End use Distilled Solvent of different range 1 1) Pharma Grade 2) Technical Grade Pharmaceutical Industry 2

Transcription

1 ANNEXURE - A DETAILS OF PRODUCTS AND IT S END-USE Sr. Quantity [MT/Month] NAME OF PRODUCTS CAS Nos. No Existing Proposed Total End use Distilled Solvent of different range Dyes & 1 1) Pharma Grade 2) Technical Grade Pharmaceutical Industry 2 All type of Thinner Textile, paint, Ink [i.e. Ink/Textile/Paint Thinner] etc. Industry 3 Dyes & Purification of Acid (through Pharmaceutical distillation) Industry 4 Pregabalin And/Or Pharmaceutical Intermediate Pharmaceutical 5 Nebivolol HCl And/Or Intermediate Pharmaceutical 6 Diclofenac Sodium And/Or Intermediate 7 Aceclofenac Pharmaceutical Intermediate 8 Chlorhexidine base Pharmaceutical Intermediate 9 Chlorhexidine Di Gluconate Pharmaceutical Intermediate 2,4,Di amino 6-Chloro Pharmaceutical 10 And/Or Pyrimidine Intermediate N,N-Dimethyl formamide dimethyl Pharmaceutical acetal Intermediate (Carbamonylmethyl)-5-methyl Pharmaceutical hexanoic acid Intermediate 13 5-Bromo 2-Chloro Pharmaceutical And/Or Benzoic Acid Intermediate 14 2 Bromo-4 Pharmaceutical And/Or Fluroacetanilide Intermediate 15 2,4,6 Trimethyle Benzoyl Pharmaceutical And/Or Chloride Intermediate 16 5 chloro 2,4 Dimethoxy Aniline And/Or Dyes Intermediate 17 2,5 Di Chloro PPD And/Or Dyes Intermediate 18 2,5 Dimethyl PPD And/Or Dyes Intermediate 19 2 Chloro 5 Methyl PPD And/Or Dyes Intermediate 20 5-Nitro Ortho Toluidine And/Or Dyes Intermediate 21 2,5-Diamino Toluene Sulphate Dyes Intermediate 22 4 Chloro 2,5-Dimethoxy Aniline Dyes Intermediate 23 1 Amino 4 Methyl Piperazine Pharmaceutical Intermediate TOTAL

2 ANNEXURE B DETAILS OF PRODUCT WISE RAW MATERIAL CONSUMPTION Sr. Product Name Raw material CAS No. MT/MT No. 1 Distilled Solvent of Spent Solvent [i.e IPA, Ethyl different range 1) Pharma Grade 2)Technical Grade Acetate, Toluene, Xylene, Methanol, Acetonitrile, Di methyl formamide, Tetra hydro furan, Mono/Di ethylene glycol, Methyl Acetate, Acetone, Butyl Alcohol, Dimethyl Sulfoxide, Xylene, etc.] 2 All type of Thinner [i.e. Ink/Textile /Paint Thinner] Acetic Acid & Formic Acid & (Carbamoyl methyl)-5-methyl hexanoic acid 1.2 Alpha Phenyl ethyl amine Chloroform Pregabalin Methanol Sulphuric acid NaOH NaOCl Iso Propyl alcohol Total Fluroro-3,4-dihydro-2-oxiranyl-2H benzopyran (benzylamino)-1-(6-fluoro-3, Nebivolol Hydrochloride 6 Diclofenac Sodium 7 Aceclofenac dihydro-2h-chromen-2yl)ethanol Methanol % Pd/C Acetonitrile H HCl Total 10.0 {2-[(2,6-dichlorophenyl)amino] phenyl}acetic acid 1.0 NaOH Total 1.1 Butanol Chloro Acetyl chloride Diclofenac Sodium Formic Acid Total 4.8

