TORRENT PHARMACEUTICALS LTD. (ONCOLOGY) · TORRENT PHARMACEUTICALS LTD. (Oncology), the flagship...

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1 ANNEXURE – 7.1 TORRENT PHARMACEUTICALS LTD. (ONCOLOGY) Survey No. 102/P, 105/P, 106, 119, 120/P, 121, 73, 74, Ahmedabad–Mehsana Highway, Vill.: Bileshwarpura, Taluka: Kalol, District: Gandhinagar RISK ASSESSMENT STUDY (For Proposed Bulk Drug Manufacturing Unit) March-2017

Transcript of TORRENT PHARMACEUTICALS LTD. (ONCOLOGY) · TORRENT PHARMACEUTICALS LTD. (Oncology), the flagship...

Page 1: TORRENT PHARMACEUTICALS LTD. (ONCOLOGY) · TORRENT PHARMACEUTICALS LTD. (Oncology), the flagship company of the Torrent Group, ... High Potent API • Module 1 : 1 MT • Module 2

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ANNEXURE – 7.1

TORRENT PHARMACEUTICALS LTD. (ONCOLOGY)

Survey No. 102/P, 105/P, 106, 119, 120/P,

121, 73, 74, Ahmedabad–Mehsana Highway, Vill.: Bileshwarpura, Taluka: Kalol,

District: Gandhinagar

RISK ASSESSMENT STUDY (For Proposed Bulk Drug Manufacturing Unit)

March-2017

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CONTENTS

SECTION NO.

CONTENTS

PAGE NO.

1 Executive Summary 4 2 Objectives, Philosophy and methodology of Risk

assessment 6

3 Introduction of the unit 7 3.1 Company Introduction 7 3.2 Details of Unit 7 3.3 Project setting 9 3.4 Organisational setup 11 3.5 List Of product 11 3.6 List of Raw material 12 3.7 Details of storage of Hazardous Materials 29 3.8 Control measures provided 30 3.9 Transportation, Unloading and handling procedure 32 3.10 Details of Fire fighting system installed at plant 36 3.11 Hazardous Properties Of The Chemicals, Compatibilities

And Special Hazard 37

3.12 Brief Description of process plant 39 4 Hazard identification 40 4.0 Introduction 40 4.1 DOW’s Fire and Explosion Index 41 4.2 Identification of Hazardous area 41 4.3 Failure Frequency 41 4.4 Evaluation of Process areas 43

5 Risk Assessment 45 5.1 Effects of Release of Hazardous Substances 45 5.2 Tank on Fire / Pool Fire 45 5.3 Dispersion cases 46 5.4 Identification of High Risk Areas 46 5.5 Modes of Failure 46 5.6 Damage Criteria for heat radiation 47

6 Consequence Analysis 48 6.1 Consequence Analysis 48 6.2 Maximum creditable loss scenario (MCLS) 48 6.3 Weather Data 48 6.4 Assumption 48 MCA Scenario-1 Unconfined pool fire due to Loss of

containment in 10 KL Methanol, Acetone IPA, Ethyl Acetate, etc. Road Tanker.

50

MCA Scenario -2 Unconfined Pool Fire Simulation for Drum Storage Area.

53

MCA Scenario – 3 BLEVE simulation for Drums Storage 55 MCA Scenario –4 Diffusion Jet Fire Simulation for 1.0 cm

copper connecting pipe to PRV station. 57

MCA Scenario –5 Over pressure / explosion for rupture of 1.0 cm copper pipe line of Hydrogen cylinder to PRV station

58

MCA Scenario – 6 pool fire simulation due to Loss of containment in HSD/FO tank 40 KL

59

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6.5 Detail regarding consequences analysis table 60 6.6 Conclusions 60

7 Risk Reduction Measures 61 8 Disaster Management plan 62 8.1 On site emergency Plan (OSEP) 62 8.2 Scope of OSEP 63 8.3 Elements of OSEP 63 8.4 Methodology 63 8.5 Emergencies Identified 63 8.6 Others 63 8.7 Emergency Organization 63 8.8 Emergency Facilities 63 8.9 Emergency Escapes 65 8.10 Assembly points 65 8.11 Wind sock 65 8.12 Emergency transportation 65 8.13 Emergency communication 65 8.14 Warning Alarm/ Communication of Emergency 65 8.15 Emergency responsibilities 65 8.16 Mutual Aids 66 8.17 Mock Drill 66

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SECTION I

EXECUTIVE SUMMARY

Executive Summary TORRENT PHARMACEUTICALS LTD. (ONCOLOGY), Survey No. 102/P, 105/P, 106, 119, 120/P, 121, 73, 74, Ahmedabad–Mehsana Highway, Vill.: Bileshwarpura, Taluka: Kalol, District: Gandhinagar. 1.1 Experts from Anand Consultants visited the site and subsequently inspection of site as per

site plan and the environs along with collection of relevant information about the proposed installation and the operations of the plant. Also a detailed discussion was held on various aspects including storage facilities, process safety and emergency preparedness with the officers of the company.

1.2 Solvents like Methanol, Toluene, Acetone, Ethyl Acetate, Hexane, etc., received through road truck and stored in CCOE approved tank farm area as per Petroleum Act and Rules. Some flammable/combustible liquid/solid chemicals will be received in drums or bags or in carboys, it will be stored in drum storage area and in RM store as per its incompatibility and other properties like flammable, toxic, corrosive and reactive.

1.3 Based on the data furnished and the study of the installation, certain hazards have been identified and their consequences are modeled mathematically using DNV-PHAST-7.11 and HAMSGAP software. Mapping of various scenario are with hazardous distances and safe distances are drawn on site plan for easy understanding of the consequences of the accident/ incident.

1.4 The study indicates that possible hazards associated with the plant are confined to (a) Petroleum underground storage tank farm area, road truck unloading area (b)Drum storage area. (c) Hydrogen cylinder and hydrogenation reaction shed. (d) HSD storage tank (e) FO storage tank. Various hazardous scenarios have been identified for Risk Assessment and the consequences modeled.

1.5 The results of the analysis have been summarized in the table appended. 1.6 It is observed from the summary that the consequences of hazards associated with any

possible spills / leaks for from drums release scenarios would be of large in nature and would be taken care of with the proposed emergency facilities and manpower employed.

1.7 The possibility of occurrence of such hazards and their effects could be further reduced by implementing the suggestions made in this report.

1.8 Catastrophic failure of tank resulting in major disaster due to fire, explosion and toxic releases is very unlikely events barring gross neglect of time tested safety standards and procedures set up by the industry.

1.9 The possibility of occurrence of major disaster due to fire, explosion and toxic release and mishaps are considered very remote.

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1.10 However considering the potential for major hazards, however remote they may be, associated with storage area, some suggestions are made in the subsequent chapters for further improvement in the areas of safety, environmental impact, Emergency facilities and emergency preparedness plan.

1.11 Conclusion Based on the 1) Risk Analysis study and information regarding the layout plan and safety systems. 2) Discussions with company officials,

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CHAPTER II

OBJECTIVE, PHILOSOPHY AND METHODOLOGY OF RISK ASSESSMENT

2.1 Objective :

The main objectives of the Risk Assessment (RA) study is to determine damage due to major hazards having damage potential to life & property and provide a scientific basis to assess safety level of the facility. The principle objective of this study was to identify major risks in the manufacture of specialty fine chemicals and storage of hazardous chemical at site and to evaluate on-site & off-site consequences of identified hazard scenarios. Pointers are then given for effective mitigation of hazards in terms of suggestions for effective disaster management, suggesting minimum preventive and protective measures & change of practices to ensure safety.

2.2 PHILOSOPHY :

This report is limited to the following: Identification of major risk areas. Hazard identification/Identification of failure cases Consequential analysis of probable risks / failure cases

o Evaluation of heat radiation & pressure wave profiles for identified failure cases o Risk assessment on the basic of the above evaluation & risk acceptability o Minimum preventive & protective measures to be taken to minimize risks to

maximum possible extent. Giving pointers for effective disaster management Suggesting other measures to further lower the probability of risk

2.3 Methodology

The procedure used for carrying out the Quantitative Risk Assessment Study is outlined bellow: Identify Credible Loss Scenarios for the facility under the study by discussion with TORRENT PHARMACEUTICALS LTD(TPL). Simulate loss Scenarios to determine the vulnerable zones for toxic dispersion, pool fire, Drum storage area fire (Thermal Radiation ), Flash fire, Explosion over pressure (Vapour cloud Explosion, Ball fire using software packages DNV-PHAST-7.11 and HAMSGAP. Suggest mitigating measures to reduce the damage, considering all aspects of the facilities. The flowchart of the methodology for the present study is shown in following page.

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RISK ASSESSMENT STUDY METHODOLOGY FLOWCHART

START

FACILITY, PROCESS AND METEOROLOGICAL DATA COLLECTION

LISTING OUT OF HAZARDOUS OPERATIONS & STORAGE DETAILS

DEFINING OF PARAMETERS FOR EACH OF CHEMICALS & EACH OF HAZARDS

IDENTIFICATION OF FAILURE SCENARIOS & QUANTIFICATION OF PROBABLE HAZARDS ASSOCIATED WITH THEM

DEFINING RELEASE TYPE (CONTINUOUS OR INSTANTANIOUS ) & DETERMINE RELEASE RATES

SIMULATION OF SELECTED CASES FOR CONSEQUENCE MODELING

PREPARATION OF SUMMERY OF CONSEQUENCE RESULTS

EVALUATION OF POTENTIAL RISK TO THE SURROUNDING POPULATION

DISCUSSION & RECOMMENDATION OF MITIGATIVE / REMEDIAL MEASURES

END

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SECTION III

INTRODUCTION OF THE UNIT

3.1 COMPANY INTRODUCTION

TORRENT PHARMACEUTICALS LTD. (Oncology), the flagship company of the Torrent Group, is planning an ambitious expansion of its manufacturing capacities in the Oncology Segment. The Bileshwarpura site will be developed as a Greenfield manufacturing facility for Oncology API and Oncology Formulations (OSD and Injectable). The facility is to be designed and constructed as per cGMP norms and would meet the regulatory requirements as per Schedule ‘M’, WHO, USFDA, MHRA, TGA and EU.

Targeted market would be major US, EU and India. API manufacturing shall be carried out in highest safety standards and equipment selected shall be designed with Isolator /Containment for OEL 5 category safety requirements.

Facilities shall be designed to cater US, EU, Brazil, ROW and domestic markets for :

High Potent API • Module 1 : 1 MT • Module 2 : 10 MT Intermediate Block ( 30 MT ) Prostaglandin Hydrogenation & Cryo block • Initial line capacity will be catering market requirement up to 2025 • Provision for future expansion

3.2 DETAILS OF UNITS TABLE: 3.1

Sr. No. Particulars

1. Full Name & Address of Unit : Torrent Pharmaceuticals Limited (Oncology) Survey No. 102/P, 105/P, 106, 119, 120/P, 121, 73, 74, Ahmedabad–Mehsana Highway, Vill.: Bileshwarpura, Taluka: Kalol, District: Gandhinagar

2. Telephone No. Fax Number: Email ID :

: Tel No: . 02764233671 (Ext No. : 396) Mo. No.: 98791 07959

3. Month & Year of Establishment : Green Field project 4. Full name & Address and phone number

of the Contact person : Mr. Harish Guttikar

Vice President – Projects Torrent Pharmaceutical limited Ahmedabad – Mehsana highway Village : Indrad, Tal : Kadi,

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Dist. : Mehsana – 382 721. 6 License & Approval:- :

Factory Inspectorate

Upcoming Unit

GPCB/PCB consent Upcoming Unit Explosive license No : Upcoming Unit

5. Man Power Existing: Proposed:

: - 100

6. No. Of shift & Shift timing General First Second Third

: Three Shifts 9:30 AM– 5:30 PM - General Shift 7:00 AM– 3:30 PM 3:00 PM– 11:30 PM 11:00 PM– 7:00 AM

7. Environs (Nearest Facilities) Latitude: 23° 18’ 12.93” N Longitude: 72° 26’ 07.10” E

8. Total Land at Plant 57,737 m2

9. Power connection Source: Uttar Gujarat Vij Company Limited (UGVCL) Power Connection: 2500 KVA

10. Power plant details : Not Applicable

11. Water Storage and source Sardar Sarovar Narmada Nigam Ltd.

12. Fire Hydrant details With drawing Fire Hydrant System will be installed with Hydrant, riser and Hose reel Hose at various locations. Drawing attached.

13. Sprinkler system with drawing --

14. Fire water source Sardar Sarovar Narmada Nigam Ltd.

15. Fire Water Reservoir capacity : M3 500 m3

16. Department wise List of fire extinguishers with mapping if available

Fire Extinguisher will be Installed at various locations as per fire load calculation.

3.3 PROJECT SETTING:

The location of the project is at Survey No. 102/P, 105/P, 106, 119, 120/P, 121, 73, 74, Ahmedabad–Mehsana Highway, Vill.: Bileshwarpura, Taluka: Kalol, District: Gandhinagar - 382 729. The geographical information of the proposed project is as given below:

Latitude: 23° 18' 13.25" N Longitude: 72° 26' 05.85" E

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Figure 1.1 Google Image

Figure 1.2 Plant layout

Latitude: 23° 18' 13.25" N Longitude: 72° 26' 05.85" E

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3.4 SAFETY ORGANIZATIONAL SET UP

Safety setup organization chart

3.5 LIST OF PRODUCTS

TABLE: 3.2

Sr. No.

Name of Product Production Capacity Kg/Annum MT/Annum

1 Lenalidomide (Amorphous) 50 0.050

2 Everolimus API 50 0.050

3 Sunitinib Maleate 50 0.050

4 Paclitaxel 50 0.050

5 Carboplatin 60 0.060

6 Pemetrexed disodium 60 0.060

7 Pazopanib 100 0.100

8 Cyclophosphamide monohydrate 180 0.180

9 Dasatinib 200 0.200

10 Erlotinib 200 0.200

11 Exemestene 250 0.250

12 Gefitinib 250 0.250

13 Methotraxate 250 0.250

14 Sorafenib tosylate 450 0.450

15 Enzalutamide 500 0.500

16 Nilotinib 550 0.550

17 Imatinib Mesylate 1,000 1.000

18 Bicultamide 1,000 1.000

Advise Company of safety legislation & updates, safety awareness, carry out safety audits, update safety policy, provide training when required, to provide investigations and reports for any accidents.

