77 107

2.33 4569.1

0 71.0

7 0.00 0.00

71.07

70.00 23.8

3 126.67

2 2,4- Dihydro-4-(4-4 hydroxy phenyl )-1-piperazinyl ) -2-(1-methyl propyl )-3H-1,2,4-Triazole-3-one

10000 333.33 11496.

67 9419.

83 406.5

0 370.0

7 370.07 764096.04 586.03 7761.57

2434.83

10196.40

428.70

0.00 0.00 428.

70 136.67

130.23

280.00

3 2-[3-methyl -4-(2,2,2-trifluoroethoxy)-2-pyridinyl ] methylthio -1H-benzimidazole

5000 166.67 2100.0

0 1508.

72 66.98

204.80

204.80 46586.10 66.34 1447.17 333.

33 1780.5

0 149.

07 0.00 0.00

149.07

90.67 51.1

0 74.67

4 4-Chloro Butyraldehyde Diethyl acetal

5000 166.67 1833.3

3 1853.

90 44.00

178.17

178.17 282011.96 91.95 2076.07 0.00 2076.0

7 20.1

2 97.08 0.00

117.20

40.00 43.9

0 60.00

5 4-Chloro-1 hydroxy butane sulphonic acid sodium salt

5000 166.67 1500.0

0 1532.

40 0.00

192.43

192.43 0.00 0.00 1724.83 0.00 1724.8

3 18.4

0 0.00 0.00

18.40

50.00 53.1

0 33.33

6 4-Dimethyl amino butytalde diethyl acetal

5000 166.67 1000.0

0 1017.

75 6.67

232.35

232.35 60904.69 22.87 1256.77 0.00 1256.7

7 14.6

5 0.00 0.00

14.65

23.33 0.00 20.00

7 Almotriptan Malate 1000 33.33 400.00

400.00

11.57 37.37 37.37 85066.97 20.43 246.93 202.

00 448.93

12.71

18.57 0.00 31.2

8 18.00

14.99

19.33

8 Celecoxib 4000 133.33

1466.67

1495.40

25.33 158.6

7 158.67 160744.50 38.00 724.73

954.67

1679.40

21.87

0.00 0.00 21.8

7 48.00

13.93

32.00

9

Cis -2-[2,4-Di Chloro Phenyl] -2-[1H-1,2,4-Triazole -1-yl Methyl ]-1,3 Dioxalane -4 yl Methanol

4000 133.33 266.67 270.9

1 76.47 56.39 56.39 460251.41 139.37 403.76 0.00 403.76

24.52

0.00 0.00 24.5

2 16.00

10.39

16.00

10 Cis -2-[2,4-Di chloro Phenyl]-2-[1H-1,2,4-Triazole -1-yl methyl]-1,3 Dioxalane-4yl Methyl ] Methane Sulfonate

5000 166.67 666.67 671.2

5 83.75

120.67

120.67 530881.25 153.72 875.67 0.00 875.67 41.4

2 0.00 0.00

41.42

40.00 11.2

5 33.33

11 Dabigartan 2000 66.67

1600.00

1607.00

16.00 69.25 69.25 121214.61 39.60 877.25 815.

00 1692.2

5 35.0

5 0.00 0.00

35.05

40.00 37.3

3 37.33

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12 Duloxetine Hydrochloride

2000 66.67 600.00 600.0

0 61.27 21.43 21.43 237109.22 86.55 459.83

222.87

682.70 20.5

1 0.00 0.00

20.51

18.00 13.3

9 16.00

13 Emitricitibine 4000 133.33

1333.33

1322.48

4.00 99.89 99.89 11703.34 12.52 1426.37 0.00 1426.3

7 117.

72 0.00

44.00

161.72

24.00 2.67 18.67

14 Imatinib Mesylate 2000 66.67

1133.33

1149.53

8.67 21.87 21.87 46802.57 15.77 676.13 503.

93 1180.0

7 23.9

9 0.00 0.00

23.99

45.33 33.6

9 56.00

15 Itraconazole 4000 133.33 666.67

670.53

8.00 25.07 25.07 47451.20 25.04 703.60 0.00 703.60 17.7

3 0.00 0.00

17.73

16.00 0.00 16.00

16 Ketorolac Tromethamine 5000 166.67

4166.67

4195.17

523.67

459.78

459.78 1133938.12 796.95 5178.62 0.00 5178.6

2 103.

98 0.00 0.00

103.98

60.00 84.0

7 40.00

17 Lansprazole 1000 33.33 833.33

839.70

12.25 54.72 54.72 23131.02 14.25 747.50 166.

67 914.17

15.78

0.00 0.00 15.7

8 20.00

11.42

18.00

18 Mesalamine 4000 133.33

1200.00

1225.87

8.00 413.7

3 413.73 39868.57 14.56 1200.40

447.20

1647.60

79.76

0.00 0.00 79.7

6 24.00

177.31

16.00

19 Olmesartan Medoxomil 4000 133.33

2800.00

2768.60

121.53

66.95 66.95 908476.75 310.35 1264.35 169

2.73 2957.0

8 92.2

8 200.0

0 0.00

292.28

72.00 74.1

7 69.33

20 Pentaprazole chloro compound (2-Chloromethyl-3,4-Dimethoxy-Pyridine)

10000 333.33 0.00 0.00 0.00 0.00 0.00 0.00 0.00 660.47 110

6.76 1767.2

3 0.00 0.00 0.00 0.00 0.00 0.00 0.00

21 Pantoprazole Sodium 9000 300.00

3000.00

3048.00

0.00 144.9

0 144.90 0.00 0.00 3192.90 0.00

3192.90

68.10

0.00 0.00 68.1

0 90.00 0.00 60.00

22 Pregabalin 4000 133.33

4000.00

4195.40

1075.27

133.53

133.53 852652.78 771.89 841.33 456

2.87 5404.2

0 1792

.27 0.00

40.00

1832.27

56.00 0.00 37.33

23 Rosuvastatin 4000 133.33

8666.67

8704.17

56.89 369.3

3 369.33 154992.07 82.05 5756.37

3374.03

9130.40

224.16

0.00 0.00 224.

16 72.00

62.17

58.67

24 Sitagliptin Phosphate Monohydrate

2000 66.67 1533.3

3 1537.

33 75.75 66.53 66.53 64691.02 61.15 1212.94

466.67

1679.61

87.33

0.00 0.00 87.3

3 14.00

52.87

12.00

25 Sumatriptan Succinate 1000 33.33 700.00

697.50

2.00 140.5

2 140.52 10417.86 3.64 640.01

200.00

840.01 139.

96 0.00 0.00

139.96

14.00 58.0

3 10.67

26 Velpatasvir 2000 66.67 400.00

403.23

10.73 16.67 16.67 236500.61 26.42 285.13 145.

50 430.63

19.47

0.00 0.00 19.4

7 42.00 5.74 28.00

27 Zolmitriptan 1000 33.33

1166.67

1165.70

27.61 111.3

1 111.31 101050.32 55.54 1639.96

335.33

1975.29

39.25

50.00 23.3

3 112.

58 20.00

38.09

18.67

Total 115000

3833.33

57530.00

55193.18

2752.89

4350.36

4350.36 6559840.69 3497.60 46777.4

4

19036.7

2

65814.16

3679.84

365.65

107.33

4152.83

1160.00

1003.68

1208.00

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Pollution loads have been calculated for each product based on chemical reactions,

material balance and subsequent process operations to get the required quantity.

2.8 Description of Process Emissions and its mitigation measures

The Predicted Process emissions are SO2, O2, CO2, (CH3)2NH, HF, CH4, H2, NH3 &

HCl which will liberate from manufacturing process of proposed products. The

process emissions are based on reactants quantity and chemical reactions between

them in relation with desired product output.

To meet the environmental standards, double stage scrubbers as a single unit is

proposed. The process emissions such as Sulphur dioxide and Hydrogen chloride

will be scrubbed with suitable scrubbing solution as applicable. During plant

operations samples will be collected to check whether process emissions are within

limits.

TABLE-2.5: Process Emission details and mitigation measures

S. No Name of the Gas Quantity

in Kg/Day Treatment Method

1 Carbon dioxide 270 Dispersed into the atmosphere

2 Oxygen 224 Dispersed into the atmosphere

3 Ammonia 9 Scrubbed by using Chilled water media

4 Hydrogen chloride 426 Scrubbed by using Chilled water media

5 Sulfur dioxide 312 Scrubbed by using C.S.Lye Solution

6 Dimethylamine 8 Scrubbed by using chilled water media

7 Hydrogen fluoride 5 Scrubbed by using C.S.Lye Solution

8 Hydrogen 35 Diffused by using Nitrogen through Flame arrestor

9 Methane 15 Dispersed into the atmosphere

TABLE-: 2.6 PROCESS EMISSION DETAILS - PRODUCT WISE

S.No. Product Name Production Capacity in Kg/Month

Production Capacity in Kg/Day

Process in kg/day

1 (S)-(-)-3-(Dimethylamino)-1-(2-Thienyl)-1-Propanol

10000 333.33 23.83

2 2,4- Dihydro-4-(4-4 hydroxy phenyl )-1-piperazinyl ) -2-(1-methyl propyl )-3H-1,2,4-Triazole-3-one

10000 333.33 130.23

3 2-[3-methyl -4-(2,2,2-trifluoroethoxy)-2-pyridinyl ] methylthio -1H-benzimidazole

5000 166.67 51.10

4 4-Chloro Butyraldehyde Diethyl acetal 5000 166.67 43.90

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5 4-Chloro-1 hydroxy butane sulphonic acid sodium salt

5000 166.67 53.10

6 4-Dimethyl amino butytalde diethyl acetal

5000 166.67 0.00

7 Almotriptan Malate 1000 33.33 14.99

8 Celecoxib 4000 133.33 13.93

9 Cis -2-[2,4-Di Chloro Phenyl] -2-[1H-1,2,4-Triazole -1-yl Methyl ]-1,3 Dioxalane -4 yl Methanol

4000 133.33 10.39

10

Cis -2-[2,4-Di chloro Phenyl]-2-[1H-1,2,4-Triazole -1-yl methyl]-1,3 Dioxalane-4yl Methyl ] Methane Sulfonate

5000 166.67 11.25

11 Dabigartan 2000 66.67 37.33

12 Duloxetine Hydrochloride 2000 66.67 13.39

13 Emitricitibine 4000 133.33 2.67

14 Imatinib Mesylate 2000 66.67 33.69

15 Itraconazole 4000 133.33 0.00

16 Ketorolac Tromethamine 5000 166.67 84.07

17 Lansprazole 1000 33.33 11.42

18 Mesalamine 4000 133.33 177.31

19 Olmesartan Medoxomil 4000 133.33 74.17

20 Pentaprazole chloro compound (2-Chloromethyl-3,4-Dimethoxy-Pyridine)

10000 333.33 0.00

21 Pantoprazole Sodium 9000 300.00 0.00

22 Pregabalin 4000 133.33 0.00

23 Rosuvastatin 4000 133.33 62.17

24 Sitagliptin Phosphate Monohydrate 2000 66.67 52.87

25 Sumatriptan Succinate 1000 33.33 58.03

26 Velpatasvir 2000 66.67 5.74

27 Zolmitriptan 1000 33.33 38.09

Total 115000 3833.33 1003.68

2.9 PROPOSED WATER CONSUMPTION DETAILS

The Total water consumption for the proposed project is 259 KLD. Water

consumption details are given in below Table. No. 2.7.

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TABLE- 2.7: Proposed Water Consumption details

S.No Purpose Water

input KLD

1 Process 59

2 Washings 10

3 Boiler make up 71

4 Cooling towers make up 104

5 Scrubbing system 5

6 Domestic 4

7 Gardening 6

Total 259

The fresh water of 175 KLD will be met from Ground Water source.

Recovered water 84 KLD from ZLD system is reused.

The permission to draw ground water for industrial and drinking water purpose was

obtained for 269 KLD from AP Ground Water & Water Audit Department and the

same has been enclosed.

TABLE- 2.8: PROPOSED WATER CONSUMPTION IN PROCESS

– PRODUCT WISE

S.No. Product Name Production

Capacity Kg/Month

Production Capacity Kg/Day

Water Input in kg/day

1 (S)-(-)-3-(Dimethylamino)-1-(2-Thienyl)-1-Propanol

10000 333.33 3000.00

2 2,4- Dihydro-4-(4-4 hydroxy phenyl )-1-piperazinyl ) -2-(1-methyl propyl )-3H-1,2,4-Triazole-3-one

10000 333.33 11496.67

3 2-[3-methyl -4-(2,2,2-trifluoroethoxy)-2-pyridinyl ] methylthio -1H-benzimidazole

5000 166.67 2100.00

4 4-Chloro Butyraldehyde Diethyl acetal 5000 166.67 1833.33

5 4-Chloro-1 hydroxy butane sulphonic acid sodium salt

5000 166.67 1500.00

6 4-Dimethyl amino butytalde diethyl acetal 5000 166.67 1000.00

7 Almotriptan Malate 1000 33.33 400.00

8 Celecoxib 4000 133.33 1466.67

9 Cis -2-[2,4-Di Chloro Phenyl] -2-[1H-1,2,4-Triazole -1-yl Methyl ]-1,3 Dioxalane -4 yl Methanol

4000 133.33 266.67

10 Cis -2-[2,4-Di chloro Phenyl]-2-[1H-1,2,4-Triazole -1-yl methyl]-1,3 Dioxalane-4yl Methyl ] Methane Sulfonate

5000 166.67 666.67

11 Dabigartan 2000 66.67 1600.00

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12 Duloxetine Hydrochloride 2000 66.67 600.00

13 Emitricitibine 4000 133.33 1333.33

14 Imatinib Mesylate 2000 66.67 1133.33

15 Itraconazole 4000 133.33 666.67

16 Ketorolac Tromethamine 5000 166.67 4166.67

17 Lansprazole 1000 33.33 833.33

18 Mesalamine 4000 133.33 1200.00

19 Olmesartan Medoxomil 4000 133.33 2800.00

20 Pentaprazole chloro compound (2-Chloromethyl-3,4-Dimethoxy-Pyridine)

10000 333.33 0.00

21 Pantoprazole Sodium 9000 300.00 3000.00

22 Pregabalin 4000 133.33 4000.00

23 Rosuvastatin 4000 133.33 8666.67

24 Sitagliptin Phosphate Monohydrate 2000 66.67 1533.33

25 Sumatriptan Succinate 1000 33.33 700.00

26 Velpatasvir 2000 66.67 400.00

27 Zolmitriptan 1000 33.33 1166.67

Total 115000 3833.33 57530.00

2.10 EXPECTED WASTE WATER GENERATION DETAILS

TABLE-2.9: Expected Effluent generation details

S.No Purpose Effluent

Details KLD

1 Process 66

2 Washings 10

3 Boiler Blow down 10

4 Cooling towers Blow down 12

5 Scrubbing system 5.00

6 Domestic 2.80

Total 105.8

TABLE-2.10: Expected HTDS & LTDS EFFLUENT GENERATION

DETAILS

S. No Purpose HTDS In KLD

LTDS In KLD

Effluent In KLD

Disposal Method

1 Process 47 19 66 HTDS Effluent sent to MEESystem.MEE Condensate sent to Biological treatment. LTDS Effluents along with Domestic sewage sent to ETP, treated effluent sent to RO followed by MEE & ATFD.

2 Washings 0 10 10

3 Boiler Blow down 0 10 10

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4 Cooling towers bleed off

0 12 12

RO Permeate and MEE Condensate water recovered for reuse MEE Salts collected and disposed to TSDF.

5 Scrubbing system 5 0 5.00

6 Domestic 0 2.8 2.80

Total 52 53.8 105.8

The generations of process effluent water HTDS & LTDS and its characteristics are

based on reactants quantity and chemical reactions between them in relation with

desired product output.

The Boiler & Cooling towers blow down water will have TDS & COD less than 5000

mg/l and scrubbing solution will have TDS more than 5000 mg/l. Floor washings and

equipment washings will have TDS less than 5000 mg/l

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TABLE- 2.11 WASTEWATER GENERATION IN KGS PER DAY - PRODUCT WISE

S.No.

Product Name

Production

Capacity

Kg/Month

Production

Capacity

Kg/Day

Kg Per Day

Water In effluent

Organics In

Effluent

In Organic

s In

Effluent

TDS COD(Mg/L) COD HTDS LTDS Total

Effluent

1 (S)-(-)-3-(Dimethylamino)-1-(2-Thienyl)-1-Propanol

10000 333.33 2892.80 20.00 583.97 583.97 179297.70 62.60 3496.77 1072.33 4569.10

2

2,4- Dihydro-4-(4-4 hydroxy phenyl )-1-piperazinyl ) -2-(1-methyl propyl )-3H-1,2,4-Triazole-3-one

10000 333.33 9419.83 406.50 370.07 370.07 764096.04 586.03 7761.57 2434.83 10196.40

3

2-[3-methyl -4-(2,2,2-trifluoroethoxy)-2-pyridinyl ] methylthio -1H-benzimidazole

5000 166.67 1508.72 66.98 204.80 204.80 46586.10 66.34 1447.17 333.33 1780.50

4 4-Chloro Butyraldehyde Diethyl acetal

5000 166.67 1853.90 44.00 178.17 178.17 282011.96 91.95 2076.07 0.00 2076.07

5 4-Chloro-1 hydroxy butane sulphonic acid sodium salt

5000 166.67 1532.40 0.00 192.43 192.43 0.00 0.00 1724.83 0.00 1724.83

6 4-Dimethyl amino butytalde diethyl acetal

5000 166.67 1017.75 6.67 232.35 232.35 60904.69 22.87 1256.77 0.00 1256.77

7 Almotriptan Malate 1000 33.33 400.00 11.57 37.37 37.37 85066.97 20.43 246.93 202.00 448.93

8 Celecoxib 4000 133.33 1495.40 25.33 158.67 158.67 160744.50 38.00 724.73 954.67 1679.40

9

Cis -2-[2,4-Di Chloro Phenyl] -2-[1H-1,2,4-Triazole -1-yl Methyl ]-1,3 Dioxalane -4 yl Methanol

4000 133.33 270.91 76.47 56.39 56.39 460251.41 139.37 403.76 0.00 403.76

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10

Cis -2-[2,4-Di chloro Phenyl]-2-[1H-1,2,4-Triazole -1-yl methyl]-1,3 Dioxalane-4yl Methyl ] Methane Sulfonate

5000 166.67 671.25 83.75 120.67 120.67 530881.25 153.72 875.67 0.00 875.67

11 Dabigartan 2000 66.67 1607.00 16.00 69.25 69.25 121214.61 39.60 877.25 815.00 1692.25

12 Duloxetine Hydrochloride 2000 66.67 600.00 61.27 21.43 21.43 237109.22 86.55 459.83 222.87 682.70

13 Emitricitibine 4000 133.33 1322.48 4.00 99.89 99.89 11703.34 12.52 1426.37 0.00 1426.37

14 Imatinib Mesylate 2000 66.67 1149.53 8.67 21.87 21.87 46802.57 15.77 676.13 503.93 1180.07

15 Itraconazole 4000 133.33 670.53 8.00 25.07 25.07 47451.20 25.04 703.60 0.00 703.60

16 Ketorolac Tromethamine 5000 166.67 4195.17 523.67 459.78 459.78 1133938.12 796.95 5178.62 0.00 5178.62

17 Lansprazole 1000 33.33 839.70 12.25 54.72 54.72 23131.02 14.25 747.50 166.67 914.17

18 Mesalamine 4000 133.33 1225.87 8.00 413.73 413.73 39868.57 14.56 1200.40 447.20 1647.60

19 Olmesartan Medoxomil 4000 133.33 2768.60 121.53 66.95 66.95 908476.75 310.35 1264.35 1692.73 2957.08

20 Pentaprazole chloro compound (2-Chloromethyl-3,4-Dimethoxy-Pyridine)

10000 333.33 0.00 0.00 0.00 0.00 0.00 0.00 660.47 1106.76 1767.23

21 Pantoprazole Sodium 9000 300.00 3048.00 0.00 144.90 144.90 0.00 0.00 3192.90 0.00 3192.90

22 Pregabalin 4000 133.33 4195.40 1075.27 133.53 133.53 852652.78 771.89 841.33 4562.87 5404.20

23 Rosuvastatin 4000 133.33 8704.17 56.89 369.33 369.33 154992.07 82.05 5756.37 3374.03 9130.40

24 Sitagliptin Phosphate Monohydrate

2000 66.67 1537.33 75.75 66.53 66.53 64691.02 61.15 1212.94 466.67 1679.61

25 Sumatriptan Succinate 1000 33.33 697.50 2.00 140.52 140.52 10417.86 3.64 640.01 200.00 840.01

26 Velpatasvir 2000 66.67 403.23 10.73 16.67 16.67 236500.61 26.42 285.13 145.50 430.63

27 Zolmitriptan 1000 33.33 1165.70 27.61 111.31 111.31 101050.32 55.54 1639.96 335.33 1975.29

Total 115000 3833.33 55193.18 2752.89 4350.36 4350.36 6559840.69 3497.60 46777.44 19036.72 65814.16

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2.11 Expected Effluent water characteristics:

*We are going to achieve zero discharge.

The effluent water characteristics before treatment are based on calculations. The

effluent water after passing through Stripper, MEE, Biological treatment plant & RO

plant the expected results after treatment are given in the above table.

2.12 HAZARDOUS & SOLID WASTE GENERATION DETAILS

The Hazardous/Solid waste generated and disposal methods from proposed project

are given below.

TABLE- 2.12: EXPECTED HAZARDOUS/SOLID WASTE GENERATION,

DISPOSAL DETAILS

S. No Name of the

Hazardous Waste Quantity Disposal Method

1 Organic Solid Waste 3757 Kg/Day

Sent to Cement Industries

2 Spent Carbon 108 Kg/Day

3 Solvent distillation residue 1174 Kg/Day

4 Organic Evaporate liquid from MEE stripper

1040 Kg/Day

5 Mixed Solvents 3933 Kg/Day

6 ETP Sludge 1000 Kg/Day

Sent to TSDF 7 Inorganic solid waste 366 Kg/Day

8 MEE Salts 4954 Kg/Day

9 Used Oils 1000

Ltrs/Annum SPCB Authorized Agencies for Reprocessing/Recycling

10 Detoxified Containers 1000

No’s/Month

After Detoxification sent back to suppliers/sent to outside Parties

11 Used Lead Acid Batteries 9 No’s/Year Send back to suppliers for buyback of New Batteries

Solid Waste Details

12 Ash from boiler 16800 Kg/Day

Sent to Brick Manufacturers

S. No Parameters Unit Results

Before treatment

After treatment*

1. pH - 8.5-9.0 7.0-7.5

2. HTDS mg/L 59316.42 <500

3. LTDS mg/L <5000 <500

4. COD mg/L 28977 <250

5. Oil & Grease mg/L 20-25 <10

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The expected quantities which are given in the above table based on calculations of

each product material balance. The ash from boiler is based on ash percentage in

the coal. The used oils and used lead acid batteries quantities are based on usage of

respective equipment. The container liners & containers are based on various

packing of raw materials.

TABLE- 2.13: SOLID WASTE GENERATION – PRODUCT WISE PER DAY

S.No.

Product Name Production

Capacity Kg/Month

Production

Capacity Kg/Day

Kg Per Day

Organic Inorga

nic Spent arbon

Total solid waste

1 (S)-(-)-3-(Dimethylamino)-1-(2-Thienyl)-1-Propanol

10000 333.33 71.07 0.00 0.00 71.07

2

2,4- Dihydro-4-(4-4 hydroxy phenyl )-1-piperazinyl ) -2-(1-methyl propyl )-3H-1,2,4-Triazole-3-one

10000 333.33 428.70 0.00 0.00 428.70

3 2-[3-methyl -4-(2,2,2-trifluoroethoxy)-2-pyridinyl ] methylthio -1H-benzimidazole

5000 166.67 149.07 0.00 0.00 149.07

4 4-Chloro Butyraldehyde Diethyl acetal

5000 166.67 20.12 97.08 0.00 117.20

5 4-Chloro-1 hydroxy butane sulphonic acid sodium salt

5000 166.67 18.40 0.00 0.00 18.40

6 4-Dimethyl amino butytalde diethyl acetal

5000 166.67 14.65 0.00 0.00 14.65

7 Almotriptan Malate 1000 33.33 12.71 18.57 0.00 31.28

8 Celecoxib 4000 133.33 21.87 0.00 0.00 21.87

9

Cis -2-[2,4-Di Chloro Phenyl] -2-[1H-1,2,4-Triazole -1-yl Methyl ]-1,3 Dioxalane -4 yl Methanol

4000 133.33 24.52 0.00 0.00 24.52

10

Cis -2-[2,4-Di chloro Phenyl]-2-[1H-1,2,4-Triazole -1-yl methyl]-1,3 Dioxalane-4yl Methyl ] Methane Sulfonate

5000 166.67 41.42 0.00 0.00 41.42

11 Dabigartan 2000 66.67 35.05 0.00 0.00 35.05

12 Duloxetine Hydrochloride 2000 66.67 20.51 0.00 0.00 20.51

13 Emitricitibine 4000 133.33 117.72 0.00 44.00 161.72

14 Imatinib Mesylate 2000 66.67 23.99 0.00 0.00 23.99

15 Itraconazole 4000 133.33 17.73 0.00 0.00 17.73

16 Ketorolac Tromethamine 5000 166.67 103.98 0.00 0.00 103.98

17 Lansprazole 1000 33.33 15.78 0.00 0.00 15.78

18 Mesalamine 4000 133.33 79.76 0.00 0.00 79.76

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19 Olmesartan Medoxomil 4000 133.33 92.28 200.00 0.00 292.28

20 Pentaprazole chloro compound (2-Chloromethyl-3,4-Dimethoxy-Pyridine)

10000 333.33 0.00 0.00 0.00 0.00

21 Pantoprazole Sodium 9000 300.00 68.10 0.00 0.00 68.10

22 Pregabalin 4000 133.33 1792.27 0.00 40.00 1832.27

23 Rosuvastatin 4000 133.33 224.16 0.00 0.00 224.16

24 Sitagliptin Phosphate Monohydrate

2000 66.67 87.33 0.00 0.00 87.33

25 Sumatriptan Succinate 1000 33.33 139.96 0.00 0.00 139.96

26 Velpatasvir 2000 66.67 19.47 0.00 0.00 19.47

27 Zolmitriptan 1000 33.33 39.25 50.00 23.33 112.58

Total 115000 3833.33 3679.84 365.65 107.33 4152.83

2.13 POWER (ENERGY) REQUIREMENT

Power requirement of proposed project will be made available through Andhra

Pradesh Southern Power Distribution Corporation Limited [APSPDCL]. The power

requirement of project will be 2000 KVA.

2.14 UTILITIES

TABLE - 2.14: Details of Utilities

2.15 PROPOSED BOILER & DG SET

For generation of Steam, the industry proposed to install 8 TPH & 4 TPH coal fired

boilers. The coal requirement will be met from government allocation or from local

authorized sources.

S. No Description Capacity

1 Coal fired boiler 8 TPH & 4 TPH

2 Thermic Fluid Heater 200000 kcal/hr

3 D.G. Set 500 KVA & 1000

KVA

4 Cooling Towers 2x200 TR, 250 TR

& 300 TR

5 Electricity supply from APSPDCL.

2000 KVA

Fuel

6 Coal 48 TPD

7 Diesel 300 Liters/Day

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The unit is proposing a 500 KVA & 1000 KVA DG sets, for usage during the power

failures.

TABLE- 2.15: Emission Characteristic details of proposed Boiler

Particulars Units 8.0 TPH Coal fired

Boiler 4.0 TPH Coal fired

Boiler

Type of Fuel -- Indian Coal with CV of 4000 kcal/kg to

5000 kcal/kg

Indian Coal with CV of 4000 kcal/kg to

5000 kcal/kg

Coal Consumption TPD 32 16

Ash Content % 35 35

Sulphur Content % 0.4 0.4

No. of Stacks No 1 1

Height of stack M 34 30

Diameter of Stack M 0.50 0.40

Temperature of Flue Gas oC 200 180

Velocity of Flue Gas m/s 16 14

Particulate Matter gm/sec 0.26 0.13

Sulphur dioxide emission gm/sec 2.95 1.48

Oxides of Nitrogen emission gm/sec 9.70 4.86

Note: 5 TPH Coal fired Boiler is kept as standby.

TABLE- 2.16: Stack Emission Details for Thermic Fluid Heater

Particulars Units 2,00,000 kcal/hr.

Thermic fluid heater

Thermo pack Boiler Capacity Kcal/hr. 2,00,000

Type of Fuel -- Diesel

Stack Temperature Before Air preheater

oC 200

Stack Temperature After Air preheater

oC 130

Stack Height m 15

Fuel Consumption per Day TPD 0.57

Diameter m 0.3

TABLE- 2.17: Stack Emission details of proposed DG Set

Capacity In KVA

Emission of SPM in mg/Nm3

Emission Of SO2 in mg/Nm3

Emission of NOx

in mg/Nm3

Stack dia. in m

Flue Gas Temp. in

OC

Stack Height in m

Flue gas Velocity in m/sec.

500 KVA (Proposed)

80 150 180 0.30 220 10 16

1000 KVA (Proposed)

120 170 200 0.35 280 10 18

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2.16 DETAILS OF PROPOSED SOLVENTS INPUT, RECOVERY & LOSS

A liquid substance capable of dissolving other substances; "the solvent does not change its state in forming a solution". Details of

solvents are given below in a table 2.18.

TABLE 2.18: DETAILS OF PROPOSED SOLVENT INPUT, RECOVERY & LOSS [PRODUCT WISE]

S.No

Product Name Production capacity Kg/Month

Solvents details Quantity in Kgs/Day

Solvent Name Solvent

Input

Solvent

Recovery

Solvent

Loss

Solvent in aste water

Solvent in

Residue

Solvent Input

Solvent Recovery

Solvent Loss

Solvent in

waste water

Solvent in

Residue

1

(S)-(-)-3-(Dimethylamino)-1-(2-Thienyl)-1-Propanol

10000 IPA 100.00 95.0 2.00 0.00 3.00 333.33 316.67 6.67 0.00 10.00

Mixed Solvents(n-Hexane + Methanol)

520.00 494.0 26.00 0.00 0.00 1733.33 1646.67 86.67 0.00 0.00

Acetone 200.00 190.0 4.00 0.00 6.00 666.67 633.33 13.33 0.00 20.00

Toluene 200.00 190.0 4.00 6.00 0.00 666.67 633.33 13.33 20.00 0.00

Methanol 200.00 190.0 4.00 0.00 6.00 666.67 633.33 13.33 0.00 20.00

Petrolium ether 200.00 190.0 4.00 0.00 6.00 666.67 633.33 13.33 0.00 20.00

4733.33 4496.67 146.67 20.00 70.00

2

2,4- Dihydro-4-(4-4 hydroxy phenyl )-1-piperazinyl ) -2-(1-methyl propyl )-3H-1,2,4-Triazole-3-one

10000 DMF 300.00 285.00 6.00 0.00 9.00 1000.00 950.00 20.00 0.00 30.00

Dimethylsulfoxide 200.00 190.0 4.00 0.00 6.00 666.67 633.33 13.33 0.00 20.00

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Acetone 200.00 190.0 4.00 0.00 6.00 666.67 633.33 13.33 0.00 20.00

Acetic acid 412.00 392.0 9.00 0.00 11.00 1373.33 1306.67 30.00 0.00 36.67

Chloroform 200.00 190.0 10.00 0.00 0.00 666.67 633.33 33.33 0.00 0.00

Methanol 300.00 285.0 6.00 0.00 9.00 1000.00 950.00 20.00 0.00 30.00

41.00 5373.33 5106.67 130.00 0.00 136.67

3

2-[3-methyl -4-(2,2,2-trifluoroethoxy)-2-pyridinyl ] methylthio -1H-benzimidazole

5000 Methanol 1780.00 1691.0 36.00 0.00 53.00 593.33 563.67 12.00 0.00 17.67

Methylenedichloride

3100.00 2945.0 62.00 0.00 93.00 1033.33 981.67 20.67 0.00 31.00

Isopropylalcohol 600.00 570.0 12.00 0.00 18.00 200.00 190.00 4.00 0.00 6.00

Methyl isobutylketone

600.00 570.0 30.00 0.00 0.00 200.00 190.00 10.00 0.00 0.00

Toluene 600.00 570.0 12.00 18.00 0.00 200.00 190.00 4.00 6.00 0.00

Acetone 3600.00 3420.0 72.00 0.00 108.00 1200.00 1140.00 24.00 0.00 36.00

3426.67 3255.33 74.67 6.00 90.67

4 4-Chloro Butyralde Diethyl acetal

5000 MDC 800.00 760.0 16.00 0.00 24.00 1333.33 1266.67 26.67 0.00 40.00

Mixed Solvents(Toluene +Methanol )

1000.00 980.0 20.00 0.00 0.00 1666.67 1633.33 33.33 0.00 0.00

3000.00 2900.00 60.00 0.00 40.00

5

4-Chloro-1 hydroxy butane sulphonic acid sodium salt

5000 MDC 800.00 760.0 16.00 0.00 24.00 1333.33 1266.67 26.67 0.00 40.00

METHANOL 200.00 190.0 4.00 0.00 6.00 333.33 316.67 6.67 0.00 10.00

1666.67 1583.33 33.33 0.00 50.00

6 4-Dimethyl amino 5000 Cyclohexane 600.00 570.0 12.00 4.00 14.00 1000.00 950.00 20.00 6.67 23.33

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butytalde diethyl acetal

1000.00 950.00 20.00 6.67 23.33

7 Almotriptan Malate 1000 Chloroform 200.00 190.0 10.00 0.00 0.00 66.67 63.33 3.33 0.00 0.00

Diisopropyl ether 200.00 190.0 10.00 0.00 0.00 66.67 63.33 3.33 0.00 0.00

Methanol 1000.00 950.0 20.00 0.00 30.00 333.33 316.67 6.67 0.00 10.00

Dimethyl formamide

200.00 190.0 4.00 0.00 6.00 66.67 63.33 1.33 0.00 2.00

Isopropyl alcohol 200.00 190.0 4.00 6.00 0.00 66.67 63.33 1.33 2.00 0.00

dichloromethane 600.00 570.0 12.00 0.00 18.00 200.00 190.00 4.00 0.00 6.00

Ethyl acetate 400.00 380.0 8.00 12.00 0.00 133.33 126.67 2.67 4.00 0.00

933.33 886.67 22.67 6.00 18.00

8 Celecoxib 4000 Methanol 1000.00 950.0 20.00 0.00 30.00 1333.33 1266.67 26.67 0.00 40.00

Toluene 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00

36.00 1600.00 1520.00 32.00 0.00 48.00

9

Cis -2-[2,4-Di Chloro Phenyl] -2-[1H-1,2,4-Triazole -1-yl Methyl ]-1,3 Dioxalane -4 yl Methanol

4000 Dimethylsulfoxide 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00

Toluene 200.00 190.0 4.00 6.00 0.00 266.67 253.33 5.33 8.00 0.00

Methanol 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00

800.00 760.00 16.00 8.00 16.00

10

Cis -2-[2,4-Di chloro Phenyl]-2-[1H-1,2,4-Triazole -1-yl methyl]-1,3 Dioxalane-4yl Methyl ] Methane

5000 Dimethylsulfoxide 200.00 190.0 4.00 0.00 6.00 333.33 316.67 6.67 0.00 10.00

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Sulfonate

Toluene 200.00 190.0 4.00 6.00 0.00 333.33 316.67 6.67 10.00 0.00

Methanol 400.00 380.0 8.00 0.00 12.00 666.67 633.33 13.33 0.00 20.00

Dichloromethane 200.00 190.0 4.00 0.00 6.00 333.33 316.67 6.67 0.00 10.00

1666.67 1583.33 33.33 10.00 40.00

11 Dabigartan 2000 n- hexane 200.00 190.0 4.00 0.00 6.00 133.33 126.67 2.67 0.00 4.00

Acetic acid 200.00 190.0 4.00 0.00 6.00 133.33 126.67 2.67 0.00 4.00

Methanol 200.00 190.0 4.00 0.00 6.00 133.33 126.67 2.67 0.00 4.00

Toluene 400.00 380.0 8.00 12.00 0.00 266.67 253.33 5.33 8.00 0.00

Ethanol 600.00 570.0 16.00 0.00 18.00 400.00 380.00 10.67 0.00 12.00

THF 400.00 380.0 8.00 0.00 12.00 266.67 253.33 5.33 0.00 8.00

Isopropyl alcohol 400.00 380.0 8.00 6.00 6.00 266.67 253.33 5.33 4.00 4.00

MDC 200.00 190.0 4.00 0.00 6.00 133.33 126.67 2.67 0.00 4.00

Ethyl acetate 200.00 190.0 4.00 6.00 0.00 133.33 126.67 2.67 4.00 0.00

60.00 1866.67 1773.33 40.00 16.00 40.00

12 Duloxetine Hydrochloride

2000 DMSO 200.00 190.0 4.00 6.00 0.00 133.33 126.67 2.67 4.00 0.00

Toluene 200.00 190.0 4.00 0.00 6.00 133.33 126.67 2.67 0.00 4.00

Diisopropylethylamine

200.00 190.0 4.00 0.00 6.00 133.33 126.67 2.67 0.00 4.00

Ethyl acetate 400.00 380.0 8.00 3.00 9.00 266.67 253.33 5.33 2.00 6.00

Methanol 200.00 190.0 4.00 0.00 6.00 133.33 126.67 2.67 0.00 4.00

800.00 760.00 16.00 6.00 18.00

13 Emitricitibine 4000 Isopropyl alcohol 100.00 95.0 2.00 0.00 3.00 133.33 126.67 2.67 0.00 4.00

Toluene 100.00 95.0 2.00 0.00 3.00 133.33 126.67 2.67 0.00 4.00

Ethanol 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00

Methanol 100.00 95.0 2.00 0.00 3.00 133.33 126.67 2.67 0.00 4.00

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MDC 100.00 95.0 2.00 0.00 3.00 133.33 126.67 2.67 0.00 4.00

800.00 760.00 16.00 0.00 24.00

14 Imatinib Mesylate 2000 IPA 300.00 285.0 6.00 0.00 9.00 200.00 190.00 4.00 0.00 6.00

n-Butanol 500.00 475.0 16.00 0.00 9.00 333.33 316.67 10.67 0.00 6.00

IPE 200.00 190.0 10.00 0.00 0.00 133.33 126.67 6.67 0.00 0.00

Methanol 800.00 760.0 16.00 0.00 24.00 533.33 506.67 10.67 0.00 16.00

2-Propanol 200.00 190.0 10.00 0.00 0.00 133.33 126.67 6.67 0.00 0.00

Chloroform 400.00 380.0 8.00 0.00 12.00 266.67 253.33 5.33 0.00 8.00

Ethyl acetate 300.00 285.0 6.00 4.00 5.00 200.00 190.00 4.00 2.67 3.33

DMF 300.00 285.0 6.00 0.00 9.00 200.00 190.00 4.00 0.00 6.00

Total 2000.00 1900.00 52.00 2.67 45.33

15 Itraconazole 4000 Methanol 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00

MDC 200.00 190.0 40.00 0.00 6.00 266.67 253.33 53.33 0.00 8.00

Toluene 200.00 190.0 4.00 6.00 0.00 266.67 253.33 5.33 8.00 0.00

Total 800.00 760.00 64.00 8.00 16.00

16 Ketorolac Tromethamine

5000 Toluene 400.00 380.0 8.00 3.00 9.00 9.00 633.33 13.33 5.00 15.00

Acetic acid 200.00 190.0 4.00 0.00 6.00 10.00 316.67 6.67 0.00 10.00

EDC 200.00 190.0 4.00 0.00 6.00 11.00 316.67 6.67 0.00 10.00

Ethyl acetate 400.00 380.0 8.00 3.00 9.00 12.00 633.33 13.33 5.00 15.00

Acetone 200.00 190.0 4.00 0.00 6.00 13.00 316.67 6.67 0.00 10.00

Total 55.00 2216.67 46.67 10.00 60.00

17 Lansprazole 1000 Methanol 400.00 380.0 8.00 0.00 12.00 133.33 126.67 2.67 0.00 4.00

MDC 500.00 475.0 10.00 0.00 15.00 166.67 158.33 3.33 0.00 5.00

IPA 200.00 190.0 4.00 0.00 6.00 66.67 63.33 1.33 0.00 2.00

Methylisobutylketone

200.00 190.0 10.00 0.00 0.00 66.67 63.33 3.33 0.00 0.00

Toluene 200.00 190.0 4.00 6.00 0.00 66.67 63.33 1.33 2.00 0.00

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Acetone 900.00 855.0 18.00 0.00 27.00 300.00 285.00 6.00 0.00 9.00

800.00 760.00 18.00 2.00 20.00

18 Mesalamine 4000 Acetone 400.00 380.0 8.00 0.00 12.00 533.33 506.67 10.67 0.00 16.00

Ethyl acetate 200.00 190.0 4.00 6.00 0.00 266.67 253.33 5.33 8.00 0.00

Methanol 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00

Total 1066.67 1013.33 21.33 8.00 24.00

19 Olmesartan Medoxomil

4000 Acetonitrile 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00

Ethyl acetate 800.00 760.0 16.00 12.00 12.00 1066.67 1013.33 21.33 16.00 16.00

n-Hexane 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00

Toluene 400.00 380.0 8.00 6.00 6.00 533.33 506.67 10.67 8.00 8.00

Diisopropylamine 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00

Dioxane 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00

Dimethl acetamide

200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00

Acetic acid 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00

Total 54.00 3200.00 3040.00 64.00 24.00 72.00

20 Pentaprazole chloro compound (2-Chloromethyl-3,4-Dimethoxy-Pyridine)

10000 Mixed Solvents(IPA +Toluene )

1000.00 980.0 20.00 0.00 0.00 666.67 653.33 13.33 0.00 0.00

Chloroform 200.00 190.0 10.00 0.00 0.00 133.33 126.67 6.67 0.00 0.00

Acetone 100.00 95.0 2.00 0.00 3.00 66.67 63.33 1.33 0.00 2.00

Methylenedi chloride

200.00 190.0 4.00 0.00 6.00 133.33 126.67 2.67 0.00 4.00

Methanol 300.00 285.0 6.00 0.00 9.00 200.00 190.00 4.00 0.00 6.00

Acetic acid 100.00 95.0 2.00 0.00 3.00 66.67 63.33 1.33 0.00 2.00

Total 21.00 1266.67 1223.33 29.33 0.00 14.00

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21 pantoprazole Sodium

9000 Acetone 400.00 380.0 8.00 0.00 12.00 1200.00 1140.00 24.00 0.00 36.00

MDC 400.00 380.0 8.00 0.00 12.00 1200.00 1140.00 24.00 0.00 36.00

Isopropyl alcohol 200.00 190.0 4.00 0.00 6.00 600.00 570.00 12.00 0.00 18.00

Total 30.00 3000.00 2850.00 60.00 0.00 90.00

22 Pregabalin 4000 Ethanol 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00

Methanol 400.00 380.0 8.00 0.00 12.00 533.33 506.67 10.67 0.00 16.00

Acetone 400.00 380.0 8.00 0.00 12.00 533.33 506.67 10.67 0.00 16.00

Toluene 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00

IPA 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00

Total 1866.67 1773.33 37.33 0.00 56.00

23 Rosuvastatin 4000 Isopropyl alcohol 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00

MDC 200.00 190.0 4.00 0.00 6.00 266.67 253.33 5.33 0.00 8.00

Methanol 600.00 570.0 12.00 0.00 18.00 800.00 760.00 16.00 0.00 24.00

Dichloro methane 400.00 380.0 8.00 0.00 12.00 533.33 506.67 10.67 0.00 16.00

DMSO 200.00 190.0 4.00 6.00 0.00 266.67 253.33 5.33 8.00 0.00

Toluene 600.00 570.0 12.00 6.00 12.00 800.00 760.00 16.00 8.00 16.00

Total 44.00 54.00 2933.33 2786.67 58.67 16.00 72.00

24

Sitagliptin Phosphate Monohydrate

2000 MDC 300.00 285.0 6.00 0.00 9.00 200.00 190.00 4.00 0.00 6.00

Toluene 200.00 190.0 4.00 6.00 0.00 133.33 126.67 2.67 4.00 0.00

Ethyl acetate 100.00 95.0 2.00 3.00 0.00 66.67 63.33 1.33 2.00 0.00

Methanol 100.00 95.0 2.00 0.00 3.00 66.67 63.33 1.33 0.00 2.00

IPA 300.00 285.0 6.00 0.00 9.00 200.00 190.00 4.00 0.00 6.00

21.00 666.67 633.33 13.33 6.00 14.00

25 Sumatriptan Succinate

1000 Toluene 400.00 380.0 8.00 6.00 6.00 133.33 126.67 2.67 2.00 2.00

Methanol 100.00 950.0 20.00 0.00 30.00 33.33 316.67 6.67 0.00 10.00

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Dichloromethane 200.00 190.0 4.00 0.00 6.00 66.67 63.33 1.33 0.00 2.00

Ethyl acetate 200.00 190.0 4.00 6.00 0.00 66.67 63.33 1.33 2.00 0.00

42.00 300.00 570.00 12.00 4.00 14.00

26 Velpatasvir 2000 MDC 200.00 190.0 4.00 0.00 6.00 133.33 126.67 2.67 0.00 4.00

THF 400.00 380.0 8.00 0.00 12.00 266.67 253.33 5.33 0.00 8.00

IPA 200.00 190.0 4.00 0.00 6.00 133.33 126.67 2.67 0.00 4.00

Methanol 900.00 855.0 18.00 0.00 27.00 600.00 570.00 12.00 0.00 18.00

Toluene 200.00 190.0 4.00 0.00 6.00 133.33 126.67 2.67 0.00 4.00

Acetic Acid 200.00 190.0 4.00 0.00 6.00 133.33 126.67 2.67 0.00 4.00

1400.00 1330.00 28.00 0.00 42.00

27 Zolmitriptan 1000 n-Hexane 600.00 570.0 12.00 0.00 18.00 200.00 190.00 4.00 0.00 6.00

Isopropylalcohol 200.00 190.0 4.00 0.00 6.00 66.67 63.33 1.33 0.00 2.00

Methanol 1200.00 1140.0 24.00 0.00 36.00 400.00 380.00 8.00 0.00 12.00

Ethyl acetate 800.00 760.0 16.00 24.00 0.00 0.00 253.33 5.33 8.00 0.00

Total 666.67 886.67 18.67 8.00 20.00

Total 115000 47688.33 48078.67 1164.00 167.33 1174.00

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2.17 LIST OF THE RAW MATERIALS PRODUCT WISE

1. (S)-(-)-3-(DIMETHYLAMINO)-1-(2-THIENYL)-1-PROPANOL

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 2-Acetylthiophene 152 506.67

2 Acetone 200 666.67

3 Dimethylamine hydrochloride

98.5 328.33

4 Formaldehyde 37.00 123.33 5 Hydrochloric acid 21.00 70.00

6 Isopropyl alcohol 100.00 333.33 7 Methanol 460.00 1533.33

8 n-Hexane 260.00 866.67

9 Petroleum ether 200.00 666.67

10 S-(+) –mandelic acid 87.00 290.00 11 Sodium borohydride 45.00 150.00 12 Sodium hydroxide 23.00 76.67

13 Toluene 200.00 666.67

2. 2,4- DIHYDRO-4-(4-4 HYDROXY PHENYL )-1-PIPERAZINYL ) –

2-(1-METHYL PROPYL)-3H-1,2,4-TRIAZOLE-3-ONE

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 1-(4-Methoxy-phenyl)-4- (4-nitro-phenyl)-piperazine

185.00 616.67

2 2-Bromo butane 55.00 183.33 3 Acetic acid 466.00 1553.33 4 Acetone 200.00 666.67 5 Chloroform 1100.00 3666.67 6 Dimethylformamide 300.00 1000.00 7 Dimethylsulfoxide 200.00 666.67

8 Formamidine 20.00 66.67

9 Hydrazine hydrate 24.00 80.00 10 Hydrobromic acid 750.00 2500.00 11 Hydrogen 1.20 4.00 12 Methanol 300.00 1000.00 13 Palladium on carbon 10.00 33.33 14 Phenyl chloroformate 87.00 290.00 15 Potassium hydroxide 23.00 76.67 15 Sodium carbonate 42.00 140.00

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3. 2-[3-METHYL -4-(2,2,2-TRIFLUOROETHOXY)-2-PYRIDINYL ]

4. METHYLTHIO -1H-BENZIMIDAZOLE

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 2,3-Lutidine 400.00 133.33

2 2-Mercaptobanzimidazole 214.00 71.33

3 Acetic acid 380.00 126.67

4 Acetic anhydride 750.00 250.00

5 Acetone 3600.00 1200.00

6 Ammonia 700.00 233.33

7 Hydrochloric acid 82.00 27.33

8 Hydrogen peroxide (50%) 360.00 120.00

9 Isopropyl alcohol 600.00 200.00

10 Methanol 1780.00 593.33

11 Methyl isobutyl ketone 600.00 200.00

12 Methylene di chloride 3100.00 1033.33 13 Nitric acid 740.00 246.67 14 Potassium carbonate 309.00 103.00 15 Sodium hydroxide 229.00 76.33 16 Sulphuric acid 1390.00 463.33

17 Tetra-n-butylammonium bromide(TBAB)

10.00 3.33

18 Thionyl chloride 182.00 60.67

19 Toluene 600.00 200.00

20 Trifluoroethanol 223.00 74.33

4. 4-CHLORO BUTYRALDEHYDE DIETHYL ACETAL

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 Tetra hydrofuran 47.00 78.33

2 Hydrochloric acid 47.60 79.33 3 MDC 800.00 1333.33 4 Methanol 500.00 833.33 5 Para toluene sulfonic acid 5.00 8.33 6 Potassium bromide 5.00 8.33 7 Sodium bicarbonate 50.00 83.33 8 Sodium carbonate 5.00 8.33 9 Sodium chloride 3.25 5.42 10 Sodium hydroxide 26.10 43.50 11 Sodium hypochlorite 45.25 75.42 12 Sodium thiosulphate 3.25 5.42 13 TEMPO 20.00 33.33 14 Toluene 500.00 833.33 15 Triethylorthoformate 84.85 141.42

