SY.NO. 501,506 KOYYALAGUDEM VILLAGE, …environmentclearance.nic.in/writereaddata/Online/TOR/0_0_25_Nov... · s.v.labs pvt.ltd. sy.no. 501,506 & 507, koyyalagudem village, choutuppal

S.V.LABS PVT.LTD. SY.NO. 501,506 & 507, KOYYALAGUDEM VILLAGE,

CHOUTUPPAL MANDAL, NALGONDA DISTRICT, TELANGANA

FORM I

Project No. 1115‐21‐01 November 2015

S.V. Labs Pvt. Ltd. Plot No: 3,4&5, First Cross, Anrich Industrial Estate, IDA Bollaram, Medak Dist ‐502325 Phone: +91 9848132877 E‐mail: [email protected]

STUDIES AND DOCUMENTATION BYTEAM Labs and Consultants B‐115‐117 & 509, Annapurna Block, Aditya Enclave, Ameerpet, Hyderabad‐500 038. Phone: 040‐23748 555/23748616, Telefax: 040‐23748666

SUBMITTED TO MINISTRY OF ENVIRONMENT, FORESTS AND CLIMATE CHANGE

GOVERNMENT OF INDIA INDIRA PARYAVARAN BHAWAN, JOR BAGH ROAD, NEW DELHI

S.V.Labs Pvt.Ltd.

Form I Page 1

APPENDIX – I (See Paragraph – 6)

FORM I I) Basic Information S.No. Item Details 1 Name of the Project/s S.V. Labs Pvt. Ltd. 2 S. No in the Schedule 5 (f) 3 Proposed capacity/area/length/tonnage to

be handled/command area/lease area/number of wells to be drilled

Area Existing: 6 Acres Permitted Production Capacity: 10.5 TPM Capacity after Expansion: 152 TPM It is proposed to manufacture 12 products at a time on campaign basis out of 34 Products

4 New/Expansion/Modernization Expansion 5 Existing Capacity/Area etc. Existing Capacity: 10.5 TPM

Area Existing: 6 Acres 6 Category of Project i.e 'A' or 'B' “A” 7 Does it attract the general condition? If yes,

please specify No

8 Does it attract the Specific condition? If yes, please specify.

No

9 Location Plot/Survey/Khasra No. Survey No. 501,506 & 507 Village Koyyalagudem Village Tehsil Choutuppal Mandal District Nalgonda District State Telangana

10 Nearest railway station/airport along with distance in km.

Railway Station: Ramannapeta– 24.65 Km Airport: Rajiv Gandhi International Airport – 41.47 Km

11 Nearest Town, City, District Headquarters along with distance in kms.

Choutuppal

12 Village Panchayats, Zilla Parishad, Municipal Corporation, Local body (complete postal address with telephone nos. to be given)

Koyyalagudem

13 Name of the Applicant P. Vijaya Kumar Reddy 14 Registered Address S.V.Labs Pvt. Ltd.,

Survey No. 501,506 & 507 Koyyalagudem Village, Choutuppal Mandal Nalgonda District‐508252

15 Address for Correspondence: Name P. Vijaya Kumar Reddy Designation(Owner/Partner/CEO) Director Address Plot no.3,4 & 5,First Cross, Anrich Industrial Estate, IDA

Bollaram, Medak District, Telangana. Pin Code 502325 E‐mail [email protected] Telephone Number 9848132877 Fax No. 040‐64565626

16 Details of alternative Sites examined, if any. Not Applicable

S.V.Labs Pvt.Ltd.

Form I Page 2

Location of these sites should be shown on a topo sheet.

17 Interlinked Projects Not applicable 18 Whether separate application of interlinked

project has been submitted? ‐NA‐

19 If yes, date of submission ‐NA‐ 20 If no, reason 21 Whether the proposal involves

approval/clearance under: if yes, details of the same and their status to be given. (a) The Forest (Conservation) Act, 1980? (b) The Wildlife (Protection) Act, 1972? (c) The C.R.Z Notification, 1991?