Directors

Factory manager (GM) (Safety Manager)

Safety Committee member

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19 Cytarabine 1,000 1.000

20 Tamoxifen Citrate 1,000 1.000

21 Ibrutinib 1,500 1.500

22 Abiraterone Acetate 2,000 2.000

23 Gemcitabine 2,000 2.000

24 Hydroxyurea 4,000 4.000

25 Capecitabine 4,500 4.500

26 Ulipristal Acetate 5 0.005

27 Travoprost 5 0.005

28 Bimatoprost 5 0.005

29 Bromophenac 5 0.005

30 Latanoprost 5 0.005

31 Briminodine Tartrate 10 0.010

32 Olopatadine Hydrochloride 10 0.010

33 Misoprostol 20 0.020

34 Brinzolamide 100 0.100

TOTAL 21,415 21.415

3.6 LIST OF RAWMATERIALS PRODUCT WISE

Sr.

No.

Name of Raw Material

Solid/ Liquid

Storage Max. Storage Container, Nos. Type Size

1. Product: Lenalidomide (Amorphous) (50 Kg/Annum)

1 Methyl 2-(bromomethyl)-3-nitrobenzoate

Solid Container 50 kg 2

2 3-aminopiperidine-2,6-dione hydrochloride

Solid Container 50 kg 1

3 Dimethyl formamide Liquid Drum 200 lit 13

4 Triethyl amine* Liquid Carboy 50 kg 1

5 Water Liquid --

--

--

6 10 % Pd/C Solid Container 10 kg 1

7 Ethyl acetate* Liquid Tank 5 Kl 1

8 Methanol* Liquid Tank 5 Kl 1

2. Product: Everolimus API (50 Kg/Annum) 1 Rapamycin (Sirolimus) Solid Container 50 Kg 1

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2 2,6-Lutidine Liquid Carboy 25 Kg 1

3 2-(t-Butyldimethylsilyl) oxyethyl triflate

Solid Container 25 Kg 1

4 Toluene* Liquid Tank 5 Kl 1

5 Ethyl Acetate* Liquid Tank 5 Kl 1

6 Sodium bicarbonate Solid Woven bag 50 kg 1

7 Sodium chloride Solid Woven bag 50 Kg 1

8 Sodium sulphate Solid Woven bag 50 Kg 1

9 Silica gel Solid Container 50 Kg 3

10 Hexanes* Liquid Tank 5 kl 4

11 Purified water Liquid --

--

--

12 Methanol* Liquid Tank 5 kl 1

13 Hydrochloric acid Liquid Carboy 35 Lit 1

3. Product: Sunitinib Maleate (50 Kg/Annum)

1 Ethyl-5-formyl-2,4-dimethyl-1H -pyrrole-3- carboxylate

Solid

Container

50 Kg

1

2 Potassium hydroxide* Solid Container 50 Kg 1

3 Methanol* Liquid Tank 5 kl 1

4 Water Liquid --

--

--

5 Hydrochloric Acid Liquid Carboy 35 Lit 1

6 Dichloromethane Liquid Tank 5 kl 1

7 N,N -diethylethane-1,2-diamine Solid Container 50 Kg 1

8 1-(3-dimethylaminopropyl- 3- ethylcarbodimide HCl

Solid

Container

50 Kg

1

9 1-hydroxybenzotriazole Solid Container 50 Kg 1

10 Triethylamine* Liquid Carboy 50 Lit 1

11 Dimethyl formamide Liquid Drum 200 Lit 1

12 Toluene* Liquid Tank 5 kl 1

13 n-Hexane* Liquid Tank 5 KL 1

14 Diethyl ether Liquid Drum 200 Lit 1

15 Ethyl acetate* Liquid

Tank 5 KL 1

16 Sodium chloride Solid Woven bag 50 kg 1

17 Sodium bicarbonate Solid Woven bag 50 kg 1

18 Sodium hydroxide* Solid Woven bag 50 kg 1

19 Pyrrolidine Liquid Carboy 25 Lit 1

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20 Ethanol* Liquid Drum 200 Lit 1

21 L-Malic acid Solid Container 25 Kg 1

22 Acetonitrile* Liquid Drum 200 Lit 3

4. Product: Paclitaxel (50 Kg/Annum)

1 7-triethylsilylbaccatine III Solid Container 50 Kg 1

2 N-benzoyl-O-(1-ethoxy- ethyl)-3-phenylisoserine

Solid

Container

50 Kg

2

3 Toluene* Liquid Tank

5 Kl 1

4 Di-2-pyridyl carbonate Solid Container 50 Kg 1

5 4-dimethylaminopyridine Solid Container 25 Kg 1

6 Ethyl acetate* Liquid Tank

5 Kl 1

7 Sodium bicarbonate Solid Woven bag 50 Kg 1

8 Water Liquid --

--

--

9 Sodium chloride Solid Woven bag 50 Kg 1

10 Sodium sulphate Solid Woven bag 50 Kg 1

11 Methylene chloride* Liquid Tank 5 Kl 1

12 Ether* Liquid Drum 200 Lit 1

13 Hydrochloric Acid Liquid Carboy 35 Lit 1

14 Ethanol* Liquid Drum 200 Lit 4

15 Methanol* Liquid Tank

5 Kl 1

16 Silica Gel Solid Container 50 Kg 6

5. Product: Carboplatin (60 Kg/Annum)

1 Cis-diamminedichloroplatinum(II)

Solid Container 25 Kg 1

2 Silver sulphate Solid Container 25 Kg 1

3 Water Liquid --

--

--

4 Barium sulphate Solid Container 25 Kg 1

5 Carboxylic acid Liquid Carboy 50 Lit 1 6. Product: Pemetrexed disodium (60 Kg/Annum)

1

Dimethyl N-[4-(4-hydroxy-6-pivaloylamino pyrrolo[2,3-d]pyrimidin-3- ylethynyl)benzoyl]-L-glutamate

Solid

Container

50 Kg

1

2 Methanol* Liquid Tank 5 Kl 1

3 Dichloromethane Liquid Tank 5 Kl 1

4 3% palladium on carbon Solid Container 10 Kg 4

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5 Hyflow powder Solid Container 50 Kg 1

6 Sodium hydroxide* Solid Woven bag 50 Kg 1

7 Purified water Liquid --

--

--

8 Ethanol* Liquid Drum 200 Lit 1

9 Acetone* Liquid Tank 5 Kl 1 7. Product: Pazopanib (100 Kg/Annum)

1 2,3-dimethyl-2H-indazol-6-amine

Solid Container 50 Kg 1

2 2,4-dichloropyrimidine Solid Container 50 Kg 1

3 Methanol* Liquid Tank 5 Kl 1

4 Sodium bicarbonate Solid Woven bag 50 Kg 2

5 Water Liquid --

--

--

6 Ethyl acetate* Liquid Tank 5 Kl 1

7 N-(2-chloropyrimidine-4-yl)-

2,3-dimethyl- 2H-indazol-6-amine

Solid

Container

50 Kg

1

8 Cesium carbonate Solid Container 50 Kg 2

9 Iodomethane Liquid Carboy 52 Lit 1

10 Dimethylformamide Liquid Drum 200 Lit 1

11 N-(2-chloropyrimidin-4yl)-N2,3-trimethyl- 2H-indazol-6-amine

Solid

Container

50 Kg

1

12 5-amino-2-methylbenzene sulfonamide

Solid Container 50 Kg 1

13 Iso propyl alcohol*(IPA) Liquid Tank 5 Kl 1

14 4M HCl in IPA Liquid Carboy 35 Lit 1 8. Product: Cyclophosphamide monohydrate (180 Kg/Annum)

1 N,N-bis(2-chloroethyl)amine hydrochloride

Solid Container 50 Kg 1

2 3-amino-1-propanol Liquid Carboy 35 Lit 1

3 Phosphoryl chloride Liquid Carboy 35 Lit 1

4 Triethylamine* Liquid Carboy 35 Lit 4

5 Dichoromethane Liquid Carboy 35 Lit 13

6 Dilute hydrochloric acid Liquid Carboy 35 Lit 1

7 Sodium carbonate Solid Woven bag 50 Kg 1

8 Sodium Sulphate Solid Woven bag 50 Kg 1

9 Activated Carbon Solid Container 25 Kg 1

10 Water Liquid --

--

--

11 Diethyl ether Liquid Carboy 35 Lit 7

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12 Hyflow Solid Container 50 Kg 1

13 Ethanol* Liquid Carboy 35 Lit 3 9. Product: Dasatinib (200 Kg/Annum)

1 Ethyl 2-amino-1,3-thiazole-5-carboxylate

Solid Container 50 Kg 1

2 di-tert-butyl carbonate Liquid Carboy 50 Lit 2

3 Catalytic 4-dimethylamino pyridine

Solid Container 50 Kg 1

4 Tetrahydrofuran* Liquid Drum 200 Lit 9

5 Dichloromethane Liquid Tank 5 Kl 1

6 Celite Solid Container 50 Kg 1

7 Purified water Liquid --

--

--

8 Hydrochloric acid Liquid Carboy 35 Lit 3

9 Sodium chloride Solid Woven bag 50 Kg 5

10 MgSO4 Solid Woven bag 50 Kg 1

11 Hexanes* Liquid Tank 5 Kl 1

12 Methanol* Liquid Tank 5 Kl 1

13 Sodium Hydroxide* Solid Woven bag 50 Kg 3

14 Ether Liquid Tank 5 Kl 1

15 Phosphorous Pentoxide* Solid Container 50 Kg 1

16 Oxalyl Chloride Liquid Carboy 50 Lit 1

17 Dimethyl formamide Liquid Drum 200 Lit 1

18 Toluene* Liquid Tank 5 Kl 1

19 2-chloro-6-methyl aniline Liquid Carboy 50 Lit 1

20 Diisopropylethylamine Liquid Drum 200 Lit 2

21 Ethyl Acetate* Liquid Tank 5 Kl 1

22 2,4-dichloro-2-methyl Pyrimidine

Solid Container 50 Kg 1

23 Sodium tert butoxide Solid Container 50 Kg 1

24 Acetone* Liquid Tank 5 Kl 1

25 Hydroxyethylpiperazine Liquid Carboy 50 Lit 2

26 N methyl Pyrrolidone Liquid Drum 200 Lit 2 10. Product: Erlotinib (200 Kg/Annum)

1 4,5-bis(2-methoxyethoxy)-2-nitrobenzoate

Solid Container 50 Kg 2

2 Methanol* Liquid Tank 5 Kl 1

3 Platinum(IV) Oxide Monohydrate

Solid Container 50 Kg 1

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4 Hydrogen* Gas Cylinder --

--

5 Formamide Liquid Carboy 50 Lit 22

6 Diethyl ether Liquid Drum 200 Lit 39

7 Acetonitrile* Liquid Carboy 50 Lit 31

8 3-Ethynylaniline Liquid Carboy 50 Lit 2

9 Dichloromethane Liquid Tank 5 Kl 1

10 Dimethyl Formamide Liquid Drum 200 Lit 1

11 POCl3 Liquid Carboy 50 Lit 2

12 Sodium Hydroxide* Solid Woven bag 50 Kg 2

13 Water Liquid --

--

--

14 Heptane Liquid Drum 200 Lit 3

15 Acetonitrile* Liquid Drum 200 Lit 4

11. Product: Exemestene (250 Kg/Annum)

1 Boldenone Solid Container 50 Kg 5

2 Dimethylamine HCl Gas Cylinder --

--

3 Isopentenol Liquid Drum 200 Lit 50

4 Parformaldehyde Solid Container 50 Kg 6

5 Sodium hydroxide* Solid Woven bag 50 Kg 3

6 water Liquid --

--

--

7 Hexane* Liquid Tank 5 Kl 1

8 Ethanol* Liquid Drum 200 Lit 6

9 Jones reagent Solid Container 50 Kg 2

10 Acetone* Liquid Tank 5 Kl 1

11 Isopropyl alcohol* Liquid Tank 5 Kl 1

12 Sodium bicarbonate Solid Woven bag 50 Kg 6 12. Product: Gefitinib (250 Kg/Annum)

1 Acetoxy-4-(3'-Chloro-4'-

fluoroanilino-7- methoxyquinazoline Hydrochloride

Solid

Container

50 Kg

3

2 Ammonium Hydroxide Solid Container 50 Kg 1

3 Water Liquid --

--

--

4 Methanol* Liquid Tank 5 Kl 1

5 3-morphilinopropyl chloride Liquid Carboy 50 Lit 2

6 potassium carbonate Solid Woven bag 50 Kg 5

7 Dimethyl formamide Liquid Drum 200 Lit 23

8 Ethyl Acetate* Liquid Tank 5 Kl 1

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9 Toluene* Liquid Tank 5 Kl 1 13. Product: Methotraxate (250 Kg/Annum)

1 2,4,5,6-

tetraaminopyrimidine dihydrate sulfate

Solid

Container

50 Kg

3

2 Barium Chloride Dihydrate Solid Container 50 Kg 3

3 Disodium p-methylaminobenzoylglutamic acid

Solid

Container

50 Kg

3

4 Water Liquid --

--

--

5 Dibromopropionaldehyde Liquid Carboy 50 lit 2

6 Acetic acid* Liquid Drum 200 Lit 1

7 Iodine* Solid Container 50 Kg 2

8 Potassium Iodide Solid Container 50 Kg 3

9 Sodium Hydroxide* Solid Woven bag 50 Kg 2 14. Product: Sorafenib tosylate (450 Kg/Annum)

1 (4-(4-Aminophenoxy)-N-

methylpyridine-2- carboxamide)