3 8 Chlorohexidine Base Chlorohexidine Di Gluconate 2,4 Di amino 6 Chloro Pyrimidine N,N-Dimethyl formamide dimethyl acetal +3- (Carbamonymethyl)- 5-methyl hexanoic acid 5 Bromo 2 Chloro Benzoic Acid 2 Bromo-4 Fluroacetanilide 2,4,6 Trimethyl Benzoyle Chloride 5 Chloro 2,4 Dimethoxy Aniline 17 2,5 Di Chloro PPD N-Butanol Hexamethylene diamine HCl Sodium Dicynamide Triethylamine NaOH P-Chloroaniline HCl Methanol Total 8.2 Glucona delta lactone Chlorohexidine Base Total 1.0 TCP[Tri Chloro Pyrimidine] NH4OH Total 2.3 DMS DMF NaOH Total 1.5 Isovaleraldehyde Cyanoacetamide Pyrrolidine Total 1.3 2, Chloro Benzoic Acid Bromine Catalyst Total Fluoroaniline Acetic Acid Toluene Bromine KBrO Charcoal Total 2.2 Mesitylene Chloro Acetyl chloride HCl Total 1.4 2,4,5 Trichloro Nitro Benzene Sodium Methoxide NaSH Total 4 2,5-Di Chloro 4 nitro aniline Hydrogen Catalyst

4 18 2,5 Di Methyl PPD Chloro 5- Methyl PPD 5-Nitro Ortho Toluidine 21 2,5-Diamino Toluene Sulphate Chloro 2,5 Dimethoxy Aniline 1 Amino 4 Methyl Piperazine Total ,5-Di methyl para nitro aniline Hydrogen Catalyst Total Chloro-5 Methyl 4 nitro aniline Hydrogen Catalyst Total 1.25 Para Toluidine Acetic Acid HNO NaOH Total 1.9 Ortho Toluidine Sodium Nitrite Hydrochloric acid H2SO Iron Powder Total 3.4 2,4,5 Trichloro Nitro Benzene Sodium Methoxide NaSH Total 4.0 N methyl Piperazine Ammonia NaOH Total 1.2

5 1.] Solvent Distillation ANNEXURE C MANUFACTURING PROCESS DESCRIPTION Process Description of Solvent Distillation: In a reactor, charge solvent and heat with the help of steam or hot oil by using Boiler or TFH. Generated Vapor will be transfer to Condenser by using Fraction Distillation Colum The vapor of solvent will condensate by primary condenser and it will be collected directly into receiver as product. Remaining vapor (after Primary condenser) will go to Secondary Condenser which is chilled by brine solution and then collected into receiver as product. The vent attached to Carbon Tower as APCM to control of Air Pollution/VOCs. Flow Diagram of Solvent Distillation:

6 2.] For Thinner Process Description of Thinner: Ensure the vessel empty, clean & decontaminated visually. Close the bottom and side valve. Then take the raw materials as specified and in required quantity, following the safety SOP during the process. As per the safety SOP, in the store rooms, ensure the floor without any foreign objects, store should be equipped with firefighting equipment and smoking is strictly prohibited Fresh solvent solvents can also be used mixed with Recovered solvent, if the quality of the same should meet the specified standards. The handling and addition of raw materials will be done automatically and hence there will not be direct manual contact. Mix the raw materials thoroughly through blending. There will be only mixing and blending of the raw materials. After completion of process withdraw samples from bottom as well as from top and check the quality. If it does not comply with the standard specification, adjust with the required solvents to fulfill the standard specification. Flow Diagram of Thinner:

7 3.] For Purification of Acid [Through Distillation] Process Description: In a reactor, charge Acetic Acid/Formic Acid [Spent/dilute/By-Product] and heat with the help of steam or hot oil by using Boiler or TFH. Generated Vapor will be transfer to Condenser by using Fraction Distillation Colum The vapor of solvent will condensate by primary condenser and it will be collected directly into receiver as product. Remaining vapor (after Primary condenser) will go to Secondary Condenser which is chilled by brine solution and then collected into receiver as product. The vent attached to Carbon Tower as APCM to control of Air Pollution/VOCs. Flow Diagram:

8 4.] Pregabalin Process Description of Pregabalin: Isomer Separation: + 3-(Carbamoyl methyl)-5-methyl hexanoic acid charged in Chloroform for isomer separation with help of +Alpha phenyl ethyl amine and methanol thru filtration. Salt Formation: Stage-I Material charged in water and precipitated with help of sulphuric acid and caustic flakes. Finally filtered to make it dry. Hoffman s Reaction: Stage-II material reacted with Hypo Chloride in presence Caustic flakes and finally precipitated with help of Sulphuric acid to get the stage-iii material. Crystallization: Stage-III material charged in solvent IPA+water to dissolve completely and finally precipitated at low temperature. Chemical Reaction of Pregabalin:

