40
Page 1 of 40 PREFEASIBILITY STUDY REPORT Of PROPOSED PROJECT FOR MANUFACTURING BULK DRUG (ACTIVE PHARMACEUTICAL INGREDIENT) PRODUCTS AND TEXTILE EMULSION AND AUXILIARY Introduced By Aditya Meruchem Pvt Ltd (Unit II) Plot No.: 11 & 12, Tirth Industrial Park, Dholka Highway, Kamod Circle, Near Paldi Kankaj Village, Dist: Ahmedabad

MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Embed Size (px)

Citation preview

Page 1: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 1 of 40

PREFEASIBILITY STUDY REPORTOf

PROPOSED PROJECT

FOR

MANUFACTURING BULK DRUG (ACTIVE

PHARMACEUTICAL INGREDIENT) PRODUCTS

AND TEXTILE EMULSION AND AUXILIARYIntroduced ByAditya Meruchem Pvt Ltd (Unit II)Plot No.: 11 & 12, Tirth Industrial Park, Dholka Highway,Kamod Circle, Near Paldi Kankaj Village,Dist: Ahmedabad

Page 2: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 2 of 40

IndexSr No Content Page Number

1. Executive Summary1.1 Introduction 031.2 Need of The Project 042. Project Description2.1 Location of the project 052.2 Process Technology 062.3 Product Details 262.4 Cost of the Project 262.5 Resources requirements 273. Pollution Potential and Mitigation Measures3.1 Water Pollution 353.2 Air Pollution 373.3 Hazardous Waste Generation and its Management 383.4 Noise and Vibration Control 383.5 Hazards and Safety Measures 393.6 Good Housekeeping 394. Conclusion 40

Page 3: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 3 of 40

1. Executive Summary1.1. IntroductionAditya Meruchem Pvt Ltd (Unit II) is proposed unit located at Plot No.: 11 & 12, TirthIndustrial Park, Dholka Highway, Kamod Circle, Near Paldi Kankaj Village, Ahmedabad. Weare in planning to set up manufacturing unit of Bulk Drug (Active PharmaceuticalIngredient) products and Textile Emulsion and Auxiliary at site. Since this project attractsapplicability of EIA notification and covered under Category 5(f) B, we are applying toobtain Environmental Clearance from SEIAA, Gandhinagar for our Proposed Expansion.SrNo

Particular Criteria forsmall scaleunit

ProjectRequirements

Reference

1. Water Consumption <25KLD 7.50 KLD includingdomestic andgardening (We willpurchase DM Waterfrom outside fromopen market)Section 3.1

2. Fuel Consumption < 25 TPD We will utilize Dieselin Hot WaterGenerator with atune of 100 L/Day itis less than 25 TPDSection 3.2

3. Category of MAH unitsas per MSIHC Rules,1989 Should not becovered in thecategory ofMAH unitsUnit will not haveStorage of HazardousChemicals which iscovered in MAHcategory as perMSIHCRules, 1989.

Section 2.5

Page 4: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 4 of 40

1.2. Need of the Project

Demand and Supply GapWe have more than 15 years of experience in the field of manufacturing of textile auxiliary.Based on our informal survey of the market with our current customers, we have foundthat there is a big potential for the product we are planning.Imports vs. Indigenous productionBased on the current cost of indigenous raw materials, unit will not have to import any rawmaterials as they are produced locally. This will make us very competitive against importedfinished products and it will increase the scope of our finished product to all over thecountry.Export possibilityDepending on the international demand of products we will explore the possibility ofexporting the products.Employment Generation (Direct and Indirect) due to projectUnit will give direct employment to local people based on qualification and requirement. Inaddition to direct employment, indirect employment shall generate ancillary business tosome extent for the local population.

Page 5: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 5 of 40

2. Project Description2.1 Location of the Proposed Project:Our company located at Plot No.: 11 & 12, Tirth Industrial Park, Dholka Highway, KamodCircle, Near Paldi Kankaj Village, Ahmedabad.in Industrial Estate.Location: 22°53'20.0"N 72°31'13.0"E