Solid

Container

50 Kg

2

2 1-Chloro-4-isocyanato-2-

(trifluoromethyl) benzene

Solid

Container

50 Kg

1

3 Methylene Chloride* Liquid Tank 5 Kl 1

4 p-Tolunesulfonic acid monohydrate

Solid Container 50 Kg 1

5 Ethanol* Liquid Drum 200 Lit 6

6 Activated charcoal Solid Container 25 Kg 1

7 Hyflow Solid Container 50 Kg 1 15. Product: Enzalutamide (500 Kg/Annum)

1 4-Amino-2-trifluoromethyl benzonitrile

Solid Container 50 Kg 8

2 Thiophosgene Liquid Carboy 50 Lit 4

3 Water Liquid --

--

--

4 Chloroform* Liquid Drum 200 Lit 59

5 Magnesium sulphate Solid Woven bag 50 Kg 9

6 Methyl-2-fluoro-4-aminobenzamide

Solid Container 50 Kg 5

7 Acetone cyanohydrins* Liquid Carboy 50 Lit 15

8 Ethyl Acetate* Liquid Tank 5 Kl 12

9 Magnesium sulphate Solid Woven bag 50 Kg 3

10 Silica Solid Container 50 Kg 48

Page 19: TORRENT PHARMACEUTICALS LTD. (ONCOLOGY) · TORRENT PHARMACEUTICALS LTD. (Oncology), the flagship company of the Torrent Group, ... High Potent API • Module 1 : 1 MT • Module 2

19

11 Dimethyl formamide Liquid Drum 200 Lit 1

12 Hydrochloric acid Liquid Carboy 35 Lit 2

16. Product: Nilotinib (550 Kg/Annum)

1 KSM-I Solid Container 50 Kg 3

2 KSM-II Solid Container 50 Kg 2

3 Diethyl cyanophosphonate Liquid Carboy 35 Lit 4

4 N,N-Dimethylformamide Liquid Carboy 35 Lit 100

5 Triethyl amine* Liquid Carboy 35 Lit 3

6 Ethyl acetate* Liquid Tank 5 Kl 1

7 Sodium hydrogen carbonate Solid Woven bag 50 Kg 3

8 Tetrahydrofuran* Liquid Drum 200 Lit 5

9 Water Liquid --

--

--

10 Methanol* Liquid Tank 5 Kl 1

11 Con.HCl Liquid Carboy 35 Lit 1

12 Hyflow Solid Woven bag 50 Kg 3 17. Product: Imatinib Mesylate (1000 Kg/Annum)

1 N-(2-methylphenyl)-

4-(3-pyridyl)-2- pyrimidine-amine

Solid

Container

50 Kg

20

2

4-(4-methyl-piperazinomethyl)-benzoyl chloride

Solid

Container

50 Kg

27

3 Pyridine* Liquid Drum 200 Lit 200

4 Water Liquid --

--

--

5 Dichloro Methane Liquid Tank 5 Kl 2

6 Methanol* Liquid Tank 5 Kl 1

7 Ethanol* Liquid Drum 200 Lit 5

8 Methane Sulfonic Acid Liquid Carboy 35 Lit 1 18. Product: Bicultamide (1000 Kg/Annum)

1 N-[4-cyano-3-

(trifluoromethyl)phenyl]-2- methyloxirane-2-carboxamide

Solid

Container

50 Kg

50

2 4-fluorobenzenethiol Solid Container 50 Kg 125

3 Tetrahydro furan* Liquid Drum 200 Lit 63

4 Sodium hydride Solid Container 50 Kg 5

5 Metachloro perbenzoic acid Solid Container 50 Kg 10

6 Dichloromethane Liquid Tank 5 Kl 2

7 Water Liquid --

--

--

Page 20: TORRENT PHARMACEUTICALS LTD. (ONCOLOGY) · TORRENT PHARMACEUTICALS LTD. (Oncology), the flagship company of the Torrent Group, ... High Potent API • Module 1 : 1 MT • Module 2

20

8 Ethyl acetate* Liquid Tank 5 Kl 2 19. Product: Cytarabine (1000 Kg/Annum)

1 1-(p-β-

dimethylaminoethoxyphenyl)-1,2- diphenylbutan-1-ol

Solid

Container

50 Kg

15

2 Phosphorus pentasulfide Solid Container 50 Kg 10

3 Pyridine* Liquid Drum 200 Lit 66

4 Purified water Liquid --

--

--

5 Chloroform* Liquid Drum 200 Lit 22

6 Sulfuric acid* Liquid Carboy 50 Lit 55

7 Sodium bicarbonate Solid Woven bag 50 Kg 28

8 Sodium sulfate Solid Woven bag 50 Kg 5

9 Methanol* Liquid Tank 5 Kl 2

10 Ammonical methanol Liquid Drum 200 Lit 185

11 Ether Liquid Drum 200 Lit 11 20. Product: Tamoxifen Citrate (1000 Kg/Annum)

1 1-(p- β-

dimethylaminoethoxyphenyl)-1,2- diphenylbutan-1-ol

Solid

Container

50 Kg

20

2 Ethanol* Liquid Drum 200 Lit 58

3 10N-hydrochloric acid Liquid Carboy 35 Lit 11

4 Methylene Chloride* Liquid Tank 5 Kl 1

5 Water Liquid --

--

--

6 Activated charcoal Solid Woven bag 50 Kg 5

7 Hyflow Solid Woven bag 50 Kg 13

8 Sodium Hydroxide* Solid Woven bag 50 Kg 9

9 Ether Liquid Drum 200 Lit 349

10 Anhydrous Sodium Sulphate Solid Woven bag 50 Kg 9

11 Methanol* Liquid Tank 5 Kl 3

12 Citric Acid Liquid Woven bag 50 Kg 20

13 Acetone* Liquid Tank 5 Kl 2 21. Product: Ibrutinib (1500 Kg/Annum)

1 3-iodo-1H-pyrazolo[3,4-d]pyimidin-4-amine

Solid Container 50 Kg 52

2 4-phenoxyphenylboronic acid Solid Container 50 Kg 46

3 Palladium tetrakistriphenylphosphine

Solid Container 50 Kg 14

Page 21: TORRENT PHARMACEUTICALS LTD. (ONCOLOGY) · TORRENT PHARMACEUTICALS LTD. (Oncology), the flagship company of the Torrent Group, ... High Potent API • Module 1 : 1 MT • Module 2

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4 Sodium carbonate Solid Woven bag 50 Kg 50

5 Ethylene glycol dimethyl ether Liquid Carboy 50 Lit 1035

6 Ethyl acetate* Liquid Tank 5 Kl 5

7 Sodium Sulphate Solid Woven bag 50 Kg 5

8 Water Liquid --

--

--

9 (S)-1-Boc-3-Hydroxypiperidine Solid Container 50 Kg 62

10 Polymer bound triphenylphosphine

Solid Container 50 Kg 103

11 Tetrahydro furan* Liquid Drum 200 Lit 345

12 Diisopropyl diazodicarboxylate Liquid Carboy 50 Lit 32

13 Hydrochloric acid Liquid Carboy 35 Lit 287

14 Acryl chloride Liquid Carboy 50 Lit 4

15 Dioxane* Liquid Drum 200 Lit 22

16 Triethyl amine* Liquid Carboy 35 Lit 15

17 Methylene dichloride Liquid Tank 5 Kl 2

18 Citric acid Solid Container 50 Kg 2

19 Sodium chloride Solid Woven bag 50 Kg 2

20 Magnesium sulphate Solid Woven bag 50 Kg 2 22. Product: Abiraterone Acetate (2000 Kg/Annum)

1 Dehydroepiandrosterone-3-acetate (KSM )

Solid Container 50 Kg 20

2 Trifluoromethane sulphonic anhydride

Solid Container 50 Kg 10

3 2,6-di-t-butyl-4-methylpyridine Liquid Carboy 50 Lit 8

4 Dichloromethane Liquid Tank 5 Kl 7

5 Hexane* Liquid Tank 5 Kl 10

6 Water Liquid --

--

--

7 Magnesium Sulphate Solid Woven bag 50 Kg 3

8 Tetra hydro furan* Liquid Drum 200 Lit 13

9 Diethyl(3-pyridyl)borane Solid Container 50 Kg 3

10 Bis(triphenylphosphine)palladium (II) chloride

Solid

Container

50 Kg

1

11 Sodium carbonate Solid Woven bag 50 Kg 9

12 Diethyl ether Liquid Drum 200 Lit 37

13 Acetonitrile* Liquid Drum 200 Lit 16 23. Product: Gemcitabine (2000 Kg/Annum)

Page 22: TORRENT PHARMACEUTICALS LTD. (ONCOLOGY) · TORRENT PHARMACEUTICALS LTD. (Oncology), the flagship company of the Torrent Group, ... High Potent API • Module 1 : 1 MT • Module 2

22

1 3,5-bis(t-

butyldimethylailyloxy)- 2-desoxy- 2,2-difluroribose

Solid

Container

50 Kg

320

2 Anhydrous Dichloromethane Liquid Drum 200 Lit 2670

3 Tri ethyl amine* Liquid Carboy 50 Lit 109

4 Methyl sulfonyl chloride Liquid Carboy 50 Lit 71

5 Ethyl Acetate* Liquid Tank 5 Kl 64

6 Sodium Bicarbonate Solid Woven bag 50 Kg 431

7 Hydrochloric acid Liquid Carboy 35 Lit 101

8 Water Liquid --

--

--

9 Sodium Chloride Solid Woven bag 50 Kg 271

10 Sodium Sulphate Solid Woven bag 50 Kg 16

11 bis(Trimethylsilyl)-N-Acetylcytosine

Solid Container 50 Kg 382

12 Trifluromethane sulfonyl oxytrimethyl silane

Liquid Carboy 50 Lit 312

13 Methanol* Liquid Tank 5 Kl 248

14 Ammonia* Liquid Carboy 50 Lit 1450

15 Bio Rad Ion exchange resin Solid Container 50 Kg 797

16 Ammonium Hydroxide Solid Container 50 Kg 399 24. Product: Hydroxyurea (4000 Kg/Annum)

1 Hydroxylamine hydrochloride Solid Container 50 Kg 35

2 Sodium cyanate Solid Container 50 Kg 99

3 Water Liquid --

--

--

4 Amberlite Resin Solid Container 50 Kg 659 25. Product: Capecitabine (4500 Kg/Annum)

1 2',3'-di-O-acetyl-5'-fluorocytidine

Solid Container 50 Kg 90

2 Dichloromethane Liquid Tank 5 Kl 79

3 Pyridine* Liquid Drum 200 Lit 11059

4 n-pentyl chloroformate Liquid Carboy 50 Lit 43065

5 Ether Liquid Drum 200 Lit 158

6 Sodium Bicarbonate Solid Woven bag 50 Kg 45

7 Water Liquid --

--

--

8 Sodium Sulfate Solid Woven bag 50 Kg 7

9 Sodium chloride Solid Woven bag 50 Kg 45

10 Sodium hydroxide* Solid Woven bag 50 Kg 13

Page 23: TORRENT PHARMACEUTICALS LTD. (ONCOLOGY) · TORRENT PHARMACEUTICALS LTD. (Oncology), the flagship company of the Torrent Group, ... High Potent API • Module 1 : 1 MT • Module 2

23

11 Methanol* Liquid Tank 5 Kl 4

12 Hydrochloric acid Liquid Carboy 35 Lit 13 26. Product: Ulipristal Acetate (5 Kg/Annum)

1

3,3,20,20-bis(ethylene-dioxy)-17α-hydroxy-19-norpregna-5(10), 9(11)-diene

Solid

Container

25 kg

1

2 Dichloromethane Liquid Tank

5 KL 1

3 Pyridine* Liquid Drum 200 Lit 1

4 Hexachloroacetone Liquid Container 25 kg 1

5 50% Hydrogen peroxide* Liquid Drum 200 Lit 1

6 Sodium thiosulfate Solid 50 Kg 1

7 Sodium Sulfate Solid Woven Bag 50 kg 1

8 Water Liquid --

--

--

9 Magnesium turnings* Solid Container 25 kg 1

10 1,2-Dibromoethane Liquid Drum 200 Lit 1

11 Tetrahydrofuran* Liquid Drum 200 Lit 1

12 4-Bromo-N,N-dimethylaniline Solid Container 25 Kg 1

13 Copper(I) chloride Solid Container 25 Kg 1

14 Ammonium Chloride Solid Container 25 Kg 1

15 Ethyl acetate* Liquid Tank

5KL 1

16 Potassium Hydrogen sulfate Solid Container 25 kg 1

17 Potassium Hydroxide* Solid Container 50 Kg 1

18 Silica gel Solid Container 50 Kg 1

19 Acetic anhydride* Liquid Drum 200 Lit 1

20 70% perchloric acid* Liquid Container 25 Kg 1

21 Sodium Acetate Solid Bag

50 kg 1

22 Isopropanol Liquid Tank

5 KL 1

23 Ethanol* Liquid Drum 200 Lit 1 27. Product: Travoprost (5 Kg/Annum)

1 (3aR,4S,5R,6aS)-4-(hydroxymethyl)-2- oxohexahydro -2H-cyclopenta[b]furan-5-yl - O.O'-biphenyl phosphate

Solid

Container

50 Kg

1

2

Dimethyl {2-oxo-3-[3-(trifluoromethyl) phenoxy]propyl}phosphonate

Solid

Container

50 Kg

1

3 Dimethy ether Liquid Drum 200 Lit 1

Page 24: TORRENT PHARMACEUTICALS LTD. (ONCOLOGY) · TORRENT PHARMACEUTICALS LTD. (Oncology), the flagship company of the Torrent Group, ... High Potent API • Module 1 : 1 MT • Module 2

24

4 Cesium chloride heptahydrate Solid Container 50 Kg 1

5 Methanol* Liquid Tank

5 KL 1

6 Sodium borohydride Solid Container 10 Kg 1

7 Potassium carbonate Solid Container 50 Kg 1

8 Diisobutyl alluminium hydride Solid Container 25 Kg 1

9 4-(carboxybutyl)-triphenyl phosphonium bromide

Solid

Container

25 Kg

1

10 Sodium methyl sulfinyl methylide

Solid Container 25 Kg 1

11 Dimethyl sulphoxide Liquid Drum 200 Lit 1

12 1,8-Diazabicyclo[5.4.0]undec-7-ene

Liquid Carboy 50 Lit 1

13 Acetone* Liquid Tank

5 KL 1

14 1-propyl iodide Liquid Carboy 50 Lit 1

15 Water Liquid --

--

--

28. Product: Bimatoprost (5 Kg/Annum)

1

Cyclopentane heptenoic acid, 5- cis-2-(3- αhydroxy-5-phenyl-1-trans-pentenyl)-3, 5 dihydroxy, [1α, 2β, 3α, 5α]