9 Flow diagram of Pregabalin:

10 5.] Nebivolol Hydrochloride Process Description of Nebivolol Hydrochloride: 6-Fluoro-3, 4-dihydro-2-oxiranyl-2H-1-benzopyran is condensed with 2-(benzylamino)-1- (6-fluoro-3,4-dihydro-2H-chromen-2-yl)ethanol in presence of methanol to yield Stage- I Compound. In presence of palladium carbon, Stage- I compound is hydrogenated and then reacted with HCl to yield Nebivolol Hydrochloride. Chemical Reaction of Nebivolol Hydrochloride:

11 Flow diagram of Nebivolol Hydrochloride:

12 6.] Diclofenac Sodium Process Description of Diclofenac Sodium: In SSR, Charge C.S.Lye solution, charge {2-[(2,6-dichlorophenyl)amino]phenyl}acetic acid, Maintain for 10 Hours 45-55⁰C temp, check TLC, Filter it, collect w/c, Dry material in FBD/Tray dyer & Pack. Chemical Reaction of Diclofenac Sodium: Flow diagram of Diclofenac Sodium:

13 7.] Aceclofenac Process Description of Aceclofenac: Dry and clean GLR, charge TBA in GLR Under stirring, charge mono chloro acetic acid cool and then chill up to -5⁰C maintain 4 hours 0-5 ⁰C settle the mass and collect TBCA upper layer. Check GLR, dry and clean collect TBCA and start heating. Charge sodium { 2- [ ( 2,6 Dichloro phenyl ) amino ] phenyl } acetate under stirring at room temp in 4 hours, maintain 6 hours at temp 80 85⁰C. check TLC, IF Condensation is okay, cool the mass up to 50⁰C, now charge formic acid, add in 2 hours at temp 50-55⁰C, maintain 60 65⁰C for 10 to 12 hours, check TLC, if ok, cool the mass up to 20 20c, filter through C/F and collect W/C, dry the material in ANFD. Chemical Reaction of Aceclofenac:

14 Flow diagram of Aceclofenac: 8.] Chlorohexidine Base Process Description of Chlorohexidine Base: Charge Hexamethylene diamine, sodium dicynamide, HCl, N-Butanol and Triethyl amine in reactor and produce N-Cyano-n'-(6-{[(cyanoamino)(imino)methyl]amino}hexyl)guanidine. And then react with P-chloro aniline HCl and NaOH Sol and generate Crude mass. It is filtered and purified and produce chlorohexidine base. Chemical Reaction of Chlorohexidine Base:

15 Flow diagram of Chlorohexidine Base: 9.] Chlorohexidine Di Gluconate Process Description of Chlorohexidine Di Gluconate: Charge Pure water in to reactor then charge Glucona Delta Lactone and Chlorhexidine Base in to the Reactor Once charging is complete, continue mixing in reactor for 1 to 2 hours, and adjust ph in between 6-7 and then take sample for testing. Once Quality is approved by Q.C. department, if it is okey then, Packed, Label and dispatch. Chemical Reaction of Chlorohexidine Di Gluconate:

16 Flow diagram of Chlorohexidine Di Gluconate: 10.] 2, 4 Di amino 6 Chloro Pyrimidine Process Description of 2, 4 Di amino 6 Chloro Pyrimidine: Charge 2, 4, 6 Trichloro pyrimidine and NH4OH and that reaction mass transfer to filtration process and produced product. Chemical Reaction of 2, 4 Di amino 6 Chloro Pyrimidine: Flow diagram of 2, 4 Di amino 6 Chloro Pyrimidine:

17 11.] N, N-Dimethyl formamide dimethyl acetal Process Description of N, N-Dimethyl formamide dimethyl acetal: Condensation of DMS and DMF in presence of sodium methoxide and water forms a product N, N-Dimethylformamide Dimethyl Acetal. Stage-I Material purified to receive product and effluent sent to ETP. Chemical Reaction of N, N-Dimethyl formamide dimethyl acetal Flow diagram of N,N-Dimethyl formamide dimethyl acetal:

