Synthetic Organic Chemicals 5(f) Bulk Drug and Bulk Drug Intermediates

Transcription

1 SEAC, Gujarat Page 1 of 18 Synthetic Organic Chemicals 5(f) Bulk Drug and Bulk Drug Intermediates For Terms of Reference [ToR] Expansion of Project 1. Basic Information of the Project: i Name & Address of the Project site (Complete details with plot no./survey no., Landmark etc. ) KARUNESH REMEDIES Plot No. 417/2, Phase-II, GIDC Industrial Estate, Panoli , Tal: Ankleshwar, Dist: Bharuch, Gujarat ii Name of the Applicant Mr. Pankaj Mangroliya iii Address for correspondence Plot No. 417/2, Phase-II, GIDC Industrial Estate, Panoli, Tal: Ankleshwar, Dist: Bharuch iv Contact no. and ID of the Applicant Mo. no. : kremedies@gmail.com v Aerial distance of nearest Habitat (KM) Panoli 2 Km vi Longitude & Latitude of the Project Site: (4 corners of the site) Corner-1: longitude 72 59'32.08"E and latitude 21 34'00.45"N Corner-2: longitude 72 59'32.79"E and latitude 21 34'01.12"N Corner-3: longitude 72 59'33.83"E and latitude 21 34'00.88"N Corner-4: longitude 72 59'33.50"E and latitude 21 33'59.27"N vii Category as per the Schedule to the EIA Notification 2006 i.e. 1(d), 2(b), 5(f) etc. 5 (f) Synthetic Organic Chemicals Sub-Category: Bulk Drug and it s intermediates viii Applicability of General Conditions of EIA Notification 2006: i.e. Ensure that (1) Protected areas notified under the Wildlife (Protection) Act, 1972; Not Applicable Page 1 of 18

2 SEAC, Gujarat Page 2 of 18 (2) CEPI areas (3) Eco-sensitive areas and (4) Inter-state boundaries and international boundaries; are not located within 5 km or 10 km (as the case may be) area from the boundary of the proposed site. 2. Online applicationreg.: a) Online application proposal no. : -- b) Date online acceptance of ToR application by SEAC: -- c) Date of presentation for ToR: Product profile: Sr. no. Name of the Products CAS no. / CI no. Quantity (MT/Month) Existin g Propose d Total End-use of the products 1 Lamotrigine Intermediates (2,3 Dishlorophenyl (oxo) acetonitrile) Lamotrigine 2 Cetirizine Dihydrochloride Intermediates (4- Chlorophenyl phenyl)methyl]piperazine Cetirizine DIhydrochloride 3 Clopidogrel Bisulphate Intermediates (Methyl amino (2- chlorophenyl)acetate) Clopidogrel Bisulphate 4 Cetirizine Dihydrochloride Anti-histamines 5 Clopidogrel Bisulphate Antiplatelet agent 6 Levocetirizine Sneezing, itchin Page 2 of 18

3 SEAC, Gujarat Page 3 of 18 Dihydrochloride 8 g, watery eyes 7 GLIMEPIRIDE Anti - Diabatic 8 Ivermectin Onchocerciasis 9 Isotretinoin Treatment of Acne Vulgaris 10 Tretinoin To smooth rough facial skin 11 Betahistine Hydrochloride To treat dizziness (vertigo) Total The project falls undercategory B of project activity5(f)asper the schedule of EIA Notification Product wise Raw material consumption: Sr. no. Name of the Products Name of the Raw Materials CAS no. / CI no. of raw materials. Existing Quantity (MT/Month) Propose d Total 1 Lamotrigine Intermediates (2,3 Dishlorophen yl (oxo) acetonitrile) 2,3 dichloro benzoyl chloride Cooper cyanide Potassium iodide Toluene Cetirizine Dihydrochlori de Intermediates (4- Chlorophenyl phenyl)methyl ]piperazine 4-chloro benzoic acid Thionyl chloride Toluene Aluminium chloride Sodium borohydride Page 3 of 18