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5. 4-CHLORO 1-HYDROXY BUTANE SULPHONIC ACID SODIUM SALT

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 Tetra hydrofuran 40.00 66.67

2 Sodium hydroxide 22.20 37.00 3 Hydrochloric acid 40.50 67.50 4 Sodium hypochlorite 39.10 65.17 5 Sodium bicarbonate 50.00 83.33 6 MDC 400.00 666.67

7

(2,2,6,6-Tetramethylpiperidin-1-yl)oxyl or (2,2,6,6-tetramethylpiperidin-1-yl)oxidanyl,(TEMPO)

20.00 33.33

8 Potassium bromide 5.00 8.33 9 Sodium thio sulphate 3.25 5.42 10 Sodium chloride 3.25 5.42 11 Hydrochloric acid 18.15 30.25 12 Sodium metabisulphate 94.60 157.67 13 MDC 400.00 666.67 14 Methanol 200.00 333.33

6. 4- DIMETHYLAMINOBUTYRALDEHYDE DIETHYL ACETAL

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 1-Bromo-3-chloro-propane

93.00 155.00

2 Cyclo hexane 600.00 1000.00 3 Dimethylamine 26.70 44.50 4 Iodine 20.00 33.33 5 Magnesium 14.00 23.33 6 Sodium hydroxide 23.65 39.42 7 Triethylorthoformate 81.50 135.83

7. ALMOTRIPTAN MALATE

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 (4-Nitro-phenyl)-methane sulfonyl chloride

73.00 24.33

2 4-Chloro-1,1-dimethoxy-butane

40.00 13.33

3 Ammonium hydroxide 52.00 17.33

4 Chloroform 200.00 66.67 5 Dichloromethane 600.00 200.00 6 Diisopropylether 200.00 66.67 7 Dimethyl formamide 200.00 66.67

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8 Disodium orthophosphate 20.00 6.67 9 Ethyl acetate 400.00 133.33 10 Formaldehyde 15.00 5.00

11 Hydrochloric acid 40.00 13.33 12 Hydrogen 0.60 0.20 13 Isopropyl alcohol 200.00 66.67 14 Malic acid 36.00 12.00 15 Methanol 1000.00 333.33 16 Oxalic acid 20.00 6.67 17 Pyrrolidine 22.00 7.33 18 Raney nickel 10.00 3.33

19 Sodium borohydride 10.00 3.33 20 Sodium nitrite 19.00 6.33 21 Tin(II) chloride 20.00 6.67

8. CELECOXIB

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 Trifluoro acetic acid 36.00 48.00

2 4-amino benzene sulfonamide

51.00 68.00

3 4-methyl acetophenone 39.80 53.07 4 Hydrochloric acid 32.50 43.33 5 Methanol 1010.00 1346.67

6 Sodium chloride 23.75 31.67 7 Sodium methoxide 16.05 21.40 8 Sodium nitrite 20.50 27.33 9 Sodiummeta bi sulphate 56.60 75.47 10 Toluene 200.00 266.67

9. CIS -2-[2, 4-DI CHLORO PHENYL] -2-[1H-1, 2,4-TRIAZOLE -1-YL METHYL

]-1,3 DIOXALANE -4 YL METHANOL

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 Cis bromo benzoate 159.00 212.00 2 1,2,4-Trazole 24.50 32.67 3 Potassium carbonate 24.50 32.67 4 Sodium hydroxide 15.00 20.00 5 Dimethylsulfoxide 200.00 266.67 6 Toluene 200.00 266.67 7 Methanol 200.00 266.67

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10. CIS -2-[2, 4-DI CHLORO PHENYL]-2-[1H-1, 2, 4-TRIAZOLE -1-YL

METHYL]-1, 3 DIOXALANE-4YL METHYL] METHANE SULFONATE

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 Cis bromo benzoate 137.00 228.33 2 1,2,4-Trazole 22.00 36.67 3 Dichloromethane 200.00 333.33 4 Dimethylsulfoxide 200.00 333.33

5 Methane sulfonyl chloride 30.00 50.00

6 Methanol 400.00 666.67

7 Potassium carbonate 22.00 36.67 8 Sodium hydroxide 13.00 21.67 9 Toluene 200.00 333.33 10 Triethylamine 27.00 45.00

11. DABIGATRAN

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 (pyridine-2-ylamine 23.00 15.33

2 2-bromoacetic acid 30.00 20.00 3 4-amino benzonitrile 25.00 16.67

4 4-chloro-3-nitro-benzoic acid

55.00 36.67

5 Acetic acid 200.00 133.33 6 Ammonia 5.00 3.33 7 Ammonium carbonate 18.00 12.00 8 Ammonium formate 20.00 13.33 9 Dichloromethane 200.00 133.33 10 Ethanol 400.00 266.67 11 Ethyl acetate 200.00 133.33

12 Ethyl acrylate 25.00 16.67 13 Hexyl chloro formate 29.00 19.33 14 Hydrochloric acid 9.00 6.00 15 Iron 12.00 8.00 16 Isopropyl alcohol 400.00 266.67 17 Methanol 200.00 133.33 18 Methyl amine 9.00 6.00 19 n-Hexane 200.00 133.33 20 Potassium carbonate 25.00 16.67 21 Tetra hydrofuran 400.00 266.67 22 Thionyl chloride 31.00 20.67 23 Toluene 400.00 266.67 24 Triethylamine 24.00 16.00

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12. DULOXETINE HYDROCHLORIDE

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 (S)-3-Dimethylamino-1-thiophen -2-yl-propan-1-ol

74.00 49.33

2 1-fluoronaphthalene 58.00 38.67

3 Diisopropyl ethylamine 200.00 133.33 4 DMSO 200.00 133.33 5 Ethyl acetate 400.00 266.67 6 Hydrochloric acid 13.00 8.67 7 Methanol 200.00 133.33

8 Oxalic acid 35.00 23.33 9 Phenyl chloro formate 60.00 40.00 10 Potassium hydroxide 10.00 6.67 11 Sodium hydroxide 16.00 10.67 12 Toluene 200.00 133.33

13. EMITRICITABINE

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1

5-(4-Amino-5-fluoro-2-oxo-2H-pyrimidin-1-yl)-[1,3]Oxa thiolane-2-carboxylic acid-2-isopropyl-5-methyl cyclo hexyl ester

200.00 266.67

2 Activated carbon 23.00 30.67

3 Dipotassium hydrogen phosphate

10.00 13.33

4 Ethanol 200.00 266.67 5 Hydrochloric Acid 20.00 26.67 6 Hyflow 10.00 13.33 7 IPA.HCl (25%) 73.20 97.60 8 Isopropyl alcohol 200.00 266.67 9 MDC 100.00 133.33 10 Methanol 100.00 133.33 11 Sodium borohydride 19.00 25.33 12 Sodium Hydroxide 11.00 14.67 13 Toluene 100.00 133.33 14 Tri ethylamine 47.00 62.67

14. IMATINIB MESYLATE

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 O-Toludine 31.00 20.67 2 2-Propanol 200.00 133.33 3 3-dimethylamino-1- 47.30 31.53

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(pyridyl0-2-propan-1-one

4 4-(4-methylpiperazine mono methyl)benzoic acid di HCl

57.00 38.00

5 Ammonia 10.00 6.67

6 Chloroform 400.00 266.67 7 Chloroform 0.00 8 Cyanamide 11.60 7.73 9 DMF 300.00 200.00 10 Ethyl acetate 600.00 400.00 11 Ethyl acetate 0.00

12 Hydrogen 1.56 1.04 13 IPA 300.00 200.00 14 IPE 200.00 133.33 15 Methane sulfonic acid 16.95 11.30 16 Methanol 800.00 533.33 17 N-Butanol 500.00 333.33

18 Nitric acid 35.65 23.77

19 Palladium on carbon 10.00 6.67 20 Sodium hydroxide 10.75 7.17 21 Sulfuric acid 28.50 19.00 22 Thionyl chloride 22.10 14.73 23 Tin(II) chloride 10.00 6.67

15. ITRACONAZOLE

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 1-[2-(2,4-Dichloro-phenyl)-4-ethy l-[1,3]dioxolan -2-ylmethyl]-1H-[1,2,4]triazole

65.00 86.67

2 2-{4-[4-(4-Hydroxy-phenyl)-piperazin- 1-yl]-phenyl}-4-isobutyl-2,4-dihydro -[1,2,4]triazol-3-one

63.00 84.00

3 Sodium hydroxide 7.00 9.33

4 Toluene 200.00 266.67 5 Methanol 200.00 266.67 6 Dichloro methane 200.00 266.67

16. KETOROLAC TROMETHAMINE

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 Benzoyl chloride 71.00 118.33 2 Acetic acid 200.00 333.33 3 Acetic anhydride 234.00 390.00 4 Acetone 200.00 333.33 5 Dichloroethane (EDC) 238.00 396.67 6 Diethylmalonate 71.00 118.33

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7 Ethyl acetate 400.00 666.67 8 Ethylchloroformate 48.00 80.00 9 Hydrochloric acid 28.20 47.00

10 Magnesium oxide 18.00 30.00 11 Manganese acetate 10.00 16.67 12 Morpholine 44.00 73.33 13 Phosphoryl chloride 73.00 121.67 14 potassium permanganate 10.00 16.67 15 Pyrrole 32.00 53.33 16 Sodium hydroxide 90.80 151.33 17 TBAB 10.00 16.67

18 Toluene 400.00 666.67 19 Tromethamine 36.00 60.00

17. LANSOPRAZOLE

S. No.

Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 2,3-Lutidine 47.00 15.67 2 2-Mercaptobanzimidazole 49.00 16.33 3 Acetic acid 200.00 66.67 4 Acetic anhydride 39.00 13.00 5 Acetone 900.00 300.00 6 Ammonia 15.00 5.00 7 Ammonium sulphate 25.00 8.33 8 Hydrochloric acid 14.00 4.67 9 Hydrogen peroxide (50%) 30.00 10.00

10 Isopropyl alcohol 200.00 66.67 11 Methanol 400.00 133.33 12 Methyl isobutyl ketone 200.00 66.67 13 Methylene di chloride 500.00 166.67 14 Nitric acid 27.00 9.00 15 Potassium carbonate 52.00 17.33 16 Sodium hydroxide 46.00 15.33 17 Sodium hypo chlorite 22.00 7.33

18 Sulphuric acid 41.00 13.67

19 Tetra-n-butylammonium bromide(TBAB)

10.00 3.33

20 Thionyl chloride 41.00 13.67

21 Toluene 200.00 66.67 22 Trifluoroethanol 38.00 12.67

18. MESALAMINE

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 2-chloro-benzaldehyde 138.00 184.00 2 Acetone 400.00 533.33 3 Ethyl acetate 200.00 266.67

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4 Hydrogen 1.50 2.00 5 Methanol 200.00 266.67 6 Nitric acid 62.00 82.67

7 Potassium hydroxide 45.00 60.00 8 Potassium permanganate 279.50 372.67 9 Raney Nickel 10.00 13.33 10 Sulphuric acid 96.50 128.67

19. OLMESARTAN MEDOXOMIL

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 DiaminoMaleonitrile 41.00 54.67

2 4-[2-(trityltetrazole)-5yl)phenyl] benzyl bromide((5-(4'-Bromomethyl-Biphenyl-2-Yl)-2- Trityl-2,5-Dihydro-1H-Tetrazole))

128.00 170.67

3 4-Chloromethyl-5-methyl-[1,3]diooxol-2-one

30.00 40.00

4 Acetic acid 200.00 266.67 5 Acetone 200.00 266.67 6 Acetonitrile 200.00 266.67 7 Diisopropyl ether 200.00 266.67 8 Dimethylacetamide 200.00 266.67 9 Dioxane 200.00 266.67 10 Ethanol 26.00 34.67 11 Ethyl acetate 800.00 1066.67 12 Hydrochloric acid 30.00 40.00 13 Lithium hydroxide mono

hydrate 10.00 13.33

14 Methyl magnesium chloride

19.00 25.33

15 n-hexane 200.00 266.67 16 Sodium sulphate 150.00 200.00 17 Thionyl chloride 35.00 46.67 18 Toluene 400.00 533.33 19 Trimethyl ortho butyrate 51.00 68.00

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20. PENTAPRAZOLE CHLORO COMPOUND

(2-CHLOROMETHYL-3,4-DIMETHOXY-PYRIDINE)

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 Maltol 411.00 274.00 2 Acetic acid 100.00 66.67 3 Acetic Anhydride 290.50 193.67 4 Acetone 100.00 66.67 5 Ammonia 54.50 36.33 6 Chloroform 200.00 133.33

7 Dimethyl sulphate 206.00 137.33 8 Hydrochloric acid 99.50 66.33 9 Hydrogen peroxide (50%) 205.00 136.67

10 IPA 500.00 333.33 11 MDC 200.0 133.33 12 Methanol 394.00 262.67 13 Phosphorous oxy chloride 476.00 317.33 14 Potassium carbonate 359.00 239.33 15 Sodium Hydroxide 228.90 152.60 16 Toluene 500.00 333.33

21. .PANTOPRAZOLE SODIUM

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 2-Chloromethyl-3,4-dimethoxy-pyridine Hydrochloride

68.00 204.00

2 5-Difluoromethoxy-2- mercaptobenzimidazole

66.00 198.00

3 Acetone 400.00 1200.00 4 Ammonium hydroxide 22.00 66.00 5 Dichloromethane 400.00 1200.00

6 Isopropylacohol 200.00 600.00

7 Sodium hydroxide 11.00 33.00 8 Sodium hypochlorite 20.00 60.00

22. PREGABALIN

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 Iso valeraldehyde 553.00 737.33 2 Acetic acid 545.00 726.67

3 Acetone 400.00 533.33 4 Activated carbon 30.00 40.00 5 Diethylmalonate 1028.50 1371.33 6 Ethanol 200.00 266.67 7 Hydrochloric acid 63.00 84.00

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8 Hydrogen 16.00 21.33 9 IPA 200.00 266.67 10 Methanol 400.00 533.33

11 Potassium hydroxide 245.00 326.67 12 Raney Nickel 10.00 13.33 13 Sodium cyanide 252.00 336.00 14 Sodium hydroxide 69.00 92.00 15 Tartric acid 280.00 373.33 16 Toluene 200.00 266.67

23. ROSUVASTATIN

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 4-Fluoro benzaldehyde 62.00 82.67 2 (6-Acetoxy-2,2-dimethyl-

[1,3] dioxan-4-yl)-acetic acid tert-butyl ester

81.00 108.00

3 2-Methyl iso thio urea 41.00 54.67

4 Dichloro methane 400.00 533.33 5 Dicyclohexylamine 42.00 56.00 6 DMSO 200.00 266.67 7 Hydrobromic acid 175.44 233.92 8 Isopropyl alcohol 200.00 266.67 9 Manganese dioxide 10.00 13.33 10 MDC 200.00 266.67 11 Methane sulfonic acid 33.00 44.00 12 Methanol 600.00 800.00 13 Methyl Amine 12.00 16.00 14 Methyl isobutyryl acetate 72.00 96.00 15 Piperidine 5.00 6.67 16 Potassium carbonate 65.00 86.67

17 Sodium bicarbonate 5.00 6.67 18 Sodium boro hydride 13.00 17.33 19 Sodium hydroxide 19.00 25.33

20 Sodium hypo chlorite 79.00 105.33 21 TEMPO 5.00 6.67 22 Toluene 600.00 800.00 23 Triphenylphosphine 68.00 90.67

24. SITAGLIPTIN PHOSPHATE MONOHYDRATE

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 2,4,5-Trifluro phenyl acetic acid

95.00 63.33

2 3-(trifluoromethyl)-5,6,7,8-tetrahydro(1,2,4)triazole(4,3,-a)Pyrazine hydrochloride

109.00 72.67

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3 Acetic acid 15.00 10.00 4 Ammonia 8.00 5.33 5 Ethyl acetate 100.00 66.67

6 Hydroxyl phenyl acetic acid 34.00 22.67 7 Isopropyl alcohol 300.00 200.00 8 Meldrum acid 72.00 48.00 9 Methane sulfonic acid 46.00 30.67 10 Methanol 100.00 66.67 11 Methylene chloride 300.00 200.00 12 Phosphoric acid 20.50 13.67 13 Sodium bicarbonate 40.00 26.67

14 Sodium borohydrate 8.50 5.67 15 Sodium hydroxide 48.50 32.33 16 Thionyl chloride 60.00 40.00 17 Toluene 200.00 133.33

25. SUMATRIPTAN SUCCINATE

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 Para Nitrobenzyl Bromide 372.00 124.00

2 4-Chloro-1-hydroxy butane-1-sodium sulfonic acid

91.00 30.33

3 Dichloromethane 200.00 66.67 4 Disodium hydrogen

orthophosphate 10.00 3.33

5 Ethyl acetate 200.00 66.67 6 Formaldehyde (50%) 42.00 14.00 7 Hydrochloric acid 42.00 14.00 8 Hydrogen 1.50 0.50 9 Methanol 1000.00 333.33 10 Mono methyl amine 38.00 12.67 11 Phosphoryl chloride 185.00 61.67

12 Raney Nickel 10.00 3.33 13 Sodium Sulphite 217.00 72.33 14 Sodium borohydride 13.00 4.33 15 Sodium dithionate 15.00 5.00 16 Sodium hydroxide 10.00 3.33 17 Sodium nitrite 40.00 13.33 18 Succinic acid 32.00 10.67 19 Toluene 400.00 133.33

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26. VELPATASVIR

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 9-Bromo-3-(2-bromo-acetyl)-10,11 -dihydro-5H,9H-6-oxa-benzo[a]anthracen-8-one

61.00 40.67

2 1-(2-Methoxycarbonylamino-3-methyl -butyryl)-5-methyl-pyrrolidine- 2-carboxylic acid

37.30 24.87

3 4-Methoxymethyl-pyrrolidine -1,2-dicarboxylic acid 1-tert-butyl ester

35.15 23.43

4 Acetic acid 200.00 133.33

5 Acetylamino-phenyl-acetic acid 22.60 15.07 6 AMMONIA 4.50 3.00 7 Ammonium acetate 19.70 13.13

8 Caesium carbonate 5.00 3.33

9 CDMT(2-Chloro-4,6-dimethoxy-1,3,5-triazine)

5.00 3.33

10 DDQ 5.00 3.33 11 Hydrochloric acid 5.00 3.33 12 IPA 200.00 133.33

13 MDC 200.00 133.33 14 Methanol 900.00 600.00 15 Phosphoric acid 5.00 3.33

16 THF 400.00 266.67 17 Toluene 200.00 133.33

27. ZOLMITRIPTAN

S. No. Raw Material Consumption/ Batch in Kgs

Consumption/ Day in Kgs

1 L-Phenylalanine 132.00 44.00

2 (4,4-Diethoxy-butyl) -dimethyl-amine

74.00 24.67

3 Activated carbon 60.00 20.00 4 Ammonia 28.00 9.33 5 Ethyl acetate 800.00 266.67 6 Ethyl chloroformate 69.00 23.00

7 Hydrochloric acid 100.00 33.33 8 Hydrogen 0.90 0.30 9 Hyflow 10.00 3.33 10 Isopropyl alcohol 200.00 66.67 11 Methanol 623.00 207.67 12 n-Hexane 600.00 200.00 13 Nitric acid 51.00 17.00 14 Raney Nickel 10.00 3.33

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15 Sodium bicarbonate 20.00 6.67 16 Sodium boro hydride 22.00 7.33 17 Sodium hydroxide 10.00 3.33

18 Sodium methoxide 27.00 9.00 19 Sodium sulphate 150.00 50.00 20 Sulphuric acid 79.00 26.33 21 Thionyl chloride 86.00 28.67

2.18 ENVIRONMENTAL ASPECTS, IMPACTS AND MITIGATION MEASURES OF

PROPOSED INDUSTRY

1. Aspect: Process gases such as SO2, HCl Emissions, DG Set emissions & Boiler

emissions into atmosphere.

Impact: Air pollution & Acid precipitation.

Mitigation measures: During production process the released gases will be

passed through double stage scrubber to scrub the gases with miscible liquid.

The scrubber will have polypropylene rings as packing media to increase the

contact surface area between gas and scrubbing solution to increase the

absorption. Gas and scrubbing solution will pass through the scrubber counter

currently.

SO2 gas will be scrubbed with caustic lye solution to convert into sodium

sulphate. In this process the entire SO2 will get scrubbed.

HF gas will be scrubbed with caustic lye solution to convert into convert into

sodium salt.

HCl gas will be scrubbed with chilled water to convert into HCl solution.

(CH3)2NH will be scrubbed with chilled water to convert into dilute solution of

Dimethylamine.

NH3 will be scrubbed with chilled water to convert into ammonium solution.

DG set emissions will be monitored regularly to maintain the emission limits

within the CPCB limits. As per norms the stack height will be provided around 9

mts to have proper dispersion. In case the limits are crossing the combustion

engine will be taken for service.

Boiler flue gases emissions will be monitored regularly to maintain the flue gases

emission limit as per CPCB Standard. The stacks of height 34 m & 30 m will be

provided to have proper dispersion of flue gases.

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2. Aspect: Organic & inorganic impurities from process & inorganic impurities High

TDS water & High COD water from utilities, floor washings entering into water

stream.

Impact; water pollution (contamination of natural resources)

Mitigation measures: The generated High& Low TDS water, floor washings will

be collected in separate streams at generation point and collected in to

respective dedicated tanks. The high TDS water sent through the MEE System to

remove COD and TDS and later passed with Low TDS water through the

Biological treatment plant to remove BOD and finally through the RO plant to get

reusable water quality. This water will be used for Cooling towers and floor

washings etc. This will minimize the fresh water requirement by 175 KLD.

3. Aspect: Noise from DG Set, Boiler & Electric motors more than 75 dB.

Impact: Noise pollution.

Mitigation measure: DG set will have acoustic enclosure and drives will have

proper maintenance to minimize vibrations and internal parts servicing to

minimize the sound pollution.

4. Aspect: Spillages of chemicals during loading /unloading, Effluent water at ETP

Plant, Solvents spillages at storage tanks, spillage of Oils from DG Set & Air

compressor/Refrigeration compressor on to the ground.

Impact: Soil pollution.

Mitigation measure: To avoid any spillage of chemicals the working area of

loading & unloading area is barricaded and the floor will be made with acid proof

tiling with a slope towards a small pit so as to collect the spilled chemicals in the

dedicated pit. This results in avoiding the spillage of chemicals on to the ground.

Effluent water will be transferred through the dedicated pipe lines from plant to

ETP plant .This will eliminate soil contamination with effluent water.

Each solvent storage tank area will have dyke wall and the floor will have cement

concrete with slope towards a pit. Hence spillage of solvent will be avoided on to

ground.

The DG set /Air compressor/refrigeration compressor area will be placed in

Utilities building with cement concrete floor. The filling and draining of Oils from

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respective equipment will be done by trained technical person to avoid any

spillage of oil on to the floor/ground.

5. Aspect: Improper Storage of hazardous waste (organic waste, inorganic waste,

spent carbon) results in leakage/Spillage on to the ground

Impact; Soil pollution

Mitigation measure: The hazardous waste in containers will be stored in

dedicated area as per its category with proper flooring having slope towards a pit

to collect any spilled material. The entire area will be barricaded with a dyke wall

and only authorized personnel will be allowed to do operations in storage area.

This avoids soil pollution.

6. Aspect: Establishment of industry may release gases emissions, effluent water

leakage to surrounding areas.

Impact: 1. Flora & Fauna, Water Bodies, Agriculture & Human habitation.

2. The positive impact is generation of employment to skilled & unskilled

people of nearby villages and economic development.

Mitigation measure: The industry will have dedicated effluent treatment (MEE,

Biological treatment plant, RO system) to achieve Zero Liquid discharge system.

This will eliminate effluent leakage to surrounding area of the plant.

7. Aspect; Improper Storage of Flammable chemicals Methanol, Toluene, Acetone

causing leakage of flammable chemical

Impact: presence of ignition source caches fire, risk to plant personnel due to

thermal radiation, release of CO, CO2, toxic gases in to atmosphere and global

warming.

Mitigation measure: Each solvent storage tank will have dyke to contain entire

contents. This will avoid leakage of solvent to the outside of dyke wall. The tanks

will be monitored regularly for any corrosion at valve joints, valve gland leakages.

The storage tanks will have fire alarm system. In case if it is catches fire, it will be

extinguished with DCP fire extinguishers and fire hydrant water. This will

minimize the thermal radiation and release of CO, CO2 and toxic gases to the

atmosphere.

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8. Aspect: ground water extraction for industry

Impact: Depletion of water resources

Mitigation measure: The industry will conserve rain water by adopting rain water

harvesting system in the plant of11536 m3/annum.

2.19 ASSESSMENT OF NEW & UNTESTED TECHNOLOGY FOR RISK OF

TECHNOLOGICAL FAILURE

No new or untested technology will be used in the proposed project but the

manufacturing process may be altered for better yields after successful lab tests and

R&D.

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DESCRIPTION OF THE

ENVIRONMENT

CHAPTER -III

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CHAPTER-III

DESCRIPTION OF THE ENVIRONMENT

3.0 INTRODUCTION

Baseline data generation is a part of the Environmental Impact Assessment study, which

helps to evaluate the predicted impacts on the various environmental attributes in the study

area by using scientifically developed and widely accepted environmental impact

assessment methodologies. This further helps in preparing an Environment Management

Plan (EMP) outlining the measures for improving the environmental quality and scope for

future improvements for environmentally sustainable development. The baseline

environmental study also helps to identify the critical environmental attributes, which are

required to be monitored after implementation of the project.

This chapter illustrates the description of the existing environmental status of the study

area with reference to the prominent environmental attributes. The existing environmental

setting is considered to adjudge the baseline conditions which are described with respect

to climate, hydro-geological aspects, atmospheric conditions, water quality, soil quality,

vegetation pattern, ecology, socio-economic profile, landuse, places of archaeological

importance etc.

3.1 STUDY AREA

Archimedis Laboratories Pvt. Ltd. proposed manufacturing unit is located at Sy No: 108

& 109, Jayanthipuram (V) Jaggayyapet (M), Krishna District, Andhra Pradesh.

3.1.2 Study Period

The baseline data was collected for the study area during the period of March – 2018 to

May – 2018.

3.2 Geological & Hydrogeological Environment

Scope and Methodology

In any given environment the occurrence and movement of ground water and its quality

and quantity is chiefly controlled and governed by many factors such as geographical set-

up, climate and rainfall conditions, hydrological features, topography, soil characteristics,

the nature and thickness of underlying rock formations and other related aspects that

prevail in an area. Therefore the study envisages indentifying the existing ground water

conditions comprising both quality and potential within the project site and its

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neighborhood, relating the projected utilization for the production, identifying the likely

impacts on surface and ground water resources and indicating mitigation measures. In

order to accomplish the proposed objective of the study, the scope and methodology

adopted is as follows:

Collection of the relevant data contained in the EIA and EMP Reports, from the

reports and maps of Central Ground Water Board (CGWB), Geological Survey of

India (GSI) and Indian Meterological Department (IMD) other Institutions and

Departments.

Identify Inter- related and Inter – dependent key factors that play vital role in the

occurrence of ground water its quality and potential.

Identify surface water resources in the project site and its catchment area.

Assess the ground water resource potential in the catchment area of the project

site.

The field investigations were carried out to study surface rock outcrops, geological cross

sections in the road cuttings. Inventory of wells representing the entire watershed area was

carried out. Hydrogeological data of about 10 wells was collected. Water levels were

measured in the Dug wells and bore wells.

Information already available and the data collected during the survey is collated and

analyzed to comprehend the overall ground water situation in the area. An attempt is made

to predict the likely changes that could occur on account of the proposed bulk drugs

manufacturing and certain mitigation measures have been indicated to avoid adverse

effect on the ground water environment.

3.2.1 Geomorphology and Soil Types:

Geomorphologically the district can be broadly divided into 3 distinct units, viz., Pediplain,

Alluvial plains, and Coastal & Deltaic plains. The pediplain area i.e., northern part of the

district consists of an undulated plain with broken ridges. Major part of the district in the

southern part is represented by the alluvial plains forming the Krishna delta. The river

Krishna and its tributaries have contributed to the formation of this alluvial plain. The

predominant soils in the district are black cotton soils/deltaic soils, red loamy soils and

sandy soils. Red clayey soils with sandy loam to clayey loam in texture and occur in the

northern part of the district.

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3.2.2 Geology

The district is underlain by variety of geological formations comprising from the oldest

Archaeans to Recent Alluvium. Hydrogeologically these formations are classified as

consolidated (Hard), semi-consolidated (Soft) and unconsolidated (Soft) formations. The

consolidated formations include crystallines (khondalites, charnockites and granitic

gneisses) and metasediments (Limestones, shales, phyllites and quartzites) of Archaean

and Pre-cambrian periods respectively.

3.2.3 Hydrogeology

The proposed manufacturing unit is located on the ridge portion of the catchment and is

over the run off zone. No major streams are passing through the site. The catchment area

of the proposed site is moderate and recharge conditions are good. However, the buffer

zone of 10 km radius has good catchment and recharge potential with streams and tanks

of considerable storage potential.

All the stream courses are ephemeral in character and carry large volumes of storm flows

during rainy season and remain dry during non - monsoon season. The width of the

streams is narrow and follows the weak planes within the hard rock formations.

A drainage map of the area around the project is shown in Figure 3.1.

3.2.4 Groundwater Conditions:

Groundwater occurs under semi-confined conditions in the fissured zone of the banded

biotite hornblende gneisses. Ten bore wells were inventoried to assess the groundwater

conditions. The depth to water levels was found to be 12-20m. The yield ranges of bore

wells was found to be 50-100 lpm. The quality of water is found to be potable.

As the extent of the proposed site is very small only roof top rainwater harvesting is

suggested for improving the recharge to the groundwater.

The proposed area is categorized as safe by the Groundwater department and scope for

development & stage of groundwater is good. The site is feasible for groundwater

extraction for the proposed Bulk drugs & intermediates manufacturing unit.

3.2.5 Drainage Pattern of Study Area

Dendritic drainage indicates homogenous rocks, the trellis, rectangular and parallel

drainage patterns indicate structural and lithological controls. The coarse drainage texture

indicates highly porous and permeable rock formations; whereas fine drainage texture is

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more common in less pervious formations. Weathering profile controls of ground water and

above all discharge of surface water along the major streams and rivers. Fractured pattern

and other structural features control drainage pattern in hard rocks. Slope / gradient of

area coupled with drainage density decide the weathering profile. These two factors

synthesized with rainfall (of a given area) provide information on the ground water potential

(weathering profile, structural factors) and discharge of surface water along streams.

Weathering profile increases groundwater potential, slope/gradient together with runoff

controls the thickness of weathered zone. Major faults, lineaments sometimes connects

two are more watersheds (Drainage Basins) and act as conduits (Interconnecting channel

ways). Flow of groundwater along these week zones is an established fact. A proper

understanding of the major faults, their influence of groundwater flow has to be understood

from drainage system and its controls. The study of the drainage for the present purpose is

to understand that, to what extent the ground water would be affected by the water

pollutants. Survey of India Topomaps, satellite data of summer season are the main input

data for preparation of drainage map. The drainage map is prepared using Toposheets of

Survey of India on 1:50,000 scale and updated using latest satellite data wherever

deviations and new developments are observed.

Step I: All the rivers its tributaries and drainage network shown on the Toposheets are

captured. The boundaries of all rivers/water bodies with names appearing are captured

from Toposheets. The drainage is drawn from whole to part, i.e., from the rivers to

tributaries to first drains to second order drains to third order drains.

Step II: Based on the post monsoon satellite image extent of water spread and dry parts

are updated. The water bodies which did not exist at the time of survey of Toposheets, if

any are also captured based on satellite imagery. The study area forms part of Mahanadi

river basin the southern of the area from western part, towards East. All these rivers and

rivulets get dry for major part of the year and carry heavy floods during rainy season. The

drainage map of study area has showing in figure 3.1.

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Table 3.1

Showing drainage density based criteria by smith and strahler.

Drainage Density

Texture Runoff Infiltration Relief Stratum

< 5.0 Coarse (High) High Low High High Impermeable

5.0 - 13.7 Medium Medium Medium Medium Medium Permeable

13.7 - 155.3 Ultra fine (Low) Low High Low Good Permeable

Table 3.2

Showing drainage density based criteria proposed by Long Bein

Drainage Density Areas Runoff

0.55 - 2.09 Steep Impervious Areas High

1.03 Humid Regions High

Table 3.3

Showing Drainage Density Based Criteria Proposed by Horton

Drainage Density Stratum Runoff

0.9 - 1.29 Steep Impervious Areas High

< 0.9 Permeable High Infiltration Areas Low

3.2.6 Drainage Map

This Draingae map consists of all water bodies, rivers, tributaries, perennial & ephemeral

streams, reservoirs, tanks, ponds and the entire drainage network from first order

originating in the area to the last order joining the rivers, tributaries and tanks based on

topography. Understanding the importance of drainage depends on the purpose and the

objective of the project. For the present study purpose the following factors have to be

understood and extracted from the study of the drainage pattern. Drainage network helps

in delineation of watersheds. Drainage density and type of drainage gives information

related to runoff, infiltration relief and permeability.

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FIGURE 3.1 SHOWING DRAINAGE MAP OF THE PROJECT STUDY AREA

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3.3 Micrometeorology and Climate

The meteorological data recorded during the study period is very useful for proper

interpretation of the baseline information as well as for input to prediction models for

air quality dispersion. Historical data on meteorological parameters will also play an

important role in identifying general meteorological regime of the region.

Automatic weather station was installed in the project site at about 10 m above the

ground level. On-site monitoring was undertaken for various meteorological variables

in order to record the site-specific data. Data was recorded every hour continuously

from March – 2018 to May – 2018.

The critical weather elements that influence air pollution are wind speed, wind

direction, temperature, which together determines atmosphere stability. The details

of the temperature, relative humidity and rainfall observed during study period

(March – 2018 to May – 2018) are given below.

A. Temperature:

During the study period the minimum and maximum temperatures were recorded as

22.1°C and 45.2°C respectively.

B. Relative Humidity:

During study period at project site, the relative humidity was recorded as 79.1%

C. Rainfall

No rainfall during the Study Period at the Project Site. Average annual rainfall is 982

mm. (Source: IMD Climatatological Normals, Nandigama 1981 - 2010)

D. Wind pattern

Dispersion of different air pollutants released into the atmosphere has significant

impacts on neighborhood air environment. The dispersion/dilution of the released

pollutant over a large area will result in considerable reduction of the concentration of

a pollutant. The dispersion in turn depends on the weather conditions like the wind

speed, wind direction, temperature, relative humidity, mixing height, cloud cover and

also the rainfall in the area.

Wind speed and direction data recorded during the study period is useful in

identifying the influence of meteorology on the air quality of the area. Wind roses on

sixteen sector basis have been drawn. Wind directions and wind speed frequency

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observed during study period is given in Table 3.4 and wind rose diagrams are

given in Figure 3.2.

The following observations can be made from the collected data;

Calm period is observed to be 16.9 % during the time of monitoring.

The predominant wind direction is S & SSW.

Other than predominant wind directions wind was blowing in ESE direction.

Average wind speed 3.7 m/s.

Mostly the wind speeds are observed to be in the range of 5.7 – 8.8 m/sec,

0.5 – 2.1 m/Sec, 3.6 - 5.7 m/Sec, with frequency of distribution percentages

ranges from 27.5, 21.1, & 16.2.

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TABLE 3.4: FREQUENCY DISTRIBUTION WIND DIRECTIONS AND WIND SPEED

S. No Wind Directions Wind Classes (m/s)

0.5 - 2.1 2.1 - 3.6 3.6 - 5.7 5.7 - 8.8 8.8 - 11.1 >= 11.1 Total (%)

1 N 348.75 - 11.25 0.7 0.2 0.2 0.3 0 0 1.4

2 NNE 11.25 - 33.75 0 0 0 0 0 0 0

3 NE 33.75 - 56.25 0.1 0 0 0 0 0 0.1

4 ENE 56.25 - 78.75 0.7 0.6 1.7 1.5 0 0 4.5

5 E 78.75 - 101.25 1.3 1.2 1.7 1.4 0 0 5.6

6 ESE 101.25 - 123.75 1 1.2 2.2 2.8 1.5 0 8.7

7 SE 123.75 - 146.25 0.7 0.5 0.9 2.3 0.6 0 5

8 SSE 146.25 - 168.75 0.2 0.3 0.8 0.5 0 0 1.8

9 S 168.75 - 191.25 9.8 4.9 2.7 9.1 0.1 0 26.6

10 SSW 191.25 - 213.75 4.1 3.6 4.3 7.4 0.8 0 20.2

11 SW 213.75 - 236.25 0 0 0 0 0 0 0

12 WSW 236.25 - 258.75 0 0 0 0 0 0 0

13 W 258.75 - 281.25 2.2 2.3 1.4 1.7 0.1 0 7.7

14 WNW 281.25 - 303.75 0 0 0 0 0 0 0

15 NW 303.75 - 326.25 0.3 0.4 0.3 0.5 0 0 1.5

16 NNW 326.25 - 348.75 0 0 0 0 0 0 0

Sub-Total 21.1 15.2 16.2 27.5 3.1 0 83.1

Calms

16.9

Missing/Incomplete

0

Total

100

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FIGURE 3.2: WINDROSE DIAGRAM PERIOD: MARCH 2018 – MAY 2018

Source: WRPLOT VIEW - Lakes Environmental Software

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3.4 AIR ENVIRONMENT

The ambient air quality with respect to the study area of 10 km radius around the

plant site forms the baseline information. The various sources of air pollution in the

region are industrial, traffic and rural activities. This will also be useful for assessing

the conformity to standards of the ambient air quality during the plant operation. The

study area represents mostly rural environment.

The baseline status of the ambient air quality has been assessed through a

scientifically designed ambient air quality monitoring network. The design of

monitoring network in the air quality surveillance programme has been based on the

following considerations:

Meteorological conditions on synoptic scale.

Topography of the study area.

Representation of plant site.

Influence of the existing sources (if any) are to be kept at minimum.

Inclusion of major distinct villages to collect the baseline status.

Representation of down wind direction.

Representation of upwind direction.

Representation of cross sectional distribution in the down wind direction.

The ambient air quality monitoring was carried out in accordance with National

Ambient Air Quality Standards (NAAQS) of CPCB. Ambient Air Quality Monitoring

(AAQM) was carried out at eight locations for 2 days per week for 12 weeks during

study period and the locations are shown in Figure 3.3. The locations of the different

stations with respect to its distance and direction from project site are shown in

Table 3.5.

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TABLE 3.5: AMBIENT AIR QUALITY SAMPLING LOCATIONS

S.No. Code Name of Sampling Location Distance (km) w.r.t Project

Direction w.r.t Project

1 A1 Project Site - -

2 A2 Jayanthipuram 1.80 WNW

3 A3 Dhramavarappadu Tanda 2.80 N

4 A4 Bhimavaram 6.70 NE

5 A5 Gauravaram 6.00 ENE

6 A6 Pochampalli 5.11 ESE

7 A7 Vedadri Tanda 3.80 S

8 A8 Ravirala 4.05 SW

The monitoring was carried out for a three month period (March 2018 – May 2018) at

a frequency of twice a week at each station adopting a continuous 24- hour

schedule.

The following parameters were monitored in the study area :

Particulate Matter (PM10)

Particulate Matter (PM2.5)

Sulphur Dioxide (SO2)

Oxides of Nitrogen (NOx)

Carbon Monoxide (CO)

Ammonia (NH3)

Volitail Organic Compounds (VOC)

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FIGURE 3.3: AMBIENT AIR QUALITY SAMPLING LOCATIONS MAP

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3.4.1. National Ambient Air Quality Standards (NAAQS)

National Ambient Air Quality Standards, 2009 for the notified Industrial, Residential,

Rural and Other Areas as well as Sensitive Areas are presented in table below. The

state has not promulgated separate Ambient Air Quality Standards.

TABLE 3.6: NATIONAL AMBIENT AIR QUALITY STANDARDS

S. No

Pollutant Time

Weighted Average

Concentration in Ambient Air

Methods of measurement

Industrial Area

Residential, Rural &

other Areas

Ecologically sensitive area

(Notified by Central Govt)

1 Sulphur Dioxide (SO2) µg/m3

Annual * 50 20 -Improved West and Gaeke method -Ultraviolet fluorescence

24 hours** 80 80

2 Oxides of Nitrogen as NO2 µg/m3

Annual * 40 30 -Modified Jocob and Hochheise(NaArsenite ) -Chemiluminescence

24 hours** 80 80

3 Particulate matter (size Less than 10µm) µg/m3

Annual * 60 60 -Gravimetric -TOEM -Beta attenuation

24 hours** 100 100

4 Particulate matter (size less than 2.5 µm) µg/m3

Annual * 40 40 -Gravimetric -TOEM -Beta attenuation

24 hours** 60 60

5 Ozone µg/m3

8 hours** 100 100 - UV Photometric -Chemiluminescence -Chemical method

1 hour** 180 180

6 Lead (Pb)

µg/m3

Annual * 0.50 0.50 -AAS/ICP method for sampling on EPM 2000 or Equivalent Filter paper -ED -XRF using Teflon filter paper

24 hours** 1.0 1.0

7 Carbon

Monooxide mg/m3

8 hours**

02 02 -Non Dispersive Infra Red (NDIR) spectroscopy 1 hour ** 04 04

8 Ammonia (NH3) µg/m3

Annual * 100 100 -Chemiluminescence -Indo-Phenol Blue method

24 hours** 400 400

9 Benzene µg/m3 Annual * 05 05

-GC based continuous analyzer - Adsorption & desorption followed by GC analysis

10 Benzo(a) pyrene (BaP)- Particulate Phase only ng/m3

Annual * 01 01 -Solvent extraction followed by GC/HPLC extraction

11 Arsenic ng/m3 Annual * 06 06

AAS/ICP method for sampling on EPM2000 OR Equivalent Filter paper

12 Nickel ng/m3 Annual *

20 20 -AAS/ICP method for sampling on EPM2000

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S. No

Pollutant Time

Weighted Average

Concentration in Ambient Air

Methods of measurement

Industrial Area

Residential, Rural &

other Areas

Ecologically sensitive area

(Notified by Central Govt)

OR Equivalent Filter paper

G.S.No.826 (E) dated 16th November, 2009. Vide letter no. F. No. Q-15017/43/2007-CPW.

*Average Arithmetic mean of minimum 104 measurements in a year taken for a week

24 hourly at uniform interval.

**24 hourly/8 hourly values should meet 98 percent of the time in a year.

3.4.2. Ambient Air Quality Data (AAQ)

The Maximum, Minimum & 98th percentile values for all the sampling are shown in

Table 3.7. The location wise monitored Ambient Air Quality details are presented in

Table 3.8 to Table 3.15.

1. Particulate Matter (PM10)

The maximum and minimum concentrations for PM10 were recorded in the study

area showed 98th percentile values in the range of 55.46 – 68.88 μg/ m3. The

maximum concentration 68.88 μg/ m3 were recorded at sampling locations at

Dhramavarappadu Tanda. The concentrations of PM10 are well below the CPCB

standard of 100 μg/ m3.

2. Particulate Matter (PM2.5)

The CPCB Standard for concentration of PM2.5 is 60 μg/ m3. The maximum and

minimum 98th percentile concentrations for Particulate Matter (PM2.5) monitored

in the study area were 18.02 – 28.92 μg/m3 respectively. Highest value of 28.92

μg/ m3 was at Dhramavarappadu Tanda. The concentration of PM2.5 is well

below the prescribed limit of 60 μg/ m3

3. Sulphur Dioxide (SO2)

98th percentile value of Sulphur dioxide in the study area from the monitored data

was in the range of 11.44 – 15.15 μg/ m3. Maximum value of Sulpur dioxide of

15.15 μg/ m3 obtained at Dhramavarappadu Tanda. The concentration of SO2 is

well below the prescribed limit of 80 μg/ m3

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4. Oxides of Nitrogen (NOx)

Ambient air quality status monitored for oxides of nitrogen in the study area were

in the range with 98th percentile values between 17.10 – 22.33 μg/ m3. A

maximum value of 22.33 μg/ m3 was prevailing at the time of sampling at

Bhimavaram. The concentration of NOX is well below the prescribed limit of 80

μg/ m3

5. Carbon Monoxide (CO)

The maximum and minimum 98th percentile concentrations for Carbon Monoxide

(CO) monitored in the study area were 0.34 – 0.74 mg/m3 respectively. Highest

value of 0.74 mg/ m3 was at the Dhramavarappadu Tanda. The concentration of

CO is well below the prescribed limit of 2 mg/ m3

6. Ammonia (NH3)

The maximum and minimum 98th percentile concentrations for Ammonia (NH3)

monitored in the study area were 12.91 – 32.75 μg/m3 respectively. Highest value

of 32.75 μg/ m3 was at Dhramavarappadu Tanda. The concentration of NH3 is

well below the prescribed limit of 400 μg/ m3

7. Volatile Organic Compounds (VOCs)

Volatile Organic Compounds (VOCs) concentration in study area was found to be

Below Detectable Limit of 1 ppm.

The ambient air quality monitoring results indicates that the overall air quality in the

study area is within permissible standards prescribed by NAAQ Standards.