Page 6: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 6 of 40

2.2 Process Technology (Manufacturing Process):

PROCESS FLOW DIAGRAM FOR COLISTIMETHATE SODIUMPRODUCT NO.: 1

Filtration and drying

Brief manufacturing process :Colistin Sulfate dissolve in D.M Water, addParaformaldehe to get manich base. Manich base suspended in D.M Water then addSodiummetabisulfite with desired pH. After completion of Process. Filtration anddrying then get final Product.Mass Balance of Colistimethate SodiumSrNo Input Kg Sr.No Out Put Kg Remarks1 Colistin Sulfate 100.000 1 ColistimethateSodium 100.000 Finalproduct2 Water 1000.0003 Paraformaldehyde 5.300 2 Water 950.000 Distilled4 SodiumMetabisulphate 8.500 3 Inorganic Salt 63.800 HW forIncinerationTOTAL 1113.800 TOTAL 1113.800

Colistin Sulfate-100Kg + D.M. Water-1000KgHeat to 60°C to 65°CAdd Paraformaldehyde-5.30Kgs+Sodium Bisulfite-8.50Kg

Colistimethate Sodium-100KgWater 950Litre distilledand Recycled

Page 7: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 7 of 40

PROCESS FLOW DIAGRAM FOR TOBRAMYCIN SULFATEPRODUCT NO:2

Vacuum drying

Brief manufacturing process: Tobramycin (base) dissolve in D.M Water, add SulphuricAcid to get desired pH and freeze drying under vacuum and get final ProductMass Balance of Tobramycin SulfateSr No Input Kg Sr.No Out Put Kg Remarks1 Tobramycin ( Base ) 66.670 1 TobramycinSulphate 100.000 Final Product2 Water 1000.0003 Sulphuric Acid 13.330 2 Water 980.000 DistilledTOTAL 1080.000 TOTAL 1080.000

Tobramycin-66.67Kg + D.M. Water-1000Kg

Add Sulphuric Acid(20%)-13.33kgto get pH 6.5 to 7.5

Tobramycin Sulfate-100KgWater 980Kg distilled &recycled

Page 8: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 8 of 40

MANUFACTURING FLOW DIAGRAM FOR VANCOMYCIN HYDROCHLORIDE

PRODUCT NO: 3

pH 3 Adjust with Hydrochloric Acid-30Kg& water

Brief manufacturing process: Vancomycin (base) dissolve in D.M Water, addHydrochloric Acid to get desired pH and freeze dry the material and get final Product.Mass Balance of Vancomycin HydrochlorideSr No Input Kg Sr.No Out Put Kg Remarks1 Vancomycin ( Base ) 100.000 1 VancomycinHydrochloride 100.000 FinalProduct2 Water 1100.0003 Hydrochloric Acid(35%) 30.000 2 Water 1130.000 DistilledTOTAL 1230.000 TOTAL 1230.000

Vancomycin ( Base )-100Kg+Dissolved in water-1100Kg

FiltrationFreeze drying

Vancomycin Hydrochloride-100Kg

Drying/ Packing

Water 1120Kgdistilled & recycled

Page 9: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 9 of 40

PROCESS FLOW DIAGRAM FOR HYDROXOCOBALAMIN ACETATE

PRODUCT NO:4

Chill to crystallization

Brief manufacturing process: Mecobalamin dissolve in D.M Water, add Acetic acid to getdesired pH and expose the reaction mixture under Photoreactor for photosynthesis. Aftercompletion of Process crystallize the material with Acetone to get HydroxocobalminAcetate temperature between 5® to 10® C.Mass Balance of Hydroxocobalamin AcetateSr No Input Kg Sr.No Out Put Kg Remarks1 Mecobalamin 100.000 1 HydroxocobalaminAcetate 100.000 FinalProduct2 Water 6000.0003 Acetic Acid 34.500 2 Water 6034.500 Distilled &recycledTOTAL 6134.500 TOTAL 6134.500

Mecobalamin-100Kg + D.M. Water-6000Kg

Add Acetic Acid-34.5Kgto get pH 3 to 4

Hydroxocobalamin Acetate-100KgWater 6034Kgdistilled & Recycled

Page 10: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 10 of 40

MANUFACTURING FLOW DIAGRAM FOR ADENOSYLCOBALAMIN

PRODUCT NO. : 5

Crystallization in Acetone-1000Kg

Brief manufacturing process:- Hydroxocobalamin Acetate in D.M Water Then chargedtosyladenosine slowly and at room temperature in 2 to 3 hours. After completion ofProcess extract the content with phenol-chloroform mixture. Crystallize the material withAcetone to get Adenosylcobalmin temperature between 5® to 10® C.Mass Balance- AdenosylcobalaminSr No Input Kg Sr.No Out Put Kg Remarks1 HydroxycobalaminAcetate 100.00 1 Adenosylcobalamin 100.00 Final Product2 D.M Water 1000.00 Phenol+Chloroform 670.00 Recover & Reuse3 Tosyladenosine 66.60 Acetone 950.00 Distilled & Reuse4 Methanol 200.00 Water 1276.60 Distilled & Reuse5 Phenol 300.00 Losses 70.00 Loss6 Chloroform 400.007 Acetone 1000.00TOTAL 3066.60 TOTAL 3066.60