4 SEAC, Gujarat Page 4 of 18 Sodium carbonate HCL Methanol Calcium Chloride HCL Piperazine anhydrous Tetra butyl ammonium bromide Clopidogrel Bisulphate Intermediates (Methyl amino (2- chlorophenyl) acetate) Amino(2- chlorophenyl) acetic acid Methanol Potassium salt MDC Liq. ammonia Cetirizine Dihydrochlori de Benzoyl Chloride Mono chloro benzene(mcb) Aluminium chloride Sodium borohydride ( 2 D 4 ) Sodium carbonate HCL Calcium Chloride Page 4 of 18

5 SEAC, Gujarat Page 5 of 18 Toluene Methanol Piperazine anhydrous Tetra butyl ammonium bromide Caustic soda flakes 2-chloro ethanol Tri ethyl amine Dimethyl formamide Sodium monochloro acetate Caustic potash flakes Sodium salt MDC Acetone Sulfuric acid Clopidogrel Bisulphate Amino(2- chlorophenyl) acetic acid Methanol Potassium salt MDC Liq. ammonia Thiophene-2- Ethanol Page 5 of 18

6 SEAC, Gujarat Page 6 of 18 p-toluene sulphonyl chloride Toluene Sodium hydroxide Acetonitrile Dipotassium phosphate Ethyl acetate HCL P- Formaldehyde Acetone Tartaric acid Sodium carbonate Activated carbon Sulfuric acid LEVOCETIRIZ INE DIHYDROCHL ORIDE Ammonium formate 4-chloro benzophenone HCL Caustic soda MDC Tartaric acid DIPEA BIS-Amide HBR in Acetic Acid Page 6 of 18

7 SEAC, Gujarat Page 7 of 18 2-Chloro Ethanol Tri Ethyl Amine Toluene Dimethyl Formamide Sodium Mono Chloro Acetate Caustic potash flakes Acetone Sulfuric Acid GLIMEPIRIDE 3-ethyl-4- methyl-2-oxo- 3-pyrroline phenyl ethyl isocyanate n-hexane Chloro sulphonic acid Ammonia Trans-4-methyl cyclohexyl isocyanate Acetone Potassium carbonate Methanol IVERMECTIN 6 -[sec-butyl]-tetr dihydroxy-tetram [11,15-methano Page 7 of 18

8 SEAC, Gujarat Page 8 of 18 2H,13H,17H-furo benzodioxacyclo dideoxy-4-o-(2,6 methyl-α-l- hexopyranosyl )-3-O-methylα-Lhexopyranosid e Acetone Isotretinoin [3-methyl-5- (2,6,6- trimethyl-1- cyclohexen-1- yl)-2,4- pentadien-1- yl]triphenylphosphonium chloride 5-hydroxy-4- methylfuran- 2(5H)-one Acetone Tretinoin [3-methyl-5- (2,6,6- trimethyl-1- cyclohexen-1- yl)-2,4- pentadien-1- yl]triphenylphosphonium chloride 5-hydroxy-4- methylfuran- 2(5H)-one Acetone Betahistine 4-Amino-2- Methyl-Ethyl Page 8 of 18

9 SEAC, Gujarat Page 9 of 18 Hydrochloride Pyridine Acetone HCL Sulfuric Acid Compliance status of the existing project: Sr. no. Particulars Brief Information/Details Remarks 1 Earlier EC details Earlier EC vide letter No. J- In case of EC not 11011/811/2017 dated: obtained, Copy of CTE &CCA obtained before /06/ Compliance of EC conditions Company has complied the EC Conditions. 3 Status of inspection by RO- No MoEF&CC, Bhopal.i.e. CCR- Certified Compliance Report 4 Status of submission of half yearly returns to concern Company submit the EC Compliance on half yearly basis. authorities. 5 Compliance of existing CC&A Company has valid Consent to Operate and comply all conditions. 6 Legal actions/closure 1 Show notice of last 5 years. directions/scn etc. Issued by GPCB. 7 Any Public Complaints There are no any public complaints. 8 Is there any litigation pending before any court of Law against the Project? There is no any litigation pending before any court of Law against the Project Page 9 of 18