‐NA‐

22 Whether there is any Government Order/Policy relevant/relating to the site?

No

23 Forest land involved (hectares) No 24 Whether there is any location pending

against the project and /or land in which the project is propose to be set up? (a) Name of the Court (b) Case No (c) Orders/directions of the Court, if any and its relevance with the proposed project.

No

S.V.Labs Pvt.Ltd.

Form I Page 3

(II) Activity 1. Construction, operation or decommissioning of the Project involving actions, which will cause physical changes in the locality (topography, land use, changes in water bodies, etc.) S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities /rates,

wherever possible) with source of information data 1.1 Permanent or temporary change in

land use, land cover or topography including increase in intensity of land use (with respect to local land use plan)

NO The proposal is for expansion of the existing unit. No additional land is required.

The land is plain and does not involve much of leveling/excavation.

1.2 Clearance of existing land, vegetation and buildings?

NO The proposal is for expansion of the existing unit. No additional land is required.

1.3 Creation of new land uses? NO Existing – industrial Acquired additional land – to be converted.

1.4 Pre‐construction investigations e.g. bore houses, soil testing?

YES Soil test done and soil load bearing capacity established.

1.5 Construction works? YES Construction activity involves creation of Production Block, Utilities, Enhancement of ZLD system.

1.6 Demolition works? NO Barren land. No structures for demolition 1.7 Temporary sites used for

construction works or housing of construction workers?

NO Construction labor from local villages shall be employed.

1.8 Above ground buildings, structures or earthworks including linear structures, cut and fill or excavations

YES Storage facilities shall be constructed. No major cut and fill or excavation is anticipated.

1.9 Underground works including mining or tunneling?

NO No underground works like mining and tunneling.

1.10 Reclamation works? NO 1.11 Dredging? NO 1.12 Offshore structures? NO 1.13 Production and manufacturing

processes? YES Enclosed in Annexure – I

1.14 Facilities for storage of goods or materials?

NO Raw materials and solvents shall be stored with in factory premises. Materials in bags and drums will be stored in flame proof ware houses.

1.15 Facilities for treatment or disposal of solid waste or liquid effluents?

YES High TDS and low TDS effluents are treated with in the plant premises. Organic waste is sent to cement plants for co‐incineration. Solid waste generated from Multiple Effect evaporators sent to secure land fill.

Details of waste treatment facilities presented in Annexure II

1.16 Facilities for long term housing of operational workers?

NO Operational workers stay in surrounding villages.

1.17 New road, rail or sea traffic during YES Construction materials shall be transported to the site.

S.V.Labs Pvt.Ltd.

Form I Page 4

construction or operation? The traffic density of the existing connecting road is negligible.

1.18 New road, rail, air waterborne or other transport infrastructure including new or altered routes and stations, ports, airports etc?

NO

1.19 Closure or diversion of existing transport routes or infrastructure leading to changes in traffic movements?

NO

1.20 New or diverted transmission lines or pipelines?

NO

1.21 Impoundment, damming, culverting, realignment or other changes to the hydrology of watercourses or aquifers?

NO

1.22 Stream crossings? NO All materials and waste streams are pumped through above ground pipe lines.

1.23 Abstraction or transfers of water form ground or surface waters?

YES Total water required shall be met from existing bore‐wells within the plant premises. Present permitted water consumption is 84.2 KLD. Total water required after expansion shall be 190.9 KLD out of which 110.9 KLD is fresh water requirement and balance is recycled water.

1.24 Changes in water bodies or the land surface affecting drainage or run‐off?

NO

1.25 Transport of personnel or materials for construction, operation or decommissioning?

YES The construction material shall be drawn from local sources within 10 km. There is no transport of personnel, as the construction workers shall be drawn from local villages.

1.26 Long‐term dismantling or decommissioning or restoration works?

NO

1.27 Ongoing activity during decommissioning which could have an impact on the environment?

NO

1.28 Influx of people to an area in either temporarily or permanently?

YES The proposed project shall increase the employment potential.