18 12.] + 3-(Carbamonylmethyl)-5-methyl hexanoic acid Process Description of + 3-(Carbamonylmethyl)-5-methyl hexanoic acid: Take Isovaleraldehyde in reaction vessel and charge Pyrrolidine as catalyst. Start addition of 2-Cyanoacetmide in controlled rate maintaining an atmospheric condition to get it condensed with isovaleraldehyde to form 2, 6-dihydroxy-4-isobutyl piridine-3, 5- dicarbonitrile. Stage-I material charged into water and sulfuric acid mixture followed by toluene addition to extract the product in toluene. Organic layer than separated to distill toluene to get the product. Chemical Reaction of + 3-(Carbamonylmethyl)-5-methyl hexanoic acid Flow diagram of + 3-(Carbamonylmethyl)-5-methyl hexanoic acid:

19 13.] 5 Bromo 2 Chloro Benzoic Acid Process Description of 5 Bromo 2 Chloro Benzoic Acid: Charge O-Chloro benzoic acid at C. Add slowly bromine in 2-3 hrs.at C. Stir for 30 min at C. Slowly raise temperature to C in 2-3 Hrs. Maintain at C for Hrs. Send the sample for HPLC, OCBA should be less than 2.0 %. Once HPLC complies, cool the reaction mass to C. Reaction mass quench over ice cold water below 20 C. Stir the reaction mass for 1.0 hr. Filter, wash with water Suck dry. Chemical Reaction of 5 Bromo 2 Chloro Benzoic Acid Flow diagram of 5 Bromo 2 Chloro Benzoic Acid:

20 14.] 2 Bromo-4 Fluroacetanilide Process Description of 2 Bromo-4 Fluroacetanilide: Acetylation process of 4-Fluoroaniline and acetic acid and produce 4-Fluroacetanilide. then bromination of 4-fluroacetanilide,in presence of KBrO3 and filter the mass then give charcoal treatment and produce 2 bromo-4-fluoracetanilide. Chemical Reaction of 2 Bromo-4 Fluroacetanilide Flow diagram of 2 Bromo-4 Fluroacetanilide

21 15.] 2, 4, 6 Trimethyl Benzoyle Chloride Process Description of 2, 4, 6 Trimethyl Benzoyle Chloride: Charge Mesitylene and iron oxide at 90-95⁰C.Start addition of Chloro Acetyle Chloride.and maintain 90-95⁰C for two hrs. Charge Water and give heat to 90-95⁰C.Transfer above reaction to isolation process. Add HCl 30% and adjust ph Settle & Separate Aq layer and then transfer to Extraction process. Separate the product. Chemical Reaction of 2, 4, 6 Trimethyl Benzoyle Chloride Flow diagram of 2, 4, 6 Trimethyl Benzoyle Chloride

22 16.] 5 chloro 2, 4 Dimethoxy Aniline Process Description of 5 chloro 2, 4 Dimethoxy Aniline: Take Sodium Methoxide. Then 2, 4, 5 Trichloro nitro benzene is added and maintained for about 1 hr. Next sodium hydro sulphide is added to induce reduction. After reduction is complete, the mass is cooled and filtered to obtain product which is dried and packed. Filtrate is sent to ETP for treatment and disposal. Chemical Reaction of 5 chloro 2, 4 Dimethoxy Aniline: Flow diagram of 5 chloro 2, 4 Dimethoxy Aniline

23 17.] 2, 5 Di Chloro PPD Process Description of 2, 5 Di Chloro PPD: Charge water in to hydrogenator then charge Raney nickel as a catalyst in to reactor Charge 2,5 di chloro 4 nitro aniline in to reactor and start stirring Start to pursing H2 gas at 5 kg/cm 2 pressure continually and heating it up to 70 0 C. Control temperature using H2 gas control and circulate water in to jacket. H2 gas pursing till reaction complete, After completion of reaction then transfer Reaction mass in to holding vessel In holding vessel circulate cooling in to jacket and decrease temperature 30 to 35 0 C gradually material will be observed. Filter the slurry and then centrifuge the wet cake. ML taken to ETP tank. Unload the centrifuge and dry material using dryer and pack it. Chemical Reaction of 2, 5 Di Chloro PPD: Flow diagram of 2, 5 Di Chloro PPD