Hydroxocobalamin Acetate-100Kg+ D.M. Water-1000Kg+Tosyladenosine-66.6KgExtraction with Phenol-300Kg+ Chloroform-400Kg

Adenosylcobalamin-100KgWater 1276Kg distilled& recycled

Page 11: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 11 of 40

MANUFACTURING FLOW DIAGRAM FOR NICORANDILPRODUCT NO.: 6

Xylene-478Kg

Nitration with Nitric Acid-54Kg andSulfuric Acid-188Kg

Crystallization in Dichloromethane-813kgPurification in Acetone-154kg and Filtration

Brief manufacturing process: Methylnicotinate dissolve in xylene, then chargeMonoethanolamine. After dissolve the material add slowly Sodium Methoxide to get Amide.Amide dissolve in D.M Water then start the nitration with Nitric Acid and sulphuricAcid.After completion of process crude material crystallize in Dichloromethane.Purification done in Acetone to get pure Nicorandil. Filtration and drying and get finalproduct

Methylnicotinate-140kg+Monoethanol Amine-71KgAmide

Nicorandil ( Crude )

Nicorandil-100KgDrying/ Packing

Water 91Kg distilled& recycled

Page 12: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 12 of 40

Mass Balance : NicorandilSr No Input Kg Sr.No Out Put Kg Remarks1 Methyl Nicotinate 140.0000 1 Nicorandil 100.0000 Final Product2 Monoethanolamine 71.0000 RecoveredSolvent2 Xylene 455.000 Recoverd & Reuse3 Sodium Methoxide 0.0060 146.00004 Xylene 478.0000 3 Acetone Recoverd & Reuse5 Acetone 154.0000 4 Dichloromethane 773.0000 Recoverd & Reuse6 Nitric Acid (70%) 54.0000 5 Hexane 2380.0000 Recoverd & Reuse7 Sulfuric Acid(98%) 188.0000 6 Chloroform 1656.0000 Recoverd & Reuse8 Dichloromethane 813.0000 Losses9 Hexane 2640.000 7 Residue 111.0350 Inceneration10 Chloroform 1840.0000 8 NO2 emission 1.130011 Ammonia 72.0000 9 Evaporation 869.841012 Sodium Sulfate 33.0000 1013 Water 100.0000 11 Water 91.0000 Distilled &ReuseTOTAL 6583.0060 TOTAL 6583.0060

Page 13: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 13 of 40

MANUFACTURING FLOW DIAGRAM FOR HYDROXYZINE HYDROCHLORIDE

PRODUCT NO.:7

Dimethylformamide-100Kg

IPA+HCL-11Kg to adjust pH

FiltrationBrief manufacturing process : 4-Chloro Phenyl Benzhedryl Piperazine dissolve inDimethylformamide, add 2-chloroethoxy Ethanol to get Hydroxyzine base. Add IPA-HCL toget desiered pH. Crystallize the material in Isopropyl Alcohol. Then filteration and drying toget final Product

Mass Balance : Hydroxyzine HydrochlorideSrNo Input Kg Sr.No Out Put Kg Remarks1 4-chlorophenylBenzhydryl Piperazine 100.0000 1 Hydroxyzinehydrochloride 100.0000 Final Product2 Dimethylformamide 100.0000 Recoverd solent3 2-chloroethoxy ethanol 52.0000 2 Dimethylformamide 95.0000 Recoverd & Reuse4 Toluene 40.0000 3 Toluene 38.0000 Recoverd & Reuse5 Water 20.0000 4 Isopropyl alcohol 143.0000 Recoverd & Reuse6 IPA-HCL 11.0000 5 Water ML 97.0000 Distilled & reuse7 Isopropylalcohol 150.0000TOTAL 473.0000 TOTAL 473.0000

4-Chloro Phenyl Benzhedryl Piperazine-100Kg+2-chloroethoxy Ethanol-52KgHydroxyzine (Base)