Solid

Container

25 kg

1

2 Acetone* Liquid Tank

5 KL 1

3 DBU (1,8 - Diazabicyclo[5.4.0]undec- 7-ene)

Liquid Container 25 kg 1

4 Methyl Iodide Solid Container 25 Kg 1

5 Ethyl Acetate* Liquid Tank

5 KL 1

6 Methanol* Liquid Tank

5 KL 1

7 Dimethylamine* Solid Bag

50 Kg 1

8 Silica gel Solid Container 50 Kg 1

29. Product: Bromophenac (5 Kg/Annum)

1 2,3-dihydro-1H-indole Solid Container 25 kg 1

2 4-bromobenzonitrile Solid Container 50 kg 1

3 Toluene* Liquid Tank

5 KL 1

4 BCl3, (Boron trichloride)* Solid Container 25 kg 1

5 AlCl3 (Aluminium chloride) Solid Container 25 kg 1

6 MnO2 (Manganese Dioxide) Solid Bag

50 Kg 1

7 Methylene chloride* Liquid Tank

5 KL 1

Page 25: TORRENT PHARMACEUTICALS LTD. (ONCOLOGY) · TORRENT PHARMACEUTICALS LTD. (Oncology), the flagship company of the Torrent Group, ... High Potent API • Module 1 : 1 MT • Module 2

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8 N chlorosuccinimide Solid Container 25 kg 1

9 N bromosuccinimide Solid Container 25 kg 1

10 2-Methoxy ethanol* Liquid Container 50 Lit 1

11 H3PO4 (Phosphoric acid)* Liquid Container 35 Lit 1

12 DME (Dimethyl ether) Liquid Drum 200 Lit 1

13 Diisopryl ether Liquid Drum 200 Lit 1

14 Water Liquid --

--

--

15 Aq. KOH (Potassium hydroxide)*

Liquid Drum 200 Lit 1

30. Product: Latanoprost (5 Kg/Annum)

1

3,3a, 4,5,6,6a-hexahydro-2-oxo-4- hydroxymethyl-5-(4'-phenyl benzoyloxy)- 2H-cyclopenta [b]furan

Solid

Container

50 Kg

1

2 Toluene* Liquid Tank

5 Kl 1

3 Dicyclohexylcarbodiimide Solid Container 50 Kg 1

4 Phsophoric acid* Liquid Carboy 35 Lit 1

5 Dimethyl sufoxide Liquid Drum 200 Lit 1

6 Triphenyl-(4-phenyl-3- oxobutyl)phosphonium iodide

Solid

Container

50 Kg

1

7 Potassium hydroxide* Solid Container 50 Kg 1

8 Methylene chloride* Liquid Tank

5 Kl 1

9 Water Liquid --

--

--

10 Con. Hydrochloric acid Liquid Carboy 35 Lit 2

11 Sodium chloride Solid Bag

50 Kg 2

12 Sodium sulphate Solid Bag

50 Kg 2

13 Methanol* Liquid Tank

5 Kl 1

14 Sodium borohydride Solid Container 10 Kg 1

15 Chloroform* Liquid Carboy 50 Kg 8

16 Ethyl acetate* Liquid Tank

5 Kl 1

17 Diisopropyl ether Liquid Drum 200 Lit 7

18 Ab. Ethanol* Liquid Drum 200 Lit 2

19 10% Pd/C Solid Container 10 Kg 1

20 Sodium nitrite Solid Container 10 Kg 1

21 Sodium bicarboante Solid Bag

50 kg 1

22 Diisobutylaluminum hydride Liquid Carboy 35 Lit 1

23 Sodium hydrogen sulphate Solid Container 50 Kg 1

Page 26: TORRENT PHARMACEUTICALS LTD. (ONCOLOGY) · TORRENT PHARMACEUTICALS LTD. (Oncology), the flagship company of the Torrent Group, ... High Potent API • Module 1 : 1 MT • Module 2

26

24 Triethylamine* Liquid Carboy 35 Lit 1

25 Potassium carbonate Solid Container 50 Kg 1

26 Hexane* Liquid Tank

5 KL 1

27 4-carboxybutyl triphenyl phosphonium bromide

Solid

Container

50 Kg

1

28 Tetrahydro furan* Liquid Drum 200 Lit 1

29 Potassium butoxide Solid Container 25 Kg 1

30 Acetone* Liquid Tank

5 Kl 1

31 Dimethyl fomamide Liquid Drum 200 Lit 1

32 Isopropyl iodide Liquid Carboy 35 Lit 1

33 Isopropanol Liquid Drum 200 Lit 1

34 Activated carbon Solid Container 10 Kg 1

35 Celite Solid Container 50 Kg 1 31. Product: Briminodine Tartrate (10 Kg/Annum)

1

6-Amino-5-bromoquinoxaline hydrobromide

Solid

Container

25 kg

1

2 Thiophosgene Liquid Carboy 25 Lit 1

3 Water Liquid --

--

--

4 Cyclohexane* Liquid Drum 200 Lit 1

5 Ethylene diamine* Liquid Carboy 50 Lit 1

6 Diethyl ether Liquid Drum 200 Lit 1

7 Methanol* Liquid Tank

5 KL 1

8 Hydrogen sulphide* Solid Container 25 kg 1 32. Product: Olopatadine Hydrochloride (10 Kg/Annum)

1

(3-dimethylaminopropyl)-triphenyl phosphonium bromide hydrobromide

Solid

Container

50 Kg

2

2 Tetrahydro furan* Liquid Drum 200 Lit 3

3 1.6N-n-butyl lithium hexane solution

Liquid Cylinder 50 Kg 3

4 11-oxo-6,11-dihydrodibenz [b,e]oxepin-2- acetic acid

Solid

Container

10 Kg

1

5 Water Liquid --

--

--

6 Diethyl ether Liquid Drum 200 Lit 2

7 Hydrochloric acid Liquid Carboy 35 Lit 1

8 Sodium hydroxide* Solid Bag

50 kg 4

9 Methanol* Liquid Tank

5 KL 1

10 Ethyl acetate* Liquid Tank

5 KL 2

Page 27: TORRENT PHARMACEUTICALS LTD. (ONCOLOGY) · TORRENT PHARMACEUTICALS LTD. (Oncology), the flagship company of the Torrent Group, ... High Potent API • Module 1 : 1 MT • Module 2

27

11 Sodium bicarboante Solid Bag

50 kg 9

12 Sodium chloride Solid Bag

50 kg 5

13 Sodium sulphate Solid Bag

50 kg 1

14 Silica gel Solid Container 50 Kg 8

15 Hexanes* Liquid Tank

5 KL 1

16 Triethyl amine* Liquid Carboy 50 Kg 10

17 p-toluene sulfonic acid Solid Container 25 Kg 2

18 Isopropyl alcohol (2-Propanol)* Liquid Drum 200 lit 4

19 Acetone* Liquid Tank

5 KL 1 33. Product: Misoprostol (20 Kg/Annum)

1 (±)4-methyloct-1-yn-4-ol Solid Container 50 Kg 1

2 Triethyl silyl chloride Solid Container 10 Kg 2

3 Dimethi Formamide Liquid Drum 200 Lit 1

4 Triiethyl amine* Liquid Carboy 50 Lit 1

5 20 % Diisobutyl aluminium hydride in Toluene

Liquid

Cylinder

50 Lit

1

6 Hexane* Liquid Tank

5 KL 1

7 Ether Liquid Drum 200 Lit 1

8 Tetrahydrofuran* Liquid Drum 200 Lit 1

9 Iodine* Solid Container 50 Kg 1

10 Copper 1-pentyne Liquid Carboy 25 Lit 1

11 n- Butyl Lithium Liquid Cylinder 50 Lit 1

12 Bis hexamethyl phosphourous triamide

Liquid Carboy 35 Lit 1

13 Dihydropyran Liquid Carboy 35 Lit 1

14 Para tolunene sulphonic acid Solid Container 50 Kg 1

15 Acetic acid* Liquid Carboy 35 Lit 1

16 Water Liquid --

--

-- 34. Product: Brinzolamide (100 Kg/Annum)

1 Thiourea* Solid Bag

50 kg 1

2 Benzyl chloride* Liquid Container 50 ltr 2

3 Ethanol* Liquid Drum 200 ltr 3

4

3-acetyl-2,5-dichlorothiophene Semi solid

Carboy

50 ltr

3

5 5.4 M aqueous sodium hydroxide*

Liquid Carboy 50 ltr 8

6 5.25% sodium hypochlorite Liquid Tank

5 KL 1

Page 28: TORRENT PHARMACEUTICALS LTD. (ONCOLOGY) · TORRENT PHARMACEUTICALS LTD. (Oncology), the flagship company of the Torrent Group, ... High Potent API • Module 1 : 1 MT • Module 2

28

7 2-propanol * Liquid Tank

5 KL 1

8 Water Liquid --

--

9 3-acetyl-5-chloro-2-(benzylthio) thiophene

Liquid Carboy 50 ltr 4

10 Ethyl acetate Liquid Tank

5 KL 2

11 Sodium tungstate dihydrate Solid Container 50 kg 2

12 30% hydrogen peroxide* Liquid Carboy 50 ltr 26

13 Sodium bisulfite Solid Woven Bag 50 kg 32

14 Aqueous sodium bicarbonate Solid Woven Bag 50 kg 32

15 Saturated aqueous sodium chloride

Solid Woven Bag 50 kg 32

16 t-butyl methyl ether Liquid Drum 200 ltr 10

17 Sodium sulfate Solid Bag 50 kg 4

18 3-acetyl-5-chloro-2-thiophenesulfonamide

Liquid Carboy 50 ltr 2

19 Sodium bicarbonate Solid Woven Bag 50 kg 1

20 Magnesium sulphate Solid Woven Bag 50 kg 2

21 Methylene chloride* Liquid Tank 5 KL 1

22 Acetonitrile* Liquid Drum 200 ltr 2

23 Trimethylorthoacetate Liquid Carboy 50 ltr 1310

3.7 LIST OF HAZARDOUS RAW MATERIAL IN BULK

TABLE: 3.3

Sr.

No.

Name of Raw Material

Solid/ Liquid

Storage Max. Storage Container, Nos.

Storage Location

Hazard

Type

Size

1. HSD Liquid Tank

40 KL 2 PESO approved area

Fire

2. FO Liquid Tank 40 KL 1 PESO approved area

Fire

3. Acetone* Liquid Tank 5 Kl 1 U/G Tank Farm Fire

4. Dichloro Methane Liquid Tank 5 Kl 2 U/G Tank Farm Fire

5. Ethyl acetate Liquid Tank 5 KL 2 U/G Tank Farm Fire

6. Ether Liquid Tank 5 Kl 1 U/G Tank Farm Fire

7. Iso propyl alcohol*(IPA)

Liquid Tank 5 Kl 2 U/G Tank Farm Fire

8. Hexane* Liquid Tank 5 Kl 2 U/G Tank Farm Fire

Page 29: TORRENT PHARMACEUTICALS LTD. (ONCOLOGY) · TORRENT PHARMACEUTICALS LTD. (Oncology), the flagship company of the Torrent Group, ... High Potent API • Module 1 : 1 MT • Module 2

29

9. Methanol* Liquid Tank 5 Kl 2 U/G Tank Farm Fire

10. Methylene Chloride*

Liquid Tank 5 Kl 1 U/G Tank Farm Fire

11. Toluene* Liquid Tank 5 Kl 1 U/G Tank Farm Fire

12. Heptane Liquid Drum 200 Lit 5 Drum store Fire

13. Pyridine* Liquid Drum 200 Lit 1 Drum store Fire

14. Tetra hydro furan* Liquid Drum 200 Lit 13 Drum store Fire

15. Ab. Ethanol* Liquid Drum 200 Lit 2 Drum store Fire

16. Acetic acid* Liquid Drum 200 Lit 1 Drum store Fire/ Corrosive

17. Acetic anhydride* Liquid Drum 200 Lit 1 Drum store Corrosive

18. Acetonitrile* Liquid Drum 200 Lit 3 Drum store Fire/Toxic

19. Chloroform* Liquid Drum 200 Lit 10 Drum store Toxic

20. Diethyl ether Liquid Drum 200 Lit 2 Drum store Fire

21. Diisopropyl ether Liquid Drum 200 Lit 7 Drum store Fire

22. Diisopropylethylamine

Liquid Drum 200 Lit 2 Drum store Fire

23. Dimethy ether Liquid Drum 200 Lit 2 Drum store Fire

24. Dimethyl fomamide

Liquid Drum 200 Lit 10 Drum store Fire

25. Dioxane* Liquid Drum 200 Lit 10 Drum store Fire/Toxic

26. DME (Dimethyl ether)

Liquid Drum 200 Lit 1 Drum store Fire

27. Ethanol* Liquid Drum 200 Lit 20 Drum store Fire

28. Ethylene diamine* Liquid Carboy 50 Lit 1 RM store Fire

29. Formamide Liquid Carboy 50 Lit 22 RM store Fire

30. Tri ethyl amine* Liquid Carboy 50 Lit 25 RM store Fire

31. H3PO4 (Phosphoric acid)*

Liquid Container

35 Lit 1 RM store Corrosive

32. Hydrochloric acid Liquid Carboy 35 Lit 10 RM store Corrosive

33. Phsophoric acid* Liquid Carboy 35 Lit 1 RM store Corrosive

34. Sulfuric acid* Liquid Carboy 50 Lit 20 RM store Corrosive

35. AlCl3 (Aluminium chloride)

Solid Container

25 kg 1 RM store Corrosive

36. Con. Hydrochloric acid

Liquid Carboy 35 Lit 2 RM store Corrosive

37. Ammonia* Liquid Carboy 50 Lit 20 RM store Toxic

38. Hydrogen* Gas Cylinder

-- -- RM store Fire/ Explosion

Page 30: TORRENT PHARMACEUTICALS LTD. (ONCOLOGY) · TORRENT PHARMACEUTICALS LTD. (Oncology), the flagship company of the Torrent Group, ... High Potent API • Module 1 : 1 MT • Module 2

30

3.8 Control measures provided for storage and handling of Chemicals. 3.8.1 For PESO Underground storage tank farm :

1. Class A petroleum products will be received through road tanker and stored in underground storage tank as per petroleum rules.

2. Tank farm will be constructed as per exp losive department requirement and separat ion distance will be maintained.

3. Stat ic earthing provis ion will be made for road tanker as well as storage tank.

4. Flame arrestor with breather valve will be provided on vent line. 5. Road tanker unload ing procedure will be prepared and implemented. 6. Fire load calculat ion will be done and as per fire load Hydrant System

will be provided as per NFPA std. and Fire ext inguishers will be provided as per fire load calculat ion.

7. Spark arrestor will be provided to all vehicles in side premises. 8. Flame proof type equipment s and light ing will be provided. 9. Trained and exper ience operator will be emplo yed for tank farm area. 10. NFPA label (hazard ident ificat ion ) capacity and content will be

displayed on storage tank. 11. Solvents will be t ransferred through pump only in plant area and day

tank will be provided. Overflow line will be return to the storage tank or Pump On-Off swit ch will be provided near day tank in plant .

12. Jumpers will be provided on so lvent hand ling pipe line flanges. 13. Flexible SS hose will be used for road tanker unloading purpose and

other temp. connect ion. 3.8.2 For Drum Storage area :

Some chemicals will be received at plant in drums by road t ruck and stored in a separate drum storage area.

1. PESO approved drum storage area will be made. 2. Auto Sprinkler system will be provided in drum storage area. 3. Gas detectors for flammable mater ial will be provided in drum storage

shed. 4. Fire hydrant system as per NFPA and TAC norm will be installed. 5. Smoke detect ion system will be provided. 6. FLP type light fit t ings will be provided. 7. Conduct ive t ype Drum pallets with containment t ray will be provided. 8. Proper vent ilat ion system will be provided. 9. Proper label and ident ificat ion board /st ickers will be provided in the

storage area. 10. Drum handling t rolley / stackers/ fork lift will be used for drum

handling. 11. Separate dispensing room with local exhaust and stat ic earthing

provision will be made. 12. Mater ials will be stored as per it s compat ibilit y study and separate

area will be made for flammable, corrosive and toxic chemical drums storage.

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31

13. Smoking and other spark, flame generat ing item will be banned from the Gate.

3.8.3 Hydrogenation Plant:

1 DCS operat ional plant will be designed. 2 FLP type area will be provided. 3 Total enclosed process system. 4 Inst rument & Plant Air System. 5 Nitrogen blanket ing in Hydrogenat ion reactor. 6 Safety valve and Rupture disc provided on reactor. 7 Cooling Chilling and power alternat ive arrangement have been made

on reactor. 8 Hydrogen and Nit rogen Cylinder bank away from the autoclave

reactor. 9 PRV stat ion with shut off valve, safety valve provis ion will be made

for hydrogenat ion react ion safety. 10 Before Hydrogen Gas charging in to reactor and after complet ion o f

react ion Nit rogen flushing will be done. 11 Flame arrestor will be provided on vent line of reactor and it will be

extended up to roof level. 12 Segregated from other process facilit ies , Open and well vent ilated

and frag ile roof will be provided to on reactor. 13 Safe Catalyst charging method will be adopted. 14 SOP will be prepared and operators will be t rained for the same. 15 Stat ic earthing and electr ic earthing (Double) provided. 16 Rector vent extended outside the process area and flame arrestor

provided on vent line. 17 Dumping vessel arrangement will be made. 18 Jumpers for stat ic earthing on pipeline flanges of flammable

chemical will be provided. 3.8.4 For Hydrogen Cylinder connecting header :

1 Hydrogen cylinder will be received by road will be stored away fro m process plant .

2 PRV stat ion provided with shut off valve and safety valve . 3 Flame proof light fit t ing installed. 4 Stat ic earthing and electr ic earthing (Double) provided. 5 Jumpers for stat ic earthing on pipeline flanges of flammable

chemical will be provided. 6 Non sparking tools will be used for hydrogen line fit t ing.

3.8.5 For Warehouse Safety Measures:

1. FLP type light f itt ings will be provided . 2. Proper ventilation will be provided RM store. 3. Proper label and identification board /stickers will be provided in the

storage area. 4. Pallets wil l be used for material bag storag e. 5. Material handling trol ley / stackers/fork li ft will be us ed.

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6. Materials wil l be stored as per its compatibility study and separat e area will be available for f lammable, corrosive and toxic chemical storage.

7. Smoking and other spark , f lame generating item are banned from the Gate.

3.9 Transportation, Unloading and handling procedure 3.9.1 For Acetone, Methanol etc., :

SR.NO. ACTIVITY TYPE OF POSSIBLE HAZARD

PROCEDURES.

1 Transportation of Methanol, Acetone etc. by road tanker

Leakage, Spillage, fire, explosion, Toxic release

Training will be provided to driver and cleaner regarding the safe driving, hazard of Flammable chemicals, emergency handling, use of SCBA sets.

TREM card will kept with TL. SCBA set will be kept with TL. Fire extinguishers will be kept with TL. Flame arrestor will be provided to TL

exhaust. Instructions will be given not to stop road

tanker in populated area. Clear Hazard Identification symbol and

emergency telephone number will be displayed as per HAZCHEM CODE.

Appropriate PPEs will be kept with TL. 2 Transportation of

Methanol, Acetone, etc. Road tanker unloading at site.

Leakage, Spillage, fire, explosion, toxic release

Priority will be given to Tanker to immediately enter the storage premises at site and will not be kept waiting near the gate or the main road.

Security person will check Licence, TREM CARD, Fire extinguisher condition, SCBA set condition, Antidote Kit, required PPEs as per SOP laid down.

Store officer will take sample as per sampling SOP from sampling point.

After approval of QC department unloading procedure will be allowed be started.

Following precautions will be adopted during unloading Wheel stopper will be provided to TL at

unloading platform. Static earthing will be provided to road

tanker. Tanker unloading procedure will be

followed according to check list and implemented.

Flexible SS hose connection will be done at TL outlet line.

The quantity remaining in the hose pipeline will be drained to a small underground storage tank, which will be subsequently transferred by nitrogen pressure to the main

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storage tank thus ensuring complete closed conditions for transfer from road tanker.

All TL valves will be closed in TL. Finally earthing connection and wheel

stopper will be removed. Only day time unloading will be permitted.

3 Methanol, Acetone Storage tank safety

Leakage, Spillage, Fire, Explosion, Toxic release.

SS storage tank will be provided as per IS code.

Dyke wall will be provided to storage tank. Level transmitter will be provided with low

level high level auto cut-off provision. Vent will be connected to water trap and

vent of water trap will be provided with flame arrestor.

Water sprinkler system will be provided to storage tank.

Fire hydrant monitor with foam attachment facility will be provided.

Dumping / Drain vessel/alternate vessel will be provided to collect dyke wall spillage material.

FLP type pump will be provided. Nitrogen blanketing will be provided to

storage tank. Double static earthing will be provided to

storage tank. Double Jumper clip will be provided to all

Solvent handling pipeline flanges. 4 Transportation of

Methanol, Acetone transfer from storage tank to Day tank

Leakage, Spillage due to Line rupture, Flange Gasket failure, Fire, Explosion, Toxic release.

Double mechanical seal type FLP type pump will be provided.

Double on / off switch will provided at tank farm and process area near day tank. Pump auto cut off with day tank high level will be provided.

Flame arrestor will be provided on day tank vent.

Over flow will be provided for additional safety and it will be connected to main storage tank.

NRV will be provided on pump discharge line.

Double Jumper clip will be provided to all solvent handling pipelines.

Double static earthing will be provided to day tank.

5 Transportation of Methanol, Acetone transfer from Day tank to reactor.

Leakage, Spillage due to Line rupture, Flange Gasket failure, Fire, Explosion, Toxic release.

Gravity transfer. Total quantity of day tank material will be

charged in to reactor at a time. NRV will be provided on day tank outlet line. Static earthing will be provided to storage

tank. Double Jumpers will be provided to pipeline

flanges.

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3.9.2 Drums Transportation, Unloading and handling procedure

SR. NO.

ACTIVITY TYPE OF POSSIBLE HAZARD

PROCEDURES.

1 Transportation of drums

Leakage, Spillage, fire, explosion, Toxic release

Training will be provided to driver and cleaner regarding the safe driving, hazard of Flammable chemicals, emergency handling, use of SCBA sets.

TREM card will kept with TL. SCBA set will be kept with TL. Fire extinguishers will be kept with TL. Flame arrestor will be provided to TL

exhaust. Instructions will be given not to stop road

tanker in populated area. Clear Hazard Identification symbol and

emergency telephone number will be displayed as per HAZCHEM CODE.

Appropriate PPEs will be kept with TL. 2 Drums unloading

at site. Leakage, Spillage, fire, explosion, toxic release

Priority will be given to truck to immediately enter the storage premises at site and will not be kept waiting near the gate or the main road.

Security person will check Licence, TREM CARD, Fire extinguisher condition, SCBA set condition, Antidote Kit, required PPEs as per SOP laid down.

Store officer will take sample as per sampling SOP from sampling point.

After approval of QC department unloading procedure will be allowed be started.

Following precautions will be adopted during unloading Wheel stopper will be provided to TL at

unloading platform. Only day time unloading will be permitted.

3 Godown /warehouse safety

Leakage, Spillage, Fire, Explosion, Toxic release.

FLP type light fittings will be provided. Proper ventilation will be provided in

godown. Proper label and identification board

/stickers will be provided in the storage area.

Conductive drum pallets will be provided. Drum handling trolley / stackers/fork lift

will be used for drum handling. Separate dispensing room with local exhaust

and static earthing provision will be made. Materials will be stored as per its

compatibility study and separate area will be made for flammable, corrosive and toxic chemical drums storage.

Smoking and other spark, flame generating item will be banned from the Gate.

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4 Solvents transfer from drum to Day tank/ reactor

Leakage, Spillage due to Line rupture, Flange Gasket failure, Fire, Explosion, Toxic release.

Solvent transfer by vacuum or by pump only. Static earthing will be provided. SS flexible hose / conductive hose will be

used.

5 Solvent transfer from Day tank to reactor.

Leakage, Spillage due to Line rupture, Flange Gasket failure, Fire, Explosion, Toxic release.

Gravity transfer. Total quantity of day tank material will be

charged in to reactor at a time. NRV will be provided on day tank outlet line. Static earthing will be provided to storage

tank. Double Jumpers will be provided to pipeline

flanges. 3.10 Details of Fire fighting system installed at plant:

Department wise List of fire extinguishers with mapping if available

Fire load calculation will be done before fire extinguishers procurements and will be installed as per fire load and type of fire requirements in all areas of the plant.

Fire hydrant system Fire hydrant system will be installed as per NFPA/TAC norms. Proposed drawing is provided in report.

Sprinkler system Sprinkler system will be installed in FO, HSD tank farm area and also will be installed automatic sprinkler system in Drum storage area. Drawing provided in report.

Manual call point MCP will be installed in plant.

Smoke detectors Will be installed in plant.

Gas detection system for flammable chemicals

Will be installed in tank farm area as well as drum storage area.

Static earthig automation with pump Will be provided at road tanker unloading point/ ramp.

Double static earthing provision in plant to each and every equipments, tanks, reactors and powder handling equipments.

Wil take take care for double static earthing provision to all equipments.

Fire and safety Organization A well established full flagged HSE organization set up will be available at site from project level.

Smoke detectors and gas detectors Smoke detectors and gas detectors (LEL % based) will be installed in drum storage area and tank farm area..

Fire department Full flagged fire department will round the clock fire fighting staff will be employed.

Fire prevention Fire prevention steps will be adopted at design level and all built in safety measures will be installed at plant.

Environment control plan. Total close process adopted for process. Vent condenser and scrubber provided for toxic gas/vapour emission control.

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3.11 HAZARDOUS PROPERTIES OF THE CHEMICALS, COMPATIBILITIES AND SPECIAL HAZARD Table-3.5

SR. NAME OF

CHEMICAL HAZA

RD FLASH POINT

0 C

BP 0 C

LEL % UEL % SP.GR. 20 0 C

VD SOLUBILITY WITH

WATER at 20 0 C

NFPA H F R

HAZARDOUS COMBUSTION

PRODUCT

TLV PPM

IDLH PPM

LC50 mg/m3

CARCINOGENIC

CHARACTERISTIC

ANTIDOT

1. Acetone CAS# 67-64-1 99

F - 20 56 2.15 13.0 0.791 2.00 Soluble 1 3 0 Irritating vapour

750 25000 LEL

- No 10 mg diazepam through injection

2. Dichloro Methane (MDC, DCM ) CAS#: 75-09-2

T N.F 39.8 14.0 22.0 1.325 2.9 20 g/ lit. 2 0 1 CO, CO2, Cocl2, HCL

(g) generated

50 2300 52 gm/m3 inhalation rat

Yes No specific Antidot

3. Ethyl Acetate CAS # 141-78-6

F -4.0 77.0 2.0 11.5 0.902 3.0 1 ml/10ml

water

1 3 0 Irritating Vapour

- 400 200 gm/m3

No Not available

4. Ether CAS # 8000-05-9

T/F -40 30 1.1 5.9 0.75 2.6 Insoluble 1 4 0 Toxic vapor are

generated

400 ppm

1100 ppm

3400 ppm for 4H rat

No Not available

5. Isopropyl alcohol CAS # 67-63-0

F 18.5 82.3 2.3 12.7 0.785 2.1 Miscible 1 3 0 Acid smoke & fumes

400 2000 LEL

- No Not available

6. Hexane CAS #110-54-3

F -7 68.7 1.2 7.7 0.659 3.0 - 1 3 0 CO & CO2 50 ppm

5000 ppm

- No No specific Antidot

7. Methanol CAS# 67-56-1

F/T 10 54 5.4 44 0.792 1.1 Soluble 1 3 0 Irritating vapour

200 6000 LEL

64000 ppm for 4H rat

No 10 mg diazepam through injection

Activated Charcoal 8. Methylene

Chloride CAS #75-09-2

T NF 39.8 12 19 1..322 2..9 soluble in cold

water.

2 0 1 CO, CO2, COCl2,

HCL

100 ppm

5000 52000 1 hours [Rat]

No Not available

9. Toluene CAS # 108-88-3

F 4.0 111 1.1 7.1 0.87 3.2 Insoluble 2 3 0 Irritating Vapour

generated

50 2000 400 ppm for 24Hr

Rat

No Diazem – 1 mg/Kg.(Intravenous), Epinephina, Efidrine

10. Pyridine CAS#110 – 86 - 1

F/T 19 115..3 1.8 12.4 0.983 - Soluble 2 3 0 - 5 PPM 1000 ppm

Not listed No Not available

11. Tetrahydrofuran CAS # 109-99-9

F/E -21 66 1.5 12 0.88 2.5 miscible 2 3 0 Toxic vapour

200 ppm

2000 ppm

21000 mg/m 3

hours [Rat

No Not available

12. Ab. Alcohol CAS # 64–17-5

F 55 78.3 3.3 19 0.790 1.6 Soluble 0 3 0 CO & CO2 1000 ppm

3300 ppm

20000 ppm for 10H rat

No 2 gm sodium bi carbonate in 250 ml water, Diazepam 10

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mg through injection

13. Acetic Acid CAS No. 64-19-7

T / F 44.4 117.9 5.4 16.0 1.015 2.1 Soluble 2 2 1 Irritating Vapour

10 ppm

50 5620 ppm/1H

No Milk of magnesia.

14. Acetic anhydride CAS No.108-24-7

F/T 49 140 2.7 10.3 1.05 3.5 Slightly 3 2 1 Emits toxic fumes

5 200 1780 mg/m3

No milk butter and milk of magnesia.

15. Acetonitrile CAS #75-05-8

T/F 42 81.6 4.4 16 0.787 1.4 Soluble 2 3 1 Toxic vapor are

generated

2.7 40 ppm 4000 ppm

No Cyanide Kit

16. Chloroform CAS # 7-66-3

T NF 61.2 NF NF 1.49 4.1 Insoluble 2 0 0 N A 10 ppm 500 ppm 47702 mg/m 4 hrs rat

Yes No specific Antidote

17. DMF(di methyl formamide) CAS#: 68-12-2

F 42.7 153°C 2.2 15.2 1.018 2.51 Insoluble in water

0.1 mg/mL at 64° F

1 2 0 Highly flammable

10 500 LC 50 rat (inhalative, 4 h) > 5900 mg/m

No No specific Antidote

18. Diethyl ether f -45 34.6 1.85 36.5 0.714 2.6 Insoluble 2 4 1 Irritating vapor

400 ppm

1900 ppm

NL No No specific Antidote

19. Ethylene Diamine 107-15-3

C/F 34.0 116 2.7 16.6 0.9 2.1 Miscible 3 3 0 CO, CO2, NOX

10 N.A. 424 4H Mouse

No Not available

20. Triethylamine CAS #121-44-8

T/F 20 89.5 1.2 8.0 0.729 3.5 Insoluble 2 3 0 Emits toxic fumes

10 ppm

1000 ppm

570 mg/kg Rabbit.

No Water -Milk

21. Sodium Hydroxide CAS #1310-73-2

C - very high

- - - - Miscible 3 0 1 Toxic fumes of sodium oxide.

2 mg/m

3

200 mg/m3

2300 mg/m3 for 2H

Rat

No Sodium Hydro-Carbonate (4%

Conc.), Milk, Lime Juice, Milk of

Magnesia 22. Hydrochloric Acid

HCL CP grade C/T NF 108 NF NF 1.12 -

1.19 1.26

7 Soluble 3 0 1 N A 5 ppm 50 ppm 3124

ppm for 1h rat

No Sodium Hydro-Carbonate (4%

Conc.), 23. Liq. Ammonia (25

% Solution) Toxic - 36 16 25 0.9 1.2 Miscible

3 1 0

Not

combustible

25

300 2000 ppm/4-hr

No Wash with Lactic Acid, Apply

soframycin Smelling Ethanol or Ether

24. Dioxane CAS# 123-91-1

H/F 12 101 2 22 1.034 NA Soluble 2 3 1 CO, CO2, Peroxide

NIOSH REL:

1 ppm

OSHA

500 48.5 mg/L ( Rat ) 4 h

Yes No specific antidote.

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PEL: 100 ppm

25. Phosphoric Acid CAS # 7664-38-2

C Not Flammable

271 NA NA 2.04 NA React with water

3 0 0 Non combustible

1 mg/m3

1000 mg/m3

1.689 mg/L (1

hour)

No No specific antidote.

26. Aluminum Chloride CAS #7446-70-0

C/T - - - - 2.44 4.5 - 3 0 2 Toxic fumes 5 ppm 100 ppm 1274 PPM No 2 to 5 gm thiosulphate in 5% sodium bi

carbonate solution in 200 ml

27. Hydrogen Gas CAS # 1333-74-0

F/E N.A. -252.8°C

3.0 74 0.0696 - Soluble in water

1 4 0 Explosive gas

250 ppm

NL LC50 >800000

ppm rat

No No specific antidote.

28. HSD Fire 32 0C (OC)

215 -376

0.6 6.0 0.86- 0.9

3.0 Insoluble 1 2 0 CO, NO 800 ACGIH

Not listed 5 g/m3 No No specific Antidote

29. Furnace Oil Fire 66 210-215 6.0 13.5 0.82-0.88

N.L Insoluble 0 2 0 N.L. N.L. No No No specific Antidote

F = FIRE T = TOXIC C = CORROSIVE E = EXPLOSIVE R = REACTIVE STEL = SHORT TERM EXPOSURE LIMIT BP = BOILING POINT LEL = LOWER EXPLOSIVE LIMIT PPM = PARTS PER MILLION UEL = UPPER EXPLOSIVE LIMIT SP.GR = SPECIFIC GRAVITY VD = VAPOUR DENSITY

ER = EVAPORATION RATE H = HEALTH HAZARD CLASS F = FIRE HAZARD CLASS R = REACTIVE HAZARD BR = BURNING RATE TLV = THRESHOLD LIMIT VALUE

NFPA =NATIONAL FIRE PROTECTION ASSOCIATION-usa N.A = NOT AVAILABLE N.L =NOT LISTED

3.12 BRIEF DESCRIPTION OF PROCESS. Process details are provided in EIA report.

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SECTION IV

HAZARD IDENTIFICATION

4.0 INTRODUCTION Risk assessment process rests on identification of specific hazards, hazardous areas and areas vulnerable to effects of hazardous situations in facilities involved in processing and storage of chemicals. In fact the very starting point of any such assessment is a detailed study of materials handled & their physical / chemical / thermodynamic properties within the complex at various stages of manufacturing activity. Such a detailed account of hazardous materials provides valuable database for identifying most hazardous materials, their behaviour under process conditions, and their inventory in process as well as storage and hence helps in identifying vulnerable areas within the complex. Hazardous posed by particular installation or a particular activity can be broadly classified as fire and explosive hazards and toxicity hazards. Whether a particular activity is fire and explosive hazardous or toxicity hazardous primarily depends on the materials handled and their properties. It will be from the above discussion that study of various materials handled is a prerequisite from any hazard identification process to be accurate. Based on this study the hazard indices are calculated for subsequent categorization of units depending upon the degree of hazard they pose. In a Pharmaceutical plant main hazard handling of hazardous chemicals like, Flammable solvents, corrosive and toxic chemicals, HSD/ FO as a fuel in Boiler and DG Sets, the primary concern has always been, fire and explosion prevention and control as these are the main hazard posed by such unit. This concern has grown through the loss of life, property and materials experienced after experienced after major disasters, which have occurred over the years. Identification of hazards is the most important step to improve the safety of any plant. The hazard study is designed to identify the hazards in terms of chemicals, inventories and vulnerable practices /operations.

The hazard evaluation procedures use as a first step by Pharma industries and petroleum refineries are checklists and safety reviews. Dow and Mond fire and explosion indices, which make use of past experience to develop relative ranking of hazards, is also extensively used. For predictive hazard analysis, Hazard and Operability studies (HAZOP), Fault tree analysis, Event tree analysis, Maximum credible accident and consequence analysis etc are employed.

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4.1 Dow’s fire and Explosion Index (F & EI) 4.1.2 Results of f ire explosion and toxicity indices.

TABLE- 4.1 Sr No

Material stored

Nh

Nf

Nr

MF

GPH SPH FEI Degree of Hazard

Radius of Exp.

(ft.)

Th Ts TI Degree of Hazard

1. Solvents Class A petroleum

1 3 0 16 2.55 2.35 95.88 Moderate 78 50 50 5.3 Light

2. FO 0 0 0 10 2.2 2.4 52.8 Light 44 0 50 2.7 Light 3. HSD 0 0 0 10 2.55 1.93 49.21 Light 41 0 50 2.4 Light

Nh = NFPA Health rating GPH = General Process Hazard Nf = NFPA Fire rating SPH = Special Process Hazard Nr = NFPA Reactive rating FEI = Fire Explosion Index MF = Material Fctor Th = Penalty Factor Ts = Penalty for Toxicity TI = Toxicity Index 4.2 Identification of Hazardous Areas:

A study of process for manufacturing Bulk Drugs as given in EIA report indicates the following: Process plant will be very small Batch sized process and multipurpose and multi utility

base plant due to that at a time inventory of raw material at production area will be very small.

All raw material and finished product will be stored in warehouse and required material will be charged in process through pump and in close circuit.

Batch size requirement chemicals will be charged into Day tank or reactor and empty drums will be sent back to RM store for neutralization and disposed off. Thus the inventory of the raw material in process area will be limited and for limited time.

Most of reactions are similar type. Various raw materials used in the manufacturing processes are listed in Table-3.3 in

Section-3 along with mode / type of storage & storage conditions. It can be readily seen that raw materials even though hazardous in nature, will be used in small quantities & storage quantities will also very low at process plant.

However some chemicals such as Methanol, Toluene, IPA, Acetone, Acetonitrile, Hexane, Ethanol, etc., will be used in one or more product and therefore their requirement is slightly higher and provision of storage of such material will be away from the process plant and dedicated tank farm area.

Drums will be stored in licenced drum storage area as per petroleum rules. Maximum Seven days running products raw material inventory will be kept in drum storage area.

List of chemicals stored in larger quantities is provided in Table-3.4, hazardous properties are provided in Table-3.5 and Occupational health impact to employees and emergency action plan and its antidotes provided in Table 3.6

4.3 Failure Frequencies 4.3.1 Hazardous material release scenarios can be broadly divided into 2 categories

I) catastrophic failures which are of low frequency and

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II) ruptures and leaks which are of relatively high frequency.

4.3.2 Typical failure frequencies are given below:-

TABLE-4.2

Item Mode of failure Failure frequencies Atmospheric storage

Catastrophic failure Significant leak

10-9 /yr 10-5 /yr

Process Pipelines < = 50 mm dia Full bore rupture

Significant leak 8.8 x 10-7 /m.yr 8.8 x 10-6 /m.yr

> 50 mm <=150mm dia Full bore rupture Significant leak

2.6 x 10-7 /m.yr 5.3 x 10-6 /m.yr

< 150 mm dia Full bore rupture Significant leak

8.8 x 10-8 /m.yr 2.6 x 10-6 /m.yr

Hoses Rupture 3.5 x 10-2 /m.yr

TABLE-4.3

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TABLE-4.4

4.4 Evaluation of Process Areas :

A study of process for manufacturing Drugs as given in EIA report indicates the following: Process plant will be Batch process and multipurpose and multi utility base plant due to

that at a time inventory of raw material at production area will be very small. All raw material and finished product will be stored in drums in drum storage area and

required material will be charged in process through pump and in close circuit. Batch size requirement chemicals will be charged in to day tank or reactor and empty

drums will be sent back to RM store for neutralization and disposed off. Thus the inventory of the raw material in process area will be limited and for limited time.

Various raw materials used in the manufacturing processes are listed in Table-3.3 in Section-3 along with mode / type of storage & storage conditions. It can be readily seen that raw materials even though hazardous in nature, will be used in small quantities & storage quantities will also very low at process plant.

However some chemicals such as Methanol, Toluene, IPA, Acetone, Acetonitrile, Hexane, Petroleum Ether, Ethanol, etc., will be used in one or more process and therefore their requirement is slightly higher.

Drums will be stored in licenced drum storage area as per petroleum rules. Maximum Seven days running products raw material inventory will be kept in drum storage area.

List of chemicals stored in larger quantities is provided in Table-3.7, hazardous properties are provided in Table-3.1

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Considering this, the risk analysis and consequences studies are concentrated on Below area. a. Petroleum underground storage tank farm area, road truck unloading area b. Drum storage area c. Hydrogen cylinder and hydrogenation reaction shed. d. HSD storage tank e. FO storage tank

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SECTION V

RISK ASSESSMENT 5.1 Effects Of Releases Of Hazardous Substances

Hazardous substances may be r eleas ed as a result of fai lures / cat astrophes , causing possible damage to the surrounding area. In the following discussion, an account is taken of vari ous effects of releas e of hazard ous substances and the parameters to be determined for quantification o f s uch damages .

In case of releas e of hazardous s ubstances the damag es wil l depend larg ely on source strength. The strength of the source means the volume of the substance released . The releas e may be instantaneous or semi -continuous . In the cas e of instantaneous releas e, the strength of the source is given in kg and in semi-continuous release the stren gth of the source depends on the outflow time (kg/s.). In order to fire the source strength, it is f irst necessary to determine the state of a substance in a vessel. The phys ical prop erties, viz . Pressure and temperature of the s ubstance determine t he phase of release. This may be gas, gas condensed to liquid and liquid in equili brium with its vapor or solids. Instantaneous release wil l occur, for exampl e, i f a storag e tank fai ls . Depending on the storag e conditions the following situations may occur. The source strength is equal t o the contents of the capacity of the storag e system. In the event of the instantaneous release of a li quid a pool of liqui d wil l form. The evaporation can be calculated on the basis of this p ool.

5.2 Pool Fire In the event of the instantaneous release of a li quid a pool of liquid wil l form. The evaporati on can be calculated on the basis of this pool . The heat load on object o utside a burning pool of liquid can be calculated with the heat radiation model . This model uses average radiation intensity, which is dependent on the liquid. Accoun t is als o taken of the diamet er -to-height ratio of t he fire , whi ch d epends on t he burnin g liquid. In addition, the heat load is also influenced by the fol lowin g factors:

Distance from the fi re The relative humidity of the air (water vapour has a relatively high heat -

absorbing capacity) The ori entation i .e . horizontal/vertical of the object ive irradiat ed with

respect to t he fire.

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5.3 DISPERSION CASES :

4.3.1 PLUMES:

Plumes are continuous releas e of hazardous gases and vapour. Smoke from a chimney is an example. Plumes can cause FIRES AND EXPLOSIONS as secondary scen arios .

4.3.2 PUFFS: Puffs are instantaneous releas e of hazardous gases and vapour. Puffs can give rise to FIRE BALLS and vapour cloud explosions (VCE). A speci al case of vapour cloud explosion is the Boiling Liquid Evaporating Vapour Explosion (BLEVE) .

4.3.3 SPILLS POOL:

Spills are liquid pools created by leaki ng liquid chemi cals . Spil ls caus e evaporation and dispersal of toxic g as es and if the spilled liquid is f lammable, t hen it can catch fire creatin g a pool f ire also t he vapour can caus e explosion.

5.4 Identification of High Risk Areas :

1. U/G tank farm area road tanker unloading point 2. Drum storage (RM) Store

5.5 Modes of Failure: Liquid release due to catastrophic failure of storage vessel or road tanker. Liquid release through a hole/crack developed at welded joints/flanges / nozzles /

valves etc. Vapour release due to exposure of liquid to atmosphere in the above scenarios. Gas release due to catastrophic failure of Ammonia cylinder or outlet valve/line failure.

Event Causes Tank on Fire/ - Catastrophic failure of tank + Ignition availability Pool fire - Failure of liquid outlet line + Ignition availability Fire Ball/ - Catastrophic failure of road tanker/ storage tank Flash Fire Vapour generation due to substrate and wind UVCE Vapour cloud generation and about 15 % of

total vapour mass Above the UEL-LEL % Ignition availability Toxic gas dispersion - Toxic Gas release due to catastrophic failure of tonner/bullet/ Tanks and ignition not available within LEL- UEL range.

Considering the quantity of storages & nature of Toxic nature and Flammable storage, following scenarios were taken up for detailed analysis & safe distances computed: Catastrophic failure of drum in drum storage area, etc. and presence of ignition source

poses heat radiation hazards to nearby areas.

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Dispersion of vapour of Bromine due to bromine bottle damage up to LC-50 ( Fatal ), Immediate Danger to Life and Health (IDLH ) and TLV ( Threshold Limit Value ) concentration Dispersion of vapour to toxic end points

Failure cases considered for consequence analysis are representative of worst-case scenarios. Probability of occurrence of such cases is negligible (less than 1 x 10-6 per year) because of strict adherence to preventive maintenance procedures within the complex. General probabilities for various failure is provided in Table-4.2, 4.3 and 4.4, but consequences of such cases can be grave & far reaching in case such systems fail during life history of the company. Hence such scenarios are considered for detailed analysis. It is to be noted however that such situations are not foreseeable or credible as long as sufficient measures are taken. Also, consequence analysis studies help us evaluate emergency planning measures of the Company.

5.6 Damage Criteria For Heat Radiation:

Damage effects vary with different scenarios. Calculations for various scenari os are made for the above failure cas es to quantify the res ult ing damages . The res ults are translated in term of i njuries and damages to exp osed personnel , equipment, building etc . Tank on fire /Pool f ire due to direct ignit ion source on tank or road tanker or catastrophic fai lure or leakage or d amag e from pipeline of storage facilit ies or road tanker unloading arm, can result in heat radiation causing burns to people depending on thermal load and period of exposure.

All such damages have to be specifi ed criteria for each such res ult ant effect , to relate the quantifier damages in this manner, damag e criteri a are used for Heat Radiation.

TABLE 4.3

DAMAGE CRITERIA – HEAT RADIATION Heat Radiation Incident Flux KW/m2 Damage 38 100% lethality, heavy damage to tanks 37.5 100% lethality, heavy damage to equipment. 25 50% lethality, non piloted ignition 14 Damage to normal buildings 12.5 1% lethality, piloted ignition 12 Damage to vegetation 6 Burns (escape routes) 4.5 Not lethal, 1st degree burns 3 1st degree burns possible (personnel only in emergency allowed) 2 Feeling of discomfort 1.5 No discomfort even after long exposure

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CHAPTER VI

CONSEQUENCE ANALYSIS

6.1 Consequence analysis.

In the risk analysis study, probable damages due to worst cas e scenari os were quantified and consequences were analyzed with object of emergency planning. Various meas ures taken by the company and findings of the study were considered for deciding acceptability of risks.

6.2 Maximum Credible loss scenarios ( MCLS)

MSCL assume maxi mum inventory of hazardous chemicals and worst weather condition prevai ling at the t ime of fai lure. Further, no credit is given for th e safety feat ures provided in the faci lity to determine maxi mum possibl e damage from the scenario selected. In real ity, leakage of hazardous chemica l will be smaller in magnitude. Als o the leakage wil l be detected immediately by plant operating staff then initiate various mitigation measures to prevent any disastrous situation. The maximum credible loss Scenarios (MCLS) identified for plant base on above criteria are listed below:

Table-6.1

Scenario No.

Failure Type Failure Mode Consequence

1. Loss of containment in Acetone, Methanol, HSD, FO, etc. road tanker.

Unloading arm 100 % failure and

immediate Ignition.

Unconfined Pool fire.

2. Fire in drum storage area Drum failure Fire in drum storage 3. Fire in drum storage area Drum failure BLEVE in drum 4. Hydrogen cylinder to

reactor. Rupture of 1.0 cm

SS/copper pipe line Diffusion Jet Fire

5. Hydrogen cylinder to reactor.

Rupture of 1.0 cm SS/copper pipe line

Over pressure

6. Loss of containment in HSD, FO, etc. storage tank.

Catastrophic failure Pool fire

6.3 Weather Data: Average wind speed : 6 m / sec. Average Ambient Temperature : 35 deg . c . Average Humidity : 60 %

6.4 Assumption :

6.4.1 Basic assumptions For 10 KL road tanker release scenario

100 % fai lure of Unloading arm is considered for 10 KL road tanker w hile unloading work. Total materi al drain will spr ead on floor. Immediat e ignit ion will give unconfined pool f ire .

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6.4.2 Basic assumptions for drum storage area

Drum Fire if direct ignit ion on road tanker . Drum storag e area fire due to heat effect and domino effect .

6.4.3 For Hydrogen Gas release scenarios

Hydrogen cylinder road skid to PRV station line damage and hydrogen gas release and it wil l be exp loid due to an y ignit ion source. Fol lowing scenari os can be possible.

Jet f ire Explosion ( Over pressure) We have calculated following hazardous dist ance for the above

mentioned scen arios . Intensity of Heat Radiation ( IHR) at groun d level (KW /m 2)

6.4.3 For FO and HSD storage tank

Pool Fire in dyke area due to catastrophic failure o f tank. Catast rophic failure is considered for FO/HSD Storage tanks. We have considered poo l fire scenar ios, Ball fire, Flash fire and UVCE were considered fo r var ious situat ions Heat Radiation Damage

37.5 100% lethality, heavy damage to equipment. 12.5 1% lethality, piloted ignition 4.5 Not lethal, 1st degree burns 1.6 No discomfort even after long exposure

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MCA Scenario-1 Unconfined pool fire due to Loss of containment in 10 KL Methanol, Acetone IPA, Ethyl Acetate, etc. Road Tanker.

TABLE –1 FOR 10 KL ROAD TANKER

Scenario : UNCONFINED POOL FIRE In put Data Results of Computations

Stored quantity 10 KL Pool diameter 15.0(m) Pool liquid depth 0.1 (m) Wind speed 6 m/s Liquid Density 791 to 890 kg/m3

Incident Intensity of Heat Radiation (

IHR) at ground level

KW /m 2

IHR- Isopleth Distance

( Meters )

Effect if IHR at Height of Simulation

37.5 18.6 Damage to process equipment. 100 % Fatal in 1 Min. 1 % fatal in 10 sec.

25.0 20.3 Min. to ignite wood ( without flame contact ). 100 % fatal in 1 Min. Significant injury in 10 sec.

12.5 28.7 Min. to ignite wood (with flame contact). 1 % fatal in 1 min. 1 st deg. burn in 10 sec.

4.0 50.6 Pain after 20 secs. Blistering unlikely.

1.6 80.0 No discomfiture even on long exposure.

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Results

In the 18.6 meter radius area is considered as 100 % fatality in 1 min. and first degree burn in 10 sec.

In the 50 meter radius area will give pain after 20 seconds. Blistering unlikely. In the 80 meter radius area is considered as safe area and no discomfiture even on long exposure. Measures to control and mitigate Emergency of road tanker accident:

Measures to be taken to prevent such accident:

1. Training will be provided to driver and cleaner regarding the safe driving, hazard of Flammable chemicals, emergency handling, use of SCBA sets.

2. TREM card will kept with TL. 3. SCBA set will be kept with TL. 4. Fire extinguishers will be kept with TL. 5. Flame arrestor will be provided to TL exhaust. 6. Instructions will be given not to stop road tanker in populated area. 7. Clear Hazard Identification symbol and emergency telephone number will be

displayed as per HAZCHEM CODE. 8. Appropriate PPEs will be kept with TL. Mitigation measures :

1. Off site emergency agency telephone provided in TRM CARD. 2. Fire extinguishers are provided in TL. 3. Training provided to control such emergency to driver and cleaner. 4. Evacuate the area up to 200 meters in all direction. 5. In case of leakage from valve road tanker should be deriver away from the populated

area. 6. Call to police, fire brigade, Users company and supplier company.

EMERGENCY RESPONSE Fire CAUTION: All these products have a very low flash point: Use of water spray when fighting fire may be inefficient. CAUTION: For mixtures containing alcohol or polar solvent, alcohol-resistant foam may be more effective. Small Fire Dry chemical, CO2, water spray or regular foam. Large Fire Water spray, fog or regular foam. Use water spray or fog; do not use straight streams. Move containers from fire area if you can do it without risk. Fire involving Tanks or Car/Trailer Loads Fight fire from maximum distance or use unmanned hose holders or monitor nozzles. Cool containers with flooding quantities of water until well after fire is out.

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Withdraw immediately in case of rising sound from venting safety devices or discoloration of tank. ALWAYS stay away from tanks engulfed in fire. For massive fire, use unmanned hose holders or monitor nozzles; if this is impossible, withdraw from area and let fire burn.

SPILL OR LEAK

ELIMINATE all ignition sources (no smoking, flares, sparks or flames in immediate area).

All equipment used when handling the product must be grounded. Do not touch or walk through spilled material. Stop leak if you can do it without risk. Prevent entry into waterways, sewers, basements or confined areas. A vapor suppressing foam may be used to reduce vapors. Absorb or cover with dry earth, sand or other non-combustible material and

transfer to containers. Use clean non-sparking tools to collect absorbed material.

Large Spill

Dike far ahead of liquid spill for later disposal. Water spray may reduce vapor; but may not prevent ignition in closed spaces.

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MCA Scenario -2 Unconfined Pool Fire Simulation for Drum Storage Area.

TABLE – 2 Unconfined Pool Fire for Drum Storage Area

Scenario : UNCONFINED POOL FIRE In put Data Results of Computations

Stored quantity 20 KL Max. IHR at flame centre height 143.48 Kw/m2 Pool diameter 25(m) Flame centre height 21.60 meter Pool liquid depth 0.01 (m) Maximum Flame width 21.59 meter Wind speed 3 m/s Mass burning rate liquid 5.02 kg/ m2/min. Liquid Density 867 kg/m3 Flame burnout time 1.66 Hrs.

Incident Intensity of Heat Radiation (

IHR) at ground level KW /m 2

IHR- Isopleth Distance

( Meters )

Effect if IHR at Height of Simulation

37.5 23.1 Damage to process equipment. 100 % Fatal in 1 Min. 1 % fatal in 10 sec.

25.0 28.3 Min. to ignite wood (without flame contact). 100 % fatal in 1 Min. Significant injury in 10 sec.

12.5 40 Min. to ignite wood (with flame contact). 1 % fatal in 1 min. 1 st deg. burn in 10 sec.

4.0 70.7 Pain after 20 secs. Blistering unlikely.

1.6 111.8 No discomfort even on long exposure.

Results In the 23.1 meter radius area is considered as 100 % fatality in 1 min. and first degree burn in 10

sec. In the 40 meter radius first degree burn in 10 sec. In the 70.7 meter radius area will give pain after 20 seconds. Blistering unlikely. In the 111.8 meter radius area is considered as safe area and no discomfiture even on long

exposure.

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MCA Scenario – 3 BLEVE simulation for Drums Storage

TABLE – 3 BLEVE simulation for Drums Storage

Scenario : FIRE BALL/ BLEVE In put Data Results of Computations

Stored quantity 20 Kl Fire Ball radius 11.17 meter Mass of vapour 80 Kgs. Fire ball Intensity of Heat

radiation 186.59 Kw /m 2

Heat of combustion 40550 Kj/Kg Fire Ball rate of energy release

292486 Kj/ sec.

Wind speed 3 m/s Fire- Ball total energy release

1.333e + 006 Kj

Liquid Density 867 kg/m3 Fire ball duration 4.56 sec.

Incident Intensity of Heat Radiation (

IHR) at ground level KW /m 2

IHR- Isopleth Distance

( Meters )

Damage effects

37.5 25 100 % Fatal . Min. to ignite wood (without flame contact)

25.0 30 Min. to ignite wood ( without flame contact ). Significant injury.

12.5 42.5 Min. to ignite wood (with flame contact). 1 st deg. burn .

4.0 76 Pain after 20 secs. Blistering unlikely.

1.6 120 No discomfort even on long exposure.

Results In the 25 meter radius area is considered as 100% fatality in 1 min. In 42.5 meter radius area is considered as 1st deg. Burn in 10 sec. and 1 % fatal in 1 minute. In the 76 meter radius area will give pain after 20 seconds. Blistering unlikely. In the 120 meter radius area is considered as safe area and no discomfiture even on long

exposure.

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MCA Scenario –4 Diffusion Jet Fire Simulation for 1.0 cm copper connecting pipe to PRV station.

TABLE – 4 For Hydrogen Cylinder skid to PRV Station.

Scenario : JET FIRE In put Data Results of Computations

Stored quantity 515 M3 Max. IHR at flame centre height

52.49 Kw/m2

Gas Jet Diameter 1 cm Flame centre height 63 meter Gas velocity in the leakage hole/ pipe

143463 m/s Maximum Flame width 12 meter

Wind speed 3 m/s Heat flux 8.5 Kw/ m2 Gas Density 0.067kg/m3 Flame surface area 3778 m2

Incident Intensity of Heat Radiation ( IHR) at ground

level KW /m 2

IHR- Isopleth Distance

( Meters )

Effect if IHR at Height of Simulation

37.5 8.3 Damage to process equipment. 100 % Fatal in 1 Min. 1 % fatal in 10 sec.

25.0 10.2 Min. to ignite wood ( without flame contact ). 100 % fatal in 1 Min. Significant injury in 10 sec.

12.5 14.4 Min. to ignite wood (with flame contact). 1 % fatal in 1 min. 1 st deg. burn in 10 sec.

4.0 25.4 Pain after 20 secs. Blistering unlikely.

1.6 40.1 No discomfort even on long exposure.

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MCA Scenario –5 Over pressure / explosion for rupture of 1.0 cm copper pipe line of Hydrogen cylinder to PRV station

TABLE – 5 For Hydrogen Gas Copper Tube Failure

Scenario : FLASH FIRE In put Data Results of Computations

Stored quantity 7 m3 Visible Flash Fire Height 0.52meter Mass of Gas 1 kgs Visible Flash Fire Width 0.26 meter Heat of combustion 42267 Kj/kg Duration of Flash-Fire in Sec. 2 sec. Fuel-Air volume ratio in Flash fire cloud

0.600 Radius of fuel-air cloud mixture 4.19 meter

Stochiometric Fuel-Air Mixture

0029 Total energy release 283720 Kj

Wind speed 6.0 m/s Max. Heat Radiation from 1 m from Flash Fire

750 Kw/ m2

Gas Density 0.067 kg/m3 Combustion efficiency 0.5

Incident Intensity of Heat Radiation (IHR) at ground level KW

/m 2

IHR- Isopleth Distance

( Meters )

Damage effects

37.5 19 100 % Fatal . Min. to ignite wood (without flame contact)

25.0 24 Significant injury. Min. to ignite wood ( without flame contact ).

12.5 32 Min. to ignite wood (with flame contact). 1st deg. burn .

4.0 57 Pain after 20 secs. Blistering unlikely.

1.6 89 No discomfort even on long exposure.

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MCA Scenario – 6 pool fire simulation due to Loss of containment in HSD/FO tank 40 KL.

TABLE – 6 Pool Fire for HSD / FOTank 40 KL.

Scenario : POOL FIRE In put Data Results of Computations

Stored quantity 40 KL Max. IHR at flame centre height 105.82 Kw/m2 Pool diameter 15(m) Flame centre height 18.60 meter Pool liquid depth 1 (m) Maximum Flame width 8.15 meter Wind speed 3 m/s Mass burning rate liquid 0.78 kg/ m2/min. Liquid Density 850 kg/m3 Flame burnout time 2.1 Hrs.

Incident Intensity of Heat Radiation (

IHR) at ground level KW /m 2

IHR- Isopleth Distance

( Meters )

Effect if IHR at Height of Simulation

37.5 16.7 Damage to process equipment. 100 % Fatal in 1 Min. 1 % fatal in 10 sec.

25.0 20.4 Min. to ignite wood (without flame contact). 100 % fatal in 1 Min. Significant injury in 10 sec.

12.5 28.8 Min. to ignite wood (with flame contact). 1 % fatal in 1 min. 1 st deg. burn in 10 sec.

4.0 50.7 Pain after 20 secs. Blistering unlikely.

1.6 80.0 No discomfort even on long exposure.

Results In the 16.7 meter radius area is considered as 100% fatality in 1 min. In 28.8 meter radius area is considered as 1st deg. Burn in 10 sec. and 1 % fatal in 1 minute. In the 50.7 meter radius area will give pain after 20 seconds. Blistering unlikely.

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6.5 Detail regarding consequences analysis table

TABLE - 6.3

6.6 Conclusions

The appended table 6.3 summarizes the consequences of the various Scenarios analyzed under this study. As can be seen from the results of the summary of the Quantitative Risk Analysis study, the Total damage and Fatality zone due to Fire & Explosion up to 25 meters in worst case scenario. First degree burn zone up to 42 meter. Within the manufacturing processes, no major hazards are for seen due to minimal storage in process area. On site emergency preparedness plan will be prepared as per risk assessment findings. Emergency control facilities and resources will be plan and rehearsal / Mock- Drill to be conducted regularly to combat emergency in minimum time.

Type of failure considered Spill quantity consideration Max. Credible loss scenario in KL.

Heat Intensity KW/ M2

37.5 12.5 4.0

MCA Scenario-1 Unconfined pool fire due to Loss of containment in 10 KL Road Tanker.

10 18.6 28.7 50.6

MCA Scenario -2 Unconfined Pool Fire Simulation for Drum Storage Area.

20 23.1 40.0 70.7

MCA Scenario – 3 BLEVE simulation for Drums Storage

20 25.0 42.5 76.0

MCA Scenario –4 Diffusion Jet Fire Simulation for 1.0 cm copper connecting pipe to PRV station

1cylinder 8.3 14.4 25.4

MCA Scenario –5 Over pressure / explosion for rupture of 1.0 cm copper pipe line of Hydrogen cylinder to PRV station

7 m3 19.0 32.0 57.0

MCA Scenario – 6 pool fire simulation due to Loss of containment in HSD/FO tank 40 KL.

40 16.7 28.8 50.7

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SECTION VII

RISK REDUCTION MEASURES

7.1 Recommendations 7.1.1 From the Risk Analysis studies conducted, it would be observed that by and large, the risks

are confined within the factory boundary walls in case of fire, explosion and spillage of chemicals. On site emergency plan & preparedness plan to be prepared and implemented to combat such situations. To minimize the consequential effects of the risk scenarios, following steps are recommended.

Fire hydrant system and sprinkler system shall be installed as per provided drawing. Plant should meet provisions of the Manufacture, storage & Import of Hazardous

Chemicals Rules, 1986 & the factories Act, 1948. Process hazard analysis and HAZOP study to be conducted for each product and

recommendation to be implemented. Safe operating procedure to be prepared for hazardous process and material handling

process. DCS operational plant to be installed for Hydrogen reaction. Manual call point, Gas detection system and smoke detection system to be provided. Follow pipeline colour code IS 2379 to plant pipeline. Permit to work system to be implemented 100 % for hazardous work in the plant. Safety manual as per Rule-68 K & P and Public awareness manual as per 41 B & C needs

to be prepared and distributed to all employees and nearby public. The details of emergency equipments are given in on site emergency Plan along with its

quantity. As per our site visit, these was found in order & working condition and sufficient for existing production Activates.

For proposed plant Fire & Safety organization setup to be planned for batter plant process safety.

Induction course for HSE to be implemented at very initial stage of the plant employees recruitment.

Periodic On Site Emergency Mock Drills and occasional Off Site Emergency Mock Drills to be conducted, so those staffs are trained and are in a state of preparedness to tackle any emergency.

Emergency handling facilities to be maintained in tip top condition at all time. Emergency siren to be provided in all plant to declare emergency. HSE management system to be prepared and implemented. Good safety culture to be adopted at the early stage of plant commissioning.

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SECTION VIII

DESASTER MANAGEMENT PLAN

An onsite emergency in the industries involving hazardous processes or in hazardous installations is one situation that has potential to cause serious injury or loss of life. It may cause extensive damage to property and serious disruption in the work area and usually, the effects are confined to factory or in several departments of factory, premise. An emergency begins when operator at the plant or in charge of storage cannot cope up with a potentially hazardous incident, which may turn into an emergency. 8.1 ONSITE EMERGENCY PLAN 8.1.1 OBJECTIVES OF ONSITE EMERGENCY PLAN

A quick and effective response at during an emergency can have tremendous significance on whether the situation is controlled with little loss or it turns into a major emergency. Therefore, purpose an emergency plan is to provide basic guidance to the personnel for effectively combating such situations to minimize loss of life, damage to property and loss of property. An objective of Emergency Planning is to maximize the resource utilisation and combined efforts towards emergency operations are as follows. :

8.1.2 DURING AN EMERGENCY.

To increase thinking accuracy and to reduce thinking time. To localize the emergency and if possible eliminates it. To minimize the effects of accident on people and property. To take correct remedial measures in the quickest time possible to contain the incident

and control it with minimum damage. To prevent spreading of the damage in the other sections. To mobilize the internal resources and utilize them in the most effective way To arrange rescue and treatment of causalities.

8.1.3 DURING NORMAL TIME.

To keep the required emergency equipment in stock at right places and ensure the

working condition. To keep the concerned personnel fully trained in the use of emergency equipment. To give immediate warning tooth surrounding localities in case of an emergency situation

arising. To mobilize transport and medical treatment of the injured. To get help from the local community and government officials to supplement manpower

and resources. To provide information to media & Government agencies, Preserving records, evidence of

situation for subsequent emergency etc.

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8.2 SCOPE OF OSEP

This OSEP is prepared for industrial emergencies like fires, explosions, toxic releases, and asphyxia and does not cover natural calamities and societal disturbances related emergencies (like strikes, bomb threats, civil commission’s etc.)

8.3 ELEMENTS OF ONSITE EMERGENCY PLAN

The important elements to be considered in plan are

Emergency organization Emergency Facilities. Roles and Responsibilities of Key Personnel and Essential Employee. Communications during Emergency Emergency Shutdown of Plant & Control of situation. Rescue Transport & Rehabilitation. Developing Important Information.

8.4 METHODOLOGY.

The consideration in preparing Emergency Plan will be included the following steps:

Identification and assessment of hazards and risks. Identifying, appointment of personnel & Assignment of Responsibilities. Identification and equipping Emergency Control Centre. Identifying Assembly, Rescue points Medical Facilities. Formulation of plan and of emergency sources. Training, Rehearsal & Evaluation. Action on Site.

Earlier, a detailed Hazard Analysis and Risk Assessment was carried out on hazards and their likely locations and consequences are estimated following the standard procedure. However the causing factors for above discussed end results may be different and causing factors are not discussed in this plan.

8.5 EMERGENCIES IDENTIFIED

Emergencies that may be likely at bulk fuel storage area, process plant, cylinder storage area, and drum storage shed, and autoclave reactor area. There are chances of fire and explosive only.

8.6 OTHERS

Other risks are earthquake, lightning, sabotage, bombing etc., which are usually, not in the purview of management control.

8.7 EMERGENCY ORGANISATION.

Plant organization is enclosed. Based on the plant organization, which includes shift organization, an Emergency Organization is constituted towards achieving objectives of this emergency plan. Plant Manager is designated as Overall in Charge and is the Site Controller.

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The following are designated as Incident Controllers for respective areas under their control. Shift in charge Engineer (Plant Operations) is designated at Incident Controller for all areas of plant.

8.8 EMERGENCY FACILITIES 8.8.1 EMERGENCY CONTROL CENTRE (ECC)

It is a location, where all key personnel like Site Controller, Incident Controller etc. can assemble in the event of onset of emergency and carry on various duties assigned to them. Plant Manager’s Office is designated as Emergency Control Centre. It has P&T telephone as well as internal telephones, ECC is accessible from plant located considerably away from process plant, Storage’s and on evaluation of other locations, Plant Manager’s Room find merit from the distance point of view, communication etc.

8.8.2 FACILITIES PROPOSED TO BE MAINTAINED AT EMERGENCY CONTROL CENTRE (ECC)

The following facilities and information would be made available at the ECC

Latest copy of Onsite Emergency Plan and off sites Emergency Plan (as provided by District Emergency Authority).

Intercom Telephone. P&T Telephone. Telephone directories (Internal, P&T) Factory Layout, Site Plan Plans indicating locations of hazardous inventories, sources of safety equipment, hydrant

layout, location of pump house, road plan, assembly points, vulnerable zones, escape routes.

Hazard chart. Emergency shut-down procedures. Nominal roll of employees. List and address of key personnel List and address of Emergency coordinators. List and address of first aides, List and address of first aid fire fighting employees, List and address of qualified Trained persons.

8.8.3 FIRE FIGHTING FACILITIES.

Internal hydrant system Portable extinguishers

8.8.4 FIRE PROTECTION SYSTEMS

These systems are proposed to protect the plant by means of different fire protection facilities and consist of Hydrant system for exterior as well as internal protection of various buildings/areas of

the plant. Portable extinguishers and hand appliances for extinguishing small fires in different areas

of the plant. Water cum foam monitor to be provided in bulk fuel storage area.

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Fire water pumps. Two (2) independent motor driven pumps each of sufficient capacity and head are

proposed for the hydrant systems which is capable to extinguish Fire or cooling purpose. 8.8.5 HYDRANT SYSTEM.

Adequate number of fire hydrants and monitors will be provided at various locations in and around the buildings and other plant areas. The hydrants will be provided on a network of hydrant mains drawing water from the hydrant pump, which starts automatically due to drop of pressure in the event of operating the hydrant valves. We are suggesting you to go for TAC approved hydrant system for foolproof safety and benefit from fire policy premium.

8.9 EMERGENCY ESCAPES

The objective of the emergency escape is to escape from the hazardous locations, to the nearest assembly point or the other safe zone, for rescue and evacuation.

8.10 ASSEMBLY POINT.

Assembly point is location, where, persons unconnected with emergency operations would proceed and await for rescue operation.

8.11 WIND SOCK.

Wind socks for knowing wind direction indication would be provided at a suitable location to visible from many locations. It is proposed to install windsocks at plant and Administration Building so as to be visible from different locations in the plant.

8.12 EMERGENCY TRANSPORT.

Emergency Ambulance would be stationed at the Administration Office and round the clock-driver would be made available for emergency transportation of injured etc. However, the other vehicles of the company also would be available for emergency services.

8.13 EMERGENCY COMMUNICATION.

There are two kinds of communication system provided.

(a) Regular P&T phones with intercom facility. (b) Mobile phone

8.14 WARNING/ALARM/COMMUNICATION OF EMERGENCY

The emergency would be communicated by operating electrical siren for continuously for five minutes with high and low pitch mode.

8.15 EMERGENCY RESPONSIBILITIES:

Priority of Emergency Protection.

Life safety Preservation of property Restoration of the normalcy

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8.16 MUTUAL AID

While necessary facilities are available and are updated from time to time, sometimes, it may be necessary to seek external assistance; it may be from the neighboring factories or from the State Government as the case may be.

8.17 MOCK DRILL

Inspite 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 see whether the plan meets the objectives of the OSEP, occasional mock drills are contemplated. Before undertaking the drill, it would be very much necessary to give adequate training to all staff members and also information about possible mock drill. After 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 shift etc. To improve preparedness once in 6 months and performance is evaluated and Site Controller maintains the record. Incident Controller (IC ) coordinates this activity.