24 18.] 2, 5- Di Methyl PPD Process Description of 2, 5- Di Methyl PPD: Charge water in to hydrogenator then charge Raney nickel as a catalyst in to reactor Charge 2,5 di methyl para nitro aniline in to reactor and start stirring Start to pursing H2 gas at 5 kg/cm2 pressure continually and heating it up to 70 0 C. Control temperature using H2 gas control and circulate water in to jacket. H2 gas pursing till reaction complete, After completion of reaction then transfer Reaction mass in to holding vessel. In holding vessel circulate cooling in to jacket and decrease temperature 30 to 35 0 C gradually material will be observed. Filter the slurry and then centrifuge the wet cake. ML taken to ETP tank. Unload the centrifuge and dry material using dryer and pack it. Chemical Reaction of 2, 5- Di Methyl PPD: Flow diagram of 2, 5- Di Methyl PPD

25 19.] 2-Chloro 5-Methyl PPD Process Description of 2-Chloro 5-Methyl PPD: Charge water in to hydrogenator then charge Raney nickel as a catalyst in to reactor. Charge 2 chloro 5 methyl 4 Nitro aniline in to reactor and start stirring Start to pursing H2 gas at 5 kg/cm 2 pressure continually and heating it up to 70 0 C. Control temperature using H2 gas control and circulate water in to jacket. H2 gas pursing till reaction complete, After completion of reaction then transfer Reaction mass in to holding vessel. In holding vessel circulate cooling in to jacket and decrease temperature 30 to 35 0 C gradually material will be observed. Filter the slurry and then centrifuge the wet cake. ML taken to ETP tank. Unload the centrifuge and dry material using dryer and pack it. Chemical Reaction of 2-Chloro 5-Methyl PPD: Flow diagram of 2-Chloro 5-Methyl PPD:

26 20.] 5-Nitro Ortho Toluidine Process Description of 5-Nitro Ortho Toluidine: Charge O-Toluidine and acetic acid in reactor. After acetylation process completed, add Nitric acid in Rector for Nitration process. Then add sodium hydroxide, and filter and dry product. Chemical Reaction of 5-Nitro Ortho Toluidine: Flow diagram of 5-Nitro Ortho Toluidine:

27 21.] 2, 5-Diamino Toluene Sulphate Process Description of 2, 5-Diamino Toluene Sulphate: O-Toluidine react with hydrochloric acid and sodium nitrite to get reaction mass. Then reaction mass react with iron powder and sulphuric acid. And filtered and dry to get product. Chemical Reaction of 2, 5-Diamino Toluene Sulphate:

28 Flow diagram of 2, 5-Diamino Toluene Sulphate:

29 22.] 4 chloro 2, 5 Dimethoxy Aniline Process Description of 4 chloro 2, 5 Dimethoxy Aniline: 2, 4, 5 Tri Chloro Nitro Benzene react with sodium methoxide and give 4 chloro 2, 5 Dimethyl nitro benzene. And then add sodium hydrosulfide in above reaction mass. After reaction completed, take filter and dry to get product. Chemical Reaction of 4 chloro 2, 5 Dimethoxy Aniline: Flow diagram of 4 chloro 2, 5 Dimethoxy Aniline

30 23.] 1 Amino 4 Methyl Piperazine Process Description of 1 Amino 4 Methyl Piperazine: N Methyl Piperazine react with ammonia and produce 1 amino 4 Methyl Piperazine. And separate waste water. And transfer into ETP for further treatment. Chemical Reaction of 1 Amino 4 Methyl Piperazine: Flow diagram of 1 Amino 4 Methyl Piperazine

31 ANNEXURE D DETAILS OF WATER CONSUMPTION AND WASTE WATER GENERATION DETAILS OF WATER CONSUMPTION: Sr. No. Purpose Consumption, KL/day Existing Proposed Total 1. Domestic Industrial a. Process + APCM b. Washing c. Boiler d. Cooling e. Gardening Sr. No. TOTAL [2] TOTAL [1+2] DETAILS OF WASTE WATER GENERATION: Generation, KL/day Purpose Existing Proposed Total 1. Domestic Industrial a. Process + APCM b. Washing c. Boiler Blow down d. Cooling bleed off e. Gardening TOTAL [2] TOTAL [1+2] Note: Domestic: Domestic waste water will be disposed in to Septic tank/soak pit. Existing: There is no any generation of industrial waste water from the process and operation. Hence unit is strictly adhere to zero discharge. Proposed: Industrial waste water will be treated into the ETP and then send to NCT-CETP. [Narmada Clean Tech] for further treatment.