Crystallization in Isopropyl Alcohol-150Kg

Hydroxyzine Hydrochloride-1000KgDrying/ PackingWater 97Kg distilled &recycled

Page 14: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 14 of 40

MANUFACTURING FLOW DIAGRAM FOR MECOBALAMIN

PRODUCT NO. : 8

Reduction with Sodium Borohydride-125Kg

Filtration/Drying

Brief manufacturing process:- Vitamin-B12 in D.M Water Then slowly add SodiumBorohydride. After completion of process charge Trimethylsulphoonium Iodide slowly andat room temperature in 2 to 3 hours. After completion of process extract the content withphenol-chloroform mixture. Crystallize the material with Acetone to get Mecobalmintemperature between 5® to 10® C then get final product.

Vitamin-B12-100Kg + D.M. Water-4500Kg(Methylation)Trimethylsulphoxonium Iodide-50Kg

Extraction with Phenol-150Kg+Chloroform-200KgCrystallization inAcetone-500Kg+Methanol-100Kg

Mecobalamin-100KgWater 4450Kg distilled & recycled

Page 15: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 15 of 40

Mass Balance of MecobalaminSrNo Input Kg Sr.No Out Put Kg Remarks1 Vitamin B12(Cyanocobalamin ) 100.00 1 Mecocobalamin(Methylcobalamin ) 100.00 Final Product2 D.M Water 4500.00 2 Phenol+Chloroform 335.00 Recover &Reuse3 Sodium Borohydride 125.00 3 Acetone 475.00 Distilled &Reuse4 TrimethylsulphoxiniumIodide 50.00 4 Methanol 95.00 Distilled &Reuse5 Phenol 150.00 5 Water 4450.00 Distilled &Reuse6 Chloroform 200.00 6 Solvent Losses 95.007 Acetone 500.00 7 Residue 175.00 Incineration8 Methanol 100.00TOTAL 5725.00 TOTAL 5725.00

Page 16: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 16 of 40

PROCESS FLOW DIAGRAM FOR POLYMYXIN B SULFATE

PRODUCT NO.: 9

Freeze drying

Brief manufacturing process : Polymyxin (base) dissolve in D.M Water, add SulphuricAcid to get desired pH and freeze dry then get final product.Mass Balance of Polymyxin B SulfateSr No Input Kg Sr.No Out Put Kg Remarks1 Polymyxin B(Base) 100.000 1 Polymyxin BSulfate 100.000 Final product2 Sulphuric Acid 3.3003 D.M Water 560.000 2 Water 563.300 DistilledTOTAL 663.300 TOTAL 663.300

Polymyxin-B(Base)-100Kg+D.M. Water-560KgAdd Sulphuric Acid(20%)-3.3kg

Polymyxin B Sulfate-100KgWater 563Kg distilled& Recycled

Page 17: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 17 of 40

PROCESS FLOW DIAGRAM FOR BACITRACIN ZINC

PRODUCT NO. : 10

Freeze drying

Brief manufacturing process: Bacitracin (base) dissolve in D.M Water, add Zinc chlorideto get desired pH and freeze dry ing then get final product.Mass Balance of Bacitracin ZincSr No Input Kg Sr.No Out Put Kg Remarks1 Bacitracin (Base) 100.000 1 BacitracinZinc 100.000 Final product2 Zinc Chloride 11.0003 D.M Water 1030.000 2 Water ML 1041.000 Distilled &RecycledTOTAL 1141.000 TOTAL 1141.000

Bacitracin (Base)-100Kg+D.M. Water-1030Kg

Add Zinc Chloride-11kg

Bacitracin Zinc-100KgWater 1041Kg distilled &recycled

Page 18: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 18 of 40

PROCESS FLOW DIAGRAM FOR ZINC CARNOSINE

PRODUCT NO. : 11

Crystallization in Methanol-300Kg

Brief manufacturing process: L-Carnosine dissolve in D.M Water, add Zinc Acetate to getdesired pH and crystallize the material in methanol Filtration and drying. Then get finalproduct.Mass Balance of Zinc CarnosineSr No Input Kg Sr.No Out Put Kg Remarks1 L-Carnosine (Base) 100.000 1 Bacitracin Zinc 100.000 Final product2 Zinc Acetate 21.0003 D.M Water 1000.000 2 Methanol+ WaterML 1200.000 Distilled &Recycled4 Methanol 300.000 3 Residue 121.000 HW forIncinerationTOTAL 1421.000 TOTAL 1421.000