10 SEAC, Gujarat Page 10 of Salient features of the project including Water, Air and Hazardous waste management: S Particulars Details r. n o. A Total cost of Proposed Project (Rs. in Crores): Existing: 0.80 Proposed:3.5 Total: 4.30 B Total Plot area ( sq. meter) Existing: 1500 Sq. m. Proposed: 00 Sq. m. Total: 1500.Sq. m. Green belt area,/tree Plantation area ( sq. meter) Existing: 300 Sq. m. Proposed: 00.Sq. m. Total: 300 Sq. m. C Employment generation Existing:15 Proposed:20 Total:35 D Water i Source of Water Supply GIDC Water Supply (GIDC Bore well, Surface water, Tanker supply etc...) Status of permission from the concern authority. GIDC Water Supply ii Water consumption (KLD) Existing KLD Proposed (Additional) KLD Total after Expansion KLD (A) Domestic (B) Gardening (C) Industrial Industrial Total Process Washing Boiler Cooling Others Grand Total Remarks Page 10 of 18

11 SEAC, Gujarat Page 11 of 18 (A+B+C) 1) Total water requirement for the project: KLD 2) Quantity to be recycle: 0.6 KLD 3) Total fresh water requirement:20.30 KLD iii Waste water generation (KLD) iv v vi Category Existing Proposed Total after Remarks KLD (Additional) KLD Expansion KLD (A) Domestic (B) Industrial Process Washing Boiler Cooling Others Total Industrial waste water Treatment facility within premises with capacity [For existing and Proposed] [In-house ETP (Primary, Secondary, Tertiary), MEE, Stripper, Spray Dryer, STP etc.. In-house ETP (Primary Treatment) 5.5 KL/Day Mode of Disposal & Final meeting point Domestic: 1.0 KL/Day Soak Pit Industrial: 3.3 KL/Day Common Spray Dryer Plant of M/s. PETL, Panoli G.I.D.C. In case of Common facility (CF) like CETP, Common Spray dryer, Common MEE, CHWIF etc. Name of Common facility Common Spray Dryer Plant of M/s. PETL, Panoli G.I.D.C. Membership of Common facility (CF) Common Spray Dryer Plant of M/s. PETL, Panoli G.I.D.C. Page 11 of 18

12 SEAC, Gujarat Page 12 of 18 vi i E Reuse/Recycle details (KLD) 0.6 KLD Air i ii Flue gas emission details No. of Boilers/TFH/Furnaces/DG sets etc. with capacities viz. TPH, Kcal/hr, MT/hr, KVA etc. Existing & Proposed - SR. no. Existing 1 Proposed Source of emission With Capacity e.g. Boiler (8 TPH) Small Industrial Boiler Steam Boiler -1.5 TPH Thermopac k Fluid Heater (1 Lac Kcal/Hr) D.G. Set (125 KVA) Stack Height (meter ) Nam e of the fuel 18 Wood 18 Agro waste 18 LDO 11 HSD Quantit y of Fuel MT/hr & MT/Day MT/Day 5 MT/Day 1 MT/Day 25 Liter/Hr Type of emission s i.e. Air Pollutant s SPM SO2 Nox SPM SO2 Nox SPM SO2 Nox SPM SO2 Nox APCM Cyclone Separato r Cyclone Separato r with bag filter Adequat e Stack Height Adequat e Stack Height Process gas i.e. Type of pollutant gases (SO 2, HCl, NH 3, Cl 2, NO x etc.) Existing & Proposed - Sr. no. Source of emission Type of emission Stack/Vent Height (meter) APCM NAAQS (National Ambient Air Quality Standards ) 150 mg/nm mg/nm 3 94 mg/nm mg/nm mg/nm 3 94 mg/nm mg/nm mg/nm 3 94 mg/nm mg/nm mg/nm 3 94 mg/nm 3 NAAQS (National Ambient Air Quality Standards) Page 12 of 18

13 SEAC, Gujarat Page 13 of 18 iii 1 Process Vent -1 (Chlorination) 2 Process Vent -2 (Sulphonation) HCl 11 SO2 11 Fugitive emission details with its mitigation measures. Water + Alkali Scrubber Two Stage Alkali Scrubber 20 mg/nm3 40 mg/nm3 Fugitive emissions are expected to be generated during construction and operation. During construction stage, main source of fugitive emission is dust which is expected mainly due to movement of vehicles carrying construction material and vehicles used for construction. Mitigate by allowing the vehicles entering the premises under cover. Control by spraying water. Hosing down the wheels of the vehicles with water and providing washing troughs for them would further mitigate the amount of dust generated. During operation stage, leakage through valves/pumps, leakage and emission from open drum containing chemicals, open feeding, storage tanks, etc. will be major sources of fugitive emissions and VOCs. Excess use of solvent/s may also results fugitive emission from the process vessels. Solid raw material charging will be done through closed system. Entire process will be carried out in the closed reactors with proper maintenance of pressure and temperature. Close feeding system will be provided for centrifuges. Centrifuge and filtrate tank vents will be connected to vent chillers. Fugitive emission over reactors, formulation areas, centrifuges, chemical loading, transfer area, will be collected through hoods and ducts by induced draft and controlled by scrubber/dust collector. Emphasis will be given to solvent management/solvent loss prevention. Control by having proper scrubbing system. Condenser to trap VOC. Enclosures to chemical storage area, collection of emission from loading of raw materials in particular solvents through hoods and ducts by induced draft, and control by scrubber/dust collector to be ensured. Nitrogen blanketing will be provided, besides special care needs to be taken for control in respect of odorous chemicals. Page 13 of 18

14 SEAC, Gujarat Page 14 of 18 F i Proper maintenance schedule will be adhered to avoid emissions through flange joints, pump seals etc. Minimum number of flanges, joints and valves in pipelines. Proper gland packing will be maintained for pumps and valves and to the extent possible pumps with mechanical seal. All Flange joints of the pipe lines which carry solvents will be covered with flange guards. All rotating equipments like pumps will be installed with mechanical seals to arrest any sort of emissions. A regular preventive maintenance schedule will be in place to replace or rectify all gaskets and joints etc. as a part of ISO systems to ensure no fugitive emissions take place. Periodic monitoring of work area will be carried out to check the fugitive emission. Solvent tank vents will be connected to vent chillers. Stand by pumps will be provided on all scrubbers. Besides, scrubbers are equipped with on-line ph meter with hooter system for better operational control. Regular inspection of floating roof seals and proper preventive maintenance of roofs and seals for tanks. Adequate ventilation will be provided. Hazardous waste (as per the Hazardous and Other Wastes (Management and Transboundary Movement) Rules Existing & Proposed S r. n o. Type/Name of Hazardous waste Source of genera tion Categ ory and Sche dule as per HW Rules. 1 ETP Sludge ETP I/35.3 Existin g Quantit y (MT/An num) Propos ed Quantit y (MT/An num) Total Quantit y (MT/An num) Disposa l Method Collectio n, Storage, transport ation and Disposal in TSDF Page 14 of 18

15 SEAC, Gujarat Page 15 of 18 2 Used Oil Machin eries 3 Discarded container/barrel/l iner/bags Raw Materia ls/ Product s 4 Distillation Residue Distillati on 5 Spent Carbon Proces s (Produc t No. 3,5) 6 Spent Solvent Proces s I/5.1 I/33.1` I/28.6 I/20.3 I/ Collectio n, Storage, transport ation and Disposal by selling to registere d reproces ser Collectio n, Storage, transport ation and Disposal by sale to authoriz ed vendors Collectio n, Storage, transport ation and Disposal at coprocessi ng, Cement industrie s or Commo n incinerat or by M/s. BEIL, Anklesh war Collectio ns, Storage, distill and reuse in plant premise Page 15 of 18

16 SEAC, Gujarat Page 16 of 18 7 Filter material Filter press 8 Inorganic Waste Proces s (Produc t No. 1) 9 Piperazine Solution (22%) NaCL solution Sodium Sulfite (18%) Proces s (Produc t No. 2, 4) Scrubb er Scrubb er I/35.1 I/28.1 I/28.1 I/28.1 I/28.1 s Collectio n, Storage, transport ation and Disposal at Commo n incinerat or by M/s. BEIL, Anklesh war Collectio n, Storage, transport ation and Disposal in TSDF Collectio n, Storage, transport ation and sell to end user who is having Rule-9 Permissi on Collectio n, Storage and send to ETP for further process Collectio n, Storage, transport ation and sell to end user Page 16 of 18

17 SEAC, Gujarat Page 17 of 18 who is having Rule-9 Permissi on. ii Membership details of TSDF, CHWIF etc. Company will obtain the iii G i Details of Non-Hazardous waste & its disposal(msw and others) Solvent management, VOC emissions etc. membership of TSDF, CHWIF. There is no generate non hazardous waste. Types of solvents, Details of Solvent recovery, % recovery. reuse of recovered Solvents All the solvents shall be directly distilled from product mixes and; if required shall be purified in packed column with the help of reflux and therefore there is no generation of any distillation residue from the solvent distillation. The solvent distillation system shall be designed so as to achieve minimum 94.0 % recovery of solvent. Pure solvent, crude solvent and distilled (recovered) solvent shall be stored only in storage tanks and we shall not be using drums at any stage in the Solvent Management System. Wherever required, the solvents shall be directly pumped into day tanks from the storage tanks and shall be charged into the reactors without involving any manual handling. All the pumps shall be mechanical seal type to avoid any leakage of solvent. All necessary fire fighting systems shall be provided with alarm system. Flame proof wiring and flame proof electrical accessories shall be provided to avoid any mishap. All the storage tank and day tank shall be connected to a vent system through cooling water and chilled brine condensers to prevent loss of solvents in the atmosphere. All the distillation column vents will be also connected to cooling water/chilled brine condensers for maximum possible recovery of the solvents. All the vents will be connected to a common carbon Adsorber for removing traces of solvent from vent gases. Residue generated from the distillation will be incinerated in-house or sent to BEIL incinerator site. Page 17 of 18

18 SEAC, Gujarat Page 18 of 18 ii Coolant to be used Primary Condensers Cooling Water Secondary Condensers Chilled Brine up to -5 0 C VOC emission sources and its mitigation measures Leakage through valves/pumps, leakage and emission from open drum containing chemicals, open feeding, storage tanks, etc. will be major sources of fugitive emissions and VOCs. Excess use of solvent/s may also results fugitive emission from the process vessels. 7. Details of Environmental Consultants: Sr. Particulars Details no. i Name of the Consultant Aqua-Air Environmental Engineers Pvt. Ltd. ii Contact no. and ID of the Consultant Mo. no. : iii Accreditation for the categories and Stay order against NABET/QCI Validity iv Any other details No any other details Name & designation of the Applicant: Mr. Pankaj Mangroliya Stamp &Signature of Applicant: Date: 10/09/2018 General Instructions Format shall be in WORD Format (Font type- Arial, Font size- 11) Do not change Format. Fill up your details / information in prescribed tables. Provide authenticated (with stamp & Signature) hard copy during presentation. Kindly send to : seacgujarat@gmail.com Above data shall be as per application Form-1 & PFR. Incorporate relevant details in respective column in the Format. Do not attach Annexure except copy of Certificates etc. Page 18 of 18