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TABLE 3.7: THE MAXIMUM, MINIMUM & 98th PERCENTILE VALUES FOR ALL THE

SAMPLING LOCATIONS

Code Name of Sampling Location

PM 10(µg/M3) PM 2.5(µg/M

3) SO2(µg/M

3) NOX(µg/M

3) CO (mg/M

3) NH3 (µg/M

3)

Min Max 98th

Min Max 98th

Min Max 98th

Min Max 98th

Min Max 98th

Min Max 98th

A1 Project Site 53.69 62.35 61.68 18.62 22.60 22.17 10.50 14.31 13.93 13.78 21.93 20.84 0.22 0.41 0.40 20.98 30.25 29.97

A2 Jayanthipuram 56.51 61.44 60.93 17.05 21.31 20.97 11.21 16.30 15.07 15.42 22.51 20.79 0.42 0.67 0.65 20.49 27.63 27.61

A3 Dhramavarappadu Tanda

59.89 70.15 68.88 18.07 30.59 28.92 11.29 15.19 15.15 15.93 19.46 19.45 0.45 0.76 0.74 28.35 32.87 32.75

A4 Bhimavaram 56.29 64.29 62.46 19.42 25.18 25.18 12.37 15.06 15.04 15.49 23.19 22.33 0.24 0.45 0.44 18.29 22.46 22.33

A5 Gauravaram 58.09 60.31 60.24 18.09 21.47 21.45 11.04 14.83 14.26 15.89 20.18 19.94 0.24 0.41 0.40 12.58 15.73 15.59

A6 Pochampalli 55.19 60.39 60.34 17.42 24.87 24.85 10.34 13.84 13.74 14.25 19.27 19.00 0.23 0.39 0.38 10.23 13.31 12.91

A7 Vedadri Tanda 49.30 55.73 55.46 14.52 18.06 18.02 10.08 12.89 12.85 15.24 17.39 17.36 0.20 0.34 0.34 12.38 15.09 15.05

A8 Ravirala 48.23 59.68 58.13 15.00 19.63 19.10 9.58 11.49 11.44 13.82 17.25 17.10 0.19 0.35 0.35 10.48 14.00 13.97

NAAQ Standards’ 100 60 80 80 2 400

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TABLE 3.8: AMBIENT AIR QUALITY, STATION: PROJECT SITE (A1)

Date Week PM 10 PM 2.5 SO2 NOX CO NH3 VOC

02.03.2018 1 53.69 19.78 13.14 19.08 0.32 23.16 BDL

03.03.2018 1 59.42 20.04 11.67 18.22 0.41 20.98 BDL

09.03.2018 2 58.31 18.76 14.31 21.93 0.39 22.45 BDL

10.03.2018 2 57.26 19.43 11.43 19.57 0.35 24.18 BDL

16.03.2018 3 60.30 20.60 12.53 15.22 0.29 23.67 BDL

17.03.2018 3 60.90 21.65 13.20 16.40 0.25 22.49 BDL

21.03.2018 4 59.35 20.44 11.45 14.66 0.31 21.08 BDL

22.03.2018 4 60.10 21.28 10.90 15.20 0.35 22.61 BDL

03.04.2018 5 62.35 19.60 11.42 13.78 0.31 30.25 BDL

04.04.2018 5 59.85 19.46 12.70 15.30 0.27 28.47 BDL

09.04.2018 6 58.30 20.30 11.28 14.84 0.22 29.64 BDL

10.04.2018 6 57.22 20.95 12.30 16.58 0.32 27.15 BDL

16.04.2018 7 56.34 18.62 10.97 16.83 0.22 26.69 BDL

17.04.2018 7 57.22 20.33 10.55 16.95 0.25 24.11 BDL

24.04.2018 8 56.55 20.62 12.41 16.84 0.33 23.35 BDL

25.04.2018 8 57.36 22.60 13.49 17.82 0.25 22.46 BDL

03.05.2018 9 59.62 21.12 12.35 15.44 0.27 21.59 BDL

04.05.2018 9 60.35 19.25 12.39 17.30 0.29 22.37 BDL

10.05.2018 10 58.33 20.12 10.50 16.98 0.31 23.61 BDL

11.05.2018 10 59.74 20.45 12.34 15.40 0.36 22.55 BDL

17.05.2018 11 56.98 19.63 11.69 18.12 0.24 21.48 BDL

18.05.2018 11 56.34 18.77 12.47 16.98 0.25 23.42 BDL

25.05.2018 12 58.62 21.67 11.33 17.83 0.29 24.16 BDL

26.05.2018 12 59.66 20.65 10.60 16.21 0.33 23.79 BDL

Minimum 53.69 18.62 10.50 13.78 0.22 20.98 0.00

Maximum 62.35 22.60 14.31 21.93 0.41 30.25 0.00

Average 58.51 20.25 11.98 16.81 0.30 23.99 0.00

98th Percentile 61.68 22.17 13.93 20.84 0.40 29.97 0.00

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TABLE 3.9: AMBIENT AIR QUALITY, STATION: JAYANTHIPURAM (A2)

Date Week PM 10 PM 2.5 SO2 NOX CO NH3 VOC

02.03.2018 1 56.69 19.85 12.63 16.85 0.52 25.46 BDL

03.03.2018 1 57.58 19.54 13.45 17.21 0.43 27.59 BDL

09.03.2018 2 59.69 20.03 13.63 17.52 0.62 23.61 BDL

10.03.2018 2 60.33 20.58 12.36 16.25 0.53 27.15 BDL

16.03.2018 3 59.82 19.47 13.54 17.20 0.67 24.39 BDL

17.03.2018 3 61.44 21.31 13.25 17.55 0.54 25.77 BDL

21.03.2018 4 56.51 17.23 13.21 17.54 0.49 24.36 BDL

22.03.2018 4 58.16 19.29 12.54 16.41 0.48 25.10 BDL

03.04.2018 5 58.45 19.04 13.62 17.74 0.51 27.63 BDL

04.04.2018 5 57.29 18.93 13.21 17.65 0.57 26.19 BDL

09.04.2018 6 59.58 19.99 16.30 22.51 0.59 23.41 BDL

10.04.2018 6 60.14 20.55 12.52 16.33 0.54 22.94 BDL

16.04.2018 7 58.29 19.68 12.41 17.28 0.43 23.84 BDL

17.04.2018 7 58.14 19.23 13.28 18.04 0.48 24.65 BDL

24.04.2018 8 57.85 20.04 12.25 16.21 0.50 25.19 BDL

25.04.2018 8 56.82 17.05 13.54 17.85 0.49 24.47 BDL

03.05.2018 9 59.08 20.01 13.24 17.45 0.42 23.19 BDL

04.05.2018 9 58.33 19.71 12.56 17.25 0.47 22.43 BDL

10.05.2018 10 58.25 19.65 13.57 18.54 0.42 23.85 BDL

11.05.2018 10 59.17 20.25 12.45 18.76 0.49 22.67 BDL

17.05.2018 11 58.54 20.22 11.58 16.65 0.52 21.75 BDL

18.05.2018 11 59.63 19.49 13.59 18.21 0.56 22.61 BDL

25.05.2018 12 58.39 18.64 11.21 15.42 0.55 20.49 BDL

26.05.2018 12 57.19 18.06 11.93 16.06 0.59 22.49 BDL

Minimum 56.51 17.05 11.21 15.42 0.42 20.49 0.00

Maximum 61.44 21.31 16.30 22.51 0.67 27.63 0.00

Average 58.56 19.49 12.99 17.44 0.52 24.22 0.00

98th Percentile 60.93 20.97 15.07 20.79 0.65 27.61 0.00

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TABLE 3.10: AMBIENT AIR QUALITY, STATION: DHRAMAVARAPPADU TANDA

(A3)

Date Week PM 10 PM 2.5 SO2 NOX CO NH3 VOC

06.03.2018 1 63.25 20.18 14.55 17.55 0.59 30.15 BDL

07.03.2018 1 65.18 25.14 15.10 19.43 0.62 29.54 BDL

13.03.2018 2 60.33 20.01 11.29 18.45 0.49 30.68 BDL

14.03.2018 2 62.95 20.91 13.90 17.60 0.45 29.46 BDL

19.03.2018 3 60.48 19.68 15.19 19.21 0.47 30.28 BDL

20.03.2018 3 62.91 19.60 14.25 17.83 0.52 30.17 BDL

26.03.2018 4 67.39 20.47 12.98 16.87 0.51 28.35 BDL

27.03.2018 4 70.15 30.59 12.74 17.31 0.56 30.69 BDL

06.04.2018 5 65.16 24.78 12.01 17.05 0.60 31.41 BDL

07.04.2018 5 64.29 23.46 13.62 18.69 0.62 28.91 BDL

12.04.2018 6 66.52 25.59 11.75 15.93 0.55 28.58 BDL

13.04.2018 6 64.73 23.10 12.35 17.00 0.60 29.37 BDL

19.04.2018 7 65.17 25.33 12.44 17.46 0.49 31.14 BDL

20.04.2018 7 60.25 19.84 13.28 18.63 0.62 32.55 BDL

27.04.2018 8 63.94 22.61 12.74 17.08 0.68 30.19 BDL

28.04.2018 8 64.07 25.15 11.95 16.93 0.71 32.61 BDL

07.05.2018 9 65.37 26.95 12.63 17.56 0.76 30.28 BDL

08.05.2018 9 60.28 18.33 13.28 18.44 0.63 29.13 BDL

14.05.2018 10 59.91 18.07 12.41 17.39 0.58 32.49 BDL

15.05.2018 10 62.31 23.49 13.29 18.24 0.63 32.42 BDL

22.05.2018 11 60.26 20.73 13.24 18.69 0.59 30.66 BDL

23.05.2018 11 59.89 19.68 14.28 19.46 0.54 32.87 BDL

28.05.2018 12 61.05 22.44 13.64 18.33 0.61 30.69 BDL

29.05.2018 12 63.39 24.19 12.88 17.29 0.58 32.25 BDL

Minimum 59.89 18.07 11.29 15.93 0.45 28.35 0.00

Maximum 70.15 30.59 15.19 19.46 0.76 32.87 0.00

Average 63.30 22.51 13.16 17.85 0.58 30.62 0.00

98th Percentile 68.88 28.92 15.15 19.45 0.74 32.75 0.00

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TABLE 3.11: AMBIENT AIR QUALITY, STATION: BHIMAVARAM (A4)

Date Week PM 10 PM 2.5 SO2 NOX CO NH3 VOC

06.03.2018 1 59.14 20.14 12.89 18.25 0.42 19.54 BDL

07.03.2018 1 57.36 23.61 14.31 19.64 0.39 18.63 BDL

13.03.2018 2 60.25 25.18 13.26 18.31 0.43 20.14 BDL

14.03.2018 2 59.34 22.19 13.87 18.76 0.38 21.08 BDL

19.03.2018 3 57.29 24.39 14.65 19.33 0.39 20.37 BDL

20.03.2018 3 58.44 25.17 13.58 18.07 0.40 19.68 BDL

26.03.2018 4 57.38 24.51 14.26 19.54 0.38 18.33 BDL

27.03.2018 4 58.29 23.67 15.06 20.31 0.36 19.47 BDL

06.04.2018 5 60.31 24.08 13.08 18.63 0.42 18.29 BDL

07.04.2018 5 58.44 21.37 14.65 19.66 0.43 19.33 BDL

12.04.2018 6 59.33 20.68 14.63 19.47 0.41 20.18 BDL

13.04.2018 6 58.49 19.42 14.22 19.63 0.39 21.05 BDL

19.04.2018 7 60.08 24.00 13.97 18.24 0.43 19.64 BDL

20.04.2018 7 59.27 20.69 13.64 21.33 0.33 18.73 BDL

27.04.2018 8 64.29 24.65 15.02 23.19 0.41 20.55 BDL

28.04.2018 8 58.46 24.17 14.87 20.69 0.24 19.63 BDL

07.05.2018 9 57.81 23.61 13.69 18.44 0.37 19.47 BDL

08.05.2018 9 56.29 23.34 14.28 17.22 0.34 20.24 BDL

14.05.2018 10 58.49 24.58 12.37 15.86 0.31 21.06 BDL

15.05.2018 10 59.18 22.69 12.71 16.58 0.38 20.39 BDL

22.05.2018 11 60.24 23.54 13.22 17.24 0.32 22.18 BDL

23.05.2018 11 59.33 22.45 12.68 15.49 0.36 20.12 BDL

28.05.2018 12 57.69 24.18 12.51 16.22 0.38 21.63 BDL

29.05.2018 12 58.06 23.57 13.24 16.27 0.45 22.46 BDL

Minimum 56.29 19.42 12.37 15.49 0.24 18.29 0.00

Maximum 64.29 25.18 15.06 23.19 0.45 22.46 0.00

Average 58.89 23.16 13.78 18.60 0.38 20.09 0.00

98th Percentile 62.46 25.18 15.04 22.33 0.44 22.33 0.00

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TABLE 3.12: AMBIENT AIR QUALITY, STATION: GAURAVARAM (A5)

Date Week PM 10 PM 2.5 SO2 NOX CO NH3 VOC

02.03.2018 1 58.32 20.15 12.45 17.69 0.33 14.05 BDL

03.03.2018 1 58.96 19.47 13.06 16.29 0.30 15.73 BDL

09.03.2018 2 59.59 20.30 12.63 17.21 0.36 13.27 BDL

10.03.2018 2 58.63 19.85 11.32 17.63 0.32 12.58 BDL

16.03.2018 3 59.81 18.72 12.56 18.63 0.39 14.38 BDL

17.03.2018 3 60.09 20.30 12.95 17.95 0.36 15.42 BDL

21.03.2018 4 58.67 18.09 13.25 18.21 0.32 13.62 BDL

22.03.2018 4 59.51 20.14 13.60 18.54 0.38 14.59 BDL

03.04.2018 5 58.60 19.89 14.83 19.65 0.35 13.41 BDL

04.04.2018 5 59.24 20.33 12.35 18.22 0.32 13.96 BDL

09.04.2018 6 59.85 20.18 13.24 20.18 0.36 14.82 BDL

10.04.2018 6 59.63 19.62 12.63 16.31 0.31 13.49 BDL

16.04.2018 7 58.09 18.46 13.45 17.65 0.35 12.64 BDL

17.04.2018 7 60.31 21.05 13.28 18.21 0.41 13.26 BDL

24.04.2018 8 59.54 19.98 11.04 16.03 0.32 14.09 BDL

25.04.2018 8 58.86 19.43 11.68 15.89 0.35 13.48 BDL

03.05.2018 9 58.96 19.68 12.43 16.94 0.39 12.69 BDL

04.05.2018 9 58.49 18.57 11.28 16.08 0.24 14.57 BDL

10.05.2018 10 58.24 19.65 12.47 16.15 0.33 13.69 BDL

11.05.2018 10 58.20 19.53 12.81 17.59 0.30 14.76 BDL

17.05.2018 11 60.15 21.47 12.64 17.42 0.35 13.28 BDL

18.05.2018 11 59.23 19.27 11.38 16.43 0.33 13.04 BDL

25.05.2018 12 60.14 21.43 12.63 18.04 0.38 14.69 BDL

26.05.2018 12 58.37 18.69 12.36 17.11 0.31 13.54 BDL

Minimum 58.09 18.09 11.04 15.89 0.24 12.58 0.00

Maximum 60.31 21.47 14.83 20.18 0.41 15.73 0.00

Average 59.15 19.76 12.60 17.50 0.34 13.88 0.00

98th Percentile 60.24 21.45 14.26 19.94 0.40 15.59 0.00

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TABLE 3.13: AMBIENT AIR QUALITY, STATION: POCHAMPALLI (A6)

Date Week PM 10 PM 2.5 SO2 NOX CO NH3 VOC

02.03.2018 1 58.71 19.69 12.95 18.39 0.35 11.01 BDL

03.03.2018 1 60.39 20.32 12.56 17.94 0.27 12.36 BDL

09.03.2018 2 59.26 22.34 11.33 16.23 0.24 10.35 BDL

10.03.2018 2 57.15 21.12 12.18 17.29 0.29 10.64 BDL

16.03.2018 3 58.54 19.86 11.26 17.32 0.30 10.23 BDL

17.03.2018 3 59.10 20.34 10.34 16.39 0.34 10.39 BDL

21.03.2018 4 60.26 21.58 10.52 16.99 0.23 11.22 BDL

22.03.2018 4 58.38 22.56 11.67 18.52 0.25 12.04 BDL

03.04.2018 5 59.22 20.17 12.69 19.27 0.31 12.37 BDL

04.04.2018 5 59.18 19.48 13.62 18.69 0.30 13.31 BDL

09.04.2018 6 57.62 24.36 13.84 18.23 0.29 11.93 BDL

10.04.2018 6 55.19 24.83 12.58 16.47 0.24 12.07 BDL

16.04.2018 7 60.25 24.19 13.24 17.46 0.31 12.26 BDL

17.04.2018 7 60.29 24.87 12.63 16.39 0.27 11.54 BDL

24.04.2018 8 56.21 20.56 13.33 17.42 0.31 12.15 BDL

25.04.2018 8 58.27 17.42 11.23 15.45 0.36 11.26 BDL

03.05.2018 9 58.12 22.32 12.24 16.25 0.32 11.09 BDL

04.05.2018 9 59.23 19.14 12.44 16.52 0.39 12.43 BDL

10.05.2018 10 58.54 21.14 11.51 15.54 0.28 11.58 BDL

11.05.2018 10 58.51 21.21 11.24 15.25 0.32 11.23 BDL

17.05.2018 11 58.74 19.52 12.40 16.15 0.30 12.09 BDL

18.05.2018 11 57.52 19.54 12.98 16.90 0.34 11.27 BDL

25.05.2018 12 59.58 20.12 11.07 14.25 0.36 11.29 BDL

26.05.2018 12 57.44 20.13 11.24 15.30 0.27 12.44 BDL

Minimum 55.19 17.42 10.34 14.25 0.23 10.23 0.00

Maximum 60.39 24.87 13.84 19.27 0.39 13.31 0.00

Average 58.57 21.12 12.13 16.86 0.30 11.61 0.00

98th Percentile 60.34 24.85 13.74 19.00 0.38 12.91 0.00

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TABLE 3.14: AMBIENT AIR QUALITY, STATION: VEDADRI TANDA (A7)

Date Week PM 10 PM 2.5 SO2 NOX CO NH3 VOC

06.03.2018 1 50.11 17.39 11.25 16.73 0.29 13.62 BDL

07.03.2018 1 52.52 16.35 12.52 16.39 0.31 12.38 BDL

13.03.2018 2 51.15 16.29 10.35 15.84 0.32 13.28 BDL

14.03.2018 2 52.34 17.42 11.39 16.30 0.29 15.09 BDL

19.03.2018 3 53.54 16.35 10.63 15.47 0.33 14.72 BDL

20.03.2018 3 52.85 18.06 10.55 15.68 0.28 14.39 BDL

26.03.2018 4 50.60 17.29 10.21 16.35 0.24 13.08 BDL

27.03.2018 4 50.95 16.35 10.08 15.38 0.30 13.47 BDL

06.04.2018 5 55.73 17.98 10.28 15.89 0.29 14.61 BDL

07.04.2018 5 53.58 17.30 11.42 16.09 0.34 13.08 BDL

12.04.2018 6 52.85 16.49 10.93 15.37 0.32 14.26 BDL

13.04.2018 6 49.55 15.03 11.47 17.33 0.20 14.59 BDL

19.04.2018 7 49.52 14.69 10.68 15.31 0.26 14.31 BDL

20.04.2018 7 53.53 16.88 12.89 17.39 0.31 15.00 BDL

27.04.2018 8 54.34 15.43 12.62 15.36 0.27 14.82 BDL

28.04.2018 8 49.30 14.52 12.80 17.28 0.24 13.79 BDL

07.05.2018 9 52.94 15.23 10.38 15.82 0.28 12.55 BDL

08.05.2018 9 53.55 17.48 10.45 15.85 0.31 14.08 BDL

14.05.2018 10 54.97 16.33 10.92 15.39 0.22 13.27 BDL

15.05.2018 10 55.14 16.46 11.59 16.47 0.27 14.66 BDL

22.05.2018 11 52.80 15.09 11.66 16.09 0.21 13.59 BDL

23.05.2018 11 53.63 16.27 10.63 16.48 0.30 13.44 BDL

28.05.2018 12 51.55 15.92 10.37 15.24 0.32 14.27 BDL

29.05.2018 12 52.49 16.34 11.52 16.35 0.25 13.68 BDL

Minimum 49.30 14.52 10.08 15.24 0.20 12.38 0.00

Maximum 55.73 18.06 12.89 17.39 0.34 15.09 0.00

Average 52.48 16.37 11.15 16.08 0.28 13.92 0.00

98th Percentile 55.46 18.02 12.85 17.36 0.34 15.05 0.00

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TABLE 3.15: AMBIENT AIR QUALITY, STATION: RAVIRALA (A8)

Date Week PM 10 PM 2.5 SO2 NOX CO NH3 VOC

06.03.2018 1 52.16 16.13 9.94 14.62 0.22 10.48 BDL

07.03.2018 1 51.85 15.69 9.58 13.82 0.19 11.32 BDL

13.03.2018 2 49.32 15.00 10.34 15.60 0.32 12.59 BDL

14.03.2018 2 50.46 16.68 11.27 16.85 0.35 13.48 BDL

19.03.2018 3 53.23 17.93 11.39 17.25 0.25 12.67 BDL

20.03.2018 3 55.85 17.69 10.36 16.87 0.26 13.28 BDL

26.03.2018 4 56.32 19.63 10.24 15.81 0.22 13.64 BDL

27.03.2018 4 50.39 16.21 11.05 16.14 0.22 13.08 BDL

06.04.2018 5 48.23 17.31 10.69 16.08 0.23 12.91 BDL

07.04.2018 5 48.38 17.06 10.03 15.47 0.27 13.26 BDL

12.04.2018 6 49.88 16.48 10.10 15.93 0.22 14.00 BDL

13.04.2018 6 52.39 17.24 11.49 16.21 0.26 13.55 BDL

19.04.2018 7 50.96 15.69 10.39 15.43 0.24 13.49 BDL

20.04.2018 7 55.64 18.47 10.48 15.66 0.31 13.61 BDL

27.04.2018 8 53.52 15.33 10.19 15.07 0.20 13.29 BDL

28.04.2018 8 54.22 15.87 10.31 16.44 0.23 12.52 BDL

07.05.2018 9 56.23 17.22 10.64 16.08 0.25 11.94 BDL

08.05.2018 9 59.68 18.25 10.60 15.73 0.28 12.38 BDL

14.05.2018 10 56.29 17.28 10.79 16.52 0.34 13.94 BDL

15.05.2018 10 52.54 16.04 10.14 15.49 0.25 12.55 BDL

22.05.2018 11 49.37 15.38 11.36 16.83 0.24 11.49 BDL

23.05.2018 11 49.51 15.84 10.28 15.39 0.26 13.40 BDL

28.05.2018 12 51.44 16.02 10.64 15.47 0.31 12.62 BDL

29.05.2018 12 50.33 15.36 11.19 16.92 0.25 13.69 BDL

Minimum 48.23 15.00 9.58 13.82 0.19 10.48 0.00

Maximum 59.68 19.63 11.49 17.25 0.35 14.00 0.00

Average 52.42 16.66 10.56 15.90 0.26 12.88 0.00

98th Percentile 58.13 19.10 11.44 17.10 0.35 13.97 0.00

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3.5 WATER ENVIRONMENT

Water sampling and subsequent analysis were carried out to determine both the

groundwater and surface water quality of the study area.

Selected water quality parameters of ground water resources and surface water

resources within 10 km radius of the study area has been studied for assessing the

quality of water.

3.5.1 Methodology for Water Quality Monitoring

Ground water sources and surface water sources covering 10 km radial distance

were examined for physico-chemical, heavy metals and bacteriological parameters

in order to assess the effect of industrial and other activities on ground water and

surface water. The samples were analyzed as per the procedures specified in

'Standard Methods for the Examination of Water and Wastewater' published by

American Public Health Association (APHA).

Samples for chemical analysis were collected in polyethylene carboys. Samples for

bacteriological analysis were collected in sterilized glass bottles. Selected

physicochemical and bacteriological parameters have been analyzed for projecting

the existing water quality status in the study area. Parameters like pH and

temperature were analyzed at the time of sample collection.

The details of surface and ground water sampling locations are given in Table 3.16

and sampling locations of ground water quality and surface quality monitoring are

shown in Figure 3.4. The physico - chemical characteristics of the ground water

samples and surface water samples are presented in the Tables 3.17 & Tables 3.18.

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TABLE 3.16: GROUND AND SURFACE WATER SAMPLING LOCATIONS

S.No. Code Name of Sampling Location Distance (km) w.r.t Project

Direction w.r.t Project

Ground Water Sampling Locations

1 GW1 Near Project Site - -

2 GW2 Jayanthipuram 1.80 WNW

3 GW3 Dhramavarappadu Tanda 2.80 N

4 GW4 Bhimavaram 6.70 NE

5 GW5 Pochampalli 5.15 ESE

6 GW6 Vedadri Tanda 4.1 S

7 GW7 Ravirala 4.05 SW

8 GW8 Jaggayyapeta 6.00 NW

Surface Water Sampling Locations

1 SW1 Gauravaram Cheruvu 5.40 ENE

2 SW2 Pochampalli Cheruvu 3.40 SE

3 SW3 Konakanchi Cheruvu 5.50 SE

4 SW4 Krishna River near Vedadri 4.10 SSW

5 SW5 Palleru River 3.45 W

6 SW6 Jaggayyapeta Cheruvu 5.75 NW

7 SW7 Water body near Shermohmammadpeta

8.45 NNW

8 SW8 Water body near Chillakallu 4.65 N

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FIGURE 3.4: GROUND & SURFACE WATER SAMPLING LOCATIONS MAP

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TABLE 3.17 GROUNDWATER QUALITY IN THE STUDY AREA

S. No Parameter Method Unit GW1 GW2 GW3 GW4 IS 10,500 Limits

Acceptable Permissible

1 pH APHA 22nd Edition 4500 H+ B -- 7.32 8.08 8.13 8.01 6.5-8.5 No Relaxation

2 Color APHA 22nd Edition 2120 B CU <1.0 < 1.0 <1.0 <1.0 5 15

3 Total Dissolved Solids APHA 22nd Edition 2540 C mg/l 467.5 545.2 612 521 500 2000

4 Total Alkalinity (as CaCO3)

APHA 22nd Edition 2320 B mg/l 175 252 142 125 200 600

5 Total Hardness (as CaCO3)

APHA 22nd Edition 2340 C mg/l 315.0 330.0 295.0 340.0 200 600

6 Calcium (as Ca ) APHA 22nd Edition 3500 Ca B mg/l 74.6 84.52 58.4 84.2 75 200

7 Magnesium (as Mg) APHA 22nd Edition 3500-Mg B mg/l 25.34 32 31.5 22.5 30 100

8 Sulphate (as SO4) APHA 22nd Edition 4500 SO4 E mg/l 32.40 49.4 52 96 200 400

9 Chloride (as Cl) APHA 22nd Edition 4500 Cl- B mg/l 154 114 185.6 148 250 1000

10 Lead as Pb APHA 22nd Edition 3111B mg/l < 0.01 < 0.01 < 0.01 < 0.01 0.01 No Relaxation

11 Cadmium as Cd APHA 22nd Edition 3111B mg/l <0.01 < 0.01 < 0.01 < 0.01 0.003 No Relaxation

12 Total Chromium as Cr APHA 22nd Edition 3111B mg/l <0.05 < 0.05 < 0.05 < 0.05 0.05 No Relaxation

13 Copper as Cu APHA 22nd Edition 3111B mg/l < 0.01 < 0.01 < 0.01 < 0.01 0.05 1.5

14 Zinc as Zn APHA 22nd Edition 3111B mg/l < 0.5 < 0.5 < 0.5 < 0.5 5 15

15 Nickel as Ni APHA 22nd Edition 3111B mg/l <0.01 < 0.01 < 0.01 < 0.01 0.02 No Relaxation

16 Fluorides as F APHA 22nd Edition 4500 F- D mg/l < 0.5 < 0.5 < 0.5 < 0.5 1 1.5

17 Aluminium as Al APHA 22nd Edition 3500 Al B mg/l <0.03 < 0.03 < 0.03 < 0.03 0.03 0.2

18 Boron as B APHA 22nd Edition 4500 B B mg/l <0.2 <0.2 <0.2 <0.2 0.5 1

19 Manganese as Mn APHA 22nd Edition 3111B mg/l <0.02 <0.02 < 0.02 < 0.02 0.1 0.3

20 Iron as Fe APHA 22nd Edition 3500 Fe B mg/l < 0.05 < 0.05 < 0.05 < 0.05 0.3 No Relaxation

21 Nitrate Nitrogen APHA 22nd Edition 4500 NO3 B mg/l 2.4 2.32 2.1 2.3 45 No Relaxation

22 Sodium as Na APHA 22nd Edition 3500 Na B mg/l 51 92 96.8 76.4 -- --

23 Potassium as K APHA 22nd Edition 3500 K B mg/l < 5.0 < 5.0 9.5 < 5.0 -- --

24 Odour APHA 22nd Edition 2150 B -- Agreeable Agreeable Agreeable Agreeable -- --

25 Electrical Conductivity APHA 22nd Edition 2510 B μmho/cm 721 840 956 812 -- --

26 Phosphorus as P APHA 22nd Edition 4500 P C mg/l 0.52 1.42 1.35 0.45 -- --

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TABLE 3.17 GROUND WATER QUALITY IN THE STUDY AREA

S. No Parameter Method Unit GW5 GW6 GW7 GW8 IS 10,500 Limits

Acceptable Permissible

1 pH APHA 22nd Edition 4500 H+ B -- 7.93 8.37 8.33 8.19 6.5-8.5 No

Relaxation

2 Color APHA 22nd Edition 2120 B CU <1.0 < 1.0 <1.0 <1.0 5 15

3 Total Dissolved Solids APHA 22nd Edition 2540 C mg/l 936 983.4 512 522 500 2000

4 Total Alkalinity (as CaCO3)

APHA 22nd Edition 2320 B mg/l 120 315 248 115 200 600

5 Total Hardness (as CaCO3)

APHA 22nd Edition 2340 C mg/l 600.0 670.0 325.0 320.0 200 600

6 Calcium (as Ca ) APHA 22nd Edition 3500 Ca B mg/l 100.8 96.8 66.2 68.4 75 200

7 Magnesium (as Mg) APHA 22nd Edition 3500-Mg B mg/l 31.4 46.2 24.5 18.46 30 100

8 Sulphate (as SO4) APHA 22nd Edition 4500 SO4 E mg/l 84 78.2 25 41.60 200 400

9 Chloride (as Cl) APHA 22nd Edition 4500 Cl- B mg/l 310 212 94.2 85 250 1000

10 Lead as Pb APHA 22nd Edition 3111B mg/l < 0.01 < 0.01 < 0.01 < 0.01 0.01 No Relaxation

11 Cadmium as Cd APHA 22nd Edition 3111B mg/l <0.01 < 0.01 < 0.01 < 0.01 0.003 No Relaxation

12 Total Chromium as Cr APHA 22nd Edition 3111B mg/l <0.05 < 0.05 < 0.05 < 0.05 0.05 No Relaxation

13 Copper as Cu APHA 22nd Edition 3111B mg/l < 0.01 < 0.01 < 0.01 < 0.01 0.05 1.5

14 Zinc as Zn APHA 22nd Edition 3111B mg/l < 0.5 < 0.5 < 0.5 < 0.5 5 15

15 Nickel as Ni APHA 22nd Edition 3111B mg/l <0.01 < 0.01 < 0.01 < 0.01 0.02 No Relaxation

16 Fluorides as F APHA 22nd Edition 4500 F- D mg/l < 0.5 < 0.5 < 0.5 < 0.5 1 1.5

17 Aluminium as Al APHA 22nd Edition 3500 Al B mg/l <0.03 < 0.03 < 0.03 < 0.03 0.03 0.2

18 Boron as B APHA 22nd Edition 4500 B B mg/l <0.2 <0.2 <0.2 <0.2 0.5 1

19 Manganese as Mn APHA 22nd Edition 3111B mg/l <0.02 <0.02 < 0.02 < 0.02 0.1 0.3

20 Iron as Fe APHA 22nd Edition 3500 Fe B mg/l < 0.05 < 0.05 < 0.05 < 0.05 0.3 No Relaxation

21 Nitrate Nitrogen APHA 22nd Edition 4500 NO3 B mg/l 2.12 2.19 2.4 2.10 45 No Relaxation

22 Sodium as Na APHA 22nd Edition 3500 Na B mg/l 86.84 86 46.2 38.4 -- --

23 Potassium as K APHA 22nd Edition 3500 K B mg/l < 5.0 < 5.0 < 5.0 < 5.0 -- --

24 Odour APHA 22nd Edition 2150 B -- Agreeable Agreeable Agreeable Agreeable -- --

25 Electrical Conductivity APHA 22nd Edition 2510 B μmho/cm

1420 1510 784 821 -- --

26 Phosphorus as P APHA 22nd Edition 4500 P C mg/l 2.56 2.45 0.86 0.38 -- --

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TABLE 3.18 SURFACE WATER QUALITY IN THE STUDY AREA

S. No Parameter Method Unit SW1 SW2 SW3 SW4

1 pH APHA 22nd

Edition 4500 H+

B -- 8.02 8.01 8.20 8.02

2 Color APHA 22nd

Edition 2120 B CU < 1.0 < 1.0 <1.0 <1.0

3 Turbidity APHA 22nd

Edition 2130 B NTU 1 1 1 1

4 Total Dissolved Solids APHA 22nd

Edition 2540 C mg/l 465 502 401 462

5 Total Alkalinity (as CaCO3) APHA 22nd

Edition 2320 B mg/l 150 115 35 75

6 Total Hardness (as CaCO3) APHA 22nd

Edition 2340 C mg/l 255 290.0 210.0 195.0

7 Calcium (as Ca ) APHA 22nd

Edition 3500 Ca B mg/l 36.4 54.2 18.6 21.4

8 Magnesium (as Mg) APHA 22nd

Edition 3500-Mg B mg/l 18.20 19.2 2.4 11.2

9 Sulphate (as SO4) APHA 22nd

Edition 4500 SO4 E mg/l 16.4 22.4 2.8 4.2

10 Chloride (as Cl) APHA 22nd

Edition 4500 Cl- B mg/l 68 72 38.6 34

11 Lead as Pb APHA 22nd

Edition 3111B mg/l < 0.01 < 0.01 < 0.01 < 0.01

12 Cadmium as Cd APHA 22nd

Edition 3111B mg/l < 0.01 < 0.01 < 0.01 < 0.01

13 Total Chromium as Cr APHA 22nd

Edition 3111B mg/l < 0.05 < 0.05 <0.05 <0.05

14 Copper as Cu APHA 22nd

Edition 3111B mg/l < 0.01 < 0.01 < 0.01 < 0.01

15 Zinc as Zn APHA 22nd

Edition 3111B mg/l < 0.5 < 0.5 < 0.5 < 0.5

16 Nickel as Ni APHA 22nd

Edition 3111B mg/l < 0.02 < 0.02 < 0.02 < 0.02

17 Fluorides as F APHA 22nd

Edition 4500 F- D mg/l < 0.5 < 0.5 < 0.5 < 0.5

18 Aluminium as Al APHA 22nd

Edition 3500 Al B mg/l < 0.03 < 0.03 < 0.03 < 0.03

19 Boron as B APHA 22nd

Edition 4500 B B mg/l < 0.2 < 0.2 < 0.2 < 0.2

20 Manganese as Mn APHA 22nd

Edition 3111B mg/l < 0.02 < 0.02 <0.02 <0.02

21 Iron as Fe APHA 22nd

Edition 3500 Fe B mg/l < 0.05 < 0.05 < 0.05 < 0.05

22 Nitrate Nitrogen APHA 22nd

Edition 4500 NO3 B mg/l 0.64 2.5 2.3 2.4

23 Chemical Oxygen Demand APHA 22nd

Edition 5220 B mg/l 48 54 34 28

24 BOD(3day’s at 27oC) IS 3025 (Part – 44) 2009 mg/l 15.6 19.2 14 10.2

25 Sodium as Na APHA 22nd

Edition 3500 Na B mg/l 20.4 32.4 12 18.2

26 Potassium as K APHA 22nd

Edition 3500 K B mg/l 1.4 < 5.0 < 5.0 < 5.0

27 Total Suspended Solids APHA 22nd

Edition 2540 D mg/l 10.5 10.6 10.9 10.3

28 Dissolved Oxygen APHA 22nd

Edition 4500 O C mg/l 5.2 5.1 5.0 5.2

29 Oil and grease APHA 22nd

Edition 5520 B mg/l <1.0 <1.0 <1.0 <1.0

30 Electrical Conductivity APHA 22nd

Edition 2510 B μmho/cm 743 804 640 732

31 Phosphorus as P APHA 22nd

Edition 4500 P C mg/l 0.24 0.34 0.29 0.24

32 Total Coliform IS 1622 MPN/100 ml 45 48 42 62

33 Feacal Coliforms IS 1622 MPN/100 ml 4 4 11.2 5

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TABLE 3.18 SURFACE WATER QUALITY IN THE STUDY AREA

S. No Parameter Method Unit SW5 SW6 SW7 SW8

1 pH APHA 22nd

Edition 4500 H+

B -- 7.52 8.22 8.51 8.25

2 Color APHA 22nd

Edition 2120 B CU < 1.0 < 1.0 <1.0 <1.0

3 Turbidity APHA 22nd

Edition 2130 B NTU 1.0 1.0 1.0 1.0

4 Total Dissolved Solids APHA 22nd

Edition 2540 C mg/l 510.0 905.0 840.0 620.0

5 Total Alkalinity (as CaCO3) APHA 22nd

Edition 2320 B mg/l 65 95 115 200

6 Total Hardness (as CaCO3) APHA 22nd

Edition 2340 C mg/l 210.0 365 455.0 275

7 Calcium (as Ca ) APHA 22nd

Edition 3500 Ca B mg/l 32 28.2 48.2 54

8 Magnesium (as Mg) APHA 22nd

Edition 3500-Mg B mg/l 12.4 8.60 38.2 30.2

9 Sulphate (as SO4) APHA 22nd

Edition 4500 SO4 E mg/l 2.5 24.3 52 64.2

10 Chloride (as Cl) APHA 22nd

Edition 4500 Cl- B mg/l 62 88.5 148 148

11 Lead as Pb APHA 22nd

Edition 3111B mg/l < 0.01 < 0.01 < 0.01 < 0.01

12 Cadmium as Cd APHA 22nd

Edition 3111B mg/l < 0.01 < 0.01 < 0.01 < 0.01

13 Total Chromium as Cr APHA 22nd

Edition 3111B mg/l < 0.05 < 0.05 <0.05 <0.05

14 Copper as Cu APHA 22nd

Edition 3111B mg/l < 0.01 < 0.01 < 0.01 < 0.01

15 Zinc as Zn APHA 22nd

Edition 3111B mg/l < 0.5 < 0.5 < 0.5 < 0.5

16 Nickel as Ni APHA 22nd

Edition 3111B mg/l < 0.02 < 0.02 < 0.02 < 0.02

17 Fluorides as F APHA 22nd

Edition 4500 F- D mg/l < 0.5 < 0.5 < 0.5 < 0.5

18 Aluminium as Al APHA 22nd

Edition 3500 Al B mg/l < 0.03 < 0.03 < 0.03 < 0.03

19 Boron as B APHA 22nd

Edition 4500 B B mg/l < 0.2 < 0.2 < 0.2 < 0.2

20 Manganese as Mn APHA 22nd

Edition 3111B mg/l < 0.02 < 0.02 <0.02 <0.02

21 Iron as Fe APHA 22nd

Edition 3500 Fe B mg/l < 0.05 < 0.05 < 0.05 < 0.05

22 Nitrate Nitrogen APHA 22nd

Edition 4500 NO3 B mg/l 1.5 2.5 5.4 4.2

23 Chemical Oxygen Demand APHA 22nd

Edition 5220 B mg/l 28.0 35.0 40.0 74

24 BOD(3day’s at 27oC) IS 3025 (Part – 44) 2009 mg/l 9.2 10.9 12.9 11.4

25 Sodium as Na APHA 22nd

Edition 3500 Na B mg/l 22.2 45 85 74

26 Potassium as K APHA 22nd

Edition 3500 K B mg/l <5 <5 <5 11.4

27 Total Suspended Solids APHA 22nd

Edition 2540 D mg/l 9.2 9.6 9.8 9.4

28 Dissolved Oxygen APHA 22nd

Edition 4500 O C mg/l 5..0 4.9 4.8 5.1

29 Oil and grease APHA 22nd

Edition 5520 B mg/l <1.0 <1.0 <1.0 <1.0

30 Electrical Conductivity APHA 22nd

Edition 2510 B μmho/cm 802 1410 1301 960

31 Phosphorus as P APHA 22nd

Edition 4500 P C mg/l 0.31 0.25 0.20 0.23

32 Total Coliform IS 1622 MPN/100 ml 51 48 56 54

33 Feacal Coliforms IS 1622 MPN/100 ml 8 4 6 5

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A. Summary of Groundwater Samples within 10 Km Radius

pH of the ground water samples collected was in the range between 7.32 –

8.37. All samples are below acceptable limits. Only drinking water samples

have fixed pH limit which is 6.5 -8.5 as per IS 10500-2012.

The acceptable limits for total dissolved solids as per IS: 10500-2012 are 500

mg/l whereas the permissible limits in absence of alternate source are 2000

mg/l, beyond this palatability decreases and may cause gastro intestinal

irritation. Total dissolved solids in the ground water samples were in the range

between 467.5 – 983.4 mg/l. one sample is below acceptable limits, seven

other samples are above acceptable limits but all samples are well below the

permissible limits of 2000 mg/l.

In the ground water samples collected from the study area, the Total hardness

was found to vary between 295 – 670 mg/l. All samples are above acceptable

limits and seven ground water samples for Total hardness are above

acceptable limit but within the permissible limits, while one sample is above the

permissible of 600 mg/l.

The acceptable limit for chloride is 250 mg/l as per IS: 10500 whereas the

permissible limit of the same is 1000 mg/l beyond this limit taste, corrosion and

palatability are affected. The Chlorides concentration was found to vary

between 94.2 – 310 mg/l. Seven samples are below acceptable limits while

one sample is above acceptable limits but within permissible limits.

Fluoride is the other important parameter, which has the acceptable limit of 1

mg/l and permissible limit of 1.5 mg/l. Fluoride concentration in all samples are

found to be below acceptable limits.

The Sulphates concentration was found to vary between 25 – 96 mg/l. All the

samples for Sulphates concentration was found are within acceptable limits of

200 mg/l.

Ground water samples collected from eight locations within 10 km radius from the

plant site & analyzed as per standard methods of water and wastewater analysis

(APHA).

The water quality of the study area is found to be above the acceptable limits of

IS10500, for parameters TDS, Total hardness, Total Alkalinity, Calcium, Magnesium,

Fluorides.

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Summary of Surface Water Samples within 10 km Radius:

pH of the water samples collected was in the range between 7.54 – 8.51.

Total dissolved solids in the samples were in the range between 401 – 905 mg/l.

Total hardness was found to be in the range of 210 – 455 mg/l.

Chlorides concentration was found to vary between 34 – 148 mg/l.

Fluoride concentration was <0.5 mg/l.

Sulphates concentration was found to vary between 2.5 – 64.2 mg/l.

3.6. NOISE ENVIRONMENT

Noise, often defined as unwanted sound, interferes with speech communication,

causes annoyance, distracts from work, and disturbs sleep thus deteriorating quality

of human environment. Noise levels in the study area have therefore been

measured, at selected points, to provide the baseline data to describe the existing

situation.

Measured noise levels displayed as a function of time provides a useful scheme for

describing the acoustical climate of a community. Noise levels records at each

station with a time interval of about one hour are computed for equivalent noise

levels. Equivalent noise level is a single number descriptor for describing time

varying noise levels.

3.6.1 Noise Monitoring Stations

In order to assess the noise levels in the study area, monitoring was carried out at

eight different locations within 10 km radius of the study area. The noise monitoring

locations are shown in figure 3.5 and distances & directions of monitoring location

mentioned in Table 3.19. Noise levels were recorded and computed for equivalent

noise levels for day-equivalent, night-equivalent & day-night equivalent.

Sound Pressure Levels (SPL) measurements were recorded at eight locations. The

readings were taken for every hour for 24-hrs. The day noise levels have been

monitored during 6 am to 10 pm and night noise levels during 10 pm to 6 am at all

the locations covered in the study area.

The noise recording stations and the summary of the minimum, maximum, day -

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equivalent, night - equivalent and day-night equivalent values computed for various

location in the study area is given in Table 3.20.

TABLE 3.19: NOISE MONITORING LOCATIONS

S No. Code Name of Sampling

Location Distance (km) w.r.t Project

Direction w.r.t Project

1. N1 Project Site - -

2. N2 Jayanthipuram 1.80 WNW

3. N3 Chillakallu 4.75 N

4. N4 Bhimavaram 6.70 NE

5. N5 Konakanchi 6.64 SE

6. N6 Vedadri Tanda 3.80 S

7. N7 Mukteswarapuram 7.10 SW

8. N8 Jaggayyapeta 6.00 NW

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FIGURE 3.5: NOISE SAMPLING LOCATIONS MAP

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TABLE 3.20: AMBIENT NOISE LEVELS WITHIN STUDY AREA

S.No

Name of the Location

Category of Area/zone

Day Time in Leq dB (A)

CPCB Standard Day Time

Night Time in Leq dB (A)

CPCB Standard

Night time

1. Project site Industrial 55.0 75dB (A) 43.8 70dB (A)

2. Jayanthipuram Residential 53.2 55dB (A) 40.4 45dB (A)

3. Chillakallu Commercial 62.3 65dB (A) 52.1 55dB (A)

4. Bhimavaram Residential 50.6 55dB (A) 42.6 45dB (A)

5. Konakanchi Residential 48.7 55dB (A) 39.2 45dB (A)

6. Vedadri Tanda Residential 50.0 55dB (A) 38.9 45dB (A)

7. Mukteswarapuram Residential 46.5 55dB (A) 39.1 45dB (A)

8. Jaggayyapeta Commercial 59.5 65dB (A) 46.2 55dB (A)

Daytime Noise Levels (Lday)

Industrial Zone: The day time noise level at the Project site was 55.0 dB(A), which

is well below the permissible limits of 75 dB(A).

Commercial Zone: The daytime noise levels in all the commercial locations were

observed to be in the range of 59.5 dB (A) to 62.3 dB(A). The noise levels at all the

locations were below the permissible limits of 65 dB(A).

Residential Zone: The daytime noise levels in all the residential locations were

observed to be in the range of 46.5 dB (A) to 53.2 dB(A). The noise levels at all the

locations were below the permissible limits of 55 dB(A).

Night time Noise Levels (Lnight)

Industrial Zone: The night time noise level in the Project site was observed be 43.8

dB(A), which is well below the permissible limits of 70 dB (A).

Commercial Zone: The night time noise levels in all the commercial locations were

observed to be in the range of 46.2 dB (A) to 52.1 dB(A). The noise levels at all the

locations were below the permissible limits of 55 dB(A).

Residential Zone: The nighttime noise levels in all the residential locations were

observed to be in the range of 38.9 dB(A) to 42.6 dB(A). The noise levels were

below the permissible limits of 45 dB(A) in nighttime at all the locations.

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3.6.2 TRAFFIC STUDY

Anthropogenic emissions not only contribute to the green house effect but also

participate in the reaction that results in photochemical oxidants. The effect of

photochemical oxidants is well known for forming smog particularly in the urban

areas.Among the anthropogenic sources of pollutants forming the green house

gases, burning of fossil fuels constitute a major source. Highway mobile sources that

contribute significantly to poor quality have been regulated for the past two decades

in countries like India. The absence of regulation in developing countries has caused

a global concern regarding potential environmental damage on a larger scale.

The traffic survey was carried out on the NH-65 (Hyderabad to Vijayawada Road)

which is 4.75 km (N) to the Project site. Vehicular traffic counts were performed on

either side of the studied roads to provide background values of traffic density, and

correlate such data to the levels of air pollution along the road. Vehicular traffic on

these roads included heavy vehicle, light vehicle, three wheelers, and two wheelers.

The additional traffic due to the project would also occur in this time duration only. A

summary of the data is presented in Table 3.21.

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TABLE 3.21: TRAFFIC STUDY AT NH - 65 HYDERABAD – VIJAYAWADA ROAD (To & From)

S.No Time Two

Wheelers 2 Wheeler

@ 0.75 PCU Three

Wheeler

3 Wheeler @ 1.2 PCU

Passenger cars

Passenger cars @ 1

PCU

Heavy vehicles

Heavy Vehicles

@3.7 PCU

Total vehicles

Total vehicles

PCU

1 06-07 am 178 134 42 40 235 235 340 1258 795 1667

2 07-08 am 245 184 47 51 249 249 387 1432 928 1916

3 08-09 am 298 224 52 78 320 320 368 1362 1038 1983

4 09-10 am 305 229 56 96 340 340 350 1295 1051 1960

5 10-11 am 260 195 60 125 380 380 333 1232 1033 1932

6 11-12 pm 242 182 66 139 355 355 320 1184 983 1860

7 12-01 pm 210 158 72 130 334 334 311 1151 927 1772

8 01-02 pm 200 150 70 106 300 300 302 1117 872 1673

9 02-03 pm 207 155 64 102 289 289 284 1051 844 1597

10 03-04 pm 193 145 60 95 261 261 245 907 759 1407

11 04-05 pm 176 132 53 90 255 255 225 833 709 1310

12 05-06 pm 196 147 50 112 310 310 210 777 766 1346

13 06-07 pm 215 161 46 125 290 290 200 740 751 1316

14 07-08 pm 196 147 45 102 275 275 186 688 702 1212

15 08-09pm 170 128 40 96 260 260 178 659 648 1142

16 09-10pm 165 124 37 68 254 254 360 1332 816 1778

17 10-11pm 155 116 33 52 258 258 440 1628 886 2054

18 11-12pm 125 94 29 46 182 182 550 2035 886 2357

19 12-01am 113 85 25 35 118 118 320 1184 576 1422

20 01-02am 90 68 20 28 90 90 301 1114 501 1299

21 02-03am 75 56 18 19 84 84 293 1084 470 1243

22 03-04am 60 45 25 8 100 100 180 666 365 819

23 04-05am 76 57 33 12 146 146 157 581 412 796

24 05-06am 88 66 38 29 195 195 280 1036 601 1326

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The highest peak observed during 11 am to 10 pm (worst Scenario) PCU/hr 2357

Total width of the Road in meters (Arterial Road) 24

Carrying capacity of the road (the road is 4 lane Divided 2 way road) As per IRC:106-1990 (PCU’s per hour) 3600

Existing V/C Ratio 0.65

LOS=Level of Service (Existing)

V/C LOS Performance

0.0-0.2 A Excellent

0.2-0.4 B Very Good

0.4-0.6 C Good

0.6-0.8 D Fair/Average

0.8-1.0 E Poor

1.0 & above F Very Poor

Note: *As per IRC Guidelines 1990

The traffic survey was carried out on the NH-65 (Hyderabad - Vijayawada Road) which is 4.75 km (N) to the Project site. The

details of the vehicles movement recorded. From the study it is observed that there is no major impact on traffic due to the

proposed project.

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3.7 SOIL ENVIRONMENT

The present study on soil quality establishes the baseline characteristics in the study

area surrounding the project site. The study has been addressed with the following

objectives.

To determine the base line characteristics

To determine the soil characteristics of plant site and surrounding areas with

in 10 km radius.

To determine the impact of industrialization/urbanization on soil

characteristics

To determine the impacts on soils from agricultural productivity point of view.

The soil samples were collected during study period. Sampling Locations are

detailed in Table 3.22. and Figure 3.6. The analysis results are given in Table 3.23.

Details of Standard Soil Classification are given in table 3.24.

The homogenized soil samples collected at different locations were packed in a

polyethylene plastic bag and sealed. The sealed samples were sent to laboratory for

analysis. The important physical, chemical parameter concentrations were

determined from all samples.

TABLE 3.22: SOIL SAMPLING LOCATIONS

S. No. Code Name of Sampling Location Distance (km) w.r.t Project

Direction w.r.t Project

1 S1 Project Site - -

2 S2 Jayanthipuram 1.80 WNW

3 S3 Dhramavarappadu Tanda 2.80 N

4 S4 Gauravaram 6.00 ENE

5 S5 Bandipalem 5.66 SE

6 S6 Vedadri Tanda 3.80 S

7 S7 Madipadu 7.25 SE

8 S8 Jaggayyapeta 6.00 NW

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FIGURE 3.6: SOIL SAMPLING LOCATIONS MAP

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TABLE 3.23: SOIL SAMPLING ANALYSIS RESULTS

S.No Parameters Units S1 S2 S3 S4 S5 S6 S7 S8

1 PH -- 7.05 6.85 6.75 7.15 7.10 7.30 7.09 7.14

2 Electrical Conductivity µ mhos 110 108 124 112 98.6 120 110.5 142

3 Bulk Density g/cc 1.23 1.25 1.35 1.18 1.21 1.26 1.14 1.18

4 Moisture Content % 7.42 8.06 8.95 6.25 6.58 8.25 6.01 6.52

5 Nitrates as N Kg/ha 112 154 172 132 134 146 158 164

6 Phosphorous as P2O5

Kg/ha 51 53 48 54 58 51 59 54

7 Potassium as K2O Kg/ha 386 345 298 324 336 294 334 314

8 Sodium as Na2O Kg/ha 174.2 156 134 153 192 140 162 201

9 Calcium as Ca mg/ kg 601 612 762 635 864 802 684 685

10 Magnesium as Mg mg/ kg 218 232.7 215.2 155.6 160.5 205.0 205.2 215.2

11 Total Organic Carbon % 0.78 0.84 0.86 0.79 0.74 0.75 0.85 0.72

12 Type of Soil -- Silt

Loam Sandy Loam

Sandy Loam

Silt Loam

Silt Loam

Sandy Loam

Sandy Loam

Silt Loam

a) Sand (%) -- 32 49 50 35 26 48 50 32

b) Silt (%) -- 48 36 40 49 49 36 33 50

c) Clay (%) -- 20 14 10 16 15 14 17 18

13 Copper as Cu mg/ kg 22.14 15.2 16.2 22 15.25 16.52 15.25 20.14

14 Chromium as Cr mg/ kg 33.05 23.2 30.2 28.6 26.52 31.25 29.63 22.15

15 Cadmium as Cd mg/ kg <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5 <0.5

16 Zinc as Zn mg/ kg 35.02 42.65 42.32 51.36 52.3 38.54 54.0 53.26

17 Lead as Pb mg/ kg 22.11 21.3 30.22 14.38 18.65 16.22 21.65 51.48

18 Nickel as Ni mg/ kg 12.52 14.01 16.25 15.69 12.54 19.23 15.24 16.24

19 Sulphates as SO4 mg/ kg 41.12 38.2 25.3 25.64 42.21 29.56 30.25 28.23

20 Iron as Fe mg/ kg 21.8 21.23 19.6 17.04 19.58 19.4 19.54 20.14

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Physicochemical characteristics of the soil samples obtained from 7 areas in the

buffer zone and one from the project site reveals that all basically Silt loams. It is due

to the fact that the upper soil layers are formed by the deposition of fine sand and silt

carried down by the storm waters from the surrounding areas. They are moderately

productive and they are not prone to water logging.