L-Carnosine (Base)-100Kg+D.M. Water-1000Kg

Add Zinc Acetate-21kg

Zinc Carnosine-100KgWater 1200Kg distilled &recycled

Page 19: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 19 of 40

Page 20: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 20 of 40

Page 21: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 21 of 40

Page 22: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 22 of 40

Page 23: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 23 of 40

Page 24: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 24 of 40

Page 25: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 25 of 40

Page 26: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 26 of 40

2.3 Product Details:

2.4 Cost of ProjectThe approx cost of the proposed project will be 95 Lac. The details of the cost of the projectis given here:Land & Building 55 LacsPlant & Machinery 40 Lcas

SR. NO PRODUCT NAME

PROPOSED CONSUMPTION(MT/MONTH)

01 COLISTIMETHATE SODIUM 0.600

02 TOBRAMYCIN SULFATE 0.600

03 VANVCOMYCIN HYDROCHLORIDE 0.600

04 HYDROXOCOBALAMIN ACETATE 0.800

05 ADENOSYLCOBALAMIN 0.400

06 NICORANDIL 0.800

07 HYDROXYZINE HYDROCHLORIDE 2.000

08 MECOBALAMIN(METHYLCOBALAMIN) 0.400

09 POLYMYXIN B SULFATE 0.400

10 BACITRACIN ZINC 0.400

11 ZINC CARNOSINE 2.000

TOTAL 9.000

12 TEXTILE AUXILIARIES 360.00

Page 27: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 27 of 40

2.4 Resources Requirements:As the proposed project will be required resource for production. The details of theresources given hereunder,Land: The total land acquired for the proposed unit is 4200 sq.m and is converted intoNon-Agricultural land for industrial purpose.Water: The total fresh water requirement for various activities like industrial, domesticand gardening will be 24.00 KLD (6.5 KLD + 17.50 KLD DM Water). The DM Water will bepurchased from outside from open market. The other water demand (6.5 KLD) will besatisfied by Industrial Estate. The domestic water (0.500 KLD) and water for gardening(0.500 KLD) will be provided by Industrial estatePower: Total power requirement for the proposed project will be 125 KW. Power demandwill satisfied by Uttar Gujarat Vij Company Limited, Ahmedabad. In addition to this, one DGSet of 125 KVA will be installed as a backup in case of power failure.Fuel: Diesel/FO will be utilized as fuel in the tune of 100 liter/Day. The unit will use HSD @10.0 Liter/hr in DG set (65 KVA) as a fuel.Raw Material requirement

SR. No NAME OF RAW MATERIAL MONTHLY QUT. MT01 COLISTIN SULFATE 0.600

02 PARAFORMALDEHYDE 0.03203 SODIUM METABISULFITE 0.05104 TOBRAMYCIN SULFATE 0.40005 SULPHURIC ACID 0.08006 VANCOMYCIN (BASE ) 0.60007 HYDROCHLORIC ACID 0.18008 CYANOCOBALAMIN ( VITAMIN B12 ) 1.20009 ACETIC ACID 0.27610 TOSYLADENOSINE 0.26611 METHANOL 1.28012 PHENOL 0.07813 CHLOROFORM 0.10414 ACETONE 0.364

Page 28: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 28 of 40

15 METHYL NICOTINATE 1.12016 MONOETHANOLAMINE 0.56817 SODIUM METHOXIDE 0.04818 XYLENE 0.18419 NITRIC ACID (70%) 0.43220 SULPHURIC ACID (98%) 1.51721 DICHLOROMETHANE 0.32022 HEXANE 2.08023 AMMONIA SOLUTION (25%) 0.57624 SODIUM SULPHATE 0.26425 4-CHLOROPHENYL BENZHYDRYLPIPERAZINE 2.00026 DIMETHYLPHORMAMIDE 0.10027 2-CHLOROETHOXY ETHANOL 1.04028 TOLUENE 0.04029 IPA+HCL 0.22030 ISOPROPYL ALCOHOL 0.14031 SODIUM BOROHYDRIDE 0.50032 TRIMETHYLSULPHOXONIUM IODIDE 0.20033 POLYMYXIN-B (BASE) 0.40034 BACITRACIN (BASE) 0.40035 ZINC CHLORIDE 0.04436 L-CARNOSINE (BASE) 2.00037 ZINC ACETATE 0.420

Page 29: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 29 of 40

The quantity of raw material in each type of product in each batch is listed as below