32 WATER FLOW DIAGRAM:-

33 FLOW DIAGRAM of EFFLUENT TREATMENT PLANT:-

34 Sr. No. Name of Hazardous Waste 1. Empty barrels/ containers/liners contaminated with hazardous chemicals /wastes ANNEXURE E DETAILS OF HAZARDOUS WASTE GENERATION AND ITS DISPOSAL Source of Generation Raw Material and Packaging Category Quantity MT/ Year Remarks as per HWM,2016 Existing Proposed Total Collection, Storage, Transportation, Decontamination, reuse or send back to supplier, and sold to Authorized Vendors. 2. Used Oil From Machinery Collection, Storage, Transportation and sold to authorized Recyclers. 3. Distillation Process Collection, Storage, Residue [1]Pregabalin Transportation and [2] Nebivolol Hydrochloride sent to Co-processing at [3]Chlorohexidine cement industry or Base CHWIF site. [4]CMHA [5] 2 Bromo-4 Fluroacetanilide [6]2,5-Diamino Toluene Sulphate

35 4. Spent/Mix Solvent Annexures to Form 1 & Pre Feasibility Report From Process [1]Pregabalin [2] Nebivolol Hydrochloride [3]Chlorohexidine Base [4]CMHA [5] 2 Bromo-4 Fluroacetanilide [6]2,5-Diamino Toluene Sulphate 20.2/ Existing: Collection, Reception from GPCB Authorized unit who has authorisation in valid CCA to sell this waste, storage and use as Raw Materials [Utilisation],Recovery. Proposed: Collection, storage, In-house recovery and utilized for manufacturing of products. 5. ETP Sludge ETP Collection, Storage, Transportation and sent to TSDF site. 6. NaSH Solution From Process A Collection, Storage, [1] N,N-Dimethyl formamide dimethyl acetal Captive consumption for the manufacturing of product or sell to authorized end users registered under rule- 7. HBr Process [1] 5 Bromo 2 Chloro Benzoic Acid [2] 2 Bromo-4 Fluroacetanilide 8. HCl Solution From Process [1]2,4,6 Trimethyl Benzoyle Chloride 9. Methyl Chloride From Process [1]2,4,6 Trimethyl Benzoyle Chloride Collection, Storage, Transportation and sell to authorized end users registered under rule Collection, Storage, Transportation and sell to authorized end users registered under rule Collection, Storage, Transportation and sell to authorized end users registered under rule-9.

36 10. Sodium Acetate From Process [1]5-Nitro Ortho Toluidine 11. Iron Sludge From Process [1]2,5-Diamino Toluene Sulphate 12. Spent Catalyst From Process [1] 2, 5 Di Chloro PPD [2] 2, 5- Di Methyl PPD [3] 2-Chloro 5- Methyl PPD 13. Spent Carbon From Process [1]Nebivolol Hydrochloride [2]2 Bromo-4 Fluroacetanilide Collection, Storage, Transportation and sell to authorized end users registered under rule Collection, Storage, Transportation and send to Co-processing at cement industry or CHWIF site Collection, Storage, Transportation and sent to TSDF site Collection, Storage, Transportation and disposal at Co- Processing or CHWIF- BEIL-Ankleshwar.

37 Sr. No Stack attached to Boiler [Cap. 800 Kg/hr.][2 Nos.] Thermic Fluid Heater [Cap. 4 Lac Kcal] Boiler [Cap. 2 TPH] Boiler [Cap. 850 Kg/hr.] DG Set [500 KVA] ANNEXURE F DETAILS OF AIR POLLUTION CONTROL MEASURES DETAILS OF FLUE GAS EMISSION Name of fuel & its consumption Briquettes /Agro waste [700 kg/hrs. and/or Natural Gas 100 m 3 /hrs.] Existing Proposed Natural Gas [2700 Nm 3 /Day] Diesel [200 Lit/Day] Stack Height [m] Air pollution Control System Cyclone Separator + Scrubber Adequate Stack height Parameters PM < 150 mg/nm 3 SO2< 100 ppm NOx< 50 ppm PM < 150 mg/nm 3 SO2< 100 ppm NOx< 50 ppm Sr. No. Stack Attached to DETAILS OF PROCESS GAS EMISSION Stack Height (m) APCM Type of Pollutants Existing 1. There shall be no any process gas from Existing process Proposed Permissible Limit 1. Process Reactor 12 Water Scrubber HCl 20 mg/nm 3 2. Process Reactor 12 Two Stage Caustic Scrubber H2S 45 mg/nm 3

38 STR.NO-4 REVISED,PROPOSED & VIOLATIVE FACTORY BUILDING PLAN ON PLOT NO;-A2 SHED-2215, AT-G.I.D.C. ESTATE AREA, ANKLESHWAR. FOR."M/S PROACTIVE PHARMA." MT. RWH GATE RWH RWH PARKING-B 8.00 X PARKING-C 7.37 X MT. OFFICE 5.54 X 3.64 STR. NO-3 STR. NO-7 U/G PETROLEUM STORAGE TANK OFFICE 5.54 X TOILET ST APPROACH ROAD STORE 8.74 X 5.67 STR. NO MT. STORE 5.97 X 5.67 STORE 4.85 X 3.89 STR. NO-1/A WORKING AREA 4.92 X STR. NO-1 WORKING A2 TYPE SHED X STR. NO-1/B WORKING AREA 4.37 X MT MT MT MT MT. APPROACH ROAD 2.07 GATE RWH PARKING AREA-A X 4.00 RWH ELE. ROOM 1.61 X 2.27

39 ANNEXURE H PROPOSED TERMS OF REFERENCE The generic structure of Environment Impact Assessment Study Report will be as under: 1. Introduction This will cover the location and justification of the proposed project and scoping and methodology for the EIA study. 2. Project Description It will include the below mention details. Location of the project Product profile Resources requirement Manufacturing process and raw material requirement Material handling and storage Details on proposed Environmental Management System and Monitoring. Storage and handling of hazardous chemicals 3. Baseline Environmental Description 1. Air The data regarding baseline environmental conditions will be collected /generated as per the guidelines of MoEF. The methodology for collection of baseline data for each of the component/environmental attribute is as follows: a. The study area will be of 10 Km radius considering the project site as center and study period will be of one season except monsoon. b. For estimation of back ground concentration of PM10, PM2.5, Oxides of Nitrogen (NOx), Sulphur Dioxide (SO2), within study area, and 6 monitoring stations will be established as per the guidelines of CPCB and Ministry of Environment & Forest, Government of India. At each station monitoring will be carried out on 24 hourly bases twice in a week for entire study period except monsoon. 2. Meteorology Meteorological data like wind speed, wind direction, humidity, temperature, will be collected at the location under consideration / from authorized agency, so as to

40 prepare wind-rose diagram and to predict the concentration of pollutants using dispersion models. These data will be collected for a period of 12 weeks. 3. Water Water samples will be collected and analyzed of raw water supply of the Notified area. 4. Noise The noise level will be measured once in a study period in Leq. at least at 6 different location within study area using an integrated sound level meter. 4. Identification and Assessment of the Impacts The activities having the potential to cause environmental impact will be identified and the degree of impact will be assessed using standard matrix methods. The following environmental attributes will be considered to establish the causeeffect relationship with the various activities of the proposed project. 5. Environmental Management and Monitoring Plan Environmental Management and Monitoring Plan will be prepared based on the anticipated environmental impact. It will also cover details on Occupational Health programs and as well as for corporate social responsibilities. 6. Risk Assessment: The study will include risk assessment for storage, handling, transportation etc. for the raw material(s) and products to be used in the plant. Occupational risk involved during operational phase of the plant will be assessed and necessary safety and protective measures will be recommended.

41 ANNEXURE-I Site Coordinates: Latitude:21 37'4.68"N Longitude:73 1'34.85"E PROJECT: M/s. Pro Active Pharma Pvt. Ltd, Plot No. A-2/2215 G.I.D.C Estate, Ankleshwar, District: Bharuch,Gujarat