It has been observed that the pH of the soil quality ranged from 6.75 to 7.30.

Percentage of Total Organic Carbon is observed in between 0.72 to 0.86

indicating that On an avg. sufficient in nature.

Table 3.24 :STANDARD SOIL CLASSIFICATION

S.No Soil Test Classification

1 pH

<4.5 Extremely acidic

4.51- 5.50 Very strongly acidic

5.51-6.00 Moderately acidic

6.01-6.50 Slightly acidic

6.51-7.30 Neutral

7.31-7.80 Slightly alkaline

7.81-8.50 Moderately alkaline

8.51-9.00 Strongly alkaline

>9.00 Very strongly alkaline

2 Salinity Electrical Conductivity

(μS/cm) (1ppm = 640 μS/cm)

Upto 1.00 Average

1.01 - 2.00 harmful to germination

2.01 - 3.00 Harmful to crops (sensitive to salts)

3 Organic Carbon (%)

Upto 0.20: Very less

0.21- 0.40: Less

0.41- 0.50: Medium,

0.51- 0.80: On an avg. sufficient

0.81 - 1.00: Sufficient

>1.00 : More than sufficient

4 Nitrogen (kg/ha)

Upto 50 Very less

51-100 Less

101-150 Good

151-300 Better

>300 Sufficient

5 Phosphorus (kg/ha)

Upto 15 Very less

16-30 Less

31-50 Medium,

51-65 On an avg. sufficient

66-80 Sufficient

>80 More than sufficient

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S.No Soil Test Classification

6 Potash (kg/ha)

0 -120 Very less

120-180 Less

181-240 Medium

241-300 Average

301-360 Better

>360 More than sufficient

Source: Hand book of Agriculture, ICAR, New Delhi

3.8 LAND USE PATTERN

Remote sensing satellite imageries were collected and interpreted for the 10-km

radius study area for analyzing the Land use pattern of the study area. Based on the

satellite data, Land use/ Land cover maps have been prepared.

Objectives

The objectives of land use studies are:

To determine the present land use pattern;

To analyze the impacts on land use due to the proposed project in the study

area; and

To give recommendations for optimizing the future land use pattern and

associated impacts.

3.8.1 DATA USED

The data is used for the preparation of different maps for the study natural

resources. The data is used by using the application of Remote Sensing and GIS

technologies.

TABLE 3.25: SHOWING THE DETAILS OF SOURCES & THE MAPS PREPARED

S No. Source Maps Prepared

1 Survey of India’s topographic maps and satellite imageries

Drainage map

2 Satellite imageries Land use / Land cover

TABLE 3.26: SHOWING THE TOPOGRAPHIC MAPS

Sl. No. Topographic Map No. Scale Year of Survey Year of Publication

1. 65D/1 1: 50,000 2010 2011 Source:Survey of India’s Topographic Maps

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TABLE 3.27:SATELLITE DATA OF NATIONAL REMOTE SENSING CENTRE

S.No. Season Sensor path/row Satellite/Sensor Date of Pass

1. Rabi 101-61-B IRS RS2 LISS IV FX 11-November-

2016

3.8.2 LAND USE / LAND COVER MAP

Land use / land cover map is prepared by visual interpretation of high-resolution

satellite data with the help of Survey of India Topographic maps on 1:50,000 scale.

Two seasons’ data (Rabi year 2017) is used for the delineation of different units. The

units are confirmed by the ground truth/field visits.

Level-II classification of National (Natural) Resources Information System (NRIS)

has been followed for the delineation of units.

Land use/ Land cover map of the study area is integrated with village map and

analyzed with the help of GIS to get the village wise findings of the present land use

of the study area, which is given elaborately in the following tables:

Land use refers to man’s activities and various uses, which are carried on land. Land

cover refers to natural vegetation, water bodies, rock/soil, artificial cover and others

resulting due to land transformation. Although land use is generally inferred based

on the cover, yet both the terms land use and land cover are closely related and

interchangeable. Information on the rate and kind of change in the use of land

resources is essential to the proper planning, management and regulation of the use

of such resources.

Knowledge about the existing land use and trends of change is essential if the nation

is to tackle the problems associated with the haphazard and uncontrolled growth. A

systematic framework is needed for updating the land use and land cover maps that

will be timely, relatively inexpensive and appropriate for different needs at national

and state level. The rapidly developing technology of remote sensing offers an

efficient and timely approach to the mapping and collection of basic land use and

land cover data over large area. The satellite imageries are potentially more

amenable to digital processing because the remote sensor output can be obtained in

digital format. Land use data are needed in the analysis of environmental processes

and problems that must be understood if living conditions and standards are to be

improved or maintained at current levels.

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3.8.2.1 Basic Concepts of Land Use

Clawson has given nine major ideas or concepts about land. These are:

Location or the relation of a specific parcel of land to the poles, the equator,

and the major oceans and landmasses. There is also relationship between

various tracts of land, as well as a political location.

Activity on the land, for what purpose this piece of land or tract is used.

Natural qualities of land, including its surface and subsurface characteristics

and its vegetative cover.

Improvements to and on the land. This is closely related to the activity.

Intensity of land use or amount of activity per unit area.

Land tenure, i.e. who owns the land, which uses it.

Land prices, land market activity and credit as applied to land.

Interrelations between activities on the land and other economic and social

activities.

Interrelations in the use between different tracts of land.

3.8.2.2 Methodology for land use / land cover mapping

The land use / land cover map is prepared by adopting the interpretation techniques

of the image in conjunction with collateral data such as Survey of India topographical

maps and census records. Image classification can be done by using visual

interpretation techniques and digital classification using any of the image processing

software. For the present study, ERDAS 9.1 version software is used for

preprocessing, rectification, enhancements and classifying the satellite data for

preparation of land use land cover map for assessing and monitoring the temporal

changes in land use land cover and land developmental activities.

The imagery is interpreted and ground checked for corrections. The final map is

prepared after field check. Flow chart showing the methodology adopted is given in

the different land use / land cover categories in the study area has been carried out

based on the NRSC land use / land cover classification system.

For analysis and interpretation, and preparation of LU / LC map, two types of data

are needed:

1. Basic data 2. Ground data

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1. Basic data includes:

Fused data of LISS IV

Toposheets on 1 : 50,000

Local knowledge

Area map on any scale to transfer details

Reports and other literature of the study area

2. Ground data: Ground data is very much essential to verify and to increase the

accuracy of the interpreted classes and also to minimize the field work.

Data analysis: For analysis and interpretation of satellite data, the study can be

divided into three parts:

Preliminary work

Field work

Post field work

A. Preliminary work includes:

to see the limitation of satellite data

to lay down the criteria for land use classification to be adopted

to fix the size of mapping units, which depends upon the scale

interpretation of different land use/land cover classes

demarcation of doubtful areas

preparation of field land use/land cover map

B. Field work:

Type of ground data to be collected

Selection of sample area for final classification

Checking of doubtful areas

Change in land use/ land cover due to wrong identification, fresh

development, nomenclature.

General verification

C. Post field work:

Reinterpretation or analysis or correction of doubtful areas

Transfer of details on base map

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Marginal information

Preparation of final land use/land cover map

A map showing Satelite Imagery Showing in Figure 3.8. A map depicting major land

use/ land cover classes comprising lands under agriculture, fallow land,

open/degraded vegetation; lands falling under water bodies, scrub and lands under

inhabitations is presented at Figure 3.9 and Flow chart for LU/LC mapping

methodology is presented at Flow chart 3.1.

The land use classification within a distance of ten kilometers from the project

location and the areas falling under the respective classifications are presented in

Table 3.28:

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FLOW CHART 3.1 : LU/LC MAPPING METHODOLOGY

Basic data

Data source

IRS LISS IV FMX

Khariff

season

Rabi

season

Preparation of base maps

Interpretation and mapping of

land use /land cover categories

Ground verification of doubtful areas and modification of thematic details

Transfer of Khariff and Rabi season

land use/land cover details on to a single base map.

Area estimation of each

land use/land cover class.

Final land use/land cover

map with symbols and

colours

Development of

interpretation keys based

on image characteristics.

Validation and final

interpretation key

Secondary data

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TABLE 3.28 : LAND USE / LAND COVER STATISTICS OF THE STUDY AREA

FIGURE 3.7 PIE DIAGRAM SHOWING LAND USE THE IN STUDY AREA

S. No. LANDUSE AREA (Sq. km) %

1.

BUILT UP LAND A. Settlements / Temple B. Industrial area

16.328 5.966

5.2 1.9

2.

WATERBODIES A. Tank / River/ Major canal

etc.

23.236

7.4

3.

FOREST A. Scrub forest

36.424

11.6

4.

CROP LAND A. Single crop B. Double crop C. Plantations D. Crop land forest

21.038

142.242 8.164 0.628

6.7

45.3 2.6 0.2

5.

WASTELANDS A. Land with scrub B. Land without scrub C. Sheet rock area D. Stony waste area E. Mining area

24.492 8.164 6.908 9.734

10.676

7.8 2.6 2.2 3.1 3.4

TOTAL 314 100

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FIGURE 3.8: SATELLITE IMAGE OF THE STUDY AREA

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FIGURE 3.9: LAND USE / LAND COVER MAP OF THE STUDY AREA

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3.9 ECOLOGICAL ENVIRONMENT

Ecological studies are one of the important aspects of Environmental Impact

Assessment with a view to conserve environmental quality and biodiversity.

Ecological systems show complex inter-relationships between biotic and abiotic

components including dependence, competition and mutualism. Biotic components

comprise of both plant and animal communities, which interact not only within and

between themselves but also with the biotic components viz. physical and chemical

components of the environment.

Generally, biological communities are good indicators of climatic and edaphic

factors. Studies on biological aspects of ecosystems are important in Environmental

Impact Assessment for safety of natural flora and fauna. The biological environment

includes terrestrial and aquatic ecosystems.

Objectives of Ecological Studies

The present study was undertaken with the following objectives to assess both

terrestrial and aquatic habitats of the study area

To assess the nature and distribution of vegetation in and around the project site

To assess the flora & fauna in the study area;

To ascertain the migratory routes of fauna, presence of breeding grounds and

sensitive habitats in the study area, if any;

To assess the presence of protected areas in the study area;

To review the information from secondary sources and discuss the issues of

concern with the relevant authority and stakeholders;

Impact prediction based on primary and secondary data sources to formulate

mitigation measures.

3.9.1 Detailed Description Of Flora And Fauna

Assessment of flora and fauna study location: Flora and Fauna studies were

carried out by using least count quadrate method at following six locations. Trees

were sampled by taking quadrates of 25 m2 and shrubs 10 m2 and in case of

herbaceous vegetation of 1 m2 distributed randomly. Table 3.29 shows the flora and

fauna study locations of the study area.

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TABLE 3.29 - Sampling locations for flora and fauna study in study area

Sl.No. Location

Code Name of the location

Distance from Project Site

(in km)

Direction from Project Site

1 T-1 Project area -- --

2 T-2 Jaggayyapeta Extension R.F 0.39 N

3 T-3 Kuntimadi R.F 5.12 SSW

4 T-4 Ginjupalle R.F 5.60 SSW

5 T-5 Venkatayapalem R.F 7.80 SSW

6 T-6 Budavada R.F 4.68 W

Note: At each sampling location the protocol adopted to collect primary data were trees - 10 quadrates of 25 m x 25 m, Shrubs – 10 Quadrates 10 m x 10 m and herbs -10 quadrates of 1 m x 1 m.

The project site is located in Sy. No. 108 & 109, Jayanthipuram Village, Jaggayyapet

Mandal, Krishna District, Andhra Pradesh. The Primary surveys were conducted in

and around project area and 10 km radius study area, Reserve forests, open areas

near villages, waste lands and agricultural lands along the water bodies to identify

the floristic composition of the area and listed the plants species identified in the

Project area and 10 km radius study area is given in Table 3.30.

FLORA: Based on the physical setting and the kind of distribution of flora and fauna,

the study area can be classified into cropland, forest land, terrestrial vegetation

structure and aquatic ecosystems etc.

TABLE 3.30: List of plants found in the project area

S.No Botanical name English name Local name

(Telugu ) Habitat

1 Bidenspilosa Beggar tick Phutium Herb

2 Cleome viscose Asian spider flower

Kukka-vaminta Herb

3 Partheniumhysterophorus Carrot Grass Chandani Herb

4 Abutilon indicum Indian Mallow Tuturabenda Shrub

5 Ageratum conyzoides Goat weed Pumpillu Shrub

6 Calotropis gigantean Crown Flower Jilledu Shrub

7 Cassia surattensis Scrambled Egg Mettatangedu Shrub

8 Cleistanthuscollinus Garari Kodisha Shrub

9 Drypetessepiaria Wild Caper Bush Bira Shrub

10 Acacia arabica Gum arabic tree Natutuma Tree

11 Acacia ferruginea Rusty Acacia Anisandra Tree

12 Acacia mearnsii black wattle Tumma Tree

13 Acacia melanoxylon Sally Wattle Kondakorinda Tree

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S.No Botanical name English name Local name

(Telugu ) Habitat

14 Acacia nilotica Babool Nallatumma Tree

15 Albizialebbeck Flea tree Dirisena Tree

16 Bambusa bamboo Bamboo Bonguveduru Tree

17 Barringtoniaacutangula Indian putat Kadimi Tree

18 Buteafrondosa Flame of the forest

Moduga Tree

19 Eucalyptus globules Eucalyptus Jamayul Tree

20 Ficusbenghalensis Banyan Marri Tree

21 Ficusreligiosa Pee pal Raavi Tree

22 Magniferaindica Mango Mamidi Tree

23 Pongamiapinnata Indian beech Kanuga Tree

24 Techtonagrandis Teak Teku Tree

3.9.2 Vegetation and Flora of the study area:

Forest types found in the study area predominantly Reserve forest, open forest type,

scrub forest are distributed in the few patches surrounding project the site. Social

forestry development induced Eucalyptus Mango plantations can be seen in the

study area. The biodiversity study was conducted to provide information on flora

present in the study area. The study was conducted in radius of 10 km from the site.

The list of places covered in the floral biodiversity and faunal biodiversity survey are

Project area, Jaggayyapeta Extension R.F, Kuntimadi R.F, Ginjupalle R.F,

Venkatayapalem R.F, Budavada R.FNear Jaggayyapeta, Krishna River Near

Madipadu, Krishna River Near Ravirala etc. The various species of flora and fauna

recorded in the study are tabulated. Discussions were held with local people to

gather related information on the richness of plant and animal resources.

More than 83 plant species were recorded during floristic survey in the project and

study area. A list of plant species representing trees, shrubs and herbs list is given in

Table 3.31. A list of grasses, herbs, Climbers and herbaceous plants found in the

study area is given in Table 3.31.

There are no rare or endangered or threatened species all the species listed in Table

3.31 are widely distributed in most parts of Deccan region.

Cropland Ecosystem: The common crops land ecosystem in study area are Oryzha

sativa and Zea maze which are mainly dependent on rainwater during monsoon

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season, canal irrigation and also through ground water source, tube wells and open

wells during non-monsoon season.

TABLE 3.31., List of Trees, Shrubs, Grasses, Herbs, Climbers and Herbaceous

Species Found the Study Area

Sl. No Scientific Name Family Vernacular name

Staple crops and commercial crops

1 Abelmoschus esculentus Malvaceae Ladies Finger

2 Capsicum frutescens Solanaceae Chilli

3 Citrus limon Rutaceae Lemon

4 Coriandrum sativum Apiaceae Coriander

5 Oryza sativa Poaceae Paddy

6 Solanum melongena Solanaceae Brinjal

7 Zea mays Poaceae Maize

Trees

1 Mangifera indica Anacardiaceae Mamidi

2 Annona squamosa Annonaceae Custard apple

3 Polyalthia longifolia Annonaceae Ashoka

4 Polyalthia pendula Annonaceae Asoka

5 Borassus flabellifer Arecaceae Taati

6 Cocos nucifera Arecaceae Coconut

7 Phoenix sylvestris Arecaceae Eetha

8 Agave americana Asparagaceae Sentry plant

9 Spathodea companulata Bignoniaceae Flame of the forest

10 Bombax ceiba Bombacaceae Booruga

11 Bauhinia racemosa Caesalpiniaceae Ari

12 Bauhinia variagata Caesalpiniaceae Mandari

13 Cassia fistula Caesalpiniaceae Rela

14 Tamarindus indica Caesalpiniaceae Chinta

15 Terminalia arjuna Combretaceae Tella maddi

16 Diospyros melanoxylon Ebenaceae Tunki

17 Breynia vitis-ideae Euphorbiaceae Nalla purugudu

18 Euphorbia caducifolia Euphorbiaceae Brahma jemudu

19 Butea monosperma Fabaceae Modugu

20 Desmodium pulchellum Fabaceae Deyyapu mokka

21 Pongamia pinnata Fabaceae Ganuga

22 Prosopis juliflora Fabaceae English tumma

23 Lagerstroemia parviflora Lythraceae Chennangi

24 Azadirachta indica Meliaceae Vepa

25 Acacia arabica Mimosaceae Nalla tumma

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Sl. No Scientific Name Family Vernacular name

26 Acacia leucophloea Mimosaceae Tella tumma

27 Pithecellobium dulce Mimosaceae Seema chinta

28 Prosopis spicigera Mimosaceae Jammi chettu

29 Samanea saman Mimosaceae Nidrabhangi

30 Ficus benghalensis Moraceae Marri

31 Ficus religiosa Moraceae Raavi

32 Moringa oleifera Moringaceae Munaga

33 Muntingia calabura Muntingiaceae Wild cherry

34 Eucalyptus spp. Myrtaceae Jama oil

35 Syzygium cumini Myrtaceae Neradu

36 Breynia retusa Phyllanthaceae Chinna purugudu

37 Phyllanthus emblica Phyllanthaceae Usiri

38 Phyllanthus eticulates Phyllanthaceae Pulasari

39 Ziziphus nummularia Rhamnaceae Gotti

40 Ziziphus rugosa Rhamnaceae Regu

41 Aegle marmelos Rutaceae Maredu

42 Chloroxylon sweitenia Rutaceae Billudu

43 Feronia elephantum Rutaceae Velaga

44 Mimusops elengi Sapotaceae Pogada

45 Sterculia foetida Sterculiaceae Adavi badam

46 Tectona grandis Verbenaceae Teku

47 Vitex negundo Verbenaceae Vaavili

Shrubs

1 Hygrophila auriculata Acanthaceae Kokilakshi

2 Calotropis procera Asclepiadaceae Jilledu

3 Cassia auriculata Caesalpiniaceae Caesalpiniaceae

4 Sida acuta Malvaceae Nelabenda

5 Acacia caesia Mimosaceae Kirintha

6 Mimosa rubicaulis Mimosaceae Pariki kampa

7 Phyllanthus reticulatus Phyllanthaceae Pulasari / Puliseru

8 Triumfetta rhomboidea Tiliaceae Oekki. Chirusitrika

9 Lantana camara Verbenaceae Lantana

Climbers

1 Aristolochia bracteolata Aristolochiaceae Gadaparaku

2 Ampelocissus latifolia Vitaceae

Bedasatiga, Bedalatiga

3 Argyreia nervosa Convolvulaceae Samudrapala

4 Ipomoea pes-carpae Convolvulaceae Chevulapilli theege

5 Merremia hederacea Convolvulaceae Kalasa

6 Rivea hypocrateriformis Convolvulaceae Nirubodi

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Sl. No Scientific Name Family Vernacular name

Herbs / Grasses

1 Allmania nodiflora Amaranthaceae Gurugu koora

2 Alternanthera pungens Amaranthaceae Mullu

3 Amaranthus spinosus Amaranthaceae Yerra Mullu-Gorinta

4 Digera muricata Amaranthaceae Chencheli-kura

5 Alternanthera sessilis Amranthaceae Ponna Ganti-Kura

6 Catharanthus pusillus Apocyanaceae Errimirapa, Guluvidi

7 Acanthospermum hispidum Asteraceae Palleru

8 Ageratum conyzoides Asteraceae Pumpullu

9 Eclipta alba Asteraceae Galagara

10 Sphaeranthus indicus Asteraceae Boddatarapu

11 Cassia absus Caesalpinaceae Chanupala-vittulu

12 Cassia occidentalis Caesalpinaceae Kasinta

13 Biophytum nervifolium Oxalidaceae Pulicenta

14 Chloris barbata Poaceae Uppu gaddi

Endangered Plants: No endangered plant species observed during study period and also from records of Botanical Survey of India (Red data of Books of Indian Plants).

Endemic Species: No endemic species recorded/reported as per BSI records.

3.9.3. Terrestrial fauna of the project area and the study area

As the animals, especially vertebrates and the winged invertebrates move from place

to place in search of food, shelter, mate or other biological needs, separate lists for

project area and study area are not feasible. As such there are no chances of

occurrence of any rare or endangered or endemic or threatened (REET) species

within the project area and study area. There are no wildlife sanctuaries, National

Parks, Tiger Reserve or Biosphere Reserve or Elephant Corridor or other protected

areas within 10 Km of radius from project area, It is evident from the available

records, reports and circumstantial evidence that the entire study area including the

project area and study area were free from any endangered animals. Among the

Mammals, only Squirrels, Mongoose, Rats, Bandicoots and Rabbits were seen

frequently during the survey. Among the reptiles, Lizards, Garden lizards were very

common. Rat snake and lizard were seen once during the survey. Other reptiles

were very rare. The amphibians were also rare. A list of Mammals, Reptiles and

Amphibians either found or reported from the area is given in Table 3.32. A list of

birds is given in Table 3.35. There were no resident birds other than Crows, Parrots,

Doves, and Weaver birds, Swifts and Mynas. It is apparent from the list that none of

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the species with the sole exception of Peacock either spotted or reported is included

in Schedule I of the Wildlife Protection Act. Peacocks are fairly common in these

areas. They do not come under the threatened category of the IUCN. Further it is

easy to multiply Peacocks and they can be easily domesticated if permitted.

3.9.3.1 Methodology for Mammals study: The mammal survey was carried out by

walking through different forest habitats, recording and collecting evidence of

mammals. Besides fixed transect survey as far as possible, random search was also

adopted to record the occurrence of mammalian species in the study area. Indirect

evidences such as scats, pug/foot marks, calls of different mammalian species and

discussion with the villagers in the surrounding villages were used for the identification

and documentation of the mammalian species there are several minor carnivorous and

herbivorous wild animals in the study area. The commonly observed or reported

mammals during study period are presented in below Table No. 3.32.

3.9.3.2 Methodology for Herpeto-fauna: Herpeto-fauna were noticed mainly in fresh

water and marshy places Different amphibians, Lizards and reptiles in the study area

Presented in below Table No. 3.33., Butterflies: Butterflies spotted in the study area

were identified as per Butterflies of India. List of butterflies in the study area are

presented in Table.3.34.

3.9.3.3 Methodology for Birds in Study Area: Survey for birds was done in

different areas like wetlands, forest types and cultivation lands. Birds were observed

mostly during most active period of the day around 5.30 hrs to 8.30 hrs and 15.30

hrs to 18.30 hrs. Birds were identified by direct observation, identifying the physical

features with the help of field guides (The book of Indian Birds by Salim Ali) and

reference books. In case of complications in identification, photographs were taken

for identification in later stages. Birds were observed in different types of habitats

and those areas where sighting chances are more. However, time schedule was

altered according to situation and availability of time. The list of avifauna observed

recorded or observed in study area is presented in below Table No. 3.35.

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TABLE 3.32 List of mammals observed in study area

S. No

Scientific Name Local name Schedule IUCN

Status

1 Canisaurius Jackal* II LC

2 Cynopterus sphinx Short-nosed fruit bat IV LC

3 Funumbulspalmarum Three striped squirrel IV LC

4 Herpestesedwardsii Common Mongoose II LC

5 Hystrixindica Indian porcupine* IV LC

6 Lepusnigricollis Indian hare IV LC

7 Macacamulata Rhesus macaque II LC

8 Musrattus Indian rat V LC

9 Rousettus leschenaultia Fruit Bat V LC

10 Susscrofa Wild Pig* III LC * Ecological data collection - interactions with local personnel, forest officials of respective forest ranges and direct indirect observation in the project area and project study area

TABLE 3.33: List of reptiles and amphibians observed in study area

Sl. No.

Scientific Name Common Name IUCN IW (P) A,

1972, Schedule

1 Bungaruscaeruleus Common Indian Krait

LC IV

2 Calotesversicolor Garden Lizard LC IV

3 Duttaphrynusmelanostictus Common Indian Toad

LC IV

4 Duttaphrynusscaber Ferguson's Toad LC IV

5 Euphlyctiscyanophlyctis Skittering Frog LC IV

6 Euphlyctishexadactylus Indian Pond Frog LC IV

7 Hemidactylusbrookii House Lizard LC IV

8 Hemidactylusmacolatus Reticulated gecko LC IV

9 Hoplobatrachustigerinus Tiger Frog LC IV

10 Mabuyacarinata Common Skink LC IV

11 Najanaja Common Cobra LC II

12 Ptyasmucosus Rat Snake LC II

13 Sitanaponticeriana Fan-throatedlizard LC IV * Ecological data collection - interactions with local personnel, forest officials of respective forest ranges and direct indirect observation in the project area and project study area

TABLE 3.34: List of butterflies observed in study area

S. No. Scientific name Common name IUCN Status W(P)A, 1972

1 Castalius rosimon Common Pierrot LC Sch-IV

2 Danaus chrysippus Plain Tiger LC Sch-IV

3 Danaus genutia Striped Tiger LC Sch-IV

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S. No. Scientific name Common name IUCN Status W(P)A, 1972

4 Euploea core Common Crow LC Sch-IV

5 Junonia lemonias Lemon Pansy LC Sch-IV

6 Papilo polymnstor Blue Mormon LC Sch-IV

7 Juninia almanac Peacock Pansey LC Sch-IV * Ecological data collection - interactions with local personnel, forest officials of respective forest ranges and direct indirect observation in the project area and project study area

TABLE 3.35: List of birds either spotted or reported from the areas in and

around the project site

S. No

Local name Scientific Name Schedule IUCN

Status

1 Ashy Prinia Priniasocialis IV LC

2 Ashy-crowned Sparrow-Lark

Eremopterixgrisea IV LC

3 Asian Koel Eudynamysscolopacea IV LC

4 Asian Open bill- Stork Anastomusoscitans IV LC

5 Asian Palm-Swift Cypsiurusbalasiensis IV LC

6 Baya Weaver Ploceusphilippnius IV LC

7 Black Drongo Dicrurusmacrocercus IV LC

8 Black Ibis Pseudibispapillosa IV LC

9 Black Kite Milvusmigrans IV LC

10 Black-Shouldered Kite Elanuscaeruleus IV LC

11 Blue Rock Pigeon Columba livia IV LC

12 Blue-tailed Bee-eater Meropsphillippinus IV LC

13 Brahminy Kite Haliasturindus IV LC

14 Cattle Egret Bubulcus ibis IV LC

15 Common Babbler Turdoidescaudatus IV LC

16 Common Myna Acridotherestristis IV LC

17 Common Swallow Hirundorustica IV LC

18 Common Tailor Bird Orthotomussutorius IV LC

19 Common Teal Anascrecca IV LC

20 Eurasian Golden Oriole Oriolusoriolus IV LC

21 Greater Coucal Centropussinensis IV LC

22 Grey Wagtail Motacillacinerea IV LC

23 House Crow Corvussplendens V LC

24 House Sparrow Passer domesticus IV LC

25 House Swift Apusaffinis IV LC

26 Indian Peafowl Pavocristatus I LC

27 Indian Pond Heron Ardeolagrayii IV LC

28 Indian Robin Saxicoloidesfulicata IV LC

29 Indian Roller Coraciasbenghalensis IV LC

30 Indian Treepie Dendrocittavagabunda IV LC

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31 Jungle Babbler Turdoidesstriatus IV LC

32 Large Cuckoo Shrike Coracinamacei IV LC

33 Large Grey Babbler Turdoidesmalcolmi IV LC

34 Large Pied Wagtail Motacillamaderaspatensis IV LC

35 Lesser Golden-backed Woodpecker

Dinopiumbenghalense IV LC

36 Little Cormorant Phalacrocoraxniger IV LC

37 Little Egret Egrettagarzetta IV LC

38 Oriental Magpie- Robin Copsychussaularis IV LC

39 Paddy field Pipit Anthusrufulus IV LC

40 Painted Stork Mycterialeucocephala IV LC

41 Pied Bushchat Saxicolacaprata IV LC

42 Purple Sunbird Nectarineaasiatica IV LC

43 Red-rumped Swallow Hirundodaurica IV LC

44 Red-vented Bulbul Pycnonotuscafer IV LC

45 Red-wattled Lapwing Vanellesindicus IV LC

46 Rose-ringed Parakeet Psittaculakrameri IV LC

47 Shikra Accipiter badius IV LC

48 Small Blue Kingfisher Alcedoatthis IV LC

49 Spot-billed Duck Anaspoecilorhyncha IV LC

50 Spotted Dove Streptopeliachinensis IV LC

51 Spotted Munia Lonchurapunctulata IV LC

52 White Wagtail Motacilla alba IV LC

53 White-breasted Kingfisher

Halcyon smyrnensis IV LC

54 White-breasted Water hen

Amauronisphoenicurus IV LC

55 Wire-tailed Swallow Hirundosmithii IV LC

56 Yellow-wattled Lapwing Vanellesmalabaricus IV LC * Ecological data collection - interactions with local personnel, forest officials of respective forest ranges and direct indirect observation in the project area and project study area

3.9.4 AQUATIC FLORA AND FAUNA:

The conditions of the aquatic ecology of the water bodies were also studied. Major

components of aquatic life that have been studied are as aquatic plant and aquatic

animals.

Plankton studies - primary survey

Biological assessment studies were conducted by collecting plankton samples from

the surface waters to assess the primary productivity of the water ecosystem. The

details of Planktonic sampling locations are presented in Table no. 3.36 given below.

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TABLE – 3.36, Aquatic ecological locations in study area

Sl. No Name of the water body Distance from

Project Site Direction from

Project Site

AS-1 Waterbody Near Jaggayyapeta 5.54 NW

AS-2 Krishna River 3.30 SSW

AS-3 Gauravaram Cheruvu 5.40 E

Results and discussions

About 14 aquatic plant species and 17 Aquatic Fauna species are recorded from all the

sampling locations. The list of recorded aquatic fauna from study area and aquatic flora

species is presented in the Table No 3.37 & 3.38.

TABLE – 3.37 Check list of fishes found in Krishna River

S. No. Scientific Name Common Name IUCN Status IW (P)A, 1972,

Schedule

FISHES

1 Catla catla Catla LC IV

2 Channa punctatus Spotted snakehead LC IV

3 Channa striatus Striped snakehead LC IV

4 Clarias batrachus Magur LC IV

5 Cyprinus carpio Common carp LC IV

6 Etroplus maculatus Orange chromide LC IV

7 Etroplus suratensis Banded pearlspot LC IV

8 Eutropiichthys vacha Batchwa vacha LC IV

9 Heteropneustes fossilis Stinging catfish LC IV

10 Labeo rohita Rohu LC IV

11 Mastacembelus armatus Tire- track spiny eel LC IV

12 Puntius dorsalis Long – snouted barb LC IV

13 Puntius fasciatus Ember barb LC IV

14 Puntius ticto Ticto barb LC IV

15 Sperata seenghala Giant river catfish LC IV

16 Striped panchax Tiger panchax LC IV

17 Tenualosa ilisha Hilsa LC IV * Ecological data collection - interactions with local personnel, forest officials of respective forest ranges and direct indirect observation in the project area and project study area

TABLE – 3.38, List of aquatic flora species recorded in study area

Sl. No. Scientific Name Family Distribution Status

1 Aponogeton natans Aponogetonaceae Common

2 Pistia stratoides Araceae Widespread

3 Azolla pinnata Azollaceae Scattered and common

4 Cyperus arenarius Cyperaceae Locally abundant

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Sl. No. Scientific Name Family Distribution Status

5 Phragmites karka Cyperaceae Dominant along boundaries

6 Vallisneria spiralis Hydrocharitaceae Widespread

7 Marsilia quadrifoliata Marsiliaceae Very common Pteridophyte

8 Nelumbo nucifera Nelumbiaceae Very common

9 Nymphoides hydrophylla Nympheaceae Scattered

10 Nymphoides indica Nympheaceae Scattered

11 Brachiaria mutica Poaceae Sporadic

12 Chrysopogon aciculatus Poaceae Occasional

13 Cynodon dactylon Poaceae Extensive and widespread

14 Paspalidium geminatum Poaceae Common * Ecological data collection - interactions with local personnel, forest officials of respective forest ranges and direct indirect observation in the project area and project study area

3.9.5 RET and Schedule I Fauna

On the basis of literature survey, from Red data books of Indian plants, detailed list

Rare and Endangered flora reveals that there are no Endangered, Threatened, Rare

plant species observed or recorded during study period.

There are no endangered animals, however recorded or observed list of wild animals

and their conservation status as per Wildlife (Protection) Act, 1972 are presented

above tables. As per Ministry of Environment, forests and climate change, Forest

department of Government of Andhra Pradesh state notifications reveals that there are

no Biospheres, Tiger Reserves, Elephant Reserves, National Parks, Wildlife

Sanctuaries, Conservation Reserves and Community Reserves in 10 - km radius from

plant boundary.

3.10. Socio Economic Study

The socio- economic aspects of people in the 10 km radius of the Project site at

Jayanthipuram (V), Jaggayyapet (M), Krishna District, Andhra Pradesh was

analyzed. The socio-economic data forms the basis for developing a suitable

enterprise social responsibility plan to address the needs of the population.

3.10.1. Methodology Adopted for the Study

The methodology adopted for the study mainly includes review of published

secondary data and primary data collection through sample survey conducted

project study area. Census of India - 2011 for respect to population, density,

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household size, sex ratio, literacy rate and occupational structure for 10 km radius

study area.

3.10.2. Distribution of Population in the study area

As per 2011 census the study area consists of 2,04,510 persons inhabited in the

study area of 10km radial distance from the periphery of the project. The distribution

of population in the study area is given in Table 3.39.

Table 3.39: Population Distribution

S. No Name of Village Number of

households

Total population 0-6 years aged population

Total Male Female Total Male Female

0 - 3 Km

1 Jayanthipuram 619 2348 1191 1157 361 198 163

Sub Total 619 2348 1191 1157 361 198 163

3 - 5 Km

2 Ravirala 316 1275 626 649 173 89 84

3 Kowthavari Agraharam 698 2759 1392 1367 329 153 176

4 Vedadri 590 2155 1099 1056 231 105 126

Sub Total 1604 6189 3117 3072 733 347 386

5-7 Km

5 Bandipalem 1163 4568 2297 2271 425 224 201

6 Konakanchi 955 3372 1690 1682 341 183 158

7 Pochampalle 978 3798 1928 1870 430 243 187

8 Gowravaram 1293 4781 2355 2426 494 243 251

9 Torraguntapalem 873 3295 1661 1634 366 179 187

10 Chillakallu 2983 11734 5779 5955 1386 686 700

11 Jaggayyapeta 32711 126275 62713 63562 13801 7061 6740

12 Mukteswarapuram 713 2742 1385 1357 253 134 119

Sub Total 41669 160565 79808 80757 17496 8953 8543

7 - 10 Km

13 Katrenipadu 1503 5673 2847 2826 608 289 319

14 Peddavaram 321 1231 645 586 96 48 48

15 Konakanchi 955 3372 1690 1682 341 183 158

16 Bhimavaram 1474 5543 2783 2760 614 333 281

17 Makkapeta 1186 4306 2106 2200 459 243 216

18 Gopinenipalem 747 2752 1368 1384 275 145 130

19 Tirumalagiri 372 1478 730 748 205 103 102

20 Veerareddi Palle 435 1835 899 936 174 97 77

21 Shermohammedpet 1822 7002 3471 3531 804 412 392

22 Tripuravaram 32 128 73 55 8 7 1

23 Srinivasapur 50 273 135 138 31 20 11

24 Kothagudem 475 1815 945 870 151 70 81

Sub Total 9372 35408 17692 17716 3766 1950 1816

Grand Total 53264 204510 101808 102702 22356 11448 10908

(Source: Hand Book of Statistics, Krishna District, 2011 and Census data 2011)

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The male and female population constitutes about 49.75 % and 50.25 % in the study

area respectively.

Figure 3.10: Diagram Showing Total Population Distribution in the Study Area

3.10.3. Literacy & Illiteracy Rate:

Literacy level is quantifiable indicator to assess the development status of any area.

The literate male and female in the study area are 68273 and 55524 which implies

that the percentage of literacy rate is 67.06 % with male and 54.06 % with female

respectively.

The male and female illiterates population in the study area are 33535 and 47178

respectively which implies that the percentage of illiteracy rate is 32.93 % with male

and 45.93 % with female respectively. The distribution of literate and literacy rate in

the study area is given in Table 3.40. The graphical presentation of literates and

illiterates in study area is given in figure 3.12.

Table 3.40: Distribution of Literacy Rate and Illiteracy Rate in the Study Area

S. No Particulars Population

1. Male Population 101808

2. Female Population 102702

3. Total Population 204510

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4. Male population Literates 68273

5. Male population Literates % 67.06 %

6. Male population illiterates 33535

7. Male population Illiterates % 32.93 %

8. Female population Literates 55524

9. Female population Literates % 54.06 %

10. Female population Illiterates 47178

11. Female population Illiterates % 45.93 % (Source: Hand Book of Statistics, Krishna District, 2011 and Census data 2011)

Figure 3.11: The Diagram Showing Literates and Illiterates in Study Area

3.10.4. Occupational Structure

The occupational structure of residents of work participation rate in the study area is

studied with reference to main workers, marginal workers and non workers. The

main workers include 10 categories of workers defined by the Census Department

consisting of cultivators, agricultural laborers, those engaged in live-stock, forestry,

fishing, mining and quarrying; manufacturing, processing and repairs in household

industry; and other than household industry, construction, trade and commerce,

transport and communication and other services.

The marginal workers are those workers engaged in some work for a period of less

than six months during the reference year prior to the census survey. The non-

workers include those engaged in unpaid household duties, students, retired

persons, dependents, beggars, vagrants etc.; institutional inmates or all other non-

workers who do not fall under the above categories.

Occupational pattern of the concerned study area is recorded to assess skills of

people.

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Occupational pattern also helps in identifying dominating economic activity in the

area. In the study area the main and marginal workers are 86663 and 13633

respectively of the total population while the remaining 104214 constitutes non-

workers.

Table 3.41: Occupational Structure in Study Area

S. No Parameter Total Male Female

1 Main Workers 86663 54319 32344

2 Marginal Workers 13633 5582 8051

3 Non-Workers 104214 41907 62307

Total Population 204510 101808 102702 (Source: Hand Book of Statistics, Krishna District, 2011 and Census data 2011)

Figure 3.12: The Diagram Showing Occupational Structure in Study Area

3.10.5 Civic Amenities Available In The Study Area

The project site is located near Jaggayyapet – where all the basic social

amenities like, Emergency Medicare, Drinking-Water, Communications,

Educational facilities , Roads and Power supply are readily available.

A) Power and Energy:

All Villages, in the Project Study Area, are electrified – both for common facilities

like, Street Lights, Public Water Pumping, etc. and also almost all houses are

electrified for home lighting, while LPG, Kerosene Oil and in some cases Waste

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Agri-Waste, Fallen Firewood, Cow Dung Cakes, etc. are used for cooking

purpose.

B) Health and Medical Facilities:

Most Villages have PHCs or Visiting ANMs / Health Counseling-cum-Primary

Health Care Mobile Units. For Maternity and Specialist Care & basic Diagnostics,

adequate facilities are available near to project site, which is 10 km from the

proposed project site. And for Critical and Advanced Medicare & Diagnostics,

local communities visit Vijayawada City, which is about 57 km from the project

site.

Ambulance is available for emergencies to evacuate patients of serious health

condition/s to the Multi-Specialty.

C) Tele-Communications:

Telecommunication facility in the Project Study Area is adequate; BSNL

Electronic Telephone Exchange is available and BSNL / Airtel / Vodafone, Idea

Cellular & Reliance Telecom Services available everywhere.

D) Local Administration & Law:

While all the Villages and Towns do have ‘Village Panchayat’, duly elected by the

local electorates to assure Sanitation, Local Law & Order and to coordinate with

various Government Departments & Other Agencies, concerned for local

Sanitation, General Hygiene, Immunisation, Nutrition Programmes, Enhancement

of Literacy Levels and Crime / Law & Order as well as all Central and State

Governmental Developmental Projects.

E) Other Administrative Issues:

They are further supported by the Mandal Revenue Office (M.R.O.) stationed at

Jaggayyapet (6.0 km).

F) Transportation & Other Important Facilities:

The nearest Police Station, the Fire Station and Bus Station are located at

Jaggayyapet which is near to the project site and there are also Bus-Station, Bus-

Stops at Jaggayyapet to all major Towns & Cities.

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3.10.6 Corporate Social Responsibility of the Project Proponent

Due to proposed project there is no major negative impact on socio

economic environment.

The proposed project requires a workforce of 100 persons. Thus industrial

activity will boost up the commercial and economical status of the locality

to some extent. And, the overall impacts on socio-economic environment

due to the proposed project are positive in nature and accrue to the

community on the long-terms basis.

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ANTICIPATED

ENVIRONMENTAL IMPACTS

&

MITIGATION MEASURES

CHAPTER -IV

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CHAPTER - IV

ANTICIPATED ENIVORNMENTAL IMPACTS

& MITIGATION MEASURES

4.1 INTRODUCTION

Environment and development should be considered as mutually Complementary,

interdependent and an instrument of reinforcing the quality of life. Environmental

Impact Assessment (EIA) is the important aspect of overall environmental

management strategy and an important tool for sustainable development. It identifies

major impacts of Industrial and associated activities on environment and provides

guideline to prepare the necessary control measure termed as Environmental

Management Plan (EMP).

The identified impacts for various components of environment viz., Air, Noise, Water,

Land, Socio-Economy, etc. are presented herewith. EIA is an activity or an attempt

to identify, predict, evaluate and communicate the likely environmental impacts of the

activity/project on the environment.

Based on results [Baseline Data] of prediction and evaluation, pollution abatement

and control measures in order to mitigate the adverse impacts on the environment

are delineated in an Environmental Management Plan

The proposed project is likely to create impact on the environment in two distinct

phases:

During the construction phase, which may be temporary and short term; and

During the operation phase that would have long-term effects.

4.2. INVESTIGATED ENVIRONMENTAL IMPACTS DUE TO PROPSED PROJECT

The environmental impact assessment is accomplished by identification and

prediction of impacts and their assessment. Potential impacts of proposed project on

various environmental attributes given below are predicted;

Air environment

Water resources and quality

Noise levels

Land use

Soil quality

Solid waste

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Terrestrial and aquatic ecology

Demography and socio-economics.

Hydrology & Geology

4.3. CONSTRUCTION PHASE

During the construction phase, the activities which are likely to contribute to impact

on various environmental components which are temporary in nature are site

clearing, leveling, construction of various structures of Drug manufacturing activities,

lying of internal roads, erection of equipment etc.

The construction activities will be confined within the project area of 11.62 acres.

The environmental impacts and management plan during construction phase are

detailed below.

4.3.1 IMPACT ON LAND USE

Present land is Barren. Now the site is converting in to industrial use and the

proposed project will be in an area of 11.62 Acres (47024.47 SQM) Change will

occur on the land use pattern of the surrounding villages

Any construction of infrastructure will lead to permanent change in land use pattern

at the site as a direct impact. No major changes in land use pattern will occur due to

the project activities.

4.3.2 IMPACT ON SOIL ENVIRONMENT

The activities of proposed project will be confined within the site premises. During

construction works, top soil generated from various activities like excavation etc. will

be stored and preserved to use it during restoration period as far as possible.

The construction activities will result in loss of topsoil and earthen material to some

extent in the plant premises. However, it is proposed to use the soil and earthen

material in greenbelt development.

No solid or hazardous waste will be generated during construction thus no impact on

soil environment is likely.

4.3.3 IMPACT ON TOPOGRAPHY

The proposed site is plain terrain and during the construction phase there would be

proper leveling of the proposed site. There is no additional stress expected due to

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this project activity on topography and soil strategy of the project site and its

surroundings

Since it is a new project, changes occur in topography due to excavation of soil in

the proposed project area and construction of buildings and facilities. During

construction, excavated soil will be restored to its original shape. Thus the impact

during the construction is reversible, for short term and insignificant.

4.3.4 IMPACT ON AIR ENVIRONMENT

The sources of air emissions during construction phase will be due to development

of site, emissions from vehicles used for transportation of men and materials and

emission from construction equipment’s. These activities are likely to result in

emission of SO2, NO2, CO2 and Particulate matter. However, the quantity of these

will be very negligible and that too only for a very short period. Hence no adverse

impact on air quality is likely to occur.

4.3.5 IMPACT ON WATER ENVIRONMENT

No surface water body is located in the vicinity of the project site; hence project

related impact on water environment would mainly be limited to the groundwater

resources. The potential impacts during construction phases are assessed based on

the various activities.

● Improper disposal of construction debris may lead to off-site contamination of

water resources.

● Unaccounted disposal of domestic wastewater from temporary labour camps.

● Spillage of oil and grease from the vehicle maintenance activity and wastewater

stream generated from activities, such as vehicles washing and maintenance.

Site Workshop:

The repair and maintenance of equipments/ vehicles at site would generate waste

containing oil and grease. The wastewater stream would also be generated from

vehicle washing. The impact can be mitigated to a great extent by installing oil and

grease traps during construction phase.

Construction of Roads and Parking Areas:

The impact from the road construction depends on both the construction practices

and the type of material used. Construction waste of electrical installation, painting

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and flooring may create significant impact. This type of waste would be stock piled

and disposed off to authorized vendor.

Development of the proposed site could lead to stockpiling and excavation activity on

site, thereby causing erosion of base soil. The run-off from the site may contain high

quantity of suspended solids (SS). The impact of runoff may not be very significant

except during rainy season. Further, construction of garland drains will reduce the

runoff from the stockpiles

Domestic Wastewater generated during construction, which will be collected in

sewage collection tank [septic tank]

The contamination of groundwater might occur due to the irrational disposal of liquid

wastes. The overall impact on water environment during construction phase due to

proposed project is likely to be short term and insignificant. There seems no impact

on the water environment of the study area.

4.3.6 IMPACT ON NOISE LEVELS

Noise will be generated due to construction traffic for loading and unloading,

fabrication and handling of equipment and materials are likely to cause an increase

in the ambient noise levels. The areas affected are those close to the site. However,

the noise will be temporary and will be restricted mostly to daytime.

4.3.7 IMPACT ON ECOLOGY

The proposed project will not involve removal of any vegetation from the soil and

loosening of the topsoil generally causes soil erosion as it is. However, such impacts

will be confined to the project site and will be minimized through paving and water

sprinkling. However, 36.8% of greenbelt will be developed in the proposed project

site. The existing trees will be preserved to the extent possible. Thus, there will no

major adverse impacts are envisaged on ecological environment due to project

activities.

4.3.8 IMPACT ON SOCIO-ECONOMIC ENVIRONMENT

Due to proposed project there is no major negative impact on socio economic

environment. The proposed project will requires a workforce of 100 persons during

plant operations. Thus industrial activity will boost up the commercial and

economical status of the locality to some extent. And, the overall impacts on socio-

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economic environment due to the proposed project are positive in nature and accrue

to the community on the long-terms basis.

TABLE – 4.1: Summary – Identification Of Impacts During Construction Phase

S.No Components Aspect Potential Impacts

1 Topography & Geology

Site development No significant adverse Impacts

2 Soil

Construction activity leading to topsoil removal and erosion.

Minor negative impact

3 Landuse & Aesthetics

Land development Positive impact

4 Water Quality

Surface runoff from project site

Oil/ fuel and waste spills

Improper debris disposal

Discharge of sewage from labour camp.

Short term, but no significant negative impact

5 Ambient Air Quality

Dust emissions from site preparation, excavation, material handling and other construction activities at site.

Short term minor negative impact inside the site premises. No negative impact outside the site.

6 Noise

Noise generated from construction activities, operation of construction equipment and traffic.

Short term minor negative impact near noise generation sources inside premises. No significant impact on ambient noise levels at sensitive receptors.

7 Ecology Flora and Fauna

Habitat disturbance during construction activity.

Short term minor negative impact

8 Socio - economy

Increased job opportunity. Economy related to semiskilled expected to boom.

Short term positive impact by employment generation

9 Traffic Pattern

Haul Truck movement and possibility of traffic congestion outside site on Sector Road

Minor negative impact

10 Solid Waste Waste will be generated from construction activities

Proper disposal plan will be implemented. No adverse impact

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4.4. MITIGATIVE MEASURES OF IMPACTS DURING CONSTRUCTION PHASE

Mitigative measures of identified impacts during construction phase are listed in

tabular form.

TABLE – 4.2: Mitigation Measures During Construction Phase

S.No Components Impacts Mitigative Measures

1 Topography & Geology

No significant adverse Impacts

Construction will be carried out within the site premises; therefore no change will occur in land use pattern as well as there will not be any significant Topographical change. However, temporary change in top layer of soil will be occurred but the construction activity will help in fixation of soil thereby reducing the soil erosion

2

Land/Soil

Short term minor negative impact due to change in top layer of soil

The earthen material generated during excavations and site grading periods, will be properly dumped and slope stabilization shall be taken. The topsoil generated during construction shall be preserved and reused for plantations

Greenbelt development will have significant impact in reduction of the soil erosion

3 Ambient Air Quality

Sort term negative impacts because of dust emission due to site cleaning, road laying, earthwork, transportation & construction

The emissions will be temporary and confined within proposed project site boundary. It is not expected to contribute significantly to the ambient air quality However, the unit will take following measures for control of dust emissions:

Use of plastic cover sheet while transporting construction material at site

Storage of sand and other such dispersible material by covering with tarpaulin sheet

Storage of sand and other such dispersible material by covering with tarpaulin sheet

Keeping minimum inventory/stock of sand and other such dispersible

material at site

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S.No Components Impacts Mitigative Measures

The heights, from which materials will be dropped, will be the minimum practical height to limit fugitive dust generation.

Use of water sprinkling system at site for dust suppression

During high wind condition, construction activities will be restricted, so that minimum flow of dust particle takes place.

Proposed Greenbelt development will be started from the construction phase

4 Water Quality

Short term, but no significant negative impact

Water requirement for construction phase will be very minor and for short period and that will be fulfilled by ground water source Thus, there will not be any significant impact on water environment

The wastewater generation will be from the domestic activities. Domestic effluent will be disposed of through septic tank into soak pit.

Measures will be implemented to prevent seepage of liquid materials into ground where it could contaminate groundwater and soil.

Fence will be constructed around the site to trap sediments whilst allowing the water to flow through.

All mud & dirt deposited on the roads from the construction activities will be cleaned.

5 Noise

Short term negative impact due to increase in noise level by site cleaning, road laying, earthwork, transportation & construction activities

The noise generated from construction machinery will be kept low by keeping the moving parts serviced and properly lubricated.

The construction activity will be carried out during day time only.

Vehicular movement carrying materials will be avoided during night time.

The vehicles will be regularly maintained and optimum use of the same will be made.

Adequate PPE’s (ear plugs, ear muffs helmet, mask etc) will be provided to the workers

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S.No Components Impacts Mitigative Measures

Greenbelt development will have significant impact in reduction of the noise

6 Ecology Flora and Fauna

Short term minor negative impact but, long term positive impact due to green belt development

The felling of trees will be kept at minimum.

Adequate Greenbelt will be developed.

7 Socio - economy

Short term positive impact by employment generation

Temporary employment will be generated due to construction activities and related services like transportation of construction materials, mechanical erections etc. [25 Workers]

8 Traffic Pattern Minor negative impact

9 Solid Waste No adverse impact

Waste will be generated from construction activities Proper disposal plan will be implemented.

4.5. PREDICTION OF IMPACTS DURING OPERATIONAL PHASE

This phase of the project is important because it generates long-term impacts as the

production starts.

The following activities related to the operational phase will have varying impacts on

the environment and are considered for impact assessment:

Air environment

Water resources and quality

Noise levels

Land use

Soil quality

Solid waste

Terrestrial and aquatic ecology

Demography and socio-economics.

Hydrology & Geology

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4.6 AIR ENVIRONMENT

The impacts on air quality from project depend on various factors like design

capacity, configuration, process technology, raw material, fuel to be used, air

pollution control measures, operation and maintenance. Apart from the above, other

activities associated with transportation of fuel, raw materials and finished products,

storage facilities and material handling within the plant premises may also contribute

to air pollution.

4.6.1 Source of Air Pollution

The operational phase activities are expected to have long - term impacts on the air

quality. The main sources from project are detailed below.

A. Flue gas Emissions

Boilers and DG set are the two main sources of emissions from the plant. Industry

proposes to install 8 TPH & 4 TPH coal fired boilers. A 500 KVA & 1000 KVA DG

Sets are kept as standby power during power failures.

PM, SO2 and NOx are the main air pollutants generated from the boilers and DG

sets.

The emissions from the boiler stacks and DG Set Stack are given in Table 4.3 & 4.4.

TABLE 4.3: Emission Details from Proposed Boiler Stack

Particulars Units 8.0 TPH Coal fired

Boiler 4.0 TPH Coal fired

Boiler

Type of Fuel -- Indian Coal with CV of 4000 kcal/kg to

5000 kcal/kg

Indian Coal with CV of 4000 kcal/kg to

5000 kcal/kg

Coal Consumption TPD 32 16

Ash Content % 35 35

Sulphur Content % 0.4 0.4

No. of Stacks No 1 1

Height of stack M 34 30

Diameter of Stack M 0.50 0.40

Temperature of Flue Gas oC 200 180

Velocity of Flue Gas m/s 16 14

Particulate Matter gm/sec 0.26 0.13

Sulphur dioxide emission gm/sec 2.95 1.48

Oxides of Nitrogen emission gm/sec 9.70 4.86

Note: 5 TPH Coal fired Boiler is kept as standby.

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TABLE 4.4: Emission Details from DG Set Stack

Capacity In KVA

Emission of SPM in mg/Nm3

Emission Of SO2 in mg/Nm3

Emission of NOx

in mg/Nm3

Stack dia. in m

Flue Gas Temp. in

OC

Stack Height in m

Flue gas Velocity in m/sec.

500 KVA (Proposed)

80 150 180 0.30 220 10 16

1000 KVA (Proposed)

120 170 200 0.35 280 10 18

B. Process Emissions

The Predicted Process emissions are

CO2, [Carbon dioxide] – Pollutant

SO2, [Sulphur dioxide] - Pollutant

O2, [Oxygen] – Non Pollutant

HCl [Hydrochloric acid] - Pollutant

NH3 [Ammonia] – Pollutant

(CH3)2NH [Dimethylamine] – Pollutant

HF [Hydrogen fluoride] – Pollutant

H2 [Hydrogen] - Non Pollutant

CH4 [Methane] - Pollutant

Which will liberate from manufacturing process of proposed products. The process

emissions are based on reactants quantity and chemical reactions between them in

relation with desired product output.

C. Fugitive emission

The main sources of fugitive emissions from project are

Storage & Handling of raw materials

Storage & Handling of Solvents.

During reaction period

During Product filtrations & Finished operations

The raw materials will be stored in PP bags, Fibre drums and HDPE drums in

elevated flat from under the roof. Bulk quantities will be stored in storage tanks with

vent condensers to avoid the fugitive emissions. Solvents are handled in closed

conditions thereby reducing the losses in the form of evaporation.

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4.6.2 Prediction of Impacts on Air Environment

The objective of dispersion modeling is to predict the ground level concentration

during the operation of plant and its impact on ambient air quality of the area.

Air quality assessment is done by integrating the measurement techniques and

modeling tools. The air modeling tools are routinely used in the environmental impact

assessments, risk analysis, emergency planning, and source apportionment studies.

Recent strategies for air pollution control in industries have largely neglected the

emission reduction measures which are the prime polluting sources. To accomplish

this, various air dispersion models have been developed and used worldwide so far

for different applications under different scenarios. The Gaussian plume model is a

standard approach for studying the transport of pollutants due to turbulent diffusion

and advection by the wind. Applications of such models have been made mandatory.

In this study, the AERMOD (the American Meteorological Society/Environmental

Protection Agency Regulatory Model Improvement Committee’s Dispersion Model,

Gaussian dispersion model is selected to predict the ground level concentrations

(GLC’s) of Particulate Matter (PM) µg/m3, sulphur dioxide (SO2) µg/m3 , and oxides

of nitrogen (NOx)- µg/m3 from point source emissions will be investigated in the

study area.

Methodology

Prediction of GLC values are made by using AERMOD software approved by U.S.

Environmental Protection Agency (USEPA) and has adopted it as its regulatory

model since 2005. In point source emissions, the stacks are subjected to plume rise

which again is dependent on force of buoyancy and momentum. The higher is the

plume rise or stack, the lesser will be ground level concentrations (GLC’s).The

emissions when released into the atmosphere are subjected to transportation,

dispersion, transformation, and fall out and wash out and finally reach the ground

level at a particular distance and concentrations. The relationship between the

source of emissions and its magnitude with the ground level concentrations (GLC’s)

at receptor points is governed by air dispersion models which take into the account

by the source strength, plume rise, atmospheric stability, mixing height, wind

velocity, terrain and other meteorological conditions. The comparison between the

predicted and field sampled downwind concentrations for PM, SO2 & NOX (µg/m3)

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will be carried out in this study to predict the average downwind ground level

concentrations (GLC’s)

Data Used for Computation

Stack emissions data have been used for prediction of short-term incremental GLC

values of PM, SO2 & NOx using the meteorological data collected at site during the

March – 2018 to May – 2018. Details of the data used for computations are given

below:

Source Characteristics/Release Characteristics

The details of estimated stack emissions load are given in Table 4.2.

Meteorological Data

The meteorological data recorded continuously during the month of March – 2018 to

May - 2018, on hourly basis. AERMOD model requires hourly surface data values for

wind speed, wind direction, temperature, relative humidity and cloud cover. Both

data files for the surface and profile files were then used to generate the

meteorological file required by the AERMOD dispersion model using the AERMET

meteorological pre-processor. This AERMET has three stages to process the data.

The first stage extracts meteorological data and assesses data quality through a

series of quality assessment checks. The second stage merges all data available for

24-hour periods and writes these data together in a single intermediate file. The third

and final stage reads the merged meteorological data and estimates the necessary

boundary layer parameters for dispersion calculations by AERMOD.

Dispersion Modeling Results

The 24 hourly average ground level concentration (GLC) values from plant have

been computed for PM, SO2 & NOx considering topographical features around the

plant and applicable stability classes. The maximum 24 hourly average GLC values

for PM, SO2 & NOx from plant are given in Table 4.5 to Table 4.6. Corresponding

isopleths plotted are shown in Figure 4.1 to Figure 4.3 for SPM, SO2 & NOx.

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TABLE 4.5: Predicted 24-Hourly Short Term Incremental Concentrations

Season Maximum Incremental GLCs

(μg/m3) Distance

(km) Direction

SPM SO2 NOx

Mar – 2018 to May – 2018

0.759 4.694 9.47 0.5 NW

TABLE 4.6: Resultant Concentrations Due to Incremental GLC's

Pollutant

Maximum Baseline

Concentration (μg/m3)

Incremental Concentrations due to Proposed Project

(μg/m3)

Resultant Concentration

(μg/m3)

NAAQ Standards (μg/m3)

SPM 68.88 0.759 69.639 100

SO2 15.15 4.694 19.844 80

NOx 22.33 9.47 31.80 80

With this marginal contribution due to the proposal of the project, the levels of SPM,

SO2 &NOx, will remain below the 24 –hourly ambient air quality standards for SO2 &

NOx (80 μg/m3) and PM10 (100μg/m3) prescribed by CPCB. The operation of plant is

not likely to cause any significant impact on the ambient air quality of the study area.

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FIGURE - 4.1: SHORT TERM 24 HOURLY INCREMENTAL GLCs OF SPM

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FIGURE - 4.2: SHORT TERM 24 HOURLY INCREMENTAL GLCs OF SO2

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FIGURE - 4.3: SHORT TERM 24 HOURLY INCREMENTAL GLCs OF NOX

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MITIGATION MEASURES

The industry will take measures for reduction of fugitive emissions emanating out of

process reactions by adopting the following;

Good ventilation will be provided to reduce the workroom concentrations.

Fugitive emissions will be reduced by providing vent condensers to the all the

reactors and Storage tanks

Adequate stack height of 34 Mtrs & 30 mts will be provided to the 8 TPH & 4

TPH boilers respectively.

Stack monitoring facilities for the periodic monitoring of the stack to verify the

compliance of the stipulated norms. Apart from this Cyclone Separator, Bag

filters will be provided to the boiler.

Table No.4.7 Process Emission details and mitigation measures

S. No Name of the Gas Quantity

in Kg/Day Treatment Method

1 Carbon dioxide 270 Dispersed into the atmosphere

2 Oxygen 224 Dispersed into the atmosphere

3 Ammonia 9 Scrubbed by using Chilled water media

4 Hydrogen chloride 426 Scrubbed by using Chilled water media

5 Sulfur dioxide 312 Scrubbed by using C.S.Lye Solution

6 Dimethylamine 8 Scrubbed by using chilled water media

7 Hydrogen fluoride 5 Scrubbed by using C.S.Lye Solution

8 Hydrogen 35 Diffused by using Nitrogen through Flame arrestor

9 Methane 15 Dispersed into the atmosphere

In order to minimize the air pollution, unit will develop greenbelt in and around

its premises.

ODOR CONTROL

The chance of odours within premises is mainly due to

Raw materials

Storage / Handling

Transportation of raw materials

Process

Raw materials transportation

During reaction

Drying

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ETP Operations

Storage / Handling

Storage

Industry will provide adequate and proper storage facilities for all the raw

materials and finished products.

Corrosive substances will be stored away from the moisture.

Solid raw material will be stored in covered area and Liquid raw material will

be stored in closed Horizontal / Vertical tanks.

Hazardous chemicals and solid wastes will be stored away from other plant

activities.

The storage yard of chemicals will be isolated and it will be equipped with all

necessary measures to control odours.

Handling

All the raw materials and finished products will be handled as per the standard

practice.

For proper handling, company will adapt good housekeeping technology to

entire shed.

To avoid any leakage or spillage of chemicals from all storage tanks, third

party will inspects transfer lines, valves, fittings and every joint periodically.

Transportation of Raw materials

All the necessary precautions will be taken while carrying out transport of the

above materials as per the Hazardous Rules of transportation.

The vehicles for transportation of raw materials and products will be parked at

specified loading facilities where there will be a provision of fire extinguishers.

The finished product will be transported by road, rail and ship route in closed

containers.

Other sources of odour nuisance are as follows

Leaks from pressurized process equipment generally occur through valves, pipe

connection, mechanical seals or related equipment.

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Control measures

To minimize & control leaks at process facilities operators carry out regular

leak detection test and repair activities.

Routine inspections of process equipment with gas detectors can be used to

identify leaks & estimate the leak rate in order to decide an appropriate

corrective action.

Proper routine maintenance of equipment reduces the likelihood of leaks.

Solvents will be transferred through the closed pipe line system.

Cleaner production practices

Process vessels:

Liquid raw material will be charged by pumping and closed loops and dosing

will be done by metering system to avoid odour.

Double mechanical seals will be provided to the process vessels having

agitator for reduction of odour and leakages.

Storage tanks

Storage tanks for products as well as raw materials will be fitted with

appropriate control devices [Condensers with chilled water circulation

systems] to avoid possible odours / leakages.

House keeping

Keep work areas clean.

Keep aisles clear.

Keep exits and entrances clear.

Use proper waste collection containers.

Cleanup spills and leaks off’s any type quickly and properly.

Follow up preventive predictive maintenance.

4.7 WATER ENVIRONMENT

With respect to water environment; three aspects are considered in EIA, availability

& Requirement of fresh water, Wastewater generation and its disposal.

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Fresh Water Requirement

The total water requirement for the proposed project is 259 KLD. Water requirement

of unit is met through Ground water. Unit will be bought water from private water

supplier through tankers in case of non-availability of main source [Ground water]

this will be kept as stand by source.

Waste water generation

Total effluent generation is 105.8 KLD, which is from process, scrubbers, boiler,

cooling towers and washing activities. The HTDS waste water of 52 KLD from

Process after neutralization taken for treatment in stripper followed by MEE and

ATFD. LTDS waste water of 53.8 KLD including domestic sewage, floor Washes.

Disposal of Effluent – ZLD System

Utilities waste water taken along with Vapour Condensate from MEE & ATFD for

Biological Effluent Treatment plant. Treated effluent from ETP sent to RO and RO

permeate water is recycled and RO rejects are sent to MEE followed by ATFD for

evaporation. Evaporation salts collected and sent to TSDF. MEE & ATFD vapour

condensate reused along with RO permeate.

MITIGATION MEASURES

Effluent generated in the plant will be treated in Proposed ZLD system.

The industry is proposing to install a MEE System with 85 KLD capacity,

Biological Treatment system of 110 KLD and RO system with 100 KLD

capacities for treatment of 105.8 KLD effluents generated from plant

operations.

Total Water requirement is 259 KLD out of which 84 KLD recycled water

recovered from ZLD system. The fresh water of 175 KLD will be met from

Ground Water source.

The leakages of oil spills from machinery shall be collected in leak proof

barrels and then disposed off to SPCB authorized dealers.

The groundwater levels need to be monitored with setting up of piezometers

in the core and buffer zone.

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Unit is proposed to recharge ground water through roof water harvesting pits

in the project area and rain water harvesting pits outside plant area wherever

possible to balance the water table.

Minimization of water use providing drip system for gardening.

Use of high-pressure hoses for cleaning the floor and process equipment to

reduce the amount of wastewater generated during washings.

Conjunctive use of groundwater.

4.8 NOISE ENVIRONMENT

PREDICTION OF IMPACT

Identification of potential impacts on noise environment from the proposed project is

as important as other components of the environment. The main sources of noise

pollution are Boiler, Reactors, DG Set, Air compressors, and other Noise generating

units. Vehicular movements during operation phase for loading / unloading of raw

materials and finished products and transporting activity may also increase noise

level. Noise levels in the ambient air are well within the permissible limits given by

the National Ambient Noise level standards as confirmed during baseline study. Leq

values of the noise levels within the plant premises will be kept less than 75 – 70 db

[A] [during day time and night time] which will be within the permissible limit.

MITIGATION MEASURES

To minimize the noise pollution the unit proposes the following noise control

measures,

Noise suppression measures such as enclosures, exhaust mufflers, buffers

and / or abatement measures that will be implemented.

Employees will be provided with earplugs or earmuffs.

Extensive oiling, lubrication and preventive maintenance will be carried out for

the machineries and equipments to reduce noise generation.

Green Belt Development.

4.9. LAND/ SOIL ENVIRONMENT

IDENTIFICATION OF IMPACTS

Infrastructural development for the proposed project as well as subsequent

developments in the nearby area may change the land use pattern of area.

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The impact on land and soil environment may be due to effluent disposal, chemical

and hazardous waste storage & handling. Spillage of chemicals during loading,

unloading and transfer, leakage of pumps, flange leakage in pipelines may create

soil/land contamination.

PREDICTION OF IMPACTS

The Proposed project will be carried out within the acquired land premises; there

will not be any change in land use pattern, forest cover or vegetation in

surrounding area. Moreover, electricity, water, roads, all basic amenities and

infrastructure are already available in the area.

There will not be any disposal of untreated effluent on land. Industrial wastewater

will be properly treated and reuse in various activities within the premises.

Spillage of chemicals during loading, unloading and transfer, leakage of pumps,

flange leakage in pipelines may create soil/land contamination. However, the

regular maintenance of pumps and flange connections in the pipelines will be

carried out and proper care will be taken while loading, unloading and transfer of

materials to avoid any soil/land contamination.

MITIGATION MEASURES

During operational phase, the chances of any enhanced soil erosion are not

anticipated. But improper disposal of toxic wastes and accidental spillages of

toxic chemicals can pose a serious threat to the soil, ground and surface waters.

But the chances of such events cannot be quantified and predicted. Since the

industry is expected all rules and regulations relating to the use, handling and

disposal of all toxic and hazardous chemicals, no additional safety methods are

required especially to prevent contamination of soil.

Liberal use of locally available farmyard manure will be used for the plants in the

greenbelt and block plantations for improving the productivity, fertility and health

of soils.

In case of any spillage, the same will be collected and treated in ETP. The unit

will provide an adequate designated storage area with impervious flooring system

and roof cover with leachate collection system for the storage of hazardous

wastes.

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Leachate, if any will be collected and treated in ETP. Thus, there will not be any

chances of contamination of soil due to the storage of chemicals and hazardous

waste.

The hazardous waste generated will be stored and handle as per the Hazardous

Wastes (Management, Handling and Transboundary Movement) Rules, 2016

The project does not have any impact on the soils beyond the boundaries of the

project site since it is a zero liquid discharge unit. Physicochemical characteristics

of the soil samples obtained from 7 areas in the buffer zone and one from the

project site reveals that all basically sandy loams.

4.10. IMPACT OF SOLID WASTE

The details of hazardous waste to be generated from the proposed project, is

mentioned at Chapter -2. The current practice of storage of generated hazardous

waste, in a closed room having an impervious bottom, and disposed of as per the

prescribed guidelines will be continued for the generation of hazardous waste.

Hence, the impact due to the same will be negligible as the handling of hazardous

waste to be generated will be disposed as per guidelines. The details of

solid/Hazardous waste details are shown in below Table. The ash from boilers will be

used in the brick manufacturing. The ash of 0.5 µm to 45 µm will be used in the

cement manufacturing as a filler material, stabilization of soft soils, mineral filler in

asphaltic concrete, floor and metal castings etc.

MITIGATION MEASURES

To reduce the quantity of solid / hazardous waste generation as well as possible

contamination of land (soil) due to spillages / leaks from the plant operations,

following

Mitigation measures can be implemented:

There will not be any leakages / spillage from the raw-materials storage and

from the storage of generated effluent from the project.

The generated Hazardous waste will be stored on floor with suitable packing

and this dedicated area will be covered with the roof.

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The records on quantity of hazardous waste generation and disposal will be

maintained for each category and possibilities will be explored for

minimization and reuse.

Classification of waste, Collection, Storage, Transportation, & disposed/sale

to authorized recycler or re-user.

Data Management and Reporting

Personnel Training

Solid/Hazardous Waste Generation and Disposal mode

Table No.4.8 Hazardous & Solid Waste Disposal Details

S. No Name of the

Hazardous Waste Quantity Disposal Method

1 Organic Solid Waste 3757 Kg/Day

Sent to Cement Industries

2 Spent Carbon 108 Kg/Day

3 Solvent distillation residue 1174 Kg/Day

4 Organic Evaporate liquid from MEE stripper

1040 Kg/Day

5 Mixed Solvents 3933 Kg/Day

6 ETP Sludge 1000 Kg/Day

Sent to TSDF 7 Inorganic solid waste 366 Kg/Day

8 MEE Salts 4954 Kg/Day

9 Used Oils 1000

Ltrs/Annum SPCB Authorized Agencies for Reprocessing/Recycling

10 Detoxified Containers 1000

No’s/Month

After Detoxification sent back to suppliers/sent to outside Parties

11 Used Lead Acid Batteries 9 No’s/Year Send back to suppliers for buyback of New Batteries

Solid Waste Details

12 Ash from boiler 16800 Kg/Day

Sent to Brick Manufacturers

4.11. IMPACTS ON ECOLOGY

Prediction of impacts is based both on the direct and indirect; short-term as well as

long-term; irreversible and irreversible impacts that are most likely to occur owing to

the industrial activity during establishment and operation. The ecological factors that

are considered most significant as far as the impact on flora and fauna are

concerned:

1. Whether there shall be any reduction in species diversity.

2. Whether there shall be any habitat loss or fragmentation.

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3. Whether there shall be any risk or threat to the rare or endangered or

endemic or threatened (REET) species.

4. Whether there shall be any impairment of ecological functions such as (i)

disruption of food chains, (ii) decline in species population and or (iii)

alterations in predator-prey relationships.

NEGATIVE IMPACTS

As there is change in the land use and land cover on account of the proposed

project, the proposed action is not going to have any direct and significant negative

impacts of flora and fauna or biodiversity.

MOST PROBABLE SCENARIO

As stated earlier, it is a new project there will be change in the land use and land

cover within the project site. No damage is going to be done to the existing green

cover within the project site. Except for a few weeds, there are only cultivated plants

and no RET species in the core area. No species is going to be lost on account of

the proposed project. No direct or indirect damage is expected to the flora and fauna

of the buffer zone. Further, as there are no rare or endangered or endemic or

threatened (REET) species, the project does not pose any threat to the flora and

fauna of the study area. As the industry is required to operate and maintain the

emissions and effluents within the limits specified by the CPCB / SPCB, the effects

of the industry on the flora and fauna of the buffer zone may be negligible. Neither

the storm water nor the effluent water nor any other kind of rain or waste water from

the industry shall get in to the drinking water resources.

MITIGATION MEASURES

Extensive plantation and green area development of 4.27 Acres is planned in the

proposed project along with landscaping. This is hereby ensured that the mostly

indigenous/local plants will be planted all around the periphery of the project area

and along the compound wall sides. Plantations would be of large leaf trees that

provide adequate shade and are semi evergreen to evergreen. Various native and

indigenous trees would be planted for mitigation purpose

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4.12. IMPACTS ON SOCIO- ECONOMY

During the erection phase short term direct or indirect employment will be

generated. Project Proponent shall give first preference to the Local people wherever

found suitable for all the jobs in the plant operations. Economic status of the local

people will improve due to the increased employment & business opportunities,

thereby, making a positive impact to the Local Economy. Educational, medical and

housing facilities in the study area will considerably improve. Thus, the proposed

project will have significant positive impact on the socio-economic environment.

MITIGATION MEASURES

Due to proposed activity the employment generation will be around 100

persons including, skilled, semi-skilled & unskilled labour and office staff.

Local qualified personnel can be employed.

Under CSR & CER Budget, the proponent has allotted 135 lakhs to take up

Environment & welfare activities.

4.13. IMPACTS ON HYROLOGY & GEOLOGY

The generation of ash from the industry will have sedimentation affect over

the wind ward side on the soil regime as well as the buffer zone over a period

of time affecting the Green cover/ plantation thereby affecting the growth of

plants / crops.

The chemically loaded waste water leakage from the industry will adversely

affect the soil, surface and groundwater.

MITIGATION MEASURES

Ash generation and storage will be monitored closely to avoid leakages and

will be disposed safely to the brick manufacturing industries and infrastructure

projects.

The ash spreading in and around the plant will be avoided by storing under

closed conditions at dedicated place till it is disposed to users. The prevention

suggested is not to allow the waste water leakage from the industry by

implementing proper storage tanks for wastewater collection and ZLD system.

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ANALYSIS OF

ALTERNATIVES

(TECHNOLOGY & SITE)

CHAPTER -V

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CHAPTER – V

ANALYSIS OF ALTERNATIVES

(TECHNOLOGY & SITE)

5. ANALYSIS OF ALTERNATIVES

This chapter deals with the criteria for site selection and process technology in the

proposed project by assessment of alternatives and comprehensive comparison of all

potential impacts, both direct and indirect and cumulative, on the environment. The goal

of evaluating alternatives is to find the most effective way of meeting the need and

purpose of the proposal.

5.1. SITE SELECTION CRITERIA

SITE LOCATION: To establish a Bulk drug Intermediates manufacturing, the site is

selected at Sy No: 108 & 109, Jayanthipuram (V) Jaggayyapet (M), Krishna District,

Andhra Pradesh based on these factors Practicability, Feasibility, Relevance,

Reasonable & Viability.

TABLE – 5.1 SITE DESCRIPTION

Project location Details

Latitude & Longitude Latitude: 16°50'51.19"N Longitude: 80°08'11.93"E

Climatic Conditions

Annual Max Temp is 47.1 0C Annual Min Temp is 9.3 0C Normal Annual Rainfall is 982 mm (Source: IMD Climatatological Normals, 1981 - 2010)

Land acquired for the plant 11.62 Acres (47024.47 Sq.m)

Land use Industrial use

Nearest Habitation Jayanthipuram Village 1.80 km (WNW)

Major urban Settlements Vijayawada - 58 km (SE)

Nearest Highway Nearest Railway station Nearest Airport

National Highway No.65 – 4.45 km (N) Motumuri Railway Station – 22.6 km (NE) Vijayawada Airport - 77 km (SE)

National Parks None within 10 km radius

Wild life sanctuary None

Water Bodies within 10 km radius

Palleru River – 3.30 kms (W) Krishna River – 3.30 kms (SSW) Nagarjuna Sagar Left bank Canal- 2.50 kms (E) Chillakallu Major canal - 2.10 km (WNW) Gauravaram Cheruvu – 5.40 kms (E) Pochampalli Cheruvu – 3.38 kms (ESE)

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The proposed project site is identified based on the following considerations:

Land acquired for proposed Project is 11.62 Acres (47024.47 Sq.m),

topographically the area is generally plain, with gentle slope.

The area is not covered by any notified forests.

Proximity of National Highways and railways stations, for transport of raw

materials and manufactured products.

Availability of infrastructure facilities.

Well connected road networks.

The location of the site have distinct advantages such as accessibility to Road, Rail,

Electricity, Ground water and other facilities which are adequate for the proposed

project and hence, no alternate sites were considered.

5.2. SELECTION OF PROCESS TECHNOLOGY

Proposed to manufacture different types of bulk drugs & intermediates.

All the products will be manufactured on a batch basis.

The products are categorized on similarity in process or therapeutic usage.

Bulk Drugs substances typically consist of structurally complex organic chemical

compounds which are manufactured via a series of intermediate steps and

reactions under precise process conditions.

Konakachi Cheruvu – 5.51 kms (ESE) Nawabpeta Cheruvu – 9.53 kms (ESE) Water body near Jaggayyapet – 5.54 kms (NW) Tank Near Chillakallu – 4.57 kms (N) Tank near Shermohammedpet – 8.55 kms (NNW)

Reserve Forest within 10 km radius

Jaggayyapeta Extension R.F – 0.52 KM (S), 0.39 KM (N) of Project Site Kuntimadi R.F- 5.12 km (SSW) Ginjupalle R.F- 5.60 km (SSW) Venkatayapalem R.F- 7.80 km (SSW) Budavada R.F- 4.68 km (W)

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The drug intermediates are manufactured by:

Chemical synthesis;

Isolation / recovery from natural sources; and /or

Combination of above.

In the proposed project, resource availability may limit the range of alternatives in a

particular context. Bulk drug Intermediates will be manufactured using proven Chemical

synthesis technology; hence no alternative technology has been analyzed thus, no new

or untested technology will be used.

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ENVIRONMENTAL

MONITORING PROGRAM

CHAPTER -VI

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CHAPTER – VI

ENVIRONMENTAL MONITORING PROGRAM

6.1. INTRODUCTION

Regular monitoring of environmental parameters is of immense importance to assess

the status of environment during plant in operation. With the knowledge of baseline

conditions, the monitoring programme will serve as an indicator for any deterioration in

environmental quality due to operation of the expansion project, to enable taking up

suitable mitigatory steps in time to safeguard the environment. Monitoring is as

important as that of control of pollution since efficiency of control measures can only be

determined by monitoring.

The baseline study is carried out for post monsoon season. Hence, post project

monitoring programme of the environmental parameters is essential to take into account

the changes in the environmental quality to ascertain the following:

State of Pollution within the plant site and in its vicinity.

Generate data for predictive or corrective purpose in respect of pollution.

Examine the efficiency of air pollution control system adopted at the site.

To assess environmental impacts.

Monitoring will be carried out at the site as per the norms of CPCB.

Environmental Monitoring Programme will be conducted for various environmental

components as per conditions stipulated in Environmental Clearance Letter issued by

MoEF&CC & Consent to Operate issued by SPCB. Six monthly compliance reports will

be submitted on regular basis, to MoEF&CC, Regional Office, Chennai on 1st of June &

1st of December. Quarterly compliance Report for conditions stipulated in Consent to

Operate will be submitted to SPCB on regular basis.

6.2. ENVIRONMENTAL MANAGEMENT SYSTEM

In order to maintain the environmental quality within the standards, regular monitoring of

various environmental components is necessary. The company will establish full-

fledged environmental management cell (EMC) reporting directly to Plant Manager for

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environmental monitoring and control. The EMC team will takes care of pollution

monitoring aspects and implementation of control measures.

A group of qualified and efficient engineers with technicians is deputed for maintenance,

up keeping and monitoring the pollution control equipment, to keep them in working at

the best of their efficiencies. For effective and consistent functioning of the plant, the

EMS at the site will be strengthened further with the following:

• Environmental management cell covering EHS (Environment, Health & Safety) team

• Environmental Monitoring

• Personnel Training

• Regular Environmental Audits and Corrective Action Plan

• Documentation – Standard operating procedures, Environmental Management plans

and other records

6.3. ENVIRONMENTAL MANAGEMENT CELL RESPONSIBILITIES

It is necessary to have a permanent organizational set up charged with the task of

ensuring its effective implementation of mitigation measures and to conduct

environmental monitoring. The major duties and responsibilities of Environmental

Management Cell will be as under:

To implement the environmental management plan (EMP)

To ensure regulatory compliance with all relevant rules and regulations

To ensure regular operation and maintenance of pollution control devices

To minimize environmental impacts of operations by strict adherence to the EMP

To initiate environmental monitoring as per approved schedule

Review and interpretation of monitored results and corrective measures with

reference to prescribed standards

Maintain documentation of good environmental practices and applicable

environmental laws for ready reference.

Maintain environment related records.

Coordination with regulatory agencies, external consultants, monitoring

laboratories.

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Organising meetings of the Environmental Management Committee and

reporting to the committee.

To improve the capacity building of the Environment Department, as a part of the

management, a separate division will be created under the leadership of Plant Manager,

who is assisted by EHS - Manager will be working for day to day operation of

environmental management systems with documentation, procedures & Compliances.

All executives/Supervisors and workmen/Helpers will be responsible for the operations.

The Organizational Structure of Environmental Health and Safety is presented in Fig.

6.1.

Any non-compliances/violations of serious nature will be addressed by the Plant general

manager in consultation with the directly involved officials and will report to the Board of

Directors of the company. The primary focus is to comply with the regulations and work

out on action taken report to be placed before the Board of Directors. Similarly a

preventive action for non-recurrence of such violations/non-compliances will also be

worked out and strict monitoring will be done by the Management for implementation of

the same

Fig - 6.1. Organisational Structure of Environment Health & Safety

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6.4. ENVIRONMENTAL MONITORING AND REPORTING PROCEDURE

Monitoring may take the form of direct measurement and recording of quantitative

information, such as concentrations of discharges, emissions and wastes, for

measurement against corporate or statutory standards, consent limits or targets. It may

also require measurement of ambient environmental quality in the vicinity of a site using

ecological/biological, physical and chemical indicators. Monitoring may include

socioeconomic interaction, through local liaison activities or even assessment of

complaints. Monitoring will also be required to meet compliance with statutory and

corporate requirements. Finally, monitoring results will provide the basis for auditing.

6.4.1. OBJECTIVES OF MONITORING

The objectives of environmental post-project monitoring are to

Verify effectiveness of planning decisions

Measure effectiveness of operational procedures

Confirm statutory and corporate compliance and

Identify unexpected changes.

6.4.2. MONITORING SCHEDULE FOR CONSTRUCTION AND OPERATION PHASES

Environmental monitoring schedules of Archimedis Laboratories Pvt. Ltd are prepared

covering various phases of project advancement, such as construction and operation

phases.

Construction Phase

The proposed project envisages setting up of buildings and machinery, establishment of

production and storage facilities. The construction activities are expected to last for

about one year. As there are no major construction activities for the plant, simple and

generic environmental monitoring measures that need to be undertaken during project

construction stage.

Operation Phase

During operation stage of the project, air emissions from process areas, Boilers,

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DG sets. Full-fledged Effluent treatment plant with ZLD Scheme operates for water

recovery and reuse, hazardous and nonhazardous waste generation is envisaged. The

following attributes which meet regular monitoring based on the environmental setting

and nature of project activities are listed below:

Source emissions and ambient air quality.

Work zone monitoring for VOCs/solvents in air.

Groundwater levels and ground water quality in bore wells.

Raw and ETP effluent quality.

Hazardous and solid waste characterization (process hazardous waste, ash,

ETP sludge, used and waste oils).

Soil quality.

Noise levels (equipment and machinery noise levels, occupational exposures

and ambient noise levels) and

Ecological preservation and afforestation.

Monitoring Schedule: Details of the Post Project Environmental Monitoring schedule,

which will be undertaken for various environmental components, are detailed below:

Table No.6.1 Post Project Environmental Monitoring schedule details

Sl. No. Description Frequency of Monitoring

1 Ambient Air Quality at Plant site Once in a month

2 Water Quality Monthly Basis

3 Noise Level Monitoring Monthly Basis

4 Soil Quality Once in six months

Methodology Adopted: Post project monitoring will be carried out as per conditions

stipulated in Environmental Clearance Letter issued by MoEF&CC, Consent issued by

concerned State PCB as well as according to CPCB guidelines. The plant site is

considered as core zone and the area lying within 10 km radius from the plant site is

considered to be the buffer zone. In the Buffer zone slight impact may be observed and

that too is occasional.

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Table No. 6.2 Environmental Monitoring Plan during Operation Phase

Sl. No Potential Impact Action to be

Followed Parameters for

Monitoring Frequency of

Monitoring

1 Air Emissions

Stack emissions from process stacks to be optimized and monitored

Gaseous emissions (HCl, SO2, NH3, as applicable)

Monthly with recommended methods of CPCB

Stack emissions from Boilers, DG sets to be monitored

Gaseous emissions (PM, SO2, HC, NOx)

Monthly with recommended methods of CPCB

Ambient air quality within the plant premises of the proposed expansion unit and nearby habitations to be monitored. Exhaust from vehicles to be minimized by use of fuel efficient vehicles and well maintained vehicles having PUC certificate.

Ambient air quality will conform to the standards for NAAQ parameters (MoEF circular dated 16-11- 2009) and HCl, Cl2 and HC Vehicle logs to be maintained

Online continuous AAQ one station and Monthly in Industry and nearby habitants with recommended methods of CPCB.

Vehicle trips to be minimized to the extent possible

Vehicle logs Daily records

2 Noise Levels

Noise generated from operation of boiler/cooling towers to be optimized and monitored (3 locations within plant and 2 locations outside plant) Noise generated from operation of DG sets to be optimized and monitored

Spot Noise Level recording; Leq(night), Leq(day), Leq(dn)

Regular and Monthly

Generation of vehicular noise

Maintain records of vehicles

Monthly

3 Waste water Discharge

Segregated effluent Stream wise (3 streams)

ETP performance will be monitored for raw and treated

Daily with internal lab and monthly from authorized lab

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Sl. No Potential Impact Action to be

Followed Parameters for

Monitoring Frequency of

Monitoring

effluent characteristics for reuse of treated effluent. Basic parameters like pH, TSS, TDS, COD, Oil & grease

In-house ETP treated Effluents reuse in Cooling Towers

pH, TDS, COD and Temperature etc.

Daily monitoring at In house Laboratory for treated effluent

4 Drainage and

effluent Management

Ensure drainage system and specific design measures are working effectively.

Visual inspection of drainage and records thereof

Daily

5 Water Quality

Surface and Groundwater quality surrounding plant site

Comprehensive monitoring as per BIS 10500-2012.

Quarterly

6 Work zone air quality

Contaminants such as VOCs to be reduced by providing adequate ventilation

Indoor monitoring of VOCs.

On Daily Basis

7 Hazardous / Solid Waste Management

Implement waste management plan that identifies and characterizes every waste arising associated with proposed activities and which identifies the procedures for collection, handling & disposal of each waste arising.

Records of solid waste generation, storage and disposal

Regular Basis during operation phase

8 Soil quality

3 locations within plant site, solid waste storage area, near production block and ETP area

Physico-chemical parameters and Heavy metals.

On regular basis (Once in six Months)

9 Occupational

Health

Employees and migrant labour health check -up

All relevant parameters including HIV

Once in a Year

Comprehensive Pre-employment medical checkup for all

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Sl. No Potential Impact Action to be

Followed Parameters for

Monitoring Frequency of

Monitoring

employees.

Medical examination will be done for all the employees once in a year.

Tie up with local hospitals and Govt. health monitoring system will be engaged during emergency.

Dispensary and ESI facility will be provided to all workers as applicable.

All safety gears will be provided to workers and care will be taken by Environmental Management Cell (EMC) that these are used properly by them. All safety norms will be followed.

6.5. LOCATION OF MONITORING STATIONS

Location of the monitoring stations will be selected on the basis of prevailing micro –

meteorological conditions of the area like; Wind direction & wind speed, Relative

Humidity, Temperature. Post project air quality monitoring will be carried out at plant site

and 2 locations (one each in upwind and downwind direction) to asses’ ambient air

quality of the area. Major surface water body lies within 10 km area of plant site and

ground water quality monitoring will be carried out. Regular monitoring of noise will be

done to control noise levels at plant site. Soil quality will be tested of the plant site area

regularly to keep check on any leakage in storing hazardous waste. Locations for the

post project monitoring will be as under:

Table No.6.3 Details of Post Project Monitoring Locations

Sl. No. Description Location of Monitoring

1 Ambient Air Quality

Plant site, Villages in upwind & downwind direction (with Max. Ground level concentration) from the plant site

2 Noise Level Monitoring

Plant Boundary, High Noise generating areas within the plant boundary

3 Water Quality From Nearby Surface water Source and Ground Water Source

4 Soil Quality At plant Site and Nearby area

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6.6. MONITORING AND DATA ANALYSIS

6.6.1. AIR QUALITY MONITORING AND DATA ANALYSIS

Stack Monitoring: The emissions from all the stacks will be monitored for exit gas

temperature, velocity and pollutant concentrations. Any deviation from the design

criteria will be thoroughly examined and appropriate correction will be initiated. Air

blowers will be checked for any drop in exit gas velocity. The monitoring will be done by

authorised laboratory and test result will be submitted to the SPCB.

Work Zone Monitoring: The concentration of air borne pollutants in the

workspace/work zone environment will be monitored periodically. If concentrations

higher than threshold limits are observed, the source of fugitive emissions will be

identified and necessary measures taken. In addition, industry will continue to monitor

the VOC in all process & storage areas on regular basis. In case, the levels are high,

suitable measures as detailed in EMP will be implemented.

Ambient Air Quality Monitoring: The concentrations of PM, SO2, NOX, VOC, CO and

HC in the ambient air will be monitored at regular intervals. In case of any excess

concentration in the ambient air quality due to the proposed production enhancement,

proponent will take necessary action and follow the air pollution control measures.

Greenbelt will further be developed for minimising dust propagation. The ambient air

quality data will be transferred and processed in a centralised computer facility

equipped with required software. Trend and statistical analysis will be carried out as per

the CPCB guidelines.

6.6.2. WATER AND WASTEWATER QUALITY MONITORING AND DATA ANALYSIS

To ensure a strict control over the water consumption, flow meters will be installed for

existing and proposed facilities for all major inlets in expansion. All leakages will be

identified and rectified. In addition, periodic water audits will be conducted to explore

possibility of water conservation.

Industry will analyse the basic parameters and the procedures prescribed in "Standard

Methods for Examination of Water and Wastewater" prepared and published jointly by

American Public Health Association (APHA), American Water Works Association

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(AWWA) will be followed for all the parameters of monitoring. As per the CPCB

guidelines, industry will be installed the online sensors in the treated effluent for pH,

Conductivity, DO with night vision cameras.

Surface and Groundwater Monitoring: The monitoring of Surface and groundwater is

the most important tool to know the variations from the baseline study. This is

indispensable as it provides detection of the presence of waste constituents in ground

water in case of leachate migration. In this project, chances are very less for leachate

as the total effluent is segregated and is sent to ETP – ZLD and the treated effluent will

be reused in cooling tower. The water samples from the nearby surface water bodies

and bore wells will be analysed for relevant parameters as per monitoring program.

Records of analysis will be documented.

Monitoring of Wastewater Streams: All the segregated wastewater streams will be

regularly measured for flow rate, physico-chemical, nutrient & demand parameters. The

monitoring will be carried out from stream wise raw wastewater, raw and treated effluent

characteristics of ETPs before recycling to utilities. These data will be documented and

compared against the design performance values of ETPs for necessary corrective

action.

The ETP will be operated and maintained by existing & additional skilled and dedicated

personnel. Daily log sheets for no. of hours of the ETP operation, chemicals, electrical

and steam consumption; effluent monitored parameters with their results, etc. will

continue to be maintained.

6.6.3. NOISE LEVELS

Noise levels in the work zone environment such as boiler house, cooling tower area,

and DG house will be monitored. The frequency will be once in a month in the work

zone. Audiometric tests will be conducted periodically for the employees working close

to the high noise sources.

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6.6.4. SOIL QUALITY

Soil quality will be tested for the parameters given in schedule for every six months.

6.7. REPORTING SCHEDULES OF THE MONITORING DATA

It is proposed that voluntary reporting of environmental performance with reference to

the EMP will be undertaken. The environmental monitoring department will co-ordinate

all monitoring programmes at site and data thus generated will be regularly furnished to

the State regulatory agency. The frequency of reporting will be on monthly basis to the

local state PCB officials and six monthly reports to Regional Office of MoEF&CC. The

Environmental Audit reports will be prepared for the entire year of operations and will be

regularly submitted to regulatory authorities in Form V Environmental Statement.

6.8. ENVIRONMENTAL LABORATORY

Environmental laboratory will be well-equipped analytical instruments and consumable

items for monitoring of environmental parameters at the site. Alternatively, monitoring

will be continued to be outsourced to a recognized/approved laboratory. The equipment

and consumable items will be made available at the site for environmental monitoring.

The sampling is done as per the standard procedures laid down by IS: 2488. The

equipment’s will be in the Environmental Laboratory are Heating Mantle, Digital

conductivity meter, Digital pH Meter, COD Digestion Apparatus, BOD Incubator, Hot air

oven, Muffle Furnace, Thermometer, Microprocessor based conductivity meter,

Microprocessor based pH Stat Analyzer, Electronic Balance, HOT Plate, Mechanical

Balance, Hand Held DO meter, Hand Held Turbidity meter, Magnetic Stirrer and

consumables, chemicals and Glassware.

6.8.1. AIR QUALITY AND METEOROLOGY

Proposed: Manual AAQ monitoring stations – 3 Nos., on monthly basis third party

monitoring will be done by NABL / MoEF&CC authorised laboratory and the test report

will be verified for any deviation in air quality standards for corrective action and the test

reports will be submitted to the respective SPCB.

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6.9. OCCUPATIONAL SAFETY AND HEALTH ASPECTS

All the preventive and corrective actions of environmental impacts to protect the health

of all the employees from any possible occupational health problems, the periodical

medical and health checkups of all the employees will be done to assess the any

occupational health problems.

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ADDITIONAL STUDIES

CHAPTER -VII

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CHAPTER – VII

ADDITIONAL STUDIES [Risk Assessment, & Disaster Management]

Archimedis Laboratories Pvt Ltd is proposed to manufacture Bulk Drugs &

Intermediates at survey no‘s. 108 &109, Jayanthipuram (v), Jaggaiahpet, Krishna

District, Andhra Pradesh and is covered under Category- A of the EIA Notification –

2006. The Environmental Public Hearing was conducted on 27/10/2018 in

Jayanthipuram village, Jaggayyapet Mandal, Krishna District, Andhra Pradesh. The

Public Hearing paper ads, PH Minutes and its compliance Report are enclosed as

enclosures.

7.1 ADDITIONAL STUDIES

In order to support the environment impact assessment and environment

management plan, following additional studies have been included in this report.

Risk Assessment

Disaster management plan

Occupational Health

7.1.1 Scope Of This Study

The QRA (Quantitative Risk Assessment) study in this report has been conducted

considering the Terms of References (TORs) given for Environment Clearance (EC).

The study has been carried out with a view to comply TOR points with respect to

Risk assessment.

7.1.2 Methodology:

The following parameters are considered to prepare Quantitative Risk

Assessment.

1. Discussions were held with Plant officials on proposed individual safety

systems of plant operations.

2. Hazard Identification exercise in coordination with plant officials was

conducted taking into consideration the proposed storage of Hazardous

Chemicals/Solvents, operating parameters and proposed safety systems.

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3. Containment failure scenarios related to flammable chemicals & hazardous

chemicals have been considered for Risk Assessment and consequences in

detail. Thus, this study is mainly oriented towards acute risks rather than

chronic risks.

4. Discussed on proposed Raw materials Hazards and their Risks in handling.

7.2 Risk Assessment

Archimedes laboratories Private Limited will handle various chemicals, some of

which are hazardous in nature by virtue of their intrinsic chemical properties or their

operating temperatures or pressures or a combination of them. Fire, explosion, toxic

release or combinations of them are the hazards associated with industrial plants

using hazardous chemicals. More comprehensive and systematic methods have

been adopted in Hazard Identification and Quantitative Risk Assessment to improve

upon the integrity, reliability and safety of the plants. The same has been discussed

in detail under their respective headings.

7.2.1 Objectives of Risk Assessment

Risk analysis follows an extensive hazard analysis. It involves the identification and

assessment of risks the neighboring populations are exposed to as a result of

hazards present. This requires a thorough knowledge of failure probability, credible

accident scenario, vulnerability of population etc., much of this information is difficult

to get or generate. Consequently, the risk analysis is often confined to maximum

credible accident studies.

The risk assessment process is primarily based on likelihood of occurrence of the

risks identified and their possible hazard consequences particularly being evaluated

through hypothetical accident scenarios. With respect to the Proposed project, major

risks are leaks from storage tanks, rupture of Pipelines, Spillages from containers

during transfer operations and Storage in the Ware house have been assessed. Risk

associated with the flammable chemicals storages have been determined semi-

quantitatively as the product of likelihood/probability and severity/consequence by

using order of magnitude data (risk ranking = severity/consequence factor X

likelihood/probability factor). Significance of such project related risks have been

established through their classification as high, medium, low, very low depending

upon risk ranking.

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It provides basis for:

The type and nature of its on-site and off-site emergency plan

The types of safety measures required

7.2.2 Identification Of Hazards

Hazard identification is carried out to ascertain the controls required and

available in order to mitigate the risk of exposure to the hazards. This would

substantially help in overcoming costly errors and prolonged delays that may

be caused due to the design changes that may be required on a later date.

Hazard assessment in the proposed plant is carried out examining the Liquid

and solid chemicals storage in the ware house such as Hydrobromic acid,

Sulfuric acid and toxic chemicals such as Thionyl chloride, Ammonia and solid

chemicals such as sodium boro hydride, potassium hydroxide and Storage of

Flammable liquid chemicals such as Methanol, Toluene, Acetone, THF, Ethyl

Acetate, n-hexane in bulk quantities in plant premises, locations to find out the

adequate facilities in place to overcome the Risks of exposure to the Hazards.

Following are the Hazards identified in proposed plant activities:

Fire Hazards due to Flammable chemicals leakage from storage tanks, pipe

line ruptures during transfer of material which may get ignited due to any

spark.

Fire Hazard due to improper earthing of storage tanks and material transfer

lines

Fire hazard due to leakage of flammable chemicals from transfer pumps gland

leaks.

Spillage/Leakage of Hazardous chemicals - Solvents, Acetic acid, Hcl,

Formaldehyde, Hcl, Thionyl chloride which leads to Air pollution, Water

pollution and Ground pollution

Explosion Hazard during hydrogenation to manufacture 2, 4- DIHYDRO-4-(4-

4 HYDROXY PHENYL) -1-PIPERAZINYL) – 2-(1-METHYL PROPYL)-3H-1, 2,

4-TRIAZOLE-3-ONE.