PRODUCT NO-1 :- COLISTIMETHATE SODIUMSR. NO NAME OF THE RAW MATERIAL MAX. QUANTITY IN KG PERMONTH01 COLISTIN SULFATE 0.60002 PARAFORMALDEHYDE 0.03203 SODIUM METABISULFITE 0.051PRODUCT NO-2 :- TOBRAMYCIN SULPHATESR. NO NAME OF THE RAW MATERIAL MAX. QUANTITY IN KG PERMONTH01 TOBRAMYCIN (BASE) 0.40002 SULPHURIC ACID (98%) 0.080PRODUCT NO-3 :- VANCOMYCIN HYDROCHLORIDESR. NO NAME OF THE RAW MATERIAL MAX. QUANTITY IN KG PERMONTH01 VANCOMYCIN (BASE) 0.60002 HYDROCHLORIC ACID (30%) 0.180PRODUCT NO-4 :- HYDROXOCOBALAMIN ACETATESR. NO NAME OF THE RAW MATERIAL MAX. QUANTITY IN KG PERMONTH01 CYANACONALAMIN 0.80002 ACETIC ACID 0.276

Page 30: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 30 of 40

PRODUCT NO-5 :- ADENOSYLCOBALAMINSR. NO NAME OF THE RAW MATERIAL MAX. QUANTITY IN KG PERMONTH01 HYDROXOCOBALAMIN ACETATE 0.40002 TOSYLADENOSINE 0.26603 PHENOL 1.20004 CHLOROFORM 1.60005 ACETONE 4.00006 METHANOL 0.800PRODUCT NO-6 :- NICORANDILSR. NO NAME OF THE RAW MATERIAL MAX. QUANTITY IN KG PERMONTH01 METHYL NICOTINATE 1.12002 MONOETHANOLAMINE 0.56803 SODIUM METHOXIDE 0.04804 ACETONE 1.23205 HEXANE 21.12006 NITRIC ACID (70%) 0.43207 SULPHURIC ACID (98%) 1.50408 DICHLOROMETHANE 6.50409 AMMONIA SOLUTION (25%) 0.576PRODUCT NO-7 :- HYDROXYZINE HYDROCHLORIDESR. NO NAME OF THE RAW MATERIAL MAX. QUANTITY IN KG PERMONTH01 4-CHLOROPHENYL BENZHYDRYLPIPERAZINE 2.00002 DIMETHYLFORMAMIDE 2.00003 2-CHLOROETHOXY ETHANOL 1.04004 TOLUENE 0.80005 IPA+HCL 0.22006 ISOPROPYL ALCOHOL 3.000

Page 31: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 31 of 40

PRODUCT NO-8 :- MECOBALAMINSR. NO NAME OF THE RAW MATERIAL MAX. QUANTITY IN KG PERMONTH01 VITAMIN B12 ( CYANOCOBALAMIN ) 0.40002 SODIUM BOROHYDRIDE 0.50003 TRIMETHYLSULPHOXONIUM IODIDE 0.20004 PHENOL 0.60005 CHLOROFORM 0.80006 ACETONE 2.00007 METHANOL 0.400PRODUCT NO-9 :- POLYMYXIN B SULPHATESR. NO NAME OF THE RAW MATERIAL MAX. QUANTITY IN KG PERMONTH01 POLYMYXIN B ( BASE ) 0.40002 SULPHURIC ACID (98%) 0.013PRODUCT NO-10 :- BACITRACIN ZINCSR. NO NAME OF THE RAW MATERIAL MAX. QUANTITY IN KG PERMONTH01 BACITRACIN (BASE) 0.40002 ZINC CHLORIDE 0.044PRODUCT NO-11 :- ZINC CARNOSINESR. NO NAME OF THE RAW MATERIAL MAX. QUANTITY IN KG PERMONTH01 L-CARNOSINE ( BASE ) 2.00002 ZINC ACETATE 0.42003 METHANOL 6.000

Page 32: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 32 of 40

We will also manufactured Textile Emulsion and Auxiliary with in this plant with a quantityof 360 MT/Month, There will be seven type of water based textile emulsion manufacture inour unit. The quantity of raw material in each type of product in 1000 KG batch is listed asbelow.PRODUCT 1Sr No Name of the Raw Material Quantity in KG/1000 KG Product1. ALPHO 15.32. Acrylamide 15.33. Butyl 182.04. Styrene 151.05. Acrylic 2.3006. PPS 1.507. SMBS 0.7508. D.M. Water 631.850PRODUCT 2Sr No Name of the Raw Material Quantity in KG/1000 KG Product1. X 405 0.302. Dainol 2.503. Butyl 521.04. MAA 9.605. PPS 1.06. D.M. Water 465.60PRODUCT 3Sr No Name of the Raw Material Quantity in KG/1000 KG Product1. ALPHO – 500 11.52. Acrylamide 12.53. Butyl 92.04. Styrene 310.05. Acrylic 5.806. SLS Powder 2.07. PLPHO X 8.68. PPS 2.59. SMBS 2.010. D.M. Water 553.10

Page 33: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 33 of 40

PRODUCT 4Sr No Name of the Raw Material Quantity in KG/1000 KG Product1. VAM 430.02. DBM 60.03. Potassium Per Sulphate 01.804. GH-17 16.005. SBC 1.206. 9.5 MOLE (Alphox-200) 0.307. NP 165 6.008. D.M. Water 484.70PRODUCT 5Sr No Name of the Raw Material Quantity in KG/1000 KG Product1. VAM 410.02. Potassium per Sulphate 1.103. GH-17 16.004. SBC 0.9005 D.M. Water 572.0PRODUCT 6Sr No Name of the Raw Material Quantity in KG/1000 KG Product1. Emulsifire SP 20 15.32. X-301 4.503. Acrylamide 10.804. Butyl 203.05. Styrene 136.06. Acrylic 2.8507. PPS 1.708. SMBS 0.8509 D.M. Water 625.0

Page 34: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 34 of 40

PRODUCT 7Sr No Name of the Raw Material Quantity in KG/1000 KG Product1. Emulsifire SP 20 32.02. X-301 4.003. Acrylamide 12.04. Butyl 200.05. Styrene 180.06. Acrylic Acid 15.07. PPS 2.08. APS 5.209 D.M. Water 549.80

Page 35: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 35 of 40

3. Pollution Potential and MitigationMeasure3.1Water Pollution:The water requirements for the proposed project will be 2.00 KLD and it will be satisfiedthrough Industrial Estate.WATER CONSUMPTION DETAILS

Sr No Category Water Consumption inKL/Day1. Domestic Purpose 0.5002. INDUSTRIALProcess (Manufacturing of Bulk Drug) 06.50Process (Textile Auxiliary) DM Water 17.50Gardening 0.500Total Wastewater Consumption (Industrial + Domestic) 25.00

WASTEWATER GENERATION DETAILS

Sr No Category Water Consumption inKL/Day1. Domestic Purpose 0.4002. INDUSTRIALProcess (Manufacturing of Bulk Drug) 0.300Process (Textile Auxiliary) DM Water NILTotal Wastewater Generation (Industrial) 0.300Total Sewage Generation 0.400Note: The industrial wastewater will be evaporated through evaporation and domesticsewage will be disposed through soak pit. Hence there will be no waste water dischargefrom plant premises. We assure you that we will maintain Zero Discharge

Page 36: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 36 of 40

WATER BALANCE DIAGRAMThere will only 0.300 KL/day wastewater will be generate from manufacturing activity andother ancillary operation. We have well established Wastewater Management Systemwithin existing premises and at present we are in practice to evaporate generatedwastewater through electric evaporator.Domestic sewage @ 0.4 KLD will be discharged into soak pit via septic tank.

Intake 25.00

Domestic 0.500

Sewage 0.400

Soak Pit 0.400

Gardening 0.500 Industrial Bulkdrug 6.50

WastewaterGeneration 0.300

KL

Evaporationthropugh

EvaporationSystem

Industrial TextileAuxilary 17.50

Process NIL

Page 37: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 37 of 40

3.2Air Emission:We will use Diesel as fuel in Steam Boiler and we will provide adequate height of stack of11.00 meter. Adequate stack height of 8 m from ground level will be provided for DG Set.There will no process gas emission from proposed project.Srno

Stack attachedto

Stack height inmeter

Fuel Consumption APCM1 Steam Boiler 11.00 Diesel 100 Liter/Day Not applicable2. D.G. Set – 125KVA 5.00 Diesel 10.00 Liter/Hour Not applicableThere will be a chance of fugitive emission from the manufacturing process as well as dueto storage & handling of raw materials and products. The unit will take following adequateprecautions for the control of fugitive emission; The entire manufacturing activities will be carried out in the closed reactors and regularchecking and maintenance of reactors will be carried out to avoid any leakages. Replacing the low pressure mixing head with high pressure system will eliminateemission of VOCs. The tank vents will be equipped with either a carbon filter or an oil trap to preventwater vapor from entering the tank as it breathes. All the motors of pumps for the handling of hazardous chemicals will be flame proof andprovided with suitable mechanical seal with stand-by arrangement. Control of all parameters on a continuous basis will be done by adequate control valves,pressure release valves and safety valves etc. All the flange joints of the pipe lines will be covered with flange guards. All the raw materials will be stored in isolated storage area and containers tightly closed. There will also be provision of adequate ventilation system in process plant andhazardous chemical storage area. A regular preventive maintenance will be planned to replace or rectify all gaskets, jointsetc.

Page 38: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 38 of 40

The unit will also develop green belt within the factory premises to control the fugitiveemission from spreading into surrounding environment.3.3Hazardous Waste Management:Used Oil & Spent Lubricant @ 0.02 MT/Year, Empty & discarded containers @ 120Numbers/Year, Process Residue 0.100 MT/Year and Evaporation Residue 0.010 MT/Yearwill be generated from process, raw material handling and storage.3.4Noise and Vibration Control:The only source of noise generation may be from the DG Set , which will be kept as stand-byand no other source of noise and vibration in the proposed unit except plant machineries.However, the following adequate precautions will be taken for control of noise & vibration; The unit will install latest technology based low noise DG Set with acousticenclosures. Proper and timely oiling, lubrication and preventive maintenance will be carried outfor the machineries and equipments to reduce noise generation. The noise generation will be mitigated by installing noise barriers/absorbersaround stationery noise sources. Adequate noise control measures such as anti-vibration pad for equipment with high vibration will be provided. All the vibrating parts will be checked periodically and serviced to reduce the noisegeneration. The equipment, which generates excessive noise, will be provided withenclosures etc. To minimize the adverse effect on the health, ear muffs / earplugs will be providedto the working under high noise area.

Page 39: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 39 of 40

3.5Hazards and Safety Measures:

All the personnel at the plant will be made aware about the operation hazards andrisk associated with them. Safe work practices will be adopted to ensure the control of hazards duringoperation and maintenance. The workers will be made aware about the hazards associated with manualhandling and operation. Safety measures in the form of ‘DO’ and ‘Don’t Do’ will be displayed at strategiclocations especially in local language. Good housekeeping will be maintained in the Mining area. The required PPEs for each area/operation should be identified and the necessaryPPEs, like, helmets, goggles, hand gloves, mask, suit, safety belts, ear muff and plug,etc. will be provided to the personnel. The plant will check and ensure that all instruments provided in the plant are ingood condition and documented. First Aid box will be provided within the plant. List of important telephone numbers will be displayed at prominent location in theplant. Lease Holder Machine Operator Helper/ Labour All the accidents and incidents if any will be recorded, investigated and analyzed inthe proposed plant. Safety awareness programmes and trainings of the worker will be carried out tomotivate the workers to increase the safety level at personal level.

3.6Good Housekeeping:The term Good Housekeeping is often loosely understood as simple floor cleaning or broomstick operation. But it has even wider meaning including up keeping of all industrialactivities in orderly manner to minimize the accidents due to improper planning,placement, arrangement, handling, etc. everywhere in industrial premises. “Place foreverything and everything on proper place”. So, Good housekeeping at quarry site willgreatly reduce unsafe conditions and so risk of accidents.

Page 40: MANUFACTURING BULK DRUG (ACTIVE · completion of Process crystallize the material with Acetone to get Hydroxocobalmin Acetate temperature between 5® to 10® C. Mass Balance of Hydroxocobalamin

Page 40 of 40

ConclusionThis is new unit going to start manufacturing of Bulk Drug (ACTIVE PHARMACEUTICALINGREDIENT) PRODUCTS AND TEXTILE EMULSION AND AUXILIARY. The unit will provideadequate measures for the prevention and control of pollution for its proposed project.With the execution and operation of such control measures along with properEnvironmental Management System, there will not be any major potential for negativeimpact on the environment due to proposed project.There will be positive impact on the socio-economic environment since proposed projectwill generate some permanent and secondary employment. The unit will also establishCordial relation with the nearby villagers and will carry out social welfare activitiesaccording to their needs.The proposed project will also boosts up ancillary industrial and commercial activity. Thus,it will improve the economic condition of the area.