1.29 Introduction of alien species? NO 1.30 Loss of native species or genetic

diversity? NO There are no major losses of tree/shrub species.

1.31 Any other actions? NO

S.V.Labs Pvt.Ltd.

Form I Page 5

2. Use of Natural resources for construction or operation of the Project (such as land, water, materials or energy, especially any resources which are non‐renewable or in short supply): S.No. Information/checklist

confirmation Yes/No Details thereof (with approximate quantities /rates,

wherever possible) with source of information data 2.1 Land especially undeveloped or

agricultural land (ha) YES 6 acres

Located at Survey No. 501,506 & 507 ,Koyyalagudem Village, Choutuppal Mandal, Nalgonda District, Telangana

2.2 Water (expected source & competing users) unit: KLD

YES Present permitted water consumption is 84.2KLD. Total water required after expansion shall be 190.9 KLD out of which 110.9 KLD is fresh water requirement and balance is recycled water. (Water Balance Enclosed in Annexure III)

2.3 Minerals (MT) NA 2.4 Construction material – stone,

aggregates, sand / soil (expected source – MT)

YES Shall be sourced from the local villages.

2.5 Forests and timber (source – MT)

NO

2.6 Energy including electricity and fuels (source, competing users) Unit: fuel (T), energy (MW)

YES The required energy shall be drawn from TSPDCL. Standby DG set of 1000 KVA is proposed in addition to existing 380 KVA and 250 KVA DG sets.

It is proposed to establish 6 TPH coal fired boiler in addition to existing 4 TPH coal fired boiler to meet the steam requirement both for process and ZLD system. Coal consumption after expansion is 35.05 TPD.

2.7 Any other natural resources (use appropriate standard units)

NA

S.V.Labs Pvt.Ltd.

Form I Page 6

3. Use, storage, transport, handling or production of substances or materials, which could be harmful to human health or the environment or raise concerns about actual or perceived risks to human health. S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates,

wherever possible) with source of information data 3.1 Use of substances or materials, which

are hazardous (as per MSIHC rules) to human health or the environment (flora, fauna, and water supplies)

YES Hazardous chemicals shall be used for manufacturing of Synthetic Organic Chemicals and intermediates. MSIHC rules shall be followed during storage, transportation and handling of raw materials. Hazardous chemicals and solvent shall be stored and handled in closed systems.

3.2 Changes in occurrence of disease or affect disease vectors (e.g. insect or water borne diseases).

NO

3.3 Affect the welfare of people e.g. by changing living conditions?

YES Shall increase the employment potential for locals and affect the living conditions for betterment.

3.4 Vulnerable groups of people who could be affected by the project e.g. hospital patients, children, the elderly etc.,

NO No sensitive receptors are present in the immediate vicinity of the site. The project shall not have any significant impact on vulnerable groups of people.

3.5 Any other causes NO

4. Production of solid wastes during construction or operation or decommissioning (MT/month) S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates,

wherever possible) with source of information data 4.1 Spoil, overburden or mine wastes NO 4.2 Municipal waste (domestic and or

commercial wastes) NO Wastes from canteen, other commercial wastes like

paper, empty containers etc. The canteen wastes and commercial wastes shall be in the range of 3 kg/day

4.3 Hazardous wastes (as per Hazardous Waste Management Rules)

YES Hazardous waste generation during construction shall be limited to waste oils, batteries and containers of paints etc. The quantity of hazardous wastes generated during operation contain salts from evaporators, process residue, and solvent residues, ETP sludge and filtration media etc.

4.4 Other industrial process wastes YES Enclosed at Annexure IV 4.5 Surplus product NO 4.6 Sewage sludge or other sludge from

effluent treatment YES Sludge from Effluent treatment plant and evaporation

salts shall be sent to TSDF. 4.7 Construction or demolition wastes NO Construction activities involve creation of Production

Blocks, Utilities and enhancement of ZLD system. 4.8 Redundant machinery or equipment NO 4.9 Contaminated soils or other materials NO All pipe lines including pipe lines of waste streams

are above ground level to eliminate the possibility of any contamination due to seepage and for ease of maintenance.