Ammonia leakage during transfer to reactors or container leakage.

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The exposure to hazards depends upon the concentration of hazard, Frequency and

duration. The exposure to hazard could be controlled by reducing either the

concentration of hazard, frequency or duration.

After a critical analysis of the chemicals propose to use, stored and for products to

manufacture a defined safe operating procedures will be in place with safety and

mitigation measures to overcome the hazards.

The exposure to the hazard could be controlled by implementing the following:

Engineering controls at the source

Environmental controls that remove the hazard from the environment

Inspection of solvents transfers pipelines & Hydrogen gas conveying lines once in a

month.

Earthing to all storage tanks and providing jumpers to transfer pipe lines to have

continuity of earthing

Process reactor which is proposing to use for hydrogenation should be kept away

from production block to minimize the effect in case of explosion.

Providing suitable personal protective equipment

Employing experienced trained personnel

All the proposed process reactors will have temperature control and pressure control

system for process as well as suitable Rupture disc followed by a safety valve to

avoid explosion due to excess pressure.

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TABLE: 7.1.AREA WISE IDENTIFIED HAZARDS, PRECAUTIONS PROPOSED WITH MITIGATION MEASURES.

S.NO

AREA

IDENTIFIED

HAZARD

SEVERITY & NO. OF

PERSONS EXPOSED

PRECAUTIONS PROPOSED

MITIGATION MEASURES

1]

RM Storage area

Spillage of chemicals

Low to medium 4 persons

1. Approved layout as per legal requirements.

2. Flame proof electrical fittings will be installed 3. Chemicals will be stored in safe Containers with secondary containment to prevent spillages. 4. Storage quantity is limited 5. Storage area will be well ventilated by a forced air ventilation system. 6. Material will be accessed only by authorized personnel using mechanized systems 7. Double door entry to ensure a clean atmosphere. 8. Showers will be provided for decontamination.

1. Area will be cordoned off.

2. Information will be passed to Emergency control center is informed. 3. Information will be given to the declarer of emergency on the scale of Leakage. 4. Emergency Response teams will be kept on alert for swift response. 5. All hot works being carried out in the surrounding areas will be stopped 6. Personnel working in the area will be evacuated.

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S.NO

AREA

IDENTIFIED

HAZARD

SEVERITY & NO. OF

PERSONS EXPOSED

PRECAUTIONS PROPOSED

MITIGATION MEASURES

9. Personnel will be provided with full body protection suits and nose masks to Prevent exposure to chemicals. 10.Fire hydrant system with hydrant points with hose reels and nozzles will be installed to mitigate fire hazards 11.Fire extinguishers will be deployed adequately 12. Fully fledged medical center will be arranged. 13. Periodical occupational health checks will be done to personnel working in the area to Access health effects, if any. 14. Liquid chemicals such as Hcl, Ethyl acetate, THF, Acetic acid, formaldehyde, and Thionyl chloride will be stored in dedicated area. Solid chemicals such as Sodium boro hydride, sodium hydroxide, potassium hydroxide, sodium methoxide will be stored in dedicated area. Solid and liquid chemicals will not be stored in the same area.

7. Spilled powders will be collected using vacuum cleaners. 8. The spillage will be cleared and the area is made fit work . 9. In case of liquid chemical spillage, the container will be shifted from ware house to the outside for arresting the leakage and transferring the contents to another vessel depends on situation. The area where leakage is occurred will be neutralized if necessary and cleaned The warehouse will have good ventilation so as to minimize the concentration of respective chemical in the working area.

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S.NO

AREA

IDENTIFIED

HAZARD

SEVERITY & NO. OF

PERSONS EXPOSED

PRECAUTIONS PROPOSED

MITIGATION MEASURES

2]

Solvents Storage area

Fire, Flammable area of vapor cloud

Medium to High two

1. Storage facility will be provided in isolated area to have natural ventilation 2. Flameproof electrical fittings to be allowed in storage area to prevent any fire hazard. 3. No electrical gadgets or items capable of generating static electric charges will be permitted in the area. 4. Personnel will be trained about Do‘s & Don‘ts during emergency. 5. No heat sources will be permitted near the Facility. 6. Hot work will be controlled through a work permit system 7.For all storage tanks double earthing will be arranged

1. Area will be cordoned off.

2. No Hot work will be carried out in the vicinity to prevent accidental spread of fire. 3. Personnel working in the area will be evacuated 4. Emergency control center will be informed 5. Information will be given to the declarer of emergency on the scale of Leakage of solvent, Fire. 6. Emergency Response teams will be kept on alert for swift response. 7. The leakage will be cleared and the area is made fit work

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S.NO

AREA

IDENTIFIED

HAZARD

SEVERITY & NO. OF

PERSONS EXPOSED

PRECAUTIONS PROPOSED

MITIGATION MEASURES

8. Adequate size Dyke wall will be provided to for containment in case of leakage of chemical /solvent. 9. Storage quantity and material will be handled by trained and authorized personnel. 10. Mechanical foam type fire & DCP fire

extinguishers will be provided at all solvent

storage tanks

11. Fire hydrant system with hose reels will be Provided in the solvents storage area. 12. Hydrocarbon detectors will be provided in the storage tanks area. 13. Flame arrestor will be provided for each storage tank.

8. In case leakage is found, the contents will be transferred to a spare tank or in to

HDPE drums.

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S.NO

AREA

IDENTIFIED

HAZARD

SEVERITY & NO. OF

PERSONS EXPOSED

PRECAUTIONS PROPOSED

MITIGATION MEASURES

3]

Production Block

Spillages / Fire Toxic gas release

Low to medium 5 persons

1.Flame proof electrical fittings will be installed

2. Freight lift will be installed for movement of material 3. Material will be stored at production blocks in safe containers for batch charging with secondary containment to prevent Spillages. 4. Earthing and bonding will be carried out for all reactor vessels and pipelines 5.Nitrogen lines will be provided to reaction vessel to create inert atmosphere inside the reactor to avoid fire and explosion 6. Work permit system will be implemented for hazard assessment in case of any hot work / work at elevated places. 8. Manufacturing area will be ventilated by a Forced air ventilation system to prevent formation of flammable mixture. 9. Fire hydrant system with hydrant points with hose reels and nozzles will be installed to mitigate fire hazards 10. Fire extinguishers will be deployed

1. Area will be cordoned off.

2. Power supply will be cut off to the area to prevent accidental fire. 3. All hot work carried out in the vicinity will be stopped. 4. Emergency control center will be informed. 5. Information will be given to the declarer of emergency on the scale of spillage / fire/Toxic gas release 6. Emergency Response teams will be Kept on alert for swift response. 7. Personnel working in the area will be Evacuated. 8.Scrubber will be kept in operating condition with caustic scrubbing solution 9. Fire hydrant system will be put in use. 10. If situation beyond control information will be given to Inspector of factories. police, fire department for their assistance.

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Production block

Ammonia Toxic gas release

25 persons

adequately 11. Emergency exit door will be provided to each floor for safe escape in case of emergency 12. Eye wash fountain / Body shower Will be provided for decontamination at each floor. 13. Limit switches will be provided for centrifuges for safe operation. 14. Nitrogen purging will be arranged for each Centrifuge to prevent formation of explosive flammable mixture. 15. Each reactor will be connected to a scrubber to neutralize or decrease the pressure

in case sudden rise in pressure. Material will be transferred to reactor by experienced operating personnel under mild negative pressure to avoid release of fumes to atmosphere

.1. Scrubber will be kept in operating condition with cooled water circulation During transfer of the material. 2. Emergency Response teams will be Kept on alert for swift response 3. Area will be cordoned off. 4. Emergency control center will be informed 5. Information will be given to the declarer of emergency on the scale of Leakage. 6. Neighboring industries and statutory authorities will be informed in case situation is severe.

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AREA IDENTIFIED

HAZARD

SEVERITY & NO. OF

PERSONS EXPOSED

PRECAUTIONS PROPOSED MITIGATION MEASURES

4]

Boiler House

Fire/ Explosion

Low to medium 2-persons

1. All requirements specified under Boiler Act will be followed 2. All electrical fittings will be of flame proof Type. 3. Entry will be restricted only to trained and Authorized personnel to work in the area. 4. Fire extinguishers will be positioned at different locations in case of any Emergencies. 5. No material storage will be permitted in the Area. 6. Auto level controller for Water and high temperature alarms will be provided. 7. Water hardness will be checked on shift wise.

1. Shutting down the plant, declaring the emergency. 2. Electrical supply will be isolated. 3. Type of emergency will be informed to the emergency declarer/ central authority. 4. Emergency response teams will be kept on alert for swift action. 5 Movement of personnel and vehicles will be prohibited.

5 Fire hydrant system will be put in use

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S.NO AREA IDENTIFIED

HAZARD

SEVERITY & NO. OF

PERSONS EXPOSED

PRECAUTIONS PROPOSED MITIGATION MEASURES

8. Area will be well ventilated and illuminated for safe working. 9. 24 x 7 manning of the area is done for monitoring of operation. 10. All maintenance /repair works will be carried out after issuing work permits and under constant supervision of experts. 11. Periodical cleaning of soot in furnace to Prevent formation of explosive mixtures. 12. Checking of boiler internals as per given schedule to prevent Accidents. 13. Signage‘s will be displayed to inform personnel about the hazards present in the area

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S.NO AREA IDENTIFIED

HAZARD

SEVERITY & NO. OF

PERSONS EXPOSED

PRECAUTIONS PROPOSED MITIGATION MEASURES

5]

Diesel Generator

Noise & Fire

Low One person

1. Noise abatement thru‘ modular acoustic paneling of D.G set 2. Secondary containment is done to prevent Diesel leakage from day tanks. 3. Two nos. of Co2 fire extinguishers will be kept to handle emergency. . 4. Entry access to the area will be only for Authorized personnel.

1. Information will be given to Emergency control center. 2. Power supply will be cut off to the storage area to prevent accidental fire. 3. All hot work around the area will be stopped and the area will be cordoned off 4. The concerned maintenance personnel will be carried repairs to mitigate the leakages. 5. Emergency Response Team will be kept on alert for swift response. 6. Periodical occupational health checks will be done to personnel working in the area to assess exposure to noise.

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S.NO AREA IDENTIFIED

HAZARD

SEVERITY & NO. OF

PERSONS EXPOSED

PRECAUTIONS PROPOSED MITIGATION MEASURES

6]

Electrical sub -station

Electric shock / fire

High One person

1. Layout confirm to legal requirements as per Indian Electrical Rules. 2. Entry will be restricted to licensed and authorized personnel only. 3. Earthing will be provided for leakage of stray Currents. 4. Electronic mimic panels will be installed for fault indication at the entry of the sub-station. 5. Insulating rubber mats confirming to IS 15652:2006 will be provided in front of all electrical panel boards. 6. Periodical inspection and maintenance Will be carried out to ensure good health of the equipment. 7. CO2 / DCP fire extinguishers will be deployed to handle emergency fires

1. Information will be given to Emergency control center. 2. Power supply will be cut off from incoming source. 3. Electricity supply company will be alerted for cut off power supply in case of major risks 4. All hot work around the area will be Stopped and the area is cordoned off. 5. The concerned maintenance personnel will be carried repairs to restore normalcy. 6.Emergency Response Team will be kept on alert for swift response

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S.NO

AREA

IDENTIFIED

HAZARD

SEVERITY & NO. OF

PERSONS EXPOSED

PRECAUTIONS PROPOSED

MITIGATION MEASURES

7]

Hazardous waste storage shed

Fire/Leakage

Low to medium 2- Persons

1. Storage shed will be at an isolated location. 2. Conditions specified in hazardous waste Authorization issued by SPCB will be implemented. 3. Compatible wastes will be stored in separate enclosures 4. Layout provides adequate ventilation and illumination 5. Secondary containment provided to prevent leakages / spillages 6. Storage quantity will be limited. 7. Periodical disposal of accumulated waste will be sent to authorized landfills. 8. Flame proof electrical fittings will be installed to prevent fire / explosion hazards

1. Information will be given to Emergency control center. 2. Power supply will be cut off from incoming source. 3. All hot work around the area will be stopped and the area is cordoned off. 4. The concerned maintenance personnel will be carried repairs to restore normalcy 5. Fire hydrant system will be put in use

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S.NO

AREA

IDENTIFIED

HAZARD

SEVERITY & NO. OF

PERSONS EXPOSED

PRECAUTIONS PROPOSED

MITIGATION MEASURES

9. Eye wash / body shower will be provided for decontamination in case of spillage on body parts. 10. PPE box will be equipped with gum boots, splash proof safety goggles, aprons for use during handling of chemicals. 11. Access to the area will be restricted to authorize personnel only. 12. Fire hydrant point with hose reels will be provided for fire mitigation

6. Emergency Response Team will be kept on alert for swift response. 7. Support of external agencies will be sought in case situation poses major risks and is not controllable by in-house infrastructure

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7.3 SOLVENTS/CHEMICALS

S.No NAME OF

SOLVENT/CHEMICAL MODE OF STORAGE

MAX. INVENTORY IN TONS

NATURE OF HAZARD

NFPA RATING

1 Methanol MS Tank 20 Flammable H : 1 F: 3 R : 0

2 Toluene MS Tank 20 Flammable H : 2 F: 3 R : 0

3 MDC MS Tank 20 Harmful H : 2 F: 1 R : 0

4 Acetic anhydride MS tank 10 Corrosive H : 3 F: 2 R : 1

5 Acetone MS Tank 20 Flammable H : 1 F: 3 R : 0

6 Ethyl acetate MS Tank 20 Flammable H : 1 F: 3 R : 0

7 Hcl PP+FRP Tank 10 Corrosive H:3 F:0 R:1

11 Ammonia Cylinders 30 no.s

(Each of 50 kgs) Toxic H : 3 F: 1 R : 0

12 Formaldehyde HDPE Carboys 1.5 Toxic H : 3 F: 2 R : 0

13 Sulfuric acid HDPE Carboys 6.0 Corrosive H:3 F:0 R:2

14 Hydrogen peroxide (50%) HDPE Carboys 2.5 Corrosive H : 2 F: 0 R : 1

15 Palladium on carbon (5%) HDPE Drums 0.05 Flammable H : 1 F: 3 R : 0

16 Hydrogen Cylinders 60 nos Explosive H:0 F:4 R:0

17 Cyclohexane HDPE Drums 10 Flammable H : 1 F: 3 R : 0

18 THF HDPE Drums 5 Flammable H : 2 F: 3 R : 1

19 Thionyl chloride HDPE Carboys 2 Toxic H:4 F:0 R:2

20 Hydrobromic acid HDPE Carboys 5 Corrosive H:3 F:0 R:1

21 Raney nickel HDPE Carboys 0.4 Flammable H:2 F:4 R:1

22 Sodium boro hydride HDPE Carboys 2.0 Flammable H:3 F:4 R:2

23 Sodium cyanide HDPE Carboys 1.5 Toxic H:3 F:0 R:0

24 n-Hexane MS Tank 20 Flammable H:1 F:3 R:0

25 Chloroform MS Tank 20 Irritant/Anesthetic H:2 F:0 R:0

26 DMF HDPE Drums 6 Flammable H:1 F:2 R:0

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7.4 Potential Hazards of solvents and chemicals

Acetone: It is a clear, volatile, flammable liquid. Vapors may form explosive

mixtures with air. Vapors are heavier than air and may travel along the ground to

some distance source of ignition and flash back.

On combustion may emit toxic fumes of carbon monoxide and CO2.

This product causes irritation of eyes, skin, and mucous membranes in case of

contact. It will cause lung damage if swallowed. Do not breathe vapors.

N-Hexane: It is a clear, volatile, highly flammable liquid. Vapors may form explosive

mixture with air. Vapors are heavier than air and may travel along the ground to

some distance source of ignition and flash back. Fire or intense heat may cause

violent rupture of packages. Hazardous combustion products may include carbon

monoxide, carbon dioxide.

Use foam, carbon dioxide or dry chemical. Suppress vapors/mists with a water spray

jet.

In case of spillage soak up with inert absorbent material such as sand, silica gel, saw

dust. Do not use sparking tools. Do not allow product to enter sewer or waterways.

Store in a well-ventilated place to effectively remove and prevent buildup of any

vapors or mists generated from handling of this product.

While handling wear impervious gloves and anti-static protective clothing. For leak,

spills, or other emergency, use full protective equipment.

It is incompatible with oxidizers, halogens, chromates, perchlorates, peroxides.

Methanol: Extremely flammable and vapour may form ignitable vapour air mixtures

in storage tanks or other containers. Ignition and busing can release carbon

monoxide, carbon dioxide and non combustible hydrocarbons (Smoke)

Inhalation can Cause dizziness, head ache and nausea, kidney and liver disorder

Sodium cyanide: All containers of sodium cyanide are to be stored in locked room.

Keys of this room should be accessible to only those persons familiar with handling

requirements. This material to be stored in area protected from possible contact with

water, acid metals such as copper, magnesium, and zinc.

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Sodium cyanide shall be dispensed and handled only in an operational fume hood.

No containers of acid should be in the hood or work area.

A pH 10 buffer solution and dilute bleach solution should be available to clean up the

surfaces after handling.

Sodium cyanide is a highly toxic compound that may be injected or absorbed

through the skin.

Sodium cyanide reacts with strong acids (Hcl, H2So4, and HNo3). With Water,

Damp air will form highly flammable Hydrogen cyanide gas.

A deadly compound when inhaled.

In the event of a dermal exposure get the person to the nearest shower and

thoroughly flush with water for at least 15 minutes while removing contaminated

clothing and shoes.

Wherever possible automatically transfer Sodium cyanide from drums or other

storage containers to process use.

Use vacuum to reduce dust during cleaning. Do not dry Sweep.

Clothing: Avoid skin contact with sodium cyanide. Wear protective gloves and

clothing. Wear impact resistant eye protection with side shields .As and when

sodium cyanide handled use air respirator with a full face piece operated in positive

pressure mode.

Raney nickel catalyst: Keep container tightly closed and to be stored in a cool, well-

ventilated area. Do not allow material to dry. If allowed to dry in air, it turns to red hot

and provides a combustion source for exposed combustible materials.

It should be kept away from incompatibles such as oxidizing agents, combustible

materials, organic materials, metals, acids, flammable solvents and source of

ignition.

In case of spill, do not touch the spilled material. Cover with wet earth and sand.

Eliminate all ignition sources.

Always use protective clothing with dust respirator and goggles while handling.

Hydrogen: It is a flammable, colorless, compressed gas packaged in cylinders at

high pressure. It poses an immediate fire and explosive hazard when concentrations

exceed 4%.It much lighter than air and burns with an invisible flame.

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It should be noted that, before suffocation could occur, the lower flammability of

hydrogen in air would exceed possibly causing both an oxygen-deficient and

explosive atmosphere. Exposure to moderate concentrations may cause dizziness,

headache, nausea and unconsciousness.

Cylinder storage locations should be well protected, well ventilated, dry, and

separated from combustible materials. Cylinders should never knowingly be allowed

to reach a temperature exceeding 520c. Cylinders of hydrogen should be separated

from oxygen cylinders or other oxidizers by minimum distance of 20 ft. Do not keep

any other cylinders in Hydrogen storage area.

Cylinders should be stored upright with valve protection cap in place and firmly

secured to prevent falling or being knocked over. Protect cylinders from physical

damage, do not drag, roll, slide or drop. Post ―No Smoking or Open flames‖ signs in

the storage areas. There should not be any sources of ignition.

All electrical equipment should be explosion proof in the storage and use areas.

Provide natural or explosion-proof ventilation adequate to ensure hydrogen does not

reach its lower explosive limit of 4% .Hydrogen is incompatible with oxidizing agents.

Sodium meth oxide: It is highly flammable and toxic. Reacts violently with water.

Keep away from sources of ignition.

In case of skin contact, flush with copious amounts of water for at least 15 minutes.

Remove contaminated clothing and shoes.

If inhaled, remove to fresh air and if necessary give artificial respiration. Material is

extremely destructive to the tissue of the mucous membranes and upper respiratory

tract.

Wear self-contained breathing apparatus and protective clothing to prevent contact

with skin and eyes.

In case of spillage cover with dry-lime, sand or soda ash. Avoid contaminating

sewers and water ways with this material.

Incompatible with water, acids, chlorides, alkali metals, oxidizing agents, chlorinated

solvents

Sulfuric acid: Water Reaction

Reaction with water is negligible unless acid strength is above 70% then heat from

hydrolysis is extreme, may cause severe burns

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Fire Hazard

It is highly reactive and capable of igniting finely-divided combustible materials on

contact. When heated, it emits highly toxic fumes. Avoid heat; water and organic

materials. Sulfuric acid is explosive or incompatible with an enormous array of

substances. Can undergo violent chemical change at elevated temperatures and

pressure. May react violently with water.

Health Hazard:

Corrosive to all body tissues. Inhalation of vapor may cause serious lung damage.

Contact with eyes may result in total loss of vision. Skin contact may produce severe

necrosis.

Fatal amount for adult: between 1 teaspoonful and one-half ounce of the

concentrated chemical. Chronic exposure may cause tracheobronchitis, stomatitis,

conjunctivitis, and gastritis. Those with chronic respiratory, gastrointestinal, or

nervous diseases and any eye and skin diseases are at greater risk.

Protective Clothing:

Skin: Wear appropriate personal protective clothing to prevent skin contact.

Eyes: Wear appropriate eye protection to prevent eye contact.

Wash skin: The worker should immediately wash the skin when it becomes

contaminated.

Remove: Work clothing that becomes wet or significantly contaminated should be

removed and replaced. Provide: Eyewash fountains should be provided in areas

where there is any possibility that workers could be exposed to the substance; this is

irrespective of the recommendation involving the wearing of eye protection.

Facilities for quickly drenching the body should be provided within the immediate

work area for emergency use where there is a possibility of exposure.

It is intended that these facilities provide a sufficient quantity or flow of water to

quickly remove the substance from anybody areas likely to be exposed.

Hydrochloric acid:

Water Reaction

An aqueous solution. Dilution may generate heat. Fumes in air.

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Fire Hazard

Special Hazards of Combustion Products: Toxic and irritating vapors are generated

when heated.

Health Hazard

Inhalation of fumes results in coughing and choking sensation, and irritation of nose

and lungs. Liquid causes burns.

Reactivity Profile

Hydrochloric Acid is an aqueous solution of hydrogen chloride, an acidic gas. Reacts

exothermically with organic bases (amines, amides) and inorganic bases (oxides and

hydroxides of metals).

Reacts exothermically with carbonates (including limestone and building materials

containing limestone) and hydrogen carbonates to generate carbon dioxide.

Reacts with sulfides, carbides, borides, and phosphates to generate toxic or

flammable gases.

Reacts with many metals (including aluminum, zinc, calcium, magnesium, iron, tin

and all of the alkali metals) to generate flammable hydrogen gas.

Protective Clothing:

Skin: If chemical is in solution, wear appropriate personal protective clothing to

prevent skin contact and to prevent skin from becoming frozen from contact with the

liquid or from contact with vessels containing the liquid.

Eyes: Wear appropriate eye protection to prevent eye contact with the liquid that

could result in burns or tissue damage from frostbite.

Wash skin: If the chemical is in solution, the worker should immediately wash the

skin when it becomes contaminated.

Remove: If chemical is in solution, work clothing that becomes wet or significantly

contaminated should be removed and replaced.

Provide: Eyewash fountains should be provided (when chemical is in solution) in

areas where there is any possibility that workers could be exposed to the substance;

this is irrespective of the recommendation involving the wearing of eye protection.

Facilities for quickly drenching the body should be provided (when chemical is in

solution) within the immediate work area for emergency use where there is a

possibility of exposure. It is intended that these facilities provide a sufficient quantity

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or flow of water to quickly remove the substance from anybody areas likely to be

exposed.

Quick drench facilities and/or eyewash fountains should be provided within the

immediate work area for emergency use where there is any possibility of exposure to

liquids that are extremely cold or rapidly evaporating.

Acetic acid:

Above 39°C explosive vapour/air mixtures may be formed. Risk of fire and explosion

on contact with strong oxidants. It is flammable.

Above 39°C use a closed system, ventilation and explosion-proof electrical

equipment. Remove all ignition sources.

Personal protection: chemical protection suit including self-contained breathing

apparatus. Do NOT let this chemical enter the environment. Collect leaking liquid in

sealable containers.

Cautiously neutralize spilled liquid with sodium carbonate only under the

responsibility of an expert.

Effects of short-term exposure: The substance is corrosive to the eyes, skin and

respiratory tract. Corrosive on ingestion. Inhalation may cause lung edema,

Protective Clothing:

Skin: Wear appropriate personal protective clothing to prevent skin contact.

Eyes: Wear appropriate eye protection to prevent eye contact.

Wash skin: The worker should immediately wash the skin when it becomes

contaminated.

Remove: Work clothing that becomes wet or significantly contaminated should be

removed and replaced.

Provide: Eyewash fountains should be provided in areas where there is any

possibility that workers could be exposed to the substance; this is irrespective of the

recommendation involving the wearing of eye protection.

Formaldehyde 37% (FORMALIN)

Formalin, when exposed to air, will emit formaldehyde gas.

Formaldehyde is a highly flammable liquid/gas and should be considered a fire

hazard. It strongly oxidizes in the presence of alkalis, acids and phenols. Store in

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well ventilated place, away from sources of ignition and direct sunlight. Avoid

contact with heat, sparks, flames, or other sources of ignition.

General Handling:

At all times, disposable gloves must be worn to prevent dermal exposure when

handling and/or mixing this product. Do not get in eyes. Avoid contact with skin and

clothing. Avoid breathing mist or vapor. Use only with adequate ventilation. Wash

thoroughly after handling.

Sodium boro hydride:

Sodium borohydride is a white to grayish crystalline powder. It is decomposed by

water to form sodium hydroxide, a corrosive material, and hydrogen, a flammable

gas. The heat of this reaction may be sufficient to ignite the hydrogen. The material

itself is easily ignited and burns vigorously once ignited. It is used to make other

chemicals, treat waste water, and for many other uses. Reaction of water with the

borohydride liberates flammable hydrogen gas. Sodium borohydride burns in air.

Fire Hazard

Behavior in Fire: Decomposes and produces highly flammable hydrogen gas.

Health Hazard

Solid irritates skin. If ingested can form large volume of gas and lead to a gas

embolism

Protective Clothing

Goggles, rubber gloves, and protective clothing

Thionyl chloride:

A colorless to yellow fuming liquid with a suffocating pungent odor. A lachrymator.

Highly corrosive and toxic.

Long-term inhalation of low concentrations or short-term inhalation of high

concentrations has adverse health effects.

Emits dense corrosive fumes in moist air. Violently reacts with water to liberate

hydrochloric acid and sulfur dioxide. Based on a scenario where the chemical is

spilled into an excess of water (at least 5 fold excess of water), half of the maximum

theoretical yield of Sulfur Dioxide gas will be created in 0.25 minutes.

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Protective Clothing

Skin: Wear appropriate personal protective clothing to prevent skin contact.

Eyes: Wear appropriate eye protection to prevent eye contact.

Wash skin: The worker should immediately wash the skin when it becomes

contaminated.

Provide eyewash fountains in areas where there is any possibility that workers

could be exposed to the substance; this is irrespective of the recommendation

involving the wearing of eye protection

Ammonia:

Appearance: Colorless gas

Main Routes of Exposure: Inhalation, Skin contact, Eye contact.

Inhalation: VERY TOXIC. Can cause severe irritation of the nose and throat. Can

cause life-threatening accumulation of fluid in the lungs (pulmonary edema).

Symptoms may include coughing, shortness of breath, difficult breathing and

tightness in the chest. Symptoms may develop hours after exposure and are made

worse by physical effort. Long-term damage may result from a severe short-term

exposure.

Skin Contact: CORROSIVE. The gas irritates or burns the skin. Permanent scarring

can result. Direct contact with the liquefied gas can chill or freeze the skin

(frostbite). Symptoms of more severe frostbite include a burning sensation and

stiffness. The skin may become waxy white or yellow. Blistering, tissue death and

infection may develop in severe cases.

Eye Contact: CORROSIVE. The gas irritates or burns the eyes. Permanent damage

including blindness can result. Direct contact with the liquefied gas can freeze the

eye. Permanent eye damage or blindness can result.

Flammable Properties: FLAMMABLE GAS. High airborne concentrations can be

ignited and pose a significant fire and explosion hazard, especially in a confined

space. A large and intense energy source is necessary to ignite ammonia gas.

Suitable Extinguishing Media: Carbon dioxide, dry chemical powder, appropriate

foam, water spray or fog.

Hazards: Heat from fire can cause a rapid build-up of pressure inside cylinders.

Explosive rupture and a sudden release of large amounts of gas may result.

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Cylinder may rocket. In a fire, the following hazardous materials may be generated:

flammable hydrogen.

Eye/Face Protection: Wear chemical safety goggles. A face shield (with safety

goggles) is necessary.

Skin Protection: Wear chemical protective clothing e.g. gloves, aprons, boots.

Hydrobromic Acid, 33% Solution in Acetic Acid:

Hazards: Very hazardous in case of skin contact (irritant) or eye contact (irritant), or

ingestion, Inhalation of the spray mist may produce severe irritation of respiratory

tract, characterized by coughing, choking, or shortness of breath.

Inflammation of the eye is characterized by redness, watering, and itching. Skin

inflammation is characterized by itching, scaling, reddening, or occasionally

blistering.

Storage: Store in a segregated and approved area. Keep container in a cool, well-

ventilated area. Keep container tightly closed and sealed until ready for use. Avoid

all possible sources of ignition (spark or flame).

Engineering Controls: Provide exhaust ventilation to keep the airborne

concentrations of vapors below their respective threshold limit value.

Ensure that eyewash stations and safety showers are proximal to the work-station

location.

Personal Protection: Face shield. Full suit.

Vapor respirator. Be sure to use an approved respirator.

Use Gloves, Boots, and personal protection in case of a Large Spill.

A self contained breathing apparatus should be used to avoid inhalation of the

product.

7.5. SAFE PRACTICES [HANDLING, STORAGE, TRANSPORTATION AND

UNLOADING OF CHEMICALS]

Liquid Raw materials will be transferred from the drums to the day tank situated at

the production block with the help of leak proof drum pumps / AODD pumps

/Vacuum .From day tank to process reactor unloading is by gravity.

7.5.1 Measures to Avoid Evaporation

All liquid chemicals/solvents stored in containers will be tightly closed.

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Will Keep away from heat, sparks, and flame

Will Keep away from sources of ignition

Ammonia will be stored in well ventilated area away from combustibles, oxidizable

materials etc.

7.5.2 Safety Systems

Designated areas with proper indication & safety signs

Double earthling systems for all solvent storage tanks & process reactors

Flame arrestor to the vent of Solvent storage tanks

Flame proof transferring pumps for all flammable chemicals

Handling precautions/sop protocol

Pressure Gauges and temperature gauges on each reactor

Level indicators, Vent lines, earthing system on all solvent storage

tanks(Methanol, Toluene, MDC, Ethyl acetate, ,Acetone, n-hexane)

Each solvent storage tank will be placed in dyke wall with Fire hydrant system

Flame proof lighting to solvent storage yard

Safety valve & Rupture disc on each process reactor.

Well ventilated warehouse with suitable fire extinguishers will be used for

storage of liquid chemicals/Ammonia/Hcl /HBr/Solid Chemicals.

7.5.3 TRANSPORTATION / UNLOADING

Highly inflammable chemicals will be transported by road. Therefore, adequate

safety precautions for transportation will be followed. During transportation of

hazardous chemicals, MSDS & TREM card will be provided to driver. As per Motor

Vehicle Rules, PESO rules and Factory Rules all safety precautions will be followed

during transportation of hazardous chemicals.

The following safety precautions are suggested during transportation of toxic,

inflammable and corrosive chemicals in tankers, while loading and unloading,

transportation and meeting the emergencies arising out of leakages and spillages of

hazardous materials:

The name of the chemical along with pictorial sign denoting the dangerous

goods should be marked on the vehicle and the packing material.

The name of the transporter, his address and telephone number should be

clearly written on the road tanker and on the vehicle.

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Only trained drivers and cleaners should transport hazardous chemicals.

The Tanker / Vehicle should be checked for its fitness and safe condition

before loading.

During loading and unloading, the tanker/vehicle should be braked and

isolated against any movement, while loading/unloading, use safety

appliances.

Park the vehicle at designated place.

Stop the engine.

Check-up spark arrester.

Provide earthing to tanker securely.

Ensure that fireman is available near the place with proper equipment‗s.

Connect the piping properly

Before start unloading, check that, there should not be any leakage.

In case of leakage, immediately attend the leakages & rectify it.

After unloading is over, close the lid properly.

Vehicle to be started only after removal of all pipelines connected with

tanker.

7.5.4 SPILL CONTROL

For all chemicals spill control procedures will be displayed. Spillage shall be

controlled as per concerned spill control procedure.

Like any spilled materials to contain, absorb spilled liquid by dry absorbent

clay or vermiculite.

Collect most of the contaminated absorbent with shovel for further

disposal/incineration.

If material spills directly on the ground, dig up and remove saturated soil for

disposal/incineration.

In case HBr /Hcl /H2So4 spills on to the ground use dry absorbent

clay/vermiculate and neutralize with sodium carbonate

The plant is more vulnerable for solvent leakages, fire due to Raney nickel

exposure to dry condition.

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7.5.5 EFFECT AND CONSEQUENCE ANALYSIS

In a plant handling hazardous chemicals, the main hazard due to storage &

handling of solvents, Ammonia, Thionylchloride, Hydrogen, HBr/Hcl/H2So4,

Sodium boro hydride ,.

If Flammable chemicals are released into the atmosphere, they may cause

damage due to resulting fires or vapor clouds.

Toxic gas dispersion due to leakage of thionyl chloride, Ammonia into

atmosphere may cause health problems to plant personnel and surrounding

areas of the plant.

7.6 INVENTORY

Inventory analysis is commonly used in understanding the relative hazards

and short listing of release scenarios.

Inventory plays an important role in regard to the potential hazard.

Larger the inventory of a vessel or a system, larger the quantity of potential

release.

The potential vapor release [source strength] depends upon the quantity of

liquid release, the properties of the materials and the operating conditions

[pressure, temperature].

If all these influencing parameters are combined into a matrix and vapor

source strength estimated for each release case, a ranking should become a

credible exercise.

7.7 LOSS OF CONTAINMENT

Plant inventory can get discharged to environment due to Loss of

Containment.

Certain features of materials to be handled at the plant need to the clearly

understood to firstly list out all significant release cases and then to short list

release scenarios for a detailed examination.

Liquid release can be either instantaneous or continuous.

Failure of a vessel leading to an instantaneous outflow assumes the sudden

appearance of such a major crack that practically all of the contents above the

crack shall be released in a very short time.

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The more likely event is the case of liquid release from a hole in a pipe

connected the vessel. The flow rate will depend on the size of the hole as well

as on the pressure, which was present, in front of the hole, prior to the

accident. Such pressure is basically dependent on the pressure in the vessel.

The vaporization of released liquid depends on the vapor pressure and

weather conditions.

In the study the largest potential hazard inventories have been considered for its

consequence Risk estimation how vulnerable the organization is to a specific

incident consequence.

Hazards from Flammable chemicals (solvents) Storages, Ammonia & Thionyl

chloride

There are a number of hazards that are present at the proposed project site

that may result in injury to people or a fatality in more serious cases. This

study is only concerned with ‗major hazards‘, which are as follows:

Jet fires;

Hydrocarbon fires associated with tank failures;

Pool fires, Vapor cloud explosion;

Each of these hazards has been described below.

Jet Fire

Jet fires result from ignited releases of pressurized flammable gas or

Superheated/pressurized liquid. The momentum of the release carries the

material forward in a long plume entraining air to give a flammable mixture.

Jet fires only occur where any other flammable gas is being handled under

pressure or when handled in gas phase and the release are unobstructed

Pool Fires

If a liquid release has time to form a pool and is then ignited before the pool

Evaporates or drains away, then a pool fire results.

Because they are less well aerated, pool fires tend to have lower flame

temperatures and produce lower levels of thermal radiation than some other

types of fire (such as jet fires); however, this means that they will produce

more smoke. Although a pool fire can still lead to structural failure of items

within the flame, this will take several times longer than in a jet fire.

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A burning liquid pool can spread along a horizontal surface or run down a

vertical surface to give a running fire. Due to the presence of kerbs, slopes,

drains and other obstacles; pool fire areas and directions can be

unpredictable.

Vapour Cloud Explosion

The facility presently stores and also plans to store highly flammable

Chemicals Methanol, Acetone, Toluene, MDC, Ethylacetate, THF,

Cyclohexane, DMSO etc. for a maximum credible loss scenario the release of

such chemicals is likely to form a vapor cloud. If the cloud encounters an

ignition source, the parts of the cloud where the concentration is within the

flammable range will burn and may in some situations, also create an

explosive force (blast wave). The effects of an explosion, defined by blast

overpressure, can be significant.

In most VCEs the expanding flame front travels more slowly than the pressure

Wave; this type of explosion is called a deflagration and the maximum

Overpressure is determined by the expansion ratio of the burning gases. If the

flame front travels fast enough to coincide with the pressure wave then the

explosion is called a detonation and very severe overpressures can be

produced. Detonation is most likely to occur with more reactive gases such as

hydrogen.

Toxic vapor release:

Toxic vapor release due to Ammonia, Thionyl chloride leakage and effected

area with airborne concentration

7.8 Damage Criteria

In consequence analysis, use is made of a number of calculation models to estimate

the physical effects of an accident [spill of hazardous material] and to predict the

damage [lethality, injury, material destruction] of the effects. The calculations can

roughly be divided in three major groups.

Determination of the source strength parameters;

Determination of the consequential effects;

Determination of the damage or damage distances.

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Table 7.3 Severity Categories and Criteria

Consequence Ranking Criteria Definition

Catastrophic 5 Multiple fatalities/permanent total disability

Major 4 Single fatality/permanent total disability

Moderate 3 Short term hospitalization & rehabilitation leading to recovery

Minor 2 Medical treatment injuries

Insignificant 1 First Aid treatment

Risk Evaluation

Based on ranking of likelihood and frequencies, each identified hazard has been

evaluated based on the likelihood of occurrence and the magnitude of

consequences. The significance of the risk is expressed as the product of likelihood

and the consequence of the risk event, expressed as follows:

Significance = Likelihood X Consequence

The below table illustrates all possible product results for the five likelihood and

consequence categories while the next table assigns risk significance criteria in three

regions that identify the limit of risk acceptability.

Depending on the position of the intersection of a column with a row in the risk

matrix, hazard prone activities have been classified as low, medium and high thereby

qualifying for a set of risk reduction / mitigation strategies.

Risk Matrix

Likelihood

Consequence Frequent Probable Unlikely Remote Improbable

5 4 3 2 1

Catastrophic 5 25 20 15 10 5

Major 4 20 16 12 8 4

Moderate 3 15 12 9 6 3

Minor 2 10 8 6 4 2

Insignificant 1 5 4 3 2 1

Risk Criteria and action Requirements

S.No. Risk Significance Criteria Definition & Action Requirements

1 High (16-25)

―Risk requires attention‖ – Project Management need to ensure that necessary mitigation are adopted to ensure that possible risk remains within acceptable limits.

2 Medium (10-15) ―Risk is tolerable‖ – Project Management to adopt

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necessary measures to prevent any change/modification of existing risk controls and ensure implementation of all practicable controls.

3 Low (5-9)

―Risk is acceptable‖ – Project related risks are managed by well established controls and routine processes/procedures. Implementation of additional controls can be considered.

4 Very Low (1-4)

―Risk is acceptable‖- All risks are managed by well established controls and routine processes/procedures. Additional risk controls need not to be considered.

The basic physical effect models consist of the following.

Source strength parameters

Calculation of the outflow of liquid, vapor or gas out of a vessel or a pipe, in

case of rupture. Also two-phase outflow can be calculated.

Calculation, in case of liquid outflow, of the instantaneous flash evaporation

and of the dimensions of the remaining liquid pool.

Calculation of the evaporation rate, as a function of volatility of the material,

pool dimensions and wind velocity.

Source strength equals pump capacities, etc. is some cases.

Consequential effects

Dispersion of gaseous material in the atmosphere as a function of source

strength, relative density of the gas, weather conditions and topographical

situation of the surrounding area.

Intensity of heat radiation [in KW / m2] due to a pool fire or a BLEVE, as a

function of the distance to the source.

Energy of vapor cloud explosions [in KW / m2], as a function of the distance to

the distance of the exploding cloud.

Concentration of gaseous material in the atmosphere, due to the dispersion of

evaporated chemical. The latter can be either explosive or toxic.

It may be obvious, that the types of models that must be used in a specific risk study

strongly depend upon the type of material involved:

Gas, vapor, liquid, solid

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Inflammable, explosive, toxic products

Stored at high/low temperatures or pressure.

Selection of Damage Criteria

The damage criteria give the relation between extent of the physical effects

(exposure) and the percentage of the people that will be killed or injured due

to those effects

The knowledge about these relations depends strongly on the exposure. For

instance, much more is known about the damage caused by heat radiation,

than about the damage due to toxic exposure, and for these toxic effects, the

knowledge differs strongly between different materials.

In consequence analysis studies, in principle three types of exposure to hazardous

effects are distinguished:

Heat radiation from a jet, pool fire or a BLEVE.

Explosion

Toxic effect from toxic materials or toxic combustion products.

Heat Radiation

The consequence caused by exposure to heat radiation is a function of:

The radiation energy onto the human body [KW / M2]

The exposure duration [sec]

The protection of the skin tissue [clothed or naked body]

The limits for 1% of the exposed people to be killed due to heat radiation, and for

second-degree burns are given in below:

7.9 DAMAGES TO HUMAN LIFE DUE TO HEAT RADIATION

Injuries to People —Definition of Burn Degrees

First Degree: A mild level of skin burn affecting the epidermis, with persistent

redness but no formation of blisters. More severe first - degree burns will produce

some pain, but no permanent damage. Flaking or scaling of the outer skin layer will

occur several days after exposure.

Second Degree: An intermediate level of skin burn characterized by the formation of

blisters. The blister depth may be shallow (epidermis), with only the surface layers of

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the skin damaged, or more severe with nearly the full depth of the skin destroyed

(epidermis and dermis).

Third Degree: Deep burns characterized by the destruction of all skin layers and by

charring. The underlying tissue may also be damaged.

Table 7.4 Heat flux Intensity and exposure time-Damage criteria for people

Thermal Radiation Intensity (kW/m2)

Type of Damage

1.6 No harm for long exposures.

4 to 5 Pain for 20 seconds exposure; first degree burn

9.5 Second degree burn after 20 Seconds

10 to 15 Potentially lethal with in 1 minute.

25 Significant injury in 10 seconds; 100 % lethality in 1 minute.

35 to 37.5 1 % lethality in 10 seconds.

Since in practical situations, only the own employees will be exposed to heat

radiation in case of a fire, it is reasonable to assume the protection by clothing. It can

be assumed that people would be able to find a cover or a shield against thermal

radiation in 10 sec. time. Furthermore, 100% lethality may be assumed for all people

suffering from direct contact with flames, such as the pool fire, a flash fire or a jet

flame.

Explosion

In case of vapor cloud explosion, two physical effects may occur:

A flash fire over the whole length of the explosive gas cloud;

A blast wave, with typical peak overpressures circular around ignition source.

As explained above, 100% lethality is assumed for all people who are present within

the cloud proper.

For the blast wave, the lethality criterion is based on:

A peak over pressure of 0.1 bars will cause serious damage to 10% of the

housing/structures.

The following damage criteria may be distinguished with respect to the peak

overpressures resulting from a blast wave:

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Table 7.5 DAMAGE DUE TO OVERPRESSURES

PEAK OVERPRESSURE

DAMAGE TYPE

0.83 bar Total destruction

0.30 bar Heavy damage

0.10 bar Moderate damage

0.03 bar Significant damage

0.01 bar Minor damage

7.10 INCIDENTS IMPACT

The identified failure scenarios in plant have been analyzed for the impact zones

considering damage due to thermal, explosive and toxic impacts. Each incident will

have Impact on the surrounding environment which in extreme case may cross plant

boundary.

7.11 MAXIMUM CREDIBLE LOSS ACCIDENT SCENARIOS

A Maximum Credible Accident (MCA) can be characterized as the worst credible

accident. In other words: an accident in an activity, resulting in the maximum

consequence distance that is still believed to be possible. A MCA-analysis does not

include a quantification of the probability of occurrence of the accident. Another

aspect, in which the pessimistic approach of MCA studies appears, is the

atmospheric condition that is used for dispersion calculations. The Maximum

Credible Loss (MCL) scenarios have been developed for the Facility. The MCL

cases considered, attempt to include the worst ―Credible‖ incidents-what constitutes

a credible incident is always subjective. Nevertheless, guidelines have evolved over

the years and based on basic engineering judgment, the cases have been found to

be credible and modeling for assessing vulnerability zones is prepared accordingly.

The objective of the study is Emergency planning, hence only holistic & conservative

assumptions are used for obvious reasons. Hence, though the outcomes may look

pessimistic, the planning for emergency concept should be borne in mind whilst

interpreting the results.

In Consequence analysis, geographical location of the source of potential release

plays an important role. Consideration of a large number of scenarios in the same

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geographical location serves little purpose if the dominant scenario has been

identified and duly considered.

The Consequence Analysis has been done for selected scenarios. The details of

software used for MCA analysis are described below.

A computer based version ALOHA is used to calculate toxic and explosive

effect of the accidental release of liquid chemicals within the plant area.

ALOHA models key hazards-toxicity, flammability, thermal radiation (Heat),

and over pressure (expansion blast force)-related to chemical releases that

result in toxic gas dispersion, fire and/or explosion

7.12. Risk analysis

Risk Analysis – Ammonia/Thionyl chloride/Solvents (Methanol, Toluene,

Acetone -Hexane)

The main hazard Toxic gas release associated with the storage and handling of

Thionyl chloride and Ammonia gas with respect to the proposed Unit.

Hazards associated with the storage and handlings of Flammable chemicals

(Solvents) are pool fire, jet fires and VCE‘s resulting from the ignition of released

material. The hazards may be realized during tank overfilling and leaks/failures

in the storage tank and ancillary equipment such as transfer pumps, metering

equipment, etc. all of which can release significant quantities of flammable

material or toxic material on failure.

7.13 Risk Modeling Scenarios

In addition to overfill, the scenarios considered for liquid and gaseous

Chemical leaks and catastrophic failures. Factors that have been identified as

having an effect on the integrity of tanks are related to design, inspection,

maintenance, and corrosion.

From the liquid chemicals Thionyl chloride has been considered for the

consequences analysis considering its hazardous nature, Storage conditions and

threshold values.

From the Solvents – Methanol, Toluene, Acetone, n-Hexane have been

considered for the consequences analysis considering their hazardous nature,

Storage conditions and threshold values.

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RISK & VULNERABLE AREAS

SITE DATA:

Location: ARCHIMEDIS LABS PVT LTD, A.P. INDIA

CHEMICAL DATA:

Chemical Name: ACETONE

CAS Number: 67-64-1

Molecular Weight: 58.08 g/mol

LEL: 26000 ppm UEL: 130000 ppm

Ambient Boiling Point: 56.20 c

ATMOSPHERIC DATA:

Wind: 2.8 meters/second from S at 3 meters

Air Temperature: 38° C

Relative Humidity: 75%

SOURCE STRENGTH:

Leak from hole in vertical cylindrical tank

Flammable chemical is burning as it escapes from tank

Tank Diameter: 2 meters

Tank Length: 6.5 meters

Tank Volume: 20.4 cubic meters

Tank contains liquid

Chemical Mass in Tank: 15.5 tons

Tank is 88% full

Total Amount Burned: 5486 kgs

Note: The chemical escaped as a liquid and formed a burning puddle.

The puddle spread to a diameter of 6.9 yards.

THREAT ZONE:

Threat Modeled: Thermal radiation from pool fire

Red : 14 yards --- (10.0 kW/(sq m) = potentially lethal within 60 sec)

Orange: 18 yards --- (5.0 kW/(sq m) = 2nd degree burns within 60 sec)

Yellow: 26 yards --- (2.0 kW/(sq m) = pain within 60 sec)

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In case the Leakage of Acetone from storage tank got ignited, the vulnerable

areas, which are in radius of 12.8 meters within a minute, will get affected.

The Thermal radiation from pool fire of Acetone having value of 10 kw/sqm is

potentially lethal to the plant personnel from south of the plant with in the radius

of 12.8 meters .The plant personnel with in radius of 16.5 meters are vulnerable

for second degree burns within a minute.

The leakage of Acetone in the plant and its consequence considered as Major

and its likelihood is unlikely

Significance = Likelihood X Consequence

=3*4

=12

As defined in Risk Criteria and action requirements

The risk significance is Medium.

―Risk is tolerable‖ –

Mitigation measure: It is Flammable liquid. Storage tank should be checked at

regular intervals for any corrosion, weak joints and tank bottom isolation valve for

its operating condition and earthing of the tank. Check regularly earth pit

resistance. At any point of time do not place any ignition source near by the tank.

In case of fire use fire hydrant system to extinguish the fire in order to minimize

the risk level and avoid fire spread to other areas of the plant. Inform plant head

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for emergency preparedness. Put water curtain on adjacent tanks to avoid heat

radiation to contents of the tank.

Acetone

SOURCE STRENGTH:

Leak from hole in vertical cylindrical tank

Flammable chemical escaping from tank (not burning)

Tank Diameter: 2 meters

Tank Length: 6.5 meters

Tank Volume: 20.4 cubic meters

Tank contains liquid

Chemical Mass in Tank: 15.5 tons

Tank is 88% full

Circular Opening Diameter: 2 inches

Total Amount Released: 4200 kgs

Note: The chemical escaped as a liquid and formed an evaporating puddle.

The puddle spread to a diameter of 23 yards.

THREAT ZONE:

Model Run: Heavy Gas make dispersion predictions less reliable for short

distances.

Orange: 66 yards --- (3200 ppm = AEGL-2 [60 min])

Yellow: 327 yards --- (200 ppm = AEGL-1 [60 min])

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In case the Leakage of Acetone from storage tank the vulnerable areas, which

are in radius of 60 meters will get affected.

The airborne concentration of Acetone will affect seriously the plant personnel &

general population towards north side of the plant with in the radius of 60 meters

They may experience eye exposure & inhalation exposure.

The leakage of Acetone in the plant and its consequence considered as

moderate and its likelihood is unlikely

Significance = Likelihood X Consequence

=3*3 =9

As defined in Risk Criteria and action requirements

The risk significance is low.

―Risk is acceptable‖ –

Mitigation measure: It is Flammable liquid. Storage tank should be checked at

regular intervals for any corrosion, weak joints and tank bottom isolation valve for

its operating condition. The tank should have dyke wall equal to 110% of the tank

volume. This is to contain the leaked Acetone in the dyke only.

In case of leakage the contents should be transferred to another spare tank to

minimize the Risk level. Prevent entry into sewers, basements or confined areas.

Keep away from heat. Keep away from sources of ignition. Meanwhile the leaked

material should be contained. Absorb with dry earth, sand or other non-

combustible material.

CHEMICAL DATA:

Chemical Name: METHANOL

Molecular Weight: 32.04 g/mol

LEL: 71800 ppm UEL: 365000 ppm

Ambient Boiling Point: 64.70 c

ATMOSPHERIC DATA:

Wind: 2.8 meters/second from S at 3 meters

Air Temperature: 38° C

Relative Humidity: 75%

SOURCE STRENGTH:

Leak from hole in vertical cylindrical tank

Flammable chemical is burning as it escapes from tank

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Tank Diameter: 2 meters Tank Length: 6.5 meters

Tank Volume: 20.4 cubic meters

Tank contains liquid

Chemical Mass in Tank: 15.4 tons

Tank is 88% full

Circular Opening Diameter: 2.5 inches

Total Amount Burned: 8187 kgs

Note: The chemical escaped as a liquid and formed a burning puddle.

The puddle spread to a diameter of 14.7 yards.

THREAT ZONE:

Threat Modeled: Thermal radiation from pool fire

Red : 15 yards --- (10.0 kW/(sq m) = potentially lethal within 60 sec)

Orange: 19 yards --- (5.0 kW/(sq m) = 2nd degree burns within 60 sec)

Yellow: 26 yards --- (2.0 kW/(sq m) = pain within 60 sec)

In case the Leakage of Methanol from storage tank got ignited, the vulnerable

areas, which are in radius of 13.7 meters within a minute, will get affected.

The Thermal radiation from pool fire of Methanol having value of 10 kw/sqm is

potentially lethal to the plant personnel towards south side of the plant with in the

radius of 13.7 meters.

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The plant personnel will be vulnerable for second degree burns within the radius

of 17.3 meters in a minute.

The fire due to leakage of Methanol in the plant and its consequence considered

as Major and its likelihood is unlikely

Significance = Likelihood X Consequence

=3*4 =12

As defined in Risk Criteria and action requirements

The risk significance is Medium.

―Risk is tolerable‖ –

Mitigation measure: It is highly flammable liquid in presence of open flames and

spark. Storage tank should be checked at regular intervals for any corrosion,

weak joints and tank bottom isolation valve for its operating condition and

earthing of the tank. Check regularly earth pit resistance. At any point of time do

not place any ignition source near by the tank.

In case of fire use fire hydrant system and fire extinguisher -alcohol foam to

extinguish the fire in order to minimize the risk level and avoid fire spread to other

areas of the plant.

Inform plant head for emergency preparedness. Put water curtain on adjacent

tanks to avoid heat radiation to contents of the tank.

CHEMICAL DATA:

Chemical Name: TOLUENE

Molecular Weight: 92.14 g/mol

LEL: 11000 ppm UEL: 71000 ppm

Ambient Boiling Point: 1100 c

ATMOSPHERIC DATA:

Wind: 2.8 meters/second from S at 3 meters

Air Temperature: 38° C

Relative Humidity: 75%

SOURCE STRENGTH:

Leak from hole in vertical cylindrical tank

Flammable chemical is burning as it escapes from tank

Tank Diameter: 2 meters

Tank Length: 6.5 meters

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Tank Volume: 20.4 cubic meters

Tank contains liquid

Chemical Mass in Tank: 16.9 tons

Tank is 88% full

Circular Opening Diameter: 2.5 inches

Opening is 6 inches from tank bottom

Total Amount Burned: 9020 kgs

Note: The chemical escaped as a liquid and formed a burning puddle.

The puddle spread to a diameter of 6.8 yards.

THREAT ZONE:

Threat Modeled: Thermal radiation from pool fire

Red : 19 yards --- (10.0 kW/(sq m) = potentially lethal within 60 sec)

Orange: 26 yards --- (5.0 kW/(sq m) = 2nd degree burns within 60 sec)

Yellow: 38 yards --- (2.0 kW/(sq m) = pain within 60 sec)

In case the Leakage of Toluene from storage tank got ignited, the vulnerable

areas, which are in radius of 17.4 meters within a minute, will get affected.

The Thermal radiation from pool fire of Toluene having value of 10 kw/sqm is

potentially lethal to the plant personnel towards south side of the plant with in

the radius of 17.4 meters .The plant personnel with in radius of 23.7 meters are

vulnerable for second degree burns within a minute.

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The leakage & fire of Toluene in the plant and its consequence considered as

Major and its likelihood is unlikely

Significance = Likelihood X Consequence

=3*4 =12

As defined in Risk Criteria and action requirements

The risk significance is Medium.

―Risk is tolerable‖ –

Mitigation measure: It is flammable liquid in presence of open flames and spark.

Storage tank should be checked at regular intervals for any corrosion, weak joints

and tank bottom isolation valve for its operating condition and earthing of the

tank. Check regularly earth pit resistance. At any point of time do not place any

ignition source near by the tank.

In case of fire use fire hydrant system and fire extinguisher -alcohol foam to

extinguish the fire in order to minimize the risk level and avoid fire spread to other

areas of the plant. Inform plant head for emergency preparedness. Put water

curtain on adjacent tanks to avoid heat radiation to contents of the tank.

CHEMICAL DATA:

Chemical Name: N-HEXANE

Molecular Weight: 86.18 g/mol

LEL: 12000 ppm UEL: 72000 ppm

Ambient Boiling Point: 68.5° c

ATMOSPHERIC DATA:

Wind: 2.8 meters/second from S at 3 meters

Air Temperature: 38° C

Relative Humidity: 75%

SOURCE STRENGTH:

Leak from hole in vertical cylindrical tank

Flammable chemical is burning as it escapes from tank

Tank Diameter: 2 meters

Tank Length: 6.5 meters

Tank Volume: 20.4 cubic meters

Tank contains liquid

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Chemical Mass in Tank: 12.9 tons

Tank is 88% full

Circular Opening Diameter: 3 inches

Opening is 6 inches from tank bottom

Total Amount burned: 11375 kgs

THREAT ZONE:

Threat Modeled: Thermal radiation from pool fire

Red : 22 yards --- (10.0 kW/(sq m) = potentially lethal within 60 sec)

Orange: 30 yards --- (5.0 kW/(sq m) = 2nd degree burns within 60 sec)

Yellow: 44 yards --- (2.0 kW/(sq m) = pain within 60 sec)

In case the Leakage of n-Hexane from storage tank got ignited, the vulnerable

areas, which are in radius of 20 meters within a minute, will get affected.

The Thermal radiation from pool fire of n-Hexane having value of 10 kw/sqm is

potentially lethal to the plant personnel towards south side of the plant with in

the radius of 20 meters .The plant personnel with in radius of 27.4 meters are

vulnerable for second degree burns within a minute.

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The leakage & fire of n-Hexane in the plant and its consequence considered as

Major and its likelihood is unlikely

Significance = Likelihood X Consequence

=3*4 =12

As defined in Risk Criteria and action requirements

The risk significance is Medium.

―Risk is tolerable‖ –

Mitigation measure: It is flammable liquid in presence of open flames and spark.

Storage tank should be checked at regular intervals for any corrosion, weak joints

and tank bottom isolation valve for its operating condition and earthing of the

tank. Check regularly earth pit resistance. At any point of time do not place any

ignition source near by the tank.

In case of fire use fire hydrant system and fire extinguisher -alcohol foam to

extinguish the fire in order to minimize the risk level and avoid fire spread to other

areas of the plant. Inform plant head for emergency preparedness. Put water

curtain on adjacent tanks to avoid heat radiation to contents of the tank.

CHEMICAL DATA:

Chemical Name: THIONYL CHLORIDE

Molecular Weight: 118.97 g/mol

ATMOSPHERIC DATA:

Wind: 2.8 meters/second from S at 3 meters

Air Temperature: 38° C

Relative Humidity: 75%

SOURCE STRENGTH:

Direct Source: 100 kilograms

Total Amount Released: 100 kgs

THREAT ZONE:

Model Run: Heavy Gas

Red : 886 yards --- (14 ppm = AEGL-3 [60 min])

Orange: 1749 yards --- (2.4 ppm = AEGL-2 [60 min])

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The leakage of Thionyl chloride liquid and its consequences are considered

as Minor and its likelihood is probable

Significance = Likelihood X Consequence

=2*4 =8

As defined in Risk Criteria and action requirements

The risk significance is low.

―Risk is Acceptable.‖ –

Mitigation measure: During unloading from Drum if unloading transfer pipe is

not fixed properly there may be sudden leakage of contents on to the

ground. This results in formation toxic area of vapor cloud of 14 ppm up to a

distance of 810 mts in which people may experience life threatening health

effects within one hour.

During transfer of material it is advisable to use diaphragm pumps where

spillages can be eliminated. While transferring the material the responsible

officer should be present.

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CHEMICAL DATA:

Chemical Name: AMMONIA

Molecular Weight: 17.03 g/mol

Ambient Boiling Point: -33°c

ATMOSPHERIC DATA:

Wind: 2.8 meters/second from S at 3 meters

Air Temperature: 38° C

Relative Humidity: 75%

SOURCE STRENGTH:

Direct Source: 50 kilograms

Total Amount Released: 50 kgs

THREAT ZONE:

Model Run: Gaussian

Red : 90 yards --- (1100 ppm = AEGL-3 [60 min])

Orange: 237 yards --- (160 ppm = AEGL-2 [60 min])

Yellow: 541 yards --- (30 ppm = AEGL-1 [60 min])

The Leakage of Ammonia gas and its consequences are considered as Minor

and its likelihood is probable

Significance = Likelihood X Consequence

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=2*4 =8

As defined in Risk Criteria and action requirements

The risk significance is low.

―Risk is Acceptable.‖ –

Mitigation measure: During charging ammonia from cylinder to reactor if

transfer pipe is not fixed properly there may be sudden leakage of gas in to

atmosphere. This results in formation toxic area of vapor cloud of 1100ppm up

to a distance of 82 mts in which people my experience life threatening health

effects within a hour.

During transfer of material it is advisable to use tested transfer pipe and its end

connections should be ensured for leak proof. While charging the material the

responsible officer should be present.

7.14. OCCUPATIONAL HEALTH

Hazardous and toxic substances will be defined as those chemicals present in the

work place which are capable of causing harm.

For handling hazardous chemicals and to take care of employee‘s health,

and predictive maintenance looking to the nature of hazardous chemicals

being handled/processed. All the equipments in the plant areas shall be

inspected / tested by an outside agency.

The various safety equipments like breathing apparatus and critical

instrumentation will be provided on various equipments are inspected and

tested frequently to ensure their operability all the time. Besides, all the first

aid, fire fighting devices will be inspected, tested and maintained by a

competent third party and kept all the time in ready to use condition.

Health of all the employees in plant area will be monitored by outside

physician. If any abnormality is found necessary treatment is also being

given time to time. Necessary history cards, records will be maintained which

is up-dated time to time.

Common Hazards

Physical such as ventilation, poor illumination, noise, extreme temperature,

humidity and radiation.

Biological such as variety of pathogenic bacteria and parasites.

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Chemical due to hazardous gases and dusts.

Ergonomic.

Industrial Hygiene Monitoring

Industrial hygiene monitoring is to be located and identify source of exposure

in the workplace so that they can be corrected and to quantify the exposure of

employees to chemicals in the air.

Occupational Health Monitoring System

A. Air samples

Locations of samples – air samples are generally collected in one or three

locations:

At the breathing zone of the worker [Personal sample]

At the operation which is generating the hazardous substance [Area

sample]

Lengths of samples – Air samples are generally collected for two lengths of time.

Grab samples [instantaneous] measure conditions at one moment in time

and can be likened to a still photograph. They give only a picture of

conditions at one place at one instant in time.

Continuous Samples [range from twenty minutes to 8 – 10 Hours].These

is used to evaluate all day exposure by a series of continuous samples.

B. Other sampling methods

Bulk samples

Bulk samples will be collected from settled dust in the work place or from drums

or bags of chemicals in the Warehouse. Their purpose is to analyze and identify

the substances present. For example, bulk samples are used to analyze the

percent of asbestos in insulation, dust & Chemical Powder. Usually, a substance

which is greater than one percent of bulk sample is considered a concern.

Wipe Samples

Wipe samples will be used when skin absorption or ingestion is a suspected

route of exposure. The purpose is to show whether skin, respirators, clothing,

lunch rooms, lockers, etc. are contaminated.

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It can show which surfaces are clean and which are contaminated. It can also

show if some surfaces are more contaminated than others.

7.14.1 Sampling Devices

The general principle of sampling is to collect an amount of a contaminant onto a

medium from a known quantity of air.

Air samples will be collected using small pumps to suck air from the workroom. The

pump is attached by tubing to a sampling device which contains the sampling

medium; for example a glass tube containing charcoal.

The sampling method will be used depends on the physical form of the substance:

DUSTS –The sampling device is a filter of plastic or paper in s holder:

VAPORS –The sampling device is a glass tube containing activated charcoal

as a medium.

GASES –The sampling device is a bubbler containing a fluid medium to

dissolved or react with the gas

The collected samples will be sent to a laboratory where the amount of the

substance on the sampling medium [filter, tube, etc.] is measured.

In some cases air monitoring will be conducted by using direct reading instrument

such as a monitoring for carbon monoxide these instruments can measure the

amount of a contaminant in the air immediately without being sent to a laboratory.

PELs [Permissible Exposure Limits] – these are legal‘s limits which have been

established by OSHA.

Recommended PELs – also reference to as RELs [Recommended Exposure

Limits] often these values are based on more recent scientific information than

the legal PELs enforced by OSHA.

TLVs [Threshold Limit Values] – These are exposure limits put out by a

nongovernmental group, the ACGIH [American Conference of Governmental

Industrial Hygienists]. Many of these were adopted as legal requirements.

Revised TLVs are often based on the most recent and accurate scientific

information.

Permissible Exposure Limits by OSHA [Occupational Safety and Health

Administration] when it started back in 1970.

IDLH [Immediate Dangerous to Life or Health] limits are prescribed by NIOSH

[National Institute of Occupational Safety and Health]

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PAC [Protective action criteria] for Hazardous chemicals prescribed by

Emergency management issues special interest group, UNITED STATES.

AEGL [Acute exposure guideline levels] values given by U.S Environmental

protection agency.

7.15 CHEMICAL EXPOSURE LIMITS & EMP FOR THE OCCUPATIONAL SAFETY

& HEALTH HAZARDS

TABLE: 7 .6 CHEMICAL EXPOSURE LIMITS

S. No SOLVENT NAME ACGIH [TLV ]

OSHA [ PEL ]

1 Methanol 200 200

2 Toluene 50 200

3 Acetone 500 1000

4 Ethyl acetate 400 400

5 MDC 50 500

6 Cyclohexane 300 300

7 Thionyl chloride 1 1

8 Ammonia 25 50

9 n-Hexane 50 50

Notes:

All the above Values are in ppm

PPE Means Personal Protective Equipment like Helmets, Safety Google,

Breathing apparatus, Nose Masks, Gloves, Gum Shoes etc.,

NOTE: Medical testing reports of the Employees will be available at the time of

industry in operation

EMP for the Occupational Safety & Health Hazards so that such exposure can be

kept within permissible exposure level (PEL) / Threshold Limit value (TLV) so as to

protect health of workers.

1. It is proposed to formulate and implement an EMP for Occupational Safety and

Health with following aim

To keep air-borne concentration of toxic (if available) and hazardous

chemicals below PEL and TLV.

Protect general health of workers likely to be exposed to such chemicals

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Providing training, guidelines, resources and facilities to concerned

department for occupational health hazards

Permanent changes to workplace procedures or work location to be done if it

is found necessary on the basis of findings from workplace Monitoring Plan.

2. Proposed EMP will be incorporated in Standard Operating Procedure also

3. The proposed EMP will also include measure to keep air-borne concentration of

toxic and hazardous chemicals below its PEL and TLV, like…

Leak Surveys

Separate storage for toxic chemicals

Exhaust Ventilation

Proper illumination

Close processes to avoid spills and exposures

Atomization of process operations to hazards of manual handling of chemicals

Supply of proper PPEs like Air mask, Breathing canisters, SCBA sets.

Decontamination procedure for empty drums and carboys.

Regular maintenance program for pumps, equipment, instruments handling

toxic and corrosive chemicals

Display of warning boards

Training to persons handling toxic and corrosive chemicals.

.

4. Workplace Monitoring Plan

It is proposed that a Workplace Monitoring Plan to be prepared &

implemented accordingly.

Each workplace must be evaluated to identify potential hazards from toxic

substances or harmful physical agents. Air-borne concentration of toxic

chemicals will be measured and record will be kept.

The current state-of-the-art exposure measurement model is as follows: For

purposes of measuring worker exposure across a single shift it is sufficient to

place a reasonably accurate exposure measuring device near the worker‘s

area, within the worker‘s breathing zone, and have it operate for nearly the full

shift. Client has been proposed to study the exposure data when the plant is

operative.

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5. Health Evaluation of Workers

It is proposed that management will devise a plan to check and evaluate the

exposure specific health status evaluation of workers.

Workers will be checked for physical fitness with special reference to the

possible health hazards likely to be present, where he/she is being expected

to work before being employed for that purpose. Basic examinations like

1. Liver Function tests,

2. Chest X-ray,

3. Audiometry,

4. Spirometry Vision testing (Far & Near vision, color vision and

Any other ocular defect)

5. ECG, etc. will be carried out.

However, the parameters and frequency of such examination will be decided in

consultation with Factory Medical Officer.

While in work, all the workers will be periodically examined for the health with

specific reference to the hazards which they are likely to be exposed to during

work. Health evaluation will be carried out considering the bodily functions

likely to be affected during work. The parameters and frequency of such

examination will be decided in consultation with Factory Medical Officer. Plan

of monthly and yearly report of the health status of workers with special

reference to Occupational Health and Safety, will be maintained.

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7.16. TREATMENT OF WORKERS AFFECTED BY ACCIDENTAL SPILLAGE OF

CHEMICALS

[Interim First Aid for General Injuries & Wounds]

Interim First Aid is essential in many injuries while injured waits for trained personnel

to arrive.

BLEEDING

Apply direct pressure on the wound with a clean dressing.

If bleeding continues and you do not suspect a fracture, elevate the wound

above the victim‘s heart and continue to apply direct pressure.

If bleeding continues, apply pressure at a pressure point.

Maintain body temperature.

Do not use a tourniquet unless this is a serious amputation.

BREATHING PROBLEMS

Move victim to fresh air if smoke or dangerous gases are present.

Otherwise, do not move victim.

If victim loses consciousness, call doctor

Never enter into a room with toxic gases released -call without protection

UNCONSCIOUS VICTIM

Move victim to fresh air if smoke or dangerous gases exist.

Begin rescue breathing- is First Aid trained ahead of time

Never enter into a room where toxic gases released

CHEMICAL BURNS

Have victim remain under a safety shower or flush skin with an available

water source for 15-30 minutes.

Remove all contaminated clothing and jewellery.

Cover burns with dry, loose dressings.

Wash all clothing thoroughly before wearing it again.

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ACID BURNS

In case of acid burn, the operator should with all possible speed get under a

safety shower and use the full flow of water - the more water the better. A

small amount of water will incase severity o f the burn Water should be used

until all traces of acid have been washed from the burn. Alkaline solutions are

not needed; if used at all they should be used only after all acid has been

washed from the burn, it may to treat in the same manner as a heat burn.

CHEMICAL INGESTIONS

Never enter into a room where toxic gases released, without protection

Do not give victim any food or liquids without specific advice from physician.

EYE INJURIES FROM CHEMICALS

Get victim to a safety shower or eye wash immediately.

Never enter into a room where toxic gases released

Flush eye for 15-30 minutes with both lids held open. Keep the injured eye

lower than the uninjured eye.

Keep the eyelids open hold fingers at top and bottom of the eyeball. Wrap a

bandage loosely around both eyes.

SAFE OPERATING PROCEDURES

Safe operating procedures will be available for all materials, operations and

equipment.

The workers will be informed of consequences of failure to observe the safe

operating procedures.

Safe operating procedures will be formulated and updated, specific to process

& equipment and distributed to concerned plant personnel.

Safety procedures will be prepared and displayed meticulously in Telugu and

English languages.

FIRE PROTECTION

Well-designed pressured hydrant system comprising with jockey pump,

electrical & diesel pumps, hydrant, monitor etc. Will be installed at the plant.

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The fire fighting system and equipment will be tested and maintained as per

relevant standards.

Heat and smoke detectors will be provided at the plant and warehouse(

solvent storage in drums) and calibrated and maintained properly.

STATIC ELECTRICITY

All equipment and Storage tanks / Containers of flammable chemicals are will

be bounded and earthed properly.

Electrical pits will be maintained clean and covered.

Electrical continuity for earthing circuits shall be maintained.

Periodic inspections shall be done for earth pits and record will be maintained.

7.18 COMMUNICATION SYSTEM

Communication facilities will be checked periodically for its proper functioning.

7.19 SAFETY INSPECTIONS

The system will be initiated for checklist based routine safety inspection and internal

audit of the plant. Safety inspection team will be formed from various disciplines and

departments.

7.17 PREDICTIVE AND PREVENTIVE MAINTENANCE

Predictive and preventive maintenance schedule will be followed in religious manner.

ELECTRICAL SAFETY

Insulation pad at HT panels will be replaced at regular interval.

Housekeeping in MCC room will be kept proper for safe working conditions.

COLOUR CODING SYSTEM

Colour coding for piping and utility lines are will be followed in accordance with IS:

2379:1990.

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DISASTER MANAGEMENT PLAN

ONSITE EMERGENCY PLAN

OFFSITE EMERGENCY PLAN

7.18. ONSITE EMERGENCY PLAN

The details of Onsite emergency plan system are discussed in the following sections

DEFINING THE NATURE / LEVEL OF EMERGENCY

The levels of emergency can be classified in three categories

LEVEL-1

The leakage or emergency which is confinable the plant, premises. It may be due to-

Small fire in the plant

Low toxic gas release for short duration.

Collapsing of equipment that do not affect outside premises.

LEVEL-2

The emergency which is confinable within the factory premises. It may arise due to-

Major fire inside the factory premises.

Medium scale explosion confined to the factory premises.

Heavy toxic/flammable gas leakage for short duration.

LEVEL-3

The emergency, which is not confinable within the factory premises and general

public in the vicinity likely to be affected. It may arise due to-

Explosion of high magnitude affecting the adjacent area

Heavy/profuse leakage of toxic/flammable gases for a long duration.

7.19 STRUCTURE OF EMERGENCY MANAGEMENT SYSTEM

The company will develop an emergency management team. The management

structure includes the following personnel

Site main Controllers

Incident Controllers and Deputy Incident Controllers

Key Personnel‘s

Essential Workers

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The other elements of Disaster management plan are

Assembly points

Emergency control center

Fire control center

Medical arrangements

Other arrangements

7.20 EMERGENCY MANAGEMENT SYSTEM – ROLES & RESPONSIBILITIES

Roles and responsibilities of the responsible persons are described.

7.20.1 SITE MAIN CONTROLLER [SMC]

PLANT HEAD will be the site main controller. In absence of PLANT HEAD, EHS

HEAD will act as a SMC

His task will be to co-ordinate all internal and external activities from the emergency

control centre at main security gate from where all operations will be directed. He

shall:

Immediately on being informed of the emergency and its location, will arrive

at the scene and handle the situation.

Relieve the incident controller from responsible of the main controller

Co-ordinate to avail services from external agencies like fire brigade,

hospitals etc. is called for, following the declaration of major emergency. If

necessary, major installations in the vicinity may also be informed of the

situation.

Exercise direct operational control of the unaffected section of the plant.

In consultation with the advisory team, expedite the shutting down of

loading/unloading operations of tankers and if necessary, instruct the

supervisor/security/personnel to evacuate tankers.

Ensure that all employees are evacuated from the affected area and the

casualties, if any, are given necessary medical attention. Instruct P&A

Assistant/security for rushing casualties to hospitals if required.

Liaise with fire and police officials, pollution control board officials and other

statutory bodies and advise them of all possible consequence effects

outside the premises.

Arrange for relief of personnel when emergency is prolonged

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Issue authorized statement or press release to the news –media

Ensure preservation of evidence for enquiries to be conducted by statutory

authorities.

Authorize the sounding of “All Clear” and “Evacuation Siren”

Arrange for obtaining the head-count of all personnel within the premises

and cross-checking with the data from records available for no. of persons

within the premise.

7.21 INCIDENT CONTROLLER/ DEPUTY INCIDENT CONTROLLER

Role of Incident Controller [Plant Manager/Shift in Charge].He is the shift supervisor

of the plant. Assume the role of the incident controller and take charge of the

situation. Keep the SMC informed of the situation from time to time.

1. Proceed to the scene of emergency and assess the situation

2. Direct all operation within the affected area with the following priorities

Safety of personnel

Minimize damage to property and loss of material

Arrange for rescue of trapped workers and those in a state of shock

Get all non-essential persons safely evacuated after stopping all the

engineering/hot jobs.

Set up a communication system with the main control center at the main

security gate through telephone or messenger system.

Pending arrival of the main controller, direct the shutting down and

evacuation of the site

Report all developments to the main controller

Preserve all evidence for use in the subsequent enquiry.

Intimate to the Emergency Control Center (Main Security Gate) the head

count of plant.

7.22 KEY PERSONNELS

Key Personnel are required to provide and to implement the decisions made

by the SMC in the light of information received on the developing situation at

the time of emergency.

As necessary, they will decide the actions needed to shut down plants,

evacuate personnel, carryout emergency engineering work, arrange for

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supplies of equipment, utilities, carryout environment monitoring, provide

catering facilities, liaise with police, fire brigade and other local authorities,

relative of casualties, hospital, press & neighboring industries

Action at assembly points, outside shelters and mutual aid center under the

direction of the SMC.

All the key personnel and other called in so to assist shall report to the ECC.

They shall be available at any time on duty or on call or on holiday.

7.23 ESSENTIAL WORKERS

A task force of essential trained workers [Expert‘s team] is available to get the work

done by the Incident controller and the SMC. Such work will include:

Fire fighting and spill control till a FIRE BRIGADE takes the charge

To help FIRE BRIGADE and MUTUAL AID teams, if it is so required

Shutting down plant and making it safe

Emergency engineering work e.g. isolating equipments, material process,

providing temporary by pass lines, safe transfer of materials, urgent repairing

or replacement, electrical work, etc

Provision of emergency power, water, lighting, instruments, equipments,

materials, etc

Movement of equipment, special vehicle and transport to or from the scene of

the accident.

Search, evacuation, rescue and welfare.

The injured is given First Aid.

Moving tankers or other vehicles from area of risk.

Carrying out atmospheric test and pollution control.

Manning of assembly points to record the arrival of evacuated personnel.

Manning for outside shelters and welfare of evacuated persons there.

Assistance at causalities reception areas to record details of causalities.

Assistance at communication centers to handle outgoing and incoming calls

and to act as messengers if necessary.

Manning of works entrances in liaison with the police to direct emergency

vehicles entering the work. To control traffic leaving the works and to turn

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away or make alternative safe arrangements for visitors for visitors,

contractors and other traffic arriving at the works.

Inform neighbouring factories and the public as directed by the Site Main

Controller.

Any special help required.

7.24 OTHER ELEMENTS OF DMP

There are some other elements of DMP which are described as follows:

7.24.1 ASSEMBLY POINT

Assembly points are those locations where the persons who are not connected with

emergency operations can await either for further instructions or for rescue transport

and rehabilitation. Security office will be considered assembly point, taking into

consideration of the size of the plant facilities.

The affected & vulnerable plants, all non-essential workers [who are not

assigned any emergency duty] will be evacuated from the area & they shall

report to specified Assembly point.

Assembly Point shall be located at a safe place, well away from area of risk

and least affected by the down wind direction.

To ensure that workers do not have to approach the affected area to reach

the Assembly point proper location and numbers have been marked at

Assembly point.

Each Assembly Point is manned by a nominated person to record the names

and dept.

At each Assembly point duties of In - charge shall be displayed in brief.

Before reaching an Assembly point or subsequently, if it is required to pass

through an affected area or due to presence of toxic substances, suitable

PPE‘s including respirators, helmet etc., are issued & made available with

workers.

7.24.2 EMERGENCY CONTROL CENTER

The emergency Control Center is the place or room from where the operations to

handle the emergency are directed and coordinated. Main Control Room has been

earmarked / identified as the Emergency Control Room. Fire Control Room shall be

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earmarked / identified as the alternative Emergency Control Room to be operated in

case of unfavorable wind direction. Adequate Telecommunication System is

available in the Emergency Control Room.

The ECC center has been equipped with the following facilities.

1. Internal and external telephone including STD facility

2. Telephone directory

3. Factory layout plan

4. Map of the area

5. Employee blood group and their address

6. Messengers / Runners for sending messages

7. Adequate numbers of PPE‘S

8. Telephone nos. of mutual aid centers, Statutory authorities & Hospitals

7.24.3 FIRE SERVICES

Fire Fighting, Gas leak Control and Rescue operation

A] Role of Manager -Fire and Safety/shift in-charge

Manager [EHS] shift in-charge [EHS] will be the only person to direct the

fire fighting and emergency operation.

Keep the constant touch with the chief emergency controller.

Direct the crew members to the scene of emergency and arrange

replenishment of man power/equipment/extinguishing media etc.

B] Fire and Safety officer

On being notified about the location of fire/gas leakage immediately

proceed to the scene of incident with fire tender and crew.

Position the fire tender in upwind direction.

Decide his line of action in consultation with incident controller and take

appropriate measures to handle the emergency.

Assessing the severity of the incident immediately report to emergency

controller about the gravity of the situation.

He will assess the extra requirement required if any from the neighboring industry.

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C] Fire Crew Members

On hearing fire alarm, emergency siren they shall immediately report to

control room and proceed to the scene of emergency and work under the

direction of shift fire & safety officer.

The personal availability at the scene of incident to be made optimize.

D] Emergency Squad Members

On hearing Emergency Siren ,they shall immediately report to site main

controller, safety in charge or incident controller

They shall combat the emergency situation as per the direction of site main

controller, Safety In- charge or Incident controller

They shall help for safe evacuation

7.24.4 MEDICAL SERVICES

A] Role of Chief Medical Officer/Medical Officer [Medical Assistance]

He will contact immediately to chief emergency controller

He will render necessary treatment as first aid center and hospital.

He will arrange for hospitalization and treatment at outside hospitals if

required.

He will mobilize extra medical assistance from outside if necessary.

He will make arrangement for treating public if necessary.

B] Role of other Medical staff

As directed by medical officers.

7.24.5 SECURITY SERVICES

Role of H.O.D. (Security) / Security Officers.

Receive message from the observer

Initiate the emergency siren to declare the emergency

Announce on the public address system

Arrange to close all the gates and stop traffic

Keep vehicle/ambulance ready and keep track of casualty sent to hospital

during off hours

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Ensure that unauthorized persons/vehicles do not enter the premises

Organize the positioning and transport of vehicles near the main gate

Depute security guard for controlling traffic at the scene of emergency

Call up for additional help from the outside agency like fire brigade,

hospitals during off hours.

Role of Security Guard

On hearing emergency siren contact security officer and work under his

directions

7.24.6 MUTUAL AID

In emergency situations, resources over and above those available at the works may

be needed. Emergency Coordinator would be contacting neighboring factories for

help. A survey of industries who can come to help and also the help, they can extend

is done as mentioned below.

The help would be in the form of technical manpower, medical aid,

transport for rescue and Rehabilitation, fire fighting, additional special

protective wear or any other help as the case may be.

Manager – Safety who is Emergency Coordinator is assigned with this

responsibility and he would maintain liaison during non-emergency period

and ensure co-operation

Similarly, the help required from civil administration, in respect of medical

aid, transport, law and order, rehabilitation etc. are identified and liaison is

established with Mandal Revenue Officer and Police Officials.

7.25 EMERGENCY RESPONSE

Concept of operations deals with the possible steps associated with an

emergency response assuming the most severe emergency scenario. This

includes:

Accident initiation and rising of alarm

Accident evaluation and emergency declaration

Off site and external agency notification

Implementation of onsite response actions

Implementation of protective actions and evacuations

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Co-ordination of response action with external agencies

Management of emergency resources

Recovery and facilitate re-entry procedures

7.26 EMERGENCY CAPABILITIES

The primary emergency response facilities comprise with emergency control

center upon declaration of emergency, the main security gate office will become

the emergency control center [ECC].The ECC is located in a low /minimal risk

zone of the plant. It is manned round.

7.27 EMERGENCY HANDLING PROCEDURES

Action plan

On hearing emergency declaration siren and announcement on public

address system, all key persons will rush to their nominated location and

start actions.

The main controller will continuously assess the situation by taking

feedback from the incident controller. He will consult the advisory team

members to get essential information if required but if does not required to

take help from advisory team; he can assign other jobs to advisory team.

Once the emergency is brought under control, Main Controller will inform to

security to give “ALL CLEAR” siren and announce on Public Address

System about termination of emergency.

In the case the emergency assumes off site dimensions and cannot be controlled,

then if the chief controller with his advisory team decides to evacuate the plant, he

will instruct the security to sound ―EVACUATION SIREN”

Procedure in case emergency tends to have off site implications

As per the sire plan and wind direction at the time of emergency, the likely

affected area will be identified and population within will estimated.

The police will be informed so that in-coming traffic on highway can be

controlled from both the ends. The police force will be helpful in

evacuation of villages, factories or other public places in the vicinity

The fire brigade will be informed and ambulance will be called and kept

ready to meet any eventuality.

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Neighboring factories will be communicated for sending help.

Statutory authorities such as factory inspector, district collector and others

concerned to be intimated.

Procedure for salvage operations

The salvage operation will be carried out under the guidance of the main

controller, his advisory team and incident controller.

They will conduct accident investigation; assess the damages-the clock by

security supervisors.

During emergency, the main controller and his advisory-team will confirm:

Layout of facility, equipment and storages, displayed on table and wall

Availability and location of personal protective equipment

Self-contained breathing apparatus sets and the spare cylinders

External telephone with direct dialing and STD facilities/Mobile phone

Internal telephone

List of important internal and external telephone numbers displayed on

table and wall.

Transport facility

Extra copies of plant layout for marking during emergency

General stationary like paper, pencil etc.

Nominal roll and address of all employees with contract telephone no‘s

and blood group

List of first aiders and emergency squad members

Details of all contractors and their employees.

Details of meteorological information during different seasons such as

wind speed, direction, temperature, humidity etc.

The location of ECC, Assembly point, availability of first aid boxes, fire

extinguishers, PPE should be marked onsite.

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7.28 MITIGATION OF ENVIRONMENTAL IMPACT DURING FIRE EMERGENCY

In case of fire, cut of contact of fire with flammable material or prevent of

fire by other means

Use water or suitable fire extinguisher to extinguish fire

Contain the contaminated water or any other liquid to prevent it going to

soil or drain and divert it to ETP storage tank. If required treat it before

sending to ETP tank.

Any solid waste generated should be collected, stored and send to TSDF

site.

During fire emergency use necessary PPE.

Bottom valve failure: mitigation of environment impact during failure of

between valves or tank failure.

In case of material coming out of the bottom valve shall be contained

inside the dyke wall and will be transferred to HDPE plastic drum by help

of pump/piping.

In case of acid spillage after pumping shall be neutralized and waste shall

be cleaned with help of water and send the water to ETP.

The failed bottom valve shall be replaced or repaired and restart. After

tank is empty valve will be repaired, or replaced. In case of leakage form

tank body tank will be repaired.

Preventions of failure: preventive maintenance of bottom value shall be

carried out as per schedule. To prevent any leakage from tank body,

thickness checking shall be same as per schedule.

In case of bottom value failure or heavy leakages from tank body material

in the tank shall be transferred to the HDPE drums, by running the pump.

Preventions of failure: preventive maintenance of bottom valve shall be

carried out as per schedule. To prevent any leakage from tank body,

thickness checking shall be same as per schedule.

In case of any material leaching the soil it shall be neutralized and

washed with water.

7.28.1 RAISING THE ALARM

Emergency alarm shall be raised in the event of an emergency.

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Any person noticing an unusual occurrence, fire,toxic or corrosive

substance leakage etc. shall inform the concerned department/section

head/shift in charge immediately and try to control/contain the incident.

Departmental head/shift in charge will immediately go to the site of

incident, assess the situation and initiate the action to ―blow the

emergency Alarm‖ by telephoning the main gate to security officer/Asst,

security officer/Security supervisor.

In case of telephone failure a messenger will be sent running to main gate

to inform.

Details of siren are given below

Siren codes

Declaration of emergency:-A long short wailing siren for one minute will

mean that there is an emergency within the premises.

All clear siren: - A long siren for one minute will mean that the emergency

declared is under control, i.e. all clear. This siren code will mean All clear,

normal condition.

Evacuation siren: - A long short wailing siren for 3 [three] minutes, will

mean that emergency declared cannot be controlled. Hence all persons in

the premises will evacuate as per the plan.

7.29 DECLARING MAJOR EMERGENCY

Major emergency may be declared after sufficient thought because it activates many

agencies and the nominated persons to declare major emergencies.

7.30 TRANSPORT AND EVACUATION ARRANGEMENTS

Arrangements shall be made for the transport and evacuation of persons in

case of any emergency situation arises in the factory.

Those employees who have own vehicles will make arrangements to shift the

injured.

7.31 PLANT OPERATIONS

1. Role of HOD

He will take plant related decisions, which will facilitate the fire fighting

operation.

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2. Plant Employees

They shall:

On heaving the siren, report to plant supervisor

Do as directed by plant supervisor

Stop all hot works

Remove unwanted persons from the affected area to the ―Assembly Point

―near main security gate viz visitors, guests

Stop all non-essential operations

3. Non-plant Employees

On hearing the siren, shall stop their work assemble at ―Assembly Point‖ near main

security gate along with guests and visitors.

7.32 TELEPHONE MESSAGES

Telephone operator has to pay vital role in case of emergency. After hearing the

siren/hooter, he/she should inform to all key personnel immediately on phone.

He/she should receiving be very sharp, precise, attentive and quick in & noticing the

message.

7.33 MOCK DRILL

In spite of detailed training, it may be necessary to try out whether, the OSEP works

out and will there be any difficulties in execution of such plan. In order to evaluate

the plan and its effectives of meeting the objective of the OSEP, occasional mock

drills are contemplated. After a few pre- informed mock drills, few un-informed mock

drills would be taken. All this is to familiarize the employees with the concept and

procedures and to see their response. These scheduled and unscheduled mock

drills would be conducted during shift change, public holidays, in night shifts etc, to

improve preparedness. Emergency Coordinator [EHS] is responsible for organizing

planned and unplanned mock drills.

Two types of Mock drills are in practice. They are

1. Announced-Once in 3 months

2. Unannounced –Once in 6 months.

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Mock drill observation

Mock drill observation team is constituted and they note down the action of various

coordinators in chronological order. The time of arrival of each coordinator and their

duties are detailed in a note. Immediately after mock drill, the advisory team and

emergency coordinators meet and review the mock drill records in chronological

order and take note of corrective action. The record of this meeting note is circulated

for compliance of concerned.

Role of Mock drill observers

Note readings of plant instruments

Meteorological conditions

Time of emergency declaration and time when the personnel responded /

reported

Ambulance reported and time when additional vehicles reported

Collect information description of the event, estimated quantity of the gas

release, fire, contamination and effected levels at various locations, injuries

and equipment damage.

7.34 OFFSITE EMERGENCY PLAN

―If the accident is such that its affects inside the factory are uncontrollable and it

may spread outside the factory premise, it is called as “OFFSITE EMERGENCY”

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FLOWCHART FOR OFFSITE EMERGENCYPLAN

The Offsite emergency plan is made based on events, which could affect people and

Environment outside the premises. The off site plan is largely a matter of ensuring

the co-ordination of proposed services and their readiness as far as possible, for the

specific hazards and problems, which may arise in as incident. Briefly two main

purposes of the plan are as under:

To provide the local district authorities, police, fire brigade, doctors etc. the basic

Information of risk and environmental impact assessment and to appraise them of

the consequences and the protection / prevention measures and control plans and to

seek their help to communicate with the public in case of major emergency.

To assist the district authorities in preparing the Offsite emergency plan of the

district or particular area. We will make our key personnel and others fully aware

about this off-site emergency plan. The function of the offsite plans are as under:

Structure of the offsite emergency plan includes the following:-

Organizational set up-Incident controller /Site main controller, Key personnel,

etc

Communication facilities - List of important telephones

Specialized emergency equipment - Firefighting equipment

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Specialized Knowledge - Trained people

Voluntary Organization - Details of organization

Chemical information - MSDS of hazardous substances

Meteorological information - Weather condition, Wind velocity etc

Humanitarian arrangement - Transport, First aid, Ambulance

7.35 ROLE OF THE FACTORY MANAGEMENT

The Onsite and Offsite plans are come together so that the emergency services are

call upon at the appropriate time and are provided with accurate information and a

correct assessment of situation.

7.35.1 ROLE OF LOCAL AUTHORITY

Generally the duty to prepare the off-site plan lies with the local authority. They may

have appointed an Emergency planning officer (EPO) to prepare whole range of

different emergency within the local authority area.

7.35.2 ROLE OF FIRE AUTHORITY

The control of a fire is normally the responsibility of the senior fire brigade officer who

would take over the handling of fire from the Incident Controller on arrival at the site.

7.35.3 ROLE OF POLICE

The overall control of an emergency is normally assumed by the police with a senior

officer designated as emergency coordinating officer. Formal duties of the police

during emergency include protection of life and property and controlling traffic

movements.

7.35.4 ROLE OF HEALTH AUTHORITIES

Health authorities, including doctors, surgeons, hospitals, ambulances etc. have a

vital role to play following a major accident and they should form an integral part of

the emergency plan. Major off site incidents are likely to require medical equipments

and facilities in addition to those available locally.

7.35.5 ROLE OF THE “MUTUAL AID” AGENCIES

Some types of mutual aids are available from the neighboring factories, as per need,

as a part of the onsite and Offsite emergency plan.

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7.25.6THE ROLE OF THE FACTORY INSPECTORATE

In the event of an accident, the factory inspector will assist the District Emergency

Authority for information and help in getting mutual aid from neighboring factories.

Unit maintains the records of details of emergency occur, corrective preventive

measures taken and in future the same practice will be continued. Unit will be

displayed the details like list of assembly points, name of the persons involve in the

safety team like Site Controller, Incident controller etc.

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PROJECT BENEFITS

CHAPTER -VIII

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CHAPTER – VIII

PROJECT BENEFITS

The proposed project will become beneficial to the surrounding area or community in

terms of employment, social development and other benefits as described hereunder;

8.1 EMPLOYMENT POTENTIAL

The proposed project has employment potential for skilled (50 persons), semi-skilled

(30 persons) and unskilled (20 persons). The preference will be given to local

population for employment; this will increase the employment opportunity in the

surrounding area. Indirect employment is also bound to be generated to provide day-to-

day needs and services to the work force and industrial activity. This will also increase

the demand for essential daily utilities in the local market. The employed people will be

benefited financially.

8.2 CORPORATE SOCIAL RESPONSIBILITY (CSR) & CORPORATE

ENVIRONMENT RESPONSIBILITY (CER)

Archimedis Laboratories Pvt. Ltd not only carries out business but also understands

obligations towards the society. Unit will employ people from the nearby villages for the

proposed project. The wages paid to direct and indirect workforce in the proposed

project will fulfill their monetary requirements, which in turn leads to socio economic

development in the surrounding villages. The Project proponent is well aware of the

obligations towards the society and to fulfill the social obligations Unit will also try to

generate maximum indirect employment in the nearby villages by appointing local

contractors during construction phase as well as during operation phase. Unit will be

contributing reasonably as part of their CSR & CER activities. Unit will spend about

2.5% for CSR & 2% for CER activities like potable water supply & educational aid and

conduct medical camps & Self Help Skill Training to the nearby villages. CSR activities

identified and planned at present are described below Table.

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CSR & CER BUDGET FROM ARCHIMEDIS LABORATORIES PVT. LTD. Project Location : Archimedes Laboratories Pvt. Ltd.

CSR Plan Period : Five Years from the date of commercial production.

Project cost : Rs. 30 Crores

Corporate Social Responsibility Budget : Rs. 75 Lakhs [2.5% of the Project cost] for 5 Years

Corporate Environment Responsibility Budget : Rs. 60.0 Lakhs [2% of the Project cost]

S.No CSR & CER

Activity 1st

Year 2nd

Year 3rd

Year 4th

Year 5th

Year

Total (Rs. In Lakhs)

Proposed Action Plan

1 Drinking water supply to nearby villages.

9.0 9.0 9.0 9.0 9.0 45.0

Proposed to establish RO plant for

drinking water supply to Jayanthipuram

Pochampalli, Ravirala & Bandipalem,

villages.

2 Educational Aid to the school students

5.0 5.0 5.0 5.0 5.0 25.0

Supply of books, uniforms and other

educational aides like computers with

internet facilities to nearby village schools.

3 Medical Camps 5.0 5.0 5.0 5.0 5.0 25.0

Free Health checkup and supply of

medicines to the sick people in the nearby

villages.

4 Self Help Skill Training

8.0 8.0 8.0 8.0 8.0 40.0

Based on local identified needs, we will

set up training centre to impart skills such

as tailoring, toys making, book binding and

basic computer skills to local women and

men

Self help skill Training : Unskilled

/Semiskilled persons will be identified in

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S.No CSR & CER

Activity 1st

Year 2nd

Year 3rd

Year 4th

Year 5th

Year

Total (Rs. In Lakhs)

Proposed Action Plan

villages and given necessary training as

per industry requirement and we will

absorb the personnel in industry as and

when need arises

Total CSR & CER Budget

27.0 27.0 27.0 27.0 27.0 135.0

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8.3 DIRECT REVENUE EARNING TO THE NATIONAL AND STATE EXCHEQUER

This project will contribute additional revenue to the Central & State exchequer in the

form of Central GST & State GST. Thus, the proposed project will help the Government

by paying taxes from time to time, which is a part of revenue and thus, will help in

developing the area. Demand of the proposed products in foreign market is also

significant, which will boost the export potential of the company as well as country.

Export oriented units plays vital role in development of economy as well as local

physical infrastructure for further boosting of industrial development with sustainable

approach as the industries need to maintain good environment & safety environment to

get better foreign market.

8.4 IMPROVEMENTS IN THE PHYSICAL INFRASTRUCTURE

The project proponent has proposed to develop infrastructural facilities like roads,

drinking water and power to the proposed site, easily accessible approach roads

required for public transport and material transport to the project site. Hence major

benefit to the public infrastructure is anticipated due to the proposed project.

8.5 IMPROVEMENTS IN THE SOCIAL INFRASTRUCTURE

The proposed project will have many employment & trade opportunities from the

inception of the construction activities. Thus, these considerable employment & trade

opportunities will eventually result in appreciable economic benefits to the local people

& businesses/contractors and helps to improve in the social infrastructure.

8.6 OTHER TANGIBLE BENEFITS

With this new unit, Archimedis Laboratories Pvt. Ltd. contributes to growth in

manufacturing sector and the country will also benefit from GST revenues, Foreign

exchange earnings from exports are envisaged. Beside economic benefits, the general

social & cultural development of the area is anticipated due to the CSR & CER activities

planned by the company. The long-term implications of this change can be definitely

considered as progressive development of surrounding area.

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ENVIRONMENT COST

BENEFIT ANALYSIS

CHAPTER -IX

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CHAPTER - IX

ENVIRONMENT COST BENEFIT ANALYSIS

9.0 COST BENEFIT ANALYSIS

During the scoping stage; no recommendation of environmental cost benefit analysis is

suggested by the appraisal committee.

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ENVIRONMENTAL

MANAGEMENT PLAN

CHAPTER -X

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CHAPTER – X

ENVIRONMENT MANAGEMENT PLAN

10.1 INTRODUCTION

Environmental Management Plan reflects the commitment of the management to

protect the environment within and outside the industrial premises. An environmental

management plan is required for formulation and monitoring of environmental

protection measures during and after construction / Modification and commissioning

of the projects. Hence, the construction and operational phase is considered for

outlining the Environmental Management Plan for the said industry. The plan

indicates the details as to how various measures have been taken by the industry to

mitigate the pollutants generated due to its operations.

The Potential Environmental Impacts from the construction and operational activities

of the industry are summarized below.

A. Construction / Modification Phase:

Site preparation, sanitation, noise, construction equipment & waste and site

security.

B. Operation Phase:

Air pollution due to emission of Particulate Matter, Sulphur dioxide, Nitrogen

oxide from the boiler stack and D.G. Set.

Gaseous emissions from process leading to workroom air pollution.

Noise pollution due to noise generating equipment operation.

Disposal of effluent generated due to plant operations.

Disposal of Solid Wastes generated due to the plant operation.

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FIGURE -10.1: FLOW CHART OF EMP

IDENTIFICATION OF THE

POTENTIAL IMPACTS

RECOMMENDED MITIGATION

MEASURES

DESCRIPTION OF MONITORING PROGRAM

ENSURE COMPLIANCE WITH RELEVANT STANDARDS AND

RESIDUAL IMPACTS

ALLOCATION OF RESOURCES AND RESPONSIBLITIES FOR

PLAN IMPLEMENTATION

IMPLEMENTATION SCHEDULE

AND REPORTING

PROCEDURES

CONTIGENCY PLAN WHEN

IMPACTS ARE GREATER THAN

EXPECTED

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10.2 PRE- PROJECT ENVIRONMENTAL MANAGEMENT PLAN

Construction related impacts:

The industry is proposed to establish Bulk Drug Intermediates manufacturing unit.

The potential for environment pollution during the construction is obviously

considerably less than when the plant is in operation. The following factors require

control during the construction phase.

10.2.1 Site Preparation

The leveling operation will involve stockpiling of backfill materials. All the disturbed

slopes shall be stabilized with grass cover and dust nuisance controlled.

10.2.2 Sanitation

The site will be provided with sufficient and suitable toilet facilities with proper

hygiene for construction workers. Adequate potable water supply will be provided for

onsite workers.

10.2.3 Noise

The total noise effect in the vicinity during construction stage will be negligible in the

site and the site is far away from the nearest human habitation.

10.2.4 Construction Equipment and Waste

It will be ensured that construction related vehicles are properly maintained to

minimize exhaust emissions. Combustible waste will be burnt in a controlled manner.

Other wastes will be disposed off in to a dedicated dump. Spent liquid waste if any,

arising from chemical treatment of built-up portions for termites etc, will be correctly

neutralized and disposed off.

10.2.5 Site Security

The site will be secured by fencing and manned at entry points.

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10.3. ENVIRONMENTAL MANAGEMENT DURING OPERATION

10.3.1 AIR QUALITY

The emissions from boilers & D.G. Set are the sources likely to contribute to air

pollution. Adequate measures are being taken to minimize the impacts of these

emissions on the environment.

The baseline data collected during the study period indicate that all five pollutants

namely PM2.5, PM10, SO2, NOX, CO, NH3 and VOCs.

For generation of Steam, the industry proposed to install 4 TPH & 8 TPH coal fired

boilers & 5 TPH coal fired boiler is kept as stand by.

The coal requirement of 48 TPD will be met from government allocation or from local

authorized sources.

A 500 KVA & 1000 KVADG set is proposed for this project for usage during the

power failures. The industry proposed to install 6x200 TR, 1x250 TR & 1x300TR

cooling towers.

10.3.1.1 AIR POLLUTION CONTROL / MANAGEMENT

Following are the proposed pollution control schemes and which will be used to

minimize and control the emission of air pollutants as well as their effective

dispersion into the atmosphere.

A. Stack Design

The stacks of height 34 mtrs & 30 mtrs with controlling equipment (cyclone separator

followed by Bag Filters) will be provided for the coal fired boilers with the

approximate flue gas exit velocity of 16 m/s & 14 m/s ensures proper dispersion of

the flue gas into atmosphere. This design will ensure the ground level concentration

of the pollutants to comply with the ambient air quality standards.

DG Set Stack emission Controlled by providing adequate stacks height to disperse

into atmosphere and maintain the air pollutants within the limits prescribed by CPCB.

B. Fugitive Emissions from Solvents

Various types of solvents will be used in the proposed Bulk Drugs manufacturing

process. The solvents will be stored in drums and Bulk quantities will be stored in

storage tanks with vent condensers. These are handled in closed conditions thereby

reducing the losses in the form of evaporation. The industry will take measures for

reduction of fugitive emissions by providing Chilled brine circulation to the

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condensers, which ensures the recovery of 95% and also controlled by closed

operations and handling methods. Good ventilation will be provided to reduce the

workroom concentrations. The reactor generating solvent vapors will be connected

to condensers with receivers.

C. Storage and Transportation of Raw Materials

The Raw materials / chemicals will be received in Fiber drums, HDPE drums, PP

bags by trucks. The same will be stored in ware house under lock & key

arrangement. Slight increase of Ground level Dust and VOC in air and it can be

minimized by developing Greenbelt in and around the plant premises and providing

proper roads for transportation.

10.3.2 NOISE POLLUTION

All the equipment in the plant would be designed as per the requirement of CPCB

standards.

NOISE ENVIRONMENT

Compressors, Boiler and DG set will be the major noise generating units in the plant,

of which generator will be functioning only at the time of power failure. There is no

need for the workers to be near the DG set & compressor units continuously. The

Generator sets will be placed in acoustic enclosures to maintain the noise levels as

permitted by CPCB.

NOISE POLLUTION CONTROL / MANAGEMENT

The noise levels in the work place environment will be monitored periodically

and if necessary action will be taken in the form of regular maintenance

schedule to reduce noise and vibration in generating sources.

The effects of the vibrations coming out of the base of the body over the

surrounding civil structures are minimized by providing Damping pads/Resilient

mounting at the time of installation.

Under the general health check up scheme as per factory act, the workers will

however be checked up for any Noise induced Hearing Loss (NIHL) by a trained

ENT Doctor.

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10.3.3 WATER QUALITY

Water is essentially used in process, Boiler and for cooling tower along with

domestic purpose. The total water required for the plant operations will be met from

Ground Water source.

WATER POLLUTION CONTROL / MANAGEMENT

The effluent generation is from process, boiler blow down, DM Plant Regeneration,

Scrubbing System, Floor & Reactor washings and Domestic sections.

The unit will provide proper wastewater collection and Treatment methods to

treat the trade effluent in the plant premises.

Process effluent will be segregated based on COD & TDS concentration and

collected separately by gravity from all sources into a collection Pit.

Collected waste water will be pumped in to the above ground level tanks

separately.

The industry by opting ZLD treatment system to recover water for recycle and

reuse for plant operations and to conserve the scarce resource of water.

Treatment system

The effluent will be neutralized, the HTDS/HCOD effluent will be sent to steam

stripping Column for collection of Organic distillate which is mixed in the waste

water stream. After stripping, effluent will be sent to Multi Effect Evaporation

System, Stripped Organics collected and sent to cement industry/TSDF

incinerator.

The concentrate from the MEE System will be sent to ATFD and salts from

the ATFD will be collected and sent to TSDF for safe disposal.

The condensate from MEE followed by ATFD sent to biological system for

Treatment.

The LTDS effluent along with MEE / ATFD condensate will be sent to

Biological treatment, treated effluent sent to RO for water recovery.

The RO permeate will be reused and RO reject will be sent to MEE followed

by ATFD for further evaporation. MEE condensate collected along with RO

permeates for reuse. Salts from ATFD collected and sent to TSDF.

All the treatment tanks etc. is constructed only with acid proof tiles and 1.5 to

2.5 meters above the ground Level.

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Roof Water Harvesting System will be put in practice to recharge the ground

water.

Strategic Control / Management

Minimizing water usage.

Segregation and collection of effluent for proper treatment and to minimize

waste generation at treatment facility and to recover water for recycle and

reuse.

Reducing the water consumption for the process by way of developing the

process and operation methods.

Prepare SOPs for handling and treatment of effluent water.

Minimize spillage and leakage of effluent to avoid Land pollution.

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FIGURE -10.2: SCHEMATIC DIAGRAM OF PROPOSED WASTE WATER TREATMENT- ZLD SYSTEM

*Water recovery from ZLD system is 84 KLD

HTDS Effluent

52 KLD

Stripper

MEE

51 KLD

ATFD

Salts to TSDF

Organic Distillate to Cement Industry @

2% 1.0 KLD

Vapor Condensate@80%

40.7 KLD

LTDS Effluent 53.8 KLD

BTP

94.5 KLD

Losses @5%

4.7 KLD

MEE

ATFD

RO System

89.8 KLD

RO permeate for Reuse

@70% 62.8 KLD

RO Reject to

MEE 27 KLD

Condensate

@80% 21.6 KLD

Water for Reuse

84.4 KLD

Salts to TSDF

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FIGURE-10.3: FLOW CHART FOR EFFLUENT TREATMENT HTDS

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FIGURE-10.4: FLOW CHART FOR LTDS EFFLUENT TREATMENT LTDS

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10.3.3.1 DETAILS OF ZLD SYSTEM

All the effluent generated from the plant are collected in the Effluent collection pits

and from those pits effluent will be pumped to the above ground storage tanks

through the closed HDPE pipe lines. All these effluent collection pits are lined with

acid proof tiling or HDPE lining.

The Industry will construct the above ground storage tanks to store the collected

effluent from various streams. The tanks consist of 6 Compartments and are used to

store the HTDS in two compartments and LTDS in four compartments effluents

separately. These tanks can accumulate more than 4 days generation of effluent.

The HTDS effluent consists of COD will be sent to the Stripping Column for the

removal of same and thereafter the effluent will be sent to the MEE system which

consists of 3 Calendrias and the condensate will be collected. The concentrate will

be sent to ATFD for separation of salts. The condensate collected from MEE &

ATFD sent to ETP for treatment. The salts generated from the ATFD will be stored &

disposed to TSDF for secure Land Fill.

Now, the Condensate water from the MEE system along with the LTDS effluent will

be sent to the ETP system for the removal of BOD etc., The ETP system consists of

Aeration and Clarification. After this the treated effluent from biological system is

passed through the Sand Filter, Carbon Filter and Micron Filters and finally sent to

RO System.

70% water recovered as RO permeates. Remaining 30% reject water will be sent to

MEE followed by ATFD system for Evaporation. In this ZLD treatment we can

recover 70% of the water for recycle and reuse in the plant Utilities.

Figure-10.5: FLOW CHART FOR EFFLUENT TREATMENT

Effluent Type Treatment Flow

HTDS

Collection Equalization & neutralization Stripper MEE ATFD TSDF MEE/ATFD Condensate sent to Biological Treatment followed by RO.

LTDS

Collection ETP (Biological Treatment) Sand Filter Carbon Filter Cartridge Filter RO Plant RO Reject to MEE. RO Permeate for Re-usage.

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10.3.3.2 THE TECHNICAL DETAILS OF THE SYSTEMS ARE AS FOLLOWS:

MEE System Capacity: 85 KLD

RO System Capacity: 100 KLD

10.3.3.3 MEE PLANT CONFIGURATION

Part – A: Stripper Unit with Flash Condenser, Re boiler and Recirculation Pump

Part – B: Triple Effect Forced Circulation Evaporation Plant with Thermo

Compressor, Required Equipment & Components.

Part – C: Agitated Thin Film Dryer

10.3.3.4 PROCESS DESCRIPTION (Part – A)

1. Feed will enter to the series of Pre heaters of Evaporator P4, P3, P2 and then

P1 using Feed Pump. From Discharge of Feed Pump Feed will be heated

through Series of Pre heater using Vapour from Jacket of respective

Calandria. Feed will be heated to the boiling point and will enter to the

recirculation loop of Stripper.

2. Recirculation Loop of Stripper will comprise of Flash Vessel, Recirculation

Pump and Re boiler.

3. Feed coming out from Pre heater of Evaporation Plant will re-circulated

through boiler and heated up using Steam.

4. Heated Feed will allow flashing in Flash Vessel and by flashing high volatiles

and Water will convert to vapour. Vapour will travel from bottom to top of

Stripping column where feed liquid will flow from top to bottom. Random

packing inside the stripping column provide mass transfer surface to vapor

liquid interface.

5. Rich organic vapour with some water vapour will come out from the top of

Stripper column. This vapour will be condensed in Flash Condenser at the top

of Stripper column.

6. Condensed organic rich liquid will be collected in Reflux pot from condenser.

From Reflux pot partly it will be withdraw according to the desired Water

Vapour/ Organic ratio and remaining will enter to the column as reflux.

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10.3.3.5 PROCESS DESCRIPTION (Part - B)

1. From Discharge of Stripper recirculation Pump feed will enter to the

Evaporation Plant. Feed will enter to the Evaporation Plant from Discharge of

recirculation pump of Stripper.

2. First Effect is a Forced Circulation Type comprising of Calandria-1, Vapour

Separator-1 and Recirculation Pump– 1. Liquid will recirculate continuously a

through Calandria Tubes at high velocity and will get heated using Heat of

Condensation of First Effect Jacket. This Heated Mass will allow flashing in

Vapour Separator and Water Vapour being generated.

3. This Flash Vapour will partly recompressed to the Jacket of First Effect using

Thermo compressor which will convert high pressure motive steam to low

pressure and will create suction and take part of the water vapour from

Vapour Separator -1.

4. Condensate from Jacket of First Effect will travel to 2nd Effect using pressure

difference available between these two Jackets.

5. Concentrate will be coming out from 1stEffect will be sent to Balance Tank -1

which will be placed between 1stand 2ndEffect.

6. Second Effect also is a Forced Circulation Type comprising of Calandria-2,

Vapour Separator-2 and Recirculation Pump– 2. Liquid will recirculate

continuously a through Calandria Tubes at high velocity and will get heated

using Heat of Condensation of Second Effect Jacket. This Heated Mass will

allow flashing in Vapour Separator and Water Vapour being generated.

7. Concentrate coming out from 2nd Effect will be below saturation level and

there will not be any crystallization takes place in 2nd effect.

8. This Heated Mass will allow flashing in Vapour Separator and Water Vapour

being generated.

9. Concentrate will be coming out from 2nd Effect will be sent to Balance Tank -2

which will be placed between 2nd and 3rd Effect

10. Condensate coming out from 3rd Effect Jacket is a mixture of Steam utilized in

Thermo compressor and Evaporated Water Vapour from 2nd and 3rd effect.

Condensate will be taken out from plant using Condensate Outlet Pump and

send for Storage.

11. Concentrate from Evaporation will be taken out from the Plant using

Concentrate Outlet Pump and send to ATFD.

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12. Water Vapour from Last Effect will be condensed in surface type condenser

using Cooling Water as condensing media. Steam Jet Ejectors/ Water ring

Vacuum Pump will maintain vacuum in the plant back to the condenser.

10.3.3.6 PROCESS DESCRIPTION (Part - C)

1. Feed Pump will be gear/ roto type pump to handle viscous Feed. Feed will not

required to preheat as it will come at 85-90 Deg C from the tank. Feed will

enter to the Vertical ATFD first for initial evaporation. Feed will splash to the

Heat Transfer Surface of ATFD using liquid distributor.

2. V-ATFD will be a hollow cylindrical Jacketed Vessel having Agitator and

specially designed Scrapper blades to wipe out the Surface of ATFD all the

time to keep it clean. This will maintain consistent performance of ATFD for a

long time.

3. ATFD Scrapper will rotate at medium RPM using Gear Box for reduction of

RPM which will be govern by Variable Frequency Drive.

4. ATFD Heat Transfer Surface will be heated through Steam in Jacket. Vapour

outlet will be connected with Entrainment Separator to avoid product

contamination in Condensate. Vapor will be condensed in Condenser and

Negative draft will be maintained by Water Ring Vacuum Pump.

5. Product coming out from bottom of Vertical ATFD. Steam will be applied in

Jacket of same to allow the product dry.

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FIGURE-10.6: SCHEMATIC DIAGRAM OF MEE SYSTEM

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10.4 HAZARDOUS / SOLID WASTE MANAGEMENT

Generation of hazardous / Solid Wastes

The hazardous / solid waste generation from process, spent carbon, used oils, ETP

sludge, Evaporation Salts, ash from boiler; will be sent to TSDF/Cement plants/Brick

manufacturers as per respective waste category.

Resource Conservation / Waste Minimization

The unit will also implement the concept of waste minimization circle including:

Volatiles in the by-products will be condensed and reused.

Volatile raw materials will be separated by rectification and these can be

recycled into process.

Good House Keeping practices make the system easier and less costly.

Some of these are as follows:

Solid wastes e.g. powders, spills, etc. in process, and packaging will be

separately collected and disposed off instead of allowing these to join

effluent streams. This will reduce load and increase the efficiency of

treatment system.

Search for future recycling schemes and evaluate their worth and

implement such schemes wherever a promise of economic feasibility

exists.

Discarded Container / Barrels/ Liners Management

Discarded containers/ barrels/ liners will be kept at a designated place

with paved surface.

These will be decontaminated (washed/ cleaned) and stored in the

designated area in scrap yard. Washed water sent to ETP.

These will be sold to the actual users/ recyclers as per the Hazardous

Waste (Management, Handling and Transboundary Movement) Rules,

2016.

The record of discarded containers/ barrels/ liners stored in scrap yard

shall be maintained and also, inventory of their selling to the registered

recyclers shall be maintained. The same shall be reviewed by the HSE

Department of the project.

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Handling of Solid Waste and Hazardous Waste

The solid wastes and hazardous wastes will be packed in double lined

PP bags and stored in dedicated area. As and when sufficient stock is

accumulated, Organic Waste will be sent to Cement Industry for

incineration and Inorganic waste will be sent to TSDF for further

treatment and safe land fill.

Industry will enter into an agreement with concerned Hazardous Waste

Management unit.

10.5 EB [ECOLOGY & BIODIVERSITY]:

The project activity does not require tree cutting. Also, the study zone does not have

any ecologically sensitive location and hence, the plant activities are not expected to

have any impact on ecology and biodiversity.

Air emissions, liquid effluent disposal and solid waste generation are likely to have

some impact on terrestrial ecosystems. However there will be no net increase in air

pollution.

Proponent will develop greenbelt around 36.8% of its total area.

Management

Raw material dispensing stations will be equipped with vacuum duct

hoods with top cover.

All tanks vents being used for storage flammable chemicals will be

connected to respective condensers to avoid VOCs in the plant area.

10.6 SE [SOCIO-ECONOMIC ASPECTS]:

This project will have positive impacts on Socio-Economic Environment.

Positive impacts

Direct employment generation potential of the project will be for about 40

persons, wherein the first preference will be given to the Qualified People

from within the Study Area.

Various modes of indirect employment i.e. providing Conveyance,

Transportation, Goods and Services will also increase.

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Overall improvement in quality of life of people of the study area will

increase.

10.7 HG [HYDROGEOLOGY, GROUND WATER & WATER CONSERVATION]:

The proposed project is located on the divide portion of the catchment and is over

the run off zone. No major streams are passing through the site. The catchment area

of the plant site is small and recharge conditions are moderate. However, the buffer

zone of 10km radius has good catchment and recharge potential with streams and

tanks of considerable storage potential.

All the stream courses are ephemeral in character and carry large volumes of storm

flows during rainy season and remain dry during non - monsoon season. The width

of the streams is narrow and follows the weak planes within the hard rock

formations.

Ground Water Conditions

Groundwater occurs under semi-confined conditions in the fissured zone of the

banded biotitic hornblende gneisses. Ten bore wells were inventoried to assess the

groundwater conditions. The depth to water levels was found to be 8 -132m bgl. The

yield ranges of bore wells were found to be 1-3 lps. The quality of water is found to

be potable.

As the extent of the proposed site is very small only roof top rainwater harvesting is

suggested for improving the recharge to the groundwater.

The proposed area is categorized as safe by the Groundwater department and

scope for development & stage of groundwater is good. The site is feasible for

groundwater extraction for the proposed Bulk drug intermediates manufacturing unit.

Possible Impacts on Groundwater & Mitigation

The generation of ash from the industry will have sedimentation affect over

the wind ward side on the soil regime as well as the buffer zone over a period

of time affecting the flow rates of water.

The chemically loaded waste water leakage from the industry may affect the

soil, surface and groundwater sources, so we will closely monitor to avoid any

spillage or leakages.

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The ash spreading in and around the plant will be avoided by storing under

closed conditions at dedicated place till it is disposed to users. The prevention

suggested is not to allow the waste water leakage from the industry by

implementing proper storage tanks for wastewater collection and ZLD system.

Ash generation and storage will be monitored closely to avoid leakages and

will be disposed safely to the brick manufacturing industries and infrastructure

projects.

All the chemically charged liquid discharges will not be allowed to be in

contact with surface/ groundwater.

10.8 GEO [GEOLOGY]:

The district is underlain by variety of geological formations comprising from the

oldest Archaeans to Recent Alluvium.

10.9 SC [SOIL CONSERVATION]:

The proposed project does not have any impact on the soils beyond the boundaries

of the project site and it is a Zero Liquid Discharge Unit; the chances of any

enhanced soil erosion are not anticipated. But improper disposal of toxic wastes and

accidental spillages of toxic chemicals can pose a serious threat to the soil, ground

and surface waters. But the chances of such events cannot be quantified and

predicted. Since the industry is expected all rules and regulations relating to the use,

handling and disposal of all toxic and hazardous chemicals, no additional safety

methods are required especially to prevent contamination of soil. Liberal use of

locally available farmyard manure will be used for the plants in the greenbelt and

block plantations for improving the productivity, fertility and health of soils.

The project does not have any impact on the soils beyond the boundaries of the

project site since it is a zero liquid discharge unit.

Physicochemical characteristics of the soil samples obtained from 7 areas in the

buffer zone and one from the project site reveals that all basically sandy loams.

10.10 RH [RISK & HAZARDS MANAGEMENT]:

All the provisions as per the Factories act, 1948 manufacture, storage and import

of hazardous chemicals [MSIHC] Rules, 1989 and amendments thereafter and

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also, the Hazardous Waste (Management, Handling and Transboundary

Movement) Rules, 2016 will be followed.

Work environment monitoring as well as noise monitoring will be carried out on

regular interval through third party.

Following hazards may occur during the operation.

Fire Hazards

Chemicals handling and Storage

Road accidents

Process hazards

Health hazards

Following procedures will be followed for effective management of any disaster in

the plant.

Identification of Hazards and Risk assessment

Identification of persons at risk

Mitigation measures to minimize or elimination of Risk

Disaster management plan

10.11 GREENBELT DEVELOPMENT

10.11.1 OBJECTIVE

The purpose of a green belt around the plant site is to capture the fugitive emissions

emanating from Plant operations, attenuate the noise generated and improve the

aesthetics.

Environmental protection has been considered as an important domain for industrial

and other developmental activities in India. Ministry of Environment, Forest and

Climate Change (MoEF&CC) has taken several policy initiatives and promoted

integration of environmental concerns in developmental projects. One such initiative

is the notification on Environmental Impact Assessment (EIA) of developmental

projects issued in 1994 and further revised notification in year 2006 under the

provisions of Environment (Protection) Act, 1986 EIA Guidance Manual for building,

construction, townships and area development projects proactively talks about the

importance of greenbelts in such projects.

Greenbelt in India refers to a buffer zone created beyond which industrial activity

may not be carried on. This concept has developed through a long line of cases and

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today, greenbelts are present not only for the purpose of protecting sensitive areas

to maintain ecological balance, but are also be found in urban areas so as to act as a

sink for the harmful gases released by vehicles and industries operating in the city

area. In this regard, comprehensive Guidelines for Developing Greenbelts have been

compiled by the Central Pollution Control Board.

10.11.2 ACTION PLAN

As per the stipulations of MoEF&CC, greenbelt is to be provided all along the

boundary by planting tall, evergreen trees and the total green area including

landscaping area will be about 36.8% of the project area. There are block plantations

within the project site. Typical industrial greenbelt on all sides of the plant site with 5

to 10 m width patches and strips of greenbelt with a spacing of 2m x 3 m (1500 trees

per Ha). About 2592 trees will be grown in the space available in the project area.

Since there will be two rows of trees, they get direct light at least from one side and

the branches can expand. Hence, potentially large trees with wide canopy are

chosen instead of the less branched and straight growing trees. In addition to

greenbelt development in the plant site, proponent proposed to develop green area

with trees such as fruit bearing, Neem, Kadamba plantations of 1000 trees/year for

five years in the nearby three identified villages (Jayanthipuram, Dhramavarappadu

Tanda and Vedadri Tanda). Soil is good and suitable for plant growth but water

supply is critical during the dry season. Special care shall be taken to water them at

least once in 3 days during the dry period. A list of plants suitable for greenbelt and

to the local agro climatic conditions.

A list of multipurpose trees proposed to be planted in the greenbelt is given in Table

10.1.

TABLE -10.1: List Of Plants Identified For Greenbelt And Avenue Plantations.

S.No Botanical name English name Local name

(Telugu ) Habitat

1 Bidenspilosa Beggar tick Phutium Herb

2 Cleome viscose Asian spider flower

Kukka-vaminta Herb

3 Partheniumhysterophorus Carrot Grass Chandani Herb

4 Abutilon indicum Indian Mallow Tuturabenda Shrub

5 Ageratum conyzoides Goat weed Pumpillu Shrub

6 Calotropis gigantean Crown Flower Jilledu Shrub

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S.No Botanical name English name Local name

(Telugu ) Habitat

7 Cassia surattensis Scrambled Egg Mettatangedu Shrub

8 Cleistanthuscollinus Garari Kodisha Shrub

9 Drypetessepiaria Wild Caper Bush Bira Shrub

10 Acacia arabica Gum arabic tree Natutuma Tree

11 Acacia ferruginea Rusty Acacia Anisandra Tree

12 Acacia mearnsii black wattle Tumma Tree

13 Acacia melanoxylon Sally Wattle Kondakorinda Tree

14 Acacia nilotica Babool Nallatumma Tree

15 Albizialebbeck Flea tree Dirisena Tree

16 Bambusa bamboo Bamboo Bonguveduru Tree

17 Barringtoniaacutangula Indian putat Kadimi Tree

18 Buteafrondosa Flame of the forest

Moduga Tree

19 Eucalyptus globules Eucalyptus Jamayul Tree

20 Ficusbenghalensis Banyan Marri Tree

21 Ficusreligiosa Pee pal Raavi Tree

22 Magniferaindica Mango Mamidi Tree

23 Pongamiapinnata Indian beech Kanuga Tree

24 Techtonagrandis Teak Teku Tree

10.12 POST PROJECT MONITORING

Regular monitoring of all significant environmental parameters is essential to check

the compliance status vis-à-vis the environmental laws and regulation. The objective

of the monitoring will be as follows.

To verify the results of the impact assessment study with respect to the

proposed project.

To study the trend of concentration values of the parameters, which have

been, identified as critical and planning the mitigate measures.

To check and assess the efficacy of pollution control equipment.

To implement the EMP, a structured Environment Management Cell (EMC)

interwoven with the management system will be created.

EMC will undertake regular monitoring of the proposed pollution control

system and conduct yearly audit of the environmental performance of the

system. It will also check that the stipulated measures are being satisfactory

implemented and operated.

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A comprehensive environmental monitoring program that will be prepared for the

purpose of implementation in the proposed manufacturing unit by the EMC is

described below.

10.12.1 AIR POLLUTION MONITORING

The Stack emissions from boilers & DG Set will be monitored once in a month for

PM10, NOX & SO2. The ambient air at the plant site will be monitored once in a month

for PM10, NOX & SO2. The Fugitive Emissions like VOC’s will be monitored in

Production block, Raw Material and Finished goods section.

10.12.2 WASTE WATER MONITORING

The quantity of waste generated from ETP unit will be regularly measured using flow

meters. Wastewater samples will be collected and analyzed for critical parameters

like pH, TDS, BOD, COD, Oil and Grease, Chlorides, Sulphates etc.,

10.12.3 GROUND WATER MONITORING

Ground water quality of bore well will be regularly monitored preferably once in a 6 /

12 months.

10.12.4 HAZARDOUS / SOLID WASTE MONITORING

Hazardous / Solid waste generated from the plant will be monitored once in a

month/change of the product.

Table- 10.2: The Details of the Monitoring Program

S. No Type of

Monitoring

Location of Monitoring

station

Frequency of

Sampling

Duration of

Sampling Instrument

Parameters to be tested

1 Ambient Air 3 Places at 120o

angle Once in a month

8 hrs/24 hrs

RDS PM10, SO2, NOX

2 Work room concentration

Production Block, Store rooms

Once in 3 Months

--- Personal Sampler

VOC’S

3 Stack Monitoring

Boilers, D.G. Sets, Scrubber vents

Once in a month

--- Stack Monitoring Instrument

PM10, SO2, NOX and Scrubbing gases.

4 Noise Levels

D.G. Set, Compressors, Chillers, Boilers section,

Once in a month

--- Noise meter Day – Night Noise levels in Leq

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Production block, Admin. block, ETP area, Open area etc.

5 Effluent

Raw HTDS & LTDS effluent, Condensate, Treated wastewater

Daily --- Internal & External Lab

Physical and Chemical Parameters

6 Ground water

Nearest Bore well

Once in six months

---

7 Solid Waste Sludge from Process, ETP

Once in six months

---

All the above observations will be complied and documented by the EMC to serve

the following purposes.

Identification of any environmental problems that are occurring in the area.

Initiating or providing solution to those problems through designed channels

and verification of the implementation status.

Controlling activities inside the plant, until the environmental problem is

corrected.

Suitably responds to emergency situations.

The industry will engage recognized laboratories to carry out all necessary

monitoring parameters. Qualified staff will be appointed for the purpose of Operation

and maintenance of the pollution control facilities. Stand-by facilities are provided to

all the facilities so as to ensure fail proof treatment.

10.13 MANAGEMENT OF PUBLIC INTERESTS

10.13.1 OBJECTIVE

To assure the neighboring communities that the promoters and management have

high consideration for the welfare of this region, the following commitments are made

by the project promoters.

10.13.2 PREFERENCE TO LOCAL POPULATION

For the recruitment of semi-skilled and unskilled workers preference will be given for

the local people.

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10.13.3 HEALTH CAMPS

Health camps will be organized along with the local administration and voluntary

organizations like Red Cross, Rotary Club etc., in the surrounding villages.

10.13.4 PUBLIC AMENITIES

The management will support the local administration with funds and other forms of

assistance for the development of public amenities in this region.

10.13.5 PUBLIC RELATIONS

The management will set up a public relations office to maintain to good line of

communication between the management and the public on matters of

environmental concern.

10.14 WATER REQUIREMENT

Proposed Water Consumption Details

Table- 10.3: Proposed Water Consumption Details

S.No Purpose Water input

KLD

1 Process 59

2 Washings 10

3 Boiler make up 71

4 Cooling towers make up 104

5 Scrubbing system 5

6 Domestic 4

7 Gardening 6

Total 259

The fresh water of 175 KLD will be met from Ground Water source.

Recovered water 84 KLD from ZLD system is reused.

10.15 PROCESS EMISSION CONTROL SYSTEM

a) No. of scrubbers and capacity : 2 No. scrubbers installed.

1 No: 300 mm (Diameter) X 3 meters (Height)

b) Type of scrubber : Scrubber material of construction is PP+FRP with

one inch poly propylene rings as packing material with a circulation pump.

C). Chemical used in scrubber : Alkali solution

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FIGURE- 10.7: SCHEMATIC DIAGRAM OF EMISSION CONTROL SCRUBBING SYSTEM

10.16 FUGITIVE EMISSIONS

Various types of solvents will be used in the manufacturing process. The solvents

will be stored in storage tanks with vent condensers. These are handled in closed

conditions. The industry will take measures for reduction of fugitive emissions by

providing chilled brine circulation to the condensers which, ensures the recovery of

95%. Good ventilation will be provided to reduce the workroom concentrations. The

reactor generating solvent vapors will be connected to condensers with reflux

system. Dyke walls will be provided to the solvent storage tanks. The solvents like

Ethyl acetate, Methanol and Toluene will be recovered up to 95 % by using

distillation and the remaining 5% will be the loss.

10.17 SOLVENT MANAGEMENT PLAN

Solvent management consists of the following:

Unloading

Storage

Handling / transferring

Process / Reaction

Recovery

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i) Unloading

Solvents are received in drums / tankers

Drums

Before unloading the drums from the truck, check the drums condition.

Drums may be MS or HDPE Carboys

Drums / barrels will be unloaded from the vehicles onto the unloading platform

by using the drum lifter provided for the purpose. Under no circumstances

drums shall be dropped or rolled on the ground or on any other material

Carboys will not be dropped or allowed to strike against each other and shall

be unloaded on the pallets

Personal protective equipments like safety goggles, hand gloves, PVC aprons

and safety shoes will be used while handling chemicals.

Road tankers

Security will ensure that vehicle personnel shall not carry any match box /

lighters

The store personnel, has to check the paper work before unloading to confirm

that the correct chemical received as well as discharged into the dedicated

tank.

Barriers and flags should be positioned to warn personnel at the unloading.

Brakes should be set and the wheels chocked.

The truck should be earthed.

Tanker should be kept under inert gas flushing through vent while unloading

Make sure that the inert gas valve remains open during the entire unloading

period of delivery is by gravity or by pumping.

Connect the flexible hose to the tanker and to the transfer pump

Check liquid level guage on storage tank to ensure liquid is being transferred

When tanker is empty, stop pump and close valves on tanker, close valves in

transfer line.

[For flammable material, stop inert gas purge]

Disconnect flexible hose and put into proper catch container to ensure no

product is lost on to the ground.

Remove choked warning signs, earthing and switch locks

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Read storage tank liquid level gauge and record reading

ii) Storage/ handling/ transferring

Storage Tanks

2 or 3 Square meter condenser [depends on solvent volatility] with cooling

water circulation is connected to each solvent storage tank to prevent solvent

vapors escaping from tank surface in to atmosphere. The condensed solvent

will go to respective tank. This results in recovery of solvent and prevention of

VOCs into the atmosphere.

The solvent pump which is having mechanical seal will be used for

transferring the solvent to the Day Tank of the respective reactor as and when

required. The entire solvent transfer takes place in a closed system. There is

no manual handling.

The above management will results in recovery of solvent more than or equal to

95%.

Drums

As and when required the solvent drums in closed condition will be transferred

to the respective reactor.

By using AODD pump the solvent will be transferred in to the reactor. Hence,

there is no loss of solvent during transfer.

iii) Reaction /Recovery

During reaction stage the solvent vapors will be sent to a primary condenser

having cooling water circulation and later to secondary condenser having

temperature < 50 C chilled brine circulation.

Above system will eliminate solvent losses during reaction stage and

recovery will be the maximum extent possible.

The above management will results in recovery of solvent more than or equal to 95%.

Chlorinated solvents

Solvent drums will be stored in ware house below 250C

As and when required the solvent drums in closed condition will be transferred

to the respective reactor. By using AODD pump the solvent will be transferred

in to the reactor. Hence, there is no loss of solvent during transfer.

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During reaction stage the solvent vapors will be sent to two primary

condensers which are arranged in parallel having cooling water circulation

followed by a secondary condenser having brine circulation at temperature of

50C.

System will eliminate solvent losses during reaction and recovery will be the

maximum extent possible.

The above management will results in recovery of solvent more than or equal to

95%.

10.18 EMISSIONS – UTILITIES

For generation of Steam, the industry proposed to install 4 TPH & 8 TPH coal fired

boilers. The coal requirement will be met from government allocation or from local

authorized sources.

The unit is proposing 500 KVA & 1000 KVA DG set, for usage during the power

failures.

The emission details are presented in bellow Table No.10.4, Table No.10.5 & Table

No. 10.6

Table- 10.4: Characteristic Details of Proposed Boiler

Particulars Units 8.0 TPH Coal fired

Boiler 4.0 TPH Coal fired

Boiler

Type of Fuel -- Indian Coal with CV of 4000 kcal/kg to

5000 kcal/kg

Indian Coal with CV of 4000 kcal/kg to

5000 kcal/kg

Coal Consumption TPD 32 16

Ash Content % 35 35

Sulphur Content % 0.4 0.4

No. of Stacks No 1 1

Height of stack M 34 30

Diameter of Stack M 0.50 0.40

Temperature of Flue Gas oC 200 180

Velocity of Flue Gas m/s 16 14

Particulate Matter gm/sec 0.26 0.13

Sulphur dioxide emission gm/sec 2.95 1.48

Oxides of Nitrogen emission gm/sec 9.70 4.86 Note: 5 TPH Coal fired Boiler is kept as standby.

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TABLE- 10.5: Stack Emission Details for Thermic Fluid Heater

Particulars Units 2,00,000 kcal/hr.

Thermic fluid heater

Thermo pack Boiler Capacity Kcal/hr. 2,00,000

Type of Fuel -- Diesel

Stack Temperature Before Air preheater

oC 200

Stack Temperature After Air preheater

oC 130

Stack Height m 15

Fuel Consumption per Day TPD 0.57

Diameter m 0.3

Table- 10.6: Stack Emission Details of Proposed DG Set

Capacity In KVA

Emission of SPM in mg/Nm3

Emission Of SO2 in mg/Nm3

Emission of NOx

in mg/Nm3

Stack dia. in m

Flue Gas Temp. in

OC

Stack Height in m

Flue gas Velocity in m/sec.

500 KVA (Proposed)

80 150 180 0.30 220 10 16

1000KVA (Proposed)

120 170 200 0.35 280 10 18

10.19 WASTEWATER LOADS

The waste water generation will be 105.8 KLD which is from process, floor & reactor

washes, cooling tower blow down, boiler blow down, scrubber, DM plant and

domestic usage. The effluent generation and its HTDS & LTDS effluent details are

given below.

Table-10.7: Effluent Generation Details

S.No Purpose Effluent

Details KLD

1 Process 66

2 Washings 10

3 Boiler Blow down 10

4 Cooling towers Blow down 12

5 Scrubbing system 5.00

6 Domestic 2.80

Total 105.8

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Table-10.8: HTDS & LTDS Effluent Details

S. No Purpose HTDS In KLD

LTDS In KLD

Effluent In KLD

Disposal Method

1 Process 47.0 19.0 66.0 HTDS Effluent sent to MEE System. MEE Condensate sent to Biological treatment. LTDS Effluents along with Domestic sewage sent to ETP, treated effluent sent to RO followed by MEE & ATFD. RO Permeate and MEE Condensate water recovered for reuse MEE Salts collected and disposed to TSDF.

2 Washings 0.0 10.0 10.0

3 Boiler Blow down 0.0 10.0 10.0

4 Cooling towers bleed off

0.0 12.0 12.0

5 Scrubbing system 5.0 0.0 5.0

6 Domestic 0.0 2.8 2.8

Total 52.0 53.8 105.8

The pollution loads for various pollutants viz., TDS, Inorganics, Organics; COD for

proposed products has worked out based on the material balance.

10.20 STAGEWISE EFFLUENT CHARACTERSTICS

The stage wise effluent characteristics have been arrived for the proposed products

based on the material balance, which is given in Chapter-II

10.21 HAZARDOUS / SOLID WASTE DETAILS

Solid Waste Generation Details

The Hazardous/Solid waste generated and disposal methods from proposed project

are given below.

Table- 10.9: Hazardous/Solid Waste Generation, Disposal Details

S. No Name of the

Hazardous Waste Quantity Disposal Method

1 Organic Solid Waste 3757 Kg/Day

Sent to Cement Industries

2 Spent Carbon 108 Kg/Day

3 Solvent distillation residue 1174 Kg/Day

4 Organic Evaporate liquid from MEE stripper

1040 Kg/Day

5 Mixed Solvents 3933 Kg/Day

6 ETP Sludge 1000 Kg/Day Sent to TSDF

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7 Inorganic solid waste 366 Kg/Day

8 MEE Salts 4954 Kg/Day

9 Used Oils 1000

Ltrs/Annum SPCB Authorized Agencies for Reprocessing/Recycling

10 Detoxified Containers 1000

No’s/Month

After Detoxification sent back to suppliers/sent to outside Parties

11 Used Lead Acid Batteries 9 No’s/Year Send back to suppliers for buyback of New Batteries

Solid Waste Details

12 Ash from boiler 16800 Kg/Day

Sent to Brick Manufacturers

Hazardous / Solid waste will be segregated. Detoxified containers, HDPE

Drums/Bags will be stored in the covered and raised platform with Leachate

collection system and disposed to authorized parties. Non- incinerabale solid waste

will be disposed to TSDF for secured landfill.

The Hazardous / solid waste will be disposed off through 7-copy manifest system

within 90 days from the generation. All records will be maintained properly.

10.22 PROPOSED ROOF WATER HARVESTING

To augment the declining ground water levels and water harvesting is the need of

the hour.

Rainwater harvesting is a mechanism involved in collecting, storing and using. A

rainwater harvesting system comprises various stages – flow of rainwater through

pipes or drains, filtration and storage in tanks for reuse or recharge. There are five

components in rainwater harvesting namely catchment, conveyance, filtration,

storage and recharge.

Roof top area is considered for harvesting rainwater for this project and other areas

are excluded due to possibility of chemical contamination. Roof top rainwater

harvesting is one of the appropriate options for augmenting ground water recharge/

storage in urban areas where natural recharge is considerably reduced due to

increased urban activities and not much land is available for implementing any other

artificial recharge measure. Roof top rainwater harvesting can supplement domestic

requirements in rural areas as well.

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Design of Roof Water Harvesting Structure

Quantity of Rain water collection and recharging depends upon

Average rainfall

Catchment area

Run-off coefficient

Infiltration rate

Evapo Transpiration

Porosity

Permeability

Generally used Rain water harvesting structures are like Recharge Pits, Invert Well,

Surface storage pond (where areas are large and Optimum rainfall), Check Dams,

Nalla Bunds.

The rain water from the Roof top will be collected through PVC pipes and transferred

to the proposed roof water harvesting pits through steps of eliminating suspended

particles, oil & grease through finally to the ground.

Since the area of harvesting is small the above parameters are not studied in detail

and only applicability as to conserve and harvest the available quantum is

considered and suitable structure suggested Based on IMD Climatological Normal,

1981-2010.

Normal Annual Rainfall =981 mm (0.98 m)

Table- 10.10: Available Rainwater (Annual) for Harvesting

Description Area (m2) Rainfall

(m/Annum)

Runoff

coefficient

Total Rainwater

(m3/Annum)

Roof Area 11536 0.98 0.8 9044.224

Total available rainwater (in m3/annum) 9044

Details of Roof water harvesting pits:

Size of pits 8m x 4m x 3m

Size of Bore 350 mm dia.

Size of pipe 150 mm dia.

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FIGURE-10.8: ROOF WATER HARVESTING STRUCTURE

10.23 INVESTMENT

The proposed total gross investment in Buildings and Plant & Machinery will be

approximately Rs. 30 Crores. Industry will allocate an amount of about Rs.110

Lakhs for Environmental Protection measures. Recurring cost will be about Rs. 20

Lakhs per annum.

10.23.1 BUDGETARY ALLOCATION

The management will be set aside adequate funds in its annual budget to fully meet

the stated objectives of the environmental policy. The capital equipment for

environmental management include effluent treatment plants, pipelines and channels

for waste water discharge, green belt development and the environment laboratory.

Table- 10.11: Proposed Budget for Environmental Management Plan [EMP]

S. No Particulars

Proposed

Capital Cost

(Rs. Lakhs)

Recurring

Cost

(Rs. Lakhs)

1

Pollution Control Equipment

(Scrubbers, Cyclone separator, Bag filter,

Sampling port arrangements etc.,)

30.0 2.0

2 ZLD System 70.0 12.0

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(MEE, RO, ETP system)

3

Rain Water Harvesting

(Roof top water collection pit and Roof top water

towards the rain water harvesting pit)

3.0 0.5

4 Green Belt Development

(Plantation and Maintenance) 5.0 2.0

5 Health & Safety

(PPEs, Medical Surveillances Expenses etc.,) 2.0 1.0

6

Environmental Monitoring

(Air, Water, Noise, VOCs, Boiler Stack flue

gases, DG sets stack monitoring expenses etc.,)

0.0 2.5

Total 110.0 20.0

10.24 MITIGATION PLAN

There will be few gaseous emissions generated or released from the manufacturing

process. The industry will provide the efficient scrubbers for controlling the gaseous

emissions and plant will be well ventilated to improve the work zone environment

and layout is worked out in such a way that the workman works in a comfortable

atmosphere by using adequate personal protective equipment. Industry will be taking

all precautions to minimize the emissions on handling of various chemicals etc.

Sufficient fire extinguishers and fire hydrants will be provided in the plant to handle

any emergency.

Full-Fledge ZLD Treatment system will be provided for treating the effluents

generated from the industrial activity. Full-Fledge Treatment facility will be

constructed above ground level to prevent seepage.

First aid kits will be provided in all the departments and training on First aid will also

provide to all the employees for early treatment.

Candidates to be recruited to work in the factory will be subjected to pre employment

medical checkup. Only those certified to be medically fit will be recruited. Candidates

on recruitment safety training will be given for one week on handling of chemicals.

Archimedis Laboratories Pvt. Ltd will strictly follow the safety norms as per the

guidelines of the Director of Factories for a process industry and will provide all the

necessary safety equipment for the protection of the Industrial establishment as well

as the personnel working in the plant premises. Personnel Protective Equipment will

be provided to all its employees who are involved in the handling of hazardous

activities. The storage and handling of various chemicals will be according to the

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norms of MSDS and the Inspector of Factories. Personnel involved in the production

will be provided with protective clothing, helmets, goggles, masks, gloves, etc.

These handling operations will be carried out under the strict supervision of the

trained and highly skilled personnel. Supervision will be provided to ensure the

usage of these PPE’s. Necessary fire fighting facilities like extinguishers, sand

buckets, etc. will be provided to meet the on-site emergencies. A detailed On-site

Emergency plan will be prepared and implemented comply the provisions of

Factories Act. An agreement with a nearest hospital for treating the employees due

to unforeseen emergencies will be entered into.

10.25 SOCIO-ECONOMIC DEVELOPMENT ACTIVITIES

Socio-Economic Development activities will be implementing in coordination with the

NGOs, Village Panchayats and other Governmental Entities.

A. Social Activities:

Health check up camps and Medical facilities to Infants and senior citizens,

free medicine supply etc., will be provide on regular basis.

Help Implement and Run a Safe Drinking Water in Vedadri Tanda village

where the project site is located to facilitate Healthy Water for both Drinking &

Cooking Purposes.

Contribution towards any development activity useful for village development.

B. Economic Activities:

The company will give preference to the local people for employment.

The company will be giving contract works like civil, machine repair,

transportation, canteen, etc. to the local people / parties.

The proposed project will create jobs for at least 100 persons.

10.26 WASTE MINIMIZATION / RESOURCE CONSERVATION 5 R Concept

(Recycle / Refuse / Reduce / Reuse / Reform)

In our company, the 5R, representing five environment-conscious words starting with

the letter R, has been adopted as a keyword for environmental activities. The five

environment-conscious words include the three R words of the 3R, the keyword for

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establishing a recycling-oriented society, and two additional words that are "Refuse"

and "Reform".

Refuse: Avoid purchase of environmentally burdensome materials

whenever possible

Reduce: Reduce waste material

Reuse: Reuse waste material without processing

Reform: Reuse materials in a different form

Recycle: Reuse materials as resources

We will achieve the above concept; all efforts will be made by the industry to carryout

R&D on the isolated by-products / wastes

FIGURE- 10.9: 5 R CONCEPT

The units shall also implement the waste minimization circle including:

Good House Keeping: Proper housekeeping practices make the system

easier and less costly.

Roof water harvesting system shall be adopted to reduce the fresh water

requirement.

Cleaner production technology may be adopted for the resource conservation

and pollution control.

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10.27 CONCLUSION

The industrialization plays an important role in their development process. The

countries with rapidly growing industrial sector were able to manage the

development problems particularly employment, poverty and inequality. The

Industrial development as legitimate objective to solve economic and social

problems, therefore project Management have appropriately decided to setup a

manufacturing unit. The infrastructure like roads, water and regular supply of power

are available at the project site. Availability of adequate skilled, semi-skilled man

power at reasonable salaries and wages, local amenities at reasonable cost, has

encouraged the technocrat. Importantly, the helping hand extended to the most

experienced and reputed person in the bulk drugs manufacturing industrial belt, by

the state Government in meeting the needs of the aspirant.

The likely adverse effects due to the operations of the unit are marginal. More over

the residential area is far away. However, the effective implementation of the

recommended Environment Management Plan and Monitoring Program, by which all

the negative effects on the environment, will be minimized.

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SUMMARY & CONCLUSION

[SUMMARY OF EIA REPORT]

CHAPTER -XI

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EIA Report Archimedis Laboratories Pvt. Ltd.

Prepared By Rightsource Industrial Solutions Pvt. Ltd. Chapter -XI Page 473

CHAPTER – XI

PROJECT SUMMARY & CONCLUSIONS

Archimedis Laboratories Pvt. Ltd. Proposed to establish a Bulk Drug & Intermediates

manufacturing unit with the production capacity of 115.00 TPM respectively.

11.1 SALIENT FEATURES OF THE PROJECT

S. No Contents Details

1 Name of the Project: Archimedis Laboratories Pvt. Ltd.

Sy No: 108 & 109, Jayanthipuram (V) Jaggayyapet (M), Krishna District, Andhra Pradesh.

2 Details of Applicant

Mr. Y Maddireddy Venkateswara Reddy (Managing Director) 5-163/1, 2nd floor, Malleswari Nilayam, Chintalkunta, LB Nagar Post, Hyderabad – 500074. E-mail: [email protected], [email protected]

3 Status

Archimedis Laboratories Pvt. Ltd. Proposed to

establish a Bulk Drugs & Intermediates

manufacturing unit at Sy No: 108 & 109,

Jayanthipuram (V) Jaggayyapet (M), Krishna

District, Andhra Pradesh.

4 Type of Land & Status Industrial land.

Proposed Land: 11.62 Acres (47024.47 Sq.m)

5 Capital Investment of the

Project, Rs. in Crores 30.0 Crores

6 Capital cost for EMP, Rs. in

Lakhs 110 Lakhs

7 Recurring cost for EMP, Rs.

in Lakhs 20 Lakhs

8 Employment opportunity 100 persons

9 Green belt Development

It is envisaged to develop greenbelt on all sides of

the industry in an area of about 4.27 Acres

(17287.11 SQM).

10

Pollution control measures adopted

Effluent water disposal ZLD System

Flue gas emission control

Adequate stacks of height of 34 mts & 30 mts are

provided for wider dispersion of pollutants.

For SPM control, provided cyclone separator followed by bag filter

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EIA Report Archimedis Laboratories Pvt. Ltd.

Prepared By Rightsource Industrial Solutions Pvt. Ltd. Chapter -XI Page 474

Process gas emission control Two stage scrubbers installed for process gas emissions

Fugitive emission control

Vent condensers to the storage tanks and reactors

Solvents and chemicals are handling in closed system

Hazardous waste management

All the hazardous waste will be collected, stored, handled, transported and disposed to TSDF as per the Hazardous Waste (Management, Handling and Transboundary Movement) Rules, 2016, amended time to time etc are major Act/rules/notification applicable to industry.

11 Expenditure for CSR activities Rs. 135 Lakhs for five years.

11.2 CONCLUSIONS

It can be concluded on a positive note that due to the adequate provision and efficient

operation of Environmental Management Systems and after the implementation of the

proposed mitigation measures and environmental management plans, the project

activities during the construction and operation phase would have manageable & largely

have reversible impacts on the environment, and on balance the project would be

beneficial to surrounding communities and the region.