Pre-Feasibility report Greenfield Facility of Manufacturing Plant for Mehtylcobalamin (b12) at HSIIDC , Barhi part 2, Tehsil - Ganaur, District - Sonipat

Project Proponent:

M/s Royal Enterprises

May 2015

2015

1 EXECUTIVE SUMMARY

Greenfield Facility of Manufacturing Plant for Methylcobalamin (b12) at HSIIDC Barhi part 2,

Tehsil Ganaur, District Sonipat by M/s Royal Enterprises

Royal enterprises main objective is to develop technologies, which are cleaner and eco friendly.

In order to reduce the usage of hazardous and polluting solvents, methods are developed using

enzymatic process and wherever possible, strict control over emissions at all levels is

maintained. The present proposal is to set up a unit for manufacturing for Methylcobalamin (b12)

at HSIIDC Barhi part 2, Tehsil Ganaur, District Sonipat

The chemical name for methylcobalamin is Coα-[α-(5,6-dimethylbenz-1H-imidazolyl)]-Coβ-

methylcobamide. Synonyms and trade names are mecobalamin, methylcobalamin,

cobaltmethylcobalamin, Algobaz and Cobamet.

The molecular formula is C63H91CoN13O14P and its molecular weight is 1344.4 g/mo

1.1 Plant Features and Production

Product - Methylcobalamin (b12)

By product – Sodium iodide

1.2 Environment

Company policy and prime aim is to ensure that Environmental Norms are strictly adhered to.

Some of the key features with respect to effluents and waste disposal in this unit are:

The trade effluents generated from proposed project are treated in ETP send to Common

Effluent Treatment Plant (maintained by HSIIDC govt organization).

The Domestic and sewage waste water stream send to Septic tank.

Our laboratories and production sites are engineered to be safe working environments in

accordance with local regulations and the company‟s high-level operating standards. Stringent

safety procedures, applicable to both internal company and external sub-contracted employees,

are practiced during the sites‟ erection stages.

The project is not likely to cause any significant impact to the ecology of the area since adequate

preventive measures will be adopted to control various pollutants within permissible limits. Green

belt development around the area would also be taking up an effective pollution mitigative

technique.

2 INTRODUCTION

2.1 Brief Description of the Project

Greenfield Facility of Manufacturing Plant for Methylcobalamin (b12) at HSIIDC Barhi part 2,

Ganaur, Sonipat by M/s Royal Enterprises

2.2 Need for the project and it’s importance to region

India ranks third with respect to the production capacity of pharmaceuticals in the world,

whereas in terms of value, India is in 14th place. The total turnover of pharmaceutical industry in

2010 was US $ 20 billion, which is 20 times when compared with the turnover in 1990 (Indian

Pharmaceutical Industry, 2010). All major therapeutic groups of drugs are manufactured in

India. In terms of generics production India ranks 4th, but in terms of export value India ranks

17th. The need is increasing every year due to continual growth of pharmaceutical industry. This

project is expected to contribute in partially fulfil the demand of pharmaceutical industries.

2.3 Employment Generation (Direct and Indirect) due to the project

It is Greenfield manufacturing plant so nearly 15 person get direct or indirect employment

through this green field project.

M/s Royal Enterprises, sonipat generate the employment on various levels time to time and give

the priority to local persons.

3 PROJECT DESCRIPTION

3.1 Type of Project including interlinked and interdependent projects, if any

The Proposed Greenfield Project falls under „Section 5(f)‟ Manufacturing / Production of

Synthetic Organic Chemicals & „Category “B”. but the Haryana SEAC committee is dissolve so

we apply our case in MOEF.

It does not attract any specific or general condition as per EIA notification dated 14 th September

2006 and its amendment on 1st December 2009.

No interlinked project.

3.2 Location (specific location and project boundary & project lay out) with coordinates

Greenfield Facility of Manufacturing Plant for Mehtylcobalamin (b12) at Village Barhi

part 2, Ganaur, Sonipat by M/s Royal Enterprises

Figure 1: Location map

Figure 2 : Location Map on Toposheet

Figure 2 : Plant Layout

3.3 Details of alternate sites considered and the basis of selecting the proposed site,

particularly the environmental considerations gone into should be highlighted

There is no interlinked project.

Since the objective is to manufacture Synthetic Organic Chemicals, a lush green & friendly

environment is being selected for installing the plant.

The project is not likely to cause any significant impact to the ecology of the area since

adequate preventive measures will be adopted to control various pollutants within permissible

limits. Green belt development around the area has been and shall be taken up as an effective

pollution mitigative technique.

3.4 Technology and Process Description

MANUFACTURING PROCESS

Step-I: Check the Glass flask is cleaned and dry. Charge Process water, heating

and addition of cynocobalamin. Cooling and addition of sodium borohydride,

stirring and addition of methyl iodide. Addition of chloroform and phenol mixure,

stirring, settling for layer separation.

Step-II: Check the Glass flask clean and dry. Charge process water, organic

layer, chloroform and acetone. Stirring settling, layer separation, distillation of

process water. Addition of acetone, cooling, filtration, drying, sieving.

Chemical reaction and mass balance

LIST OF RAW MATERIAL

D.M water purchase from market for processing—400 ltr / 5kg batch.

Sr. No. Raw Material Unit Quantity Standard

Per Month

Per year

5.0 KG BATCH

SIZE

30 kg/month

1 Cyanocobalamin Kg 5.00 30 345

2 Methyl Iodide Kg 4.50 27 311

3 Sodium Borohydride

Kg 5.50 33 380

4 Chloroform Kg 98.00 588 6762

5 Acetone Kg 60.00 360 4140

6 Phenol Kg 25.00 150 1725

7 Methanol Kg 13.00 78 897

Figure 3: Solvent recovery

Utilities

A. Laboratory

S. No. Equipment Make

1. HPLC (Manual) Younglin

2. G.C. Nucon

3. pH Meter Analab Scientific

4. Karl Fischer Analab Scientific

5. Analytical Balance Shimadzu

6. Ultrasonic Bath Analab Scientific

7. Stability Chamber (Long Term) Thermolab

8. Stability Chamber (Accelerated) Thermolab

9. Melting Point Apparatus Jay Lab Instruments

10. Vacuum Drying Oven Durga Traders

11. Freeze LG

12. Hot Plate

13. Thermometer (-10º to 110º C)

14. Thermometer (-10º to 360º C)

B. Plant Equipment

S No Equipment Qty. Capacity

1. Glass Flask 1 200 L

2. Glass Flask 1 100 L

3. Nutch Filter 1 125 L

4. Vaccum tray T.Ddryer 1 6 Tray

C. Others

S. No. Equipment Qty. Capacity

1 Cooling Tower 2 200 TR

2 Chilling plant 3 26 TR

3 Hot Water System 2 2 KL

4 D.G. Set 1 60 K.V.A

5 Electric Heater 1 200 Kg

6 Vacuum Pump 1 20 HP

7 Air handling handing 1 3000 C.F.M

3.5 Raw material required along with estimated quantity, likely source, marketing area

of final products, mode of transport of raw material and finished product.

3.5.1 Transportation details of Raw Materials

The transportation of raw materials will be done by trucks as per MSHIC rule.

3.6 Availability of water its source, energy/power requirement and source should be

given

The unit is located in Notified Industrial Estate.

Water will be procured by HSIIDC through tankers.

3.6.1 Fuel

Fuel consumption i.e HSD used 50 liter /day, one DG set of 60 KVA

*Note: Dg Sets will be used only during Power failure.

3.6.2 Quantity of waste to be generated (liquid and solid) and scheme for their

management /disposal

Table: Hazardous Waste Generation and disposal Details

Recovered Solvents and Chemical

`Chemical (5 kg Per Batch Size)

per month (30 kg/month)

per year(for 30 kg/month)

Disposal

Sodium Iodide

50-55 gm

300 3450 SEND TO DISTILLATION

UNIT Chloroform 60-65 Kg

360 4140

Acetone 30-35 Kg

180 2070

4 SITE ANALYSIS

4.1 Connectivity

Plot Survey / Khasra No. Plot no. 555

Village HSIIDC, Barhi

Tehsil / Taluka / Mandal Ganaur

District Sonipat

State Haryana

Nearest railway station / airport / along with

distance in km. Narela railway station 30 KM in South

Nearest town, city, district headquarters along

with distances in km IGI airport 62 KM in South

S. No.

Information/Checklist confirmation

Yes / No?

Details thereof (with approximate quantities / rates, wherever possible) with source of information data

1 Areas protected under international conventions, national or local legislation for their ecological, landscape, cultural or other related value

No There are no Areas protected under international conventions, national or local legislation for their ecological, landscape, cultural or other related value

2 Areas which are important or sensitive for ecological reasons -Wetlands, watercourses or other water bodies, coastal zone, biospheres, mountains, forests

Yes Yamuna River (9.27 km,East)

3 Areas used by protected, important or sensitive species of flora or fauna for breeding, nesting, foraging, resting, over wintering, migration

No There are no Areas used by protected, important or sensitive species of flora or fauna for breeding, nesting, foraging, resting, over wintering, migration

4 Inland, coastal, marine or underground waters

Yes Yamuna River (9.27 km,East)

5 State, National boundaries Yes State boundary (Uttar Pradesh)8.78 km

6 Routes or facilities used by the public for access to recreation or other tourist, pilgrim areas

Yes NH-1(0.25,East)

7 Defense installations No There are No Defense installations

8 Densely populated or built-up area

Yes Barhi,(00 km),GANOUR (3 KM,nw)

9 Areas occupied by sensitive man-made land uses (hospitals, schools, places of worship, community facilities)

Yes Rishikul vidyapeeth school(South,10.91km),South Point public school(SSW,10.78km)Apolo international school(0.5km,West Handa hospital(South,13.40km),Mital Nursing home(South,13.60km)

10 Areas containing important, high quality or scarce resources (ground water resources, surface resources, forestry, agriculture, fisheries, tourism, minerals)

--

11 Areas already subjected to pollution or environmental damage. (Those where existing legal environmental standards are exceeded)

NO

12 Areas susceptible to natural hazard which could cause the project to present environmental problems (earthquakes, subsidence, landslides, erosion, flooding or extreme or adverse climatic conditions)

ZONE IV(HIGH EARTHQUAKE ZONE)

4.2 Climatic data from secondary sources

4.3 Weather

4.3.1 Climate

The climate of the district is characterized by the dryness of the air with an intensely hot summer

and a cold winter. The cold season starts by late November and extends to about he middle of

March. It is followed by hot season, which continues to about the end of June when the

southwest monsoon arrives over the district. The period from July to September is the southwest

monsoon season. Rainfall: The normal annual rainfall of the district, based on the record for the

period 1901-1980 is 567 mm recorded in 30 rainy days in a year. There is no meteorological

observatory in the district, so the climatological data of the near by observatory at Delhi has

been taken as representative of the climatological conditions of the district. About 76% of the

annual rainfall is recorded during the southwest monsoon from June-September. July is the

wettest month of the year with 7.5 rainy days and 169 mm rainfall. During the period 1901-80,

deficient to scanty rainfall was recorded in 18 years. The probability of occurrence of rainfall in

the range 400-700 mm is 0.65. January is the coldest month with mean daily maximum

temperature 21.3o C and mean daily minimum temp 7.3oC. May is the hottest month with mean

daily maximum temp 26.6oC. In May and June, the maximum temperature sometimes reaches

about 47oC.

4.3.2 Cloud Cover

The area remains cloudy between June - November, which is the active period of the monsoon

reason. Generally, cloud cover ranges from 0 Oktas during this Post Monsoon Season 2013.

4.4 Social infrastructure available

It‟s Greenfield Project. The same facilities shall be available after implementation of the project.

5 PROPOSED INFRASTRUCTURE

5.1 Industrial Area (processing area)

HSIIDC Industrial area

5.2 Residential Area (non-processing area)

Not applicable

5.3 Green belt

33% of total plot area will be developed as greenbelt.

5.4 Drinking water management (source & supply of water)

300 liter per day Through tanker

5.5 Sewage system

Sewage will be disposed in soak pit.

5.6 Industrial waste management

Generated waste has been categorized in below categories

Domestic waste

Solid waste (Non hazardous)

Hazardous waste

5.7 Power requirement & supply/ source

The power requirement will be 49 KWA sourced from Uttar Haryana Vidhyut Nigam Limited.

6 REHABILITATION AND RESETTLEMENTS (R& R) PLAN

6.1 Policy to be adopted (central/state) in respect of the project affected persons

including home oustees, land oustees and landless labourers (a brief outline

to be given)

Not Applicable

Project Schedule and Cost Estimate

Likely date of start of construction and likely data of completion (time schedule for the

project to be given)

It is estimated that the project can be fully implemented in by 2015-2016 with concurrent

sanction of funds.

This is a tentative schedule in which flexibility can be exercised depending upon the market

demand and fund availability.

6.2 Estimated project cost along with analysis in terms of economic viability of the

project.

Cost of Estimates of the Greenfield Project is 155 lacs. Project work will be start after getting the

environmental clearance.

Serial No. Particulars Amount In Lacs

1. Land And Site Development 35

2. Building & Civil Construction 50

3. Plant & Machinery with laboratory 45

4. Controlling equipments (AHU, ETP other utilities) 25

Total 155

7 ANALYSIS OF PROPOSAL

Any Industrialization will benefit the local population in a number of ways. Already more than 20

local persons are getting the benefits directly or indirectly. Royal Enterprises, Barhi part 2,

Ganaur, Sonipat shall prefer to recruit new appointees from nearby locality, subject to

availability.Employment potential both direct and indirect coupled with business opportunity and

strong social commitment of the company in the form of different social work would result in

enhancement in the status and standard of living of the local population resulting in positive

impact.