4.10 Agricultural wastes NO 4.11 Other solid wastes YES Enclosed at Annexure IV

S.V.Labs Pvt.Ltd.

Form I Page 7

5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr) S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates,

wherever possible) with source of information data 5.1 Emissions from combustion of fossil

fuels from stationary or mobile sourcesYES Coal Shall be used as fuel. Emissions details are

enclosed in Annexure V 5.2 Emissions from production processes

YES Gaseous emissions from process are HCl, SO2, are scrubbed in two stage scrubbers. Water is used as scrubbing media in primary scrubbers and caustic in secondary scrubbers.

5.3 Emissions from materials handling including storage or transport

NO Material transfer takes place in closed pipeline systems using pumps with mechanical seals.

5.4 Emissions from construction activities including plant and equipment

YES Dust may rise during transport of material and construction activity. The dust emissions shall be mitigated by water spraying on the roads within the premises.

5.5 Dust or odors from handling of materials including construction materials, sewage and waste

NO Sewage will be treated in the existing treatment plant.

5.6 Emissions from incineration of waste NO Organic waste streams are sent to cement plants for co‐incineration.

5.7 Emissions from burning of waste in open air (e.g. slash materials, construction debris)

NO

5.8 Emissions from any other sources NO

S.V.Labs Pvt.Ltd.

Form I Page 8

6. Generation of Noise and Vibration, and Emissions of Light and Heat: S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates,

wherever possible) with source of information data with source of information data

6.1 From operation of equipment e.g. engines, ventilation plant, crushers

YES Material transport and construction equipment shall be source of noise, while transfer pumps, vacuum systems, DG sets are the sources of noise during operation.

6.2 From industrial or similar processes YES DG sets controlled by providing Acoustic Enclosures. 6.3 From construction or demolition YES Noise during construction shall be due to construction

equipment and emergency DG sets. 6.4 From blasting or piling NO 6.5 From construction or operational

traffic NO The increased traffic shall not have any significant

impact. 6.6 From lighting or cooling systems NO 6.7 From any other sources NO

7.Risks of contamination of land or water from releases of pollutants into the ground or into sewers, surface waters, groundwater, coastal waters or the sea: S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates,

wherever possible) with source of information data 7.1 From handling, storage, use or

spillage of hazardous materials NO All pipe lines, storage facilities and waste treatment

facilities are above ground. Same philosophy will be followed for the after expansion

7.2 From discharge of sewage or other effluents to water or the land (expected mode and place of discharge)

NO All the waste from domestic operations sent to biological treatment system in ZLD system.

7.3 By deposition of pollutants emitted to air into the land or into water

NO All the emissions from process are controlled by providing control equipment like scrubbers, Bag filters.

7.4 From any other sources NO 7.5 Is there a risk of long term build up

of pollutants in environment from these sources?

NO

S.V.Labs Pvt.Ltd.

Form I Page 9

8.Risk of accidents during construction or operation of the Project, which could affect human health or the environment

S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities/rates, wherever possible) with source of information data

8.1 From explosions, spillages, fires etc from storage, handling, use or production of hazardous substances

YES All Inbuilt Safety precautions will be adopted and there will not be any damage to environment or human health

8.2 From any other causes NA 8.3 Could the project be affected by natural disasters

causing environmental damage (e.g. Floods, earthquakes, landslides, cloudburst etc)?

NO

9.Factors which should be considered (such as consequential development) which could lead to environmental effects or the potential for cumulative impacts with other existing or planned activities in the locality S. No. Information/Checklist confirmation Yes/No Details thereof (with approximate

quantities/rates, wherever possible) with source of information data

9.1 Lead to development of supporting. facilities, ancillary development or development stimulated by the project which could have impact on the environment e.g.: • Supporting infrastructure (roads, power supply, waste or waste water treatment, etc.) • housing development • extractive industries • supply industries • other

YES The project shall enhance the socio economic status of the area by increasing the demand for housing, improving the employment.

9.2 Lead to after‐use of the site, which could haven impact on the environment

NO

9.3 Set a precedent for later developments NO

9.4 Have cumulative effects due to proximity to other existing or planned projects with similar effects

NO The baseline environmental status of the surrounding areas is within the prescribed limits as observed from the Secondary data.

S.V.Labs Pvt.Ltd.

Form I Page 10

(III) Environmental Sensitivity S.No. Areas Name/

Identity Aerial distance (within 15 km.) Proposed project location boundary

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

NA

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

YES Tangallapali Chervu – 2.5 km S Lakkaram RF – 2.2 km – NE Choutuppal RF – 5 km – NE Malkapuram RF – 2.3 km – W Hafizpura RF – 5.1 km – SW Rajkonda RF – 7.5 km – S Meharnagar RF – 9.4 km ‐ NW

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

NA

4 Inland, coastal, marine or underground waters NO5 State, National boundaries NO 6 Routes or facilities used by the public for access to

recreation or other tourist, pilgrim areas NO

7 Defense installations NO 8 Densely populated or built‐up area YES

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

NA Nearest habitation from the site is Koyyalagudem village at a distance of 0.6 km in west direction.

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

NO

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

NO

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

NO



ANNEXURES

Project No. 1115‐21‐01 November 2015

S.V. Labs Pvt. Ltd. Plot No: 3,4&5, First Cross, Anrich Industrial Estate, IDA Bollaram, Medak Dist ‐502325 Phone: +91 9848132877 E‐mail: [email protected]

STUDIES AND DOCUMENTATION BY TEAM Labs and Consultants B‐115‐117 & 509, Annapurna Block, Aditya Enclave, Ameerpet, Hyderabad‐500 038. Phone: 040‐23748 555/23748616, Telefax: 040‐23748666

SUBMITTED TO MINISTRY OF ENVIRONMENT, FORESTS AND CLIMATE CHANGE

GOVERNMENT OF INDIA INDIRA PARYAVARAN BHAWAN, JOR BAGH ROAD, NEW DELHI

S.V.Labs Pvt. Ltd., Form I Annexures

Page 1

Fig

A.1

Loc

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Page 2

Fig A.2 Plant Layout of S.V.Labs Pvt. Ltd.,


Page 3

ANNEXURE - I

S.V.Labs Pvt. Ltd., Located at Survey No. 501, 506 & 507 ,Koyyalagudem (V), Choutuppal

Mandal, Nalgonda District, Telangana obtained consent and authorization (CFO) for

manufacturing of 10.5 TPM of Drugs & Intermediates vide Letter No.

TSPCB/RCP/NLG/16593/CFO&HWM/HO/2014-655 dated 03.01.2015. It is proposed to

expand the manufacturing capacity from 10.5 TPM to 152 TPM by addition of production

blocks, facility for utility proposed and enhancement of ZLD system. Capacity permitted

and after proposed expansion is presented in Table A-1 and A-2.

Table A-1 Manufacturing Capacity - Permitted S.No Name of the Product Capacity

Kg/Day TPM Bulk Drugs

1 Niacinamide 66.67 2.0 2 Glucoasamine Hydrochloride 66.67 2.0 3 Cetirizine Dihydrochloride 66.67 2.0 4 Carvedilol 50 1.5 5 Terbinafine Hydrochloride 50 1.5 6 Omeprazole 100 3.0 7 Fluconazole 50 1.5

Intermediates 8 Cis-Bromo Benzoate 66.67 2.0 9 4 Amino-1-Methyl-3n-Propyl Pyrazole5- Carboxamide 83.33 2.5 10 Trityl Tetrazole Bromomethyl Biphenyl 100 3.0 11 Thionordiazepam 16.67 0.5

Total (Max production from Bulk Drugs & Intermediates) 350 10.5


Page 4

Table A-2 Manufacturing Capacity –After Expansion S.No Name of the Product Capacity

Kg/day TPM 1 Cetirizine Dihydrochloride 100 3.0 2 Carvedilol 100 3.0 3 Terbinafine Hydrochloride 100 3.0 4 Omeprazole 100 3.0 5 Fluconazole 100 3.0 6 Cis-Bromo Benzoate 200 6.0 7 4 Amino-1-Methyl-3n-Propyl Pyrazole5- Carboxamide 83 2.5 8 Trityl Tetrazole Bromomethyl Biphenyl 300 9.0 9 Thionordiazepam 50 1.5

10 Tetralone 1500 45 11 Citalopram Hydrobromide 150 4.5 12 Losartan Potassium 150 4.5 13 CBX 100 3.0 14 SSB 300 9.0 15 2-Acetyl Thiophene 100 3.0 16 Bosentan 100 3.0 17 Dapagliflozin propanediol 100 3.0 18 Ponatinib 100 3.0 19 Pozaconazole 35 1.1 20 Vidagliptin 35 1.1 21 Abacavir Sulfate(CHN) 35 1.1 22 Sumatriptan(KSM) 100 3.0 23 Amlodipine Maleate 100 3.0 24 4-BBFA 200 3.0 25 Ezetimibe-1 100 3.0 26 Methyl 2- (2-Chlorophenyl) Aceetate 700 21.0 27 Trityl Chloride 1000 30.0 28 Atorvatatin Calcium 100 3.0 29 Pregabalin 100 3.0 30 Rosuvastatin Clacium 100 3.0 31 Rabeprazole Sodium 30 0.9 32 Sildenafil Citrate 100 3.0 33 Quetiapine Fumerate 100 3.0 34 Darunavir Ethanolate 350 10.5 Total (Worst Case 12 Products) 5050 152


Page 5

Process Description of Atorvatatin Calcium

Reaction Schemes

Stage I

Stage II

Stage III


Page 6

Process Description:

Stage I:

2-(2-(4-fluorophenyl)-2-oxo-1-phenylethyl)-4-methyl-3-oxo-N-phenylpentanamide reacts

with tert-butyl 2-((4R,6R)-6-(2-aminoethyl)-2,2-dimethyl-1,3-dioxan-4-yl)acetate in presence

of pivalic aicd. cyclohexane and Isopropylalcohol gives tert-butyl 2-((4R,6R)-6-(2-(2-(4-

fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl)-2,2-dimethyl-1,3-

dioxan-4-yl)acetate.

Stage II:

Tert-butyl 2-((4R,6R)-6-(2-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-

1H-pyrrol-1-yl)-2,2-dimethyl-1,3-dioxan-4-yl)acetate reacts with water in presence of

Acetonitrile, Hydrochloric acid and Sodium carbonate gives (3R,5R)-tert butyl 7-(2-(4-

fluorophenyl)-5-isopropyl-3-phenyl-4-(phenyl carbamoyl)- 1H- pyrrol-1-yl)-3,5- dihydroxy

heptanoate.

Stage III:

(3R,5R)-tert butyl 7-(2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)-1H-

pyrrol-1-yl)-3,5-dihydroxyheptanoate reacts with water and calciumacetate in presence of

Acetonitrile,Ethyl acetate and sodiumhydroxide gives monocalcium mono (3R,5R)-7-(2-(4-

fluorophenyl)-5-isopropyl-3-phenyl-4--(phenylcarbamoyl)- 1H-pyrrol-1-yl)-3,5-dihydroxy

heptanoate). The process flow diagram for Atorvastatin Calcuim is presented in Fig A.3 and

material balance is presented in Table A.3.


Page 7

Stage I: Stage II:

Stage III:

Fig A.3 Process Flow Diagram of Atorvatatin Calcium


Page 8

Table A-3 Material Balance of Atorvatatin Calcium Stage I Input Quantity

(Kg/day) Output Quantity

(Kg/day) Remarks

1,1-dimethyl ethyl -6-(2-aminoethyl)

77.0 Ecetoxy Atorvastatin ester 174.3 To Stage-II

4-Fluoro -2-methyl-1-oxopropyl

117.6 Water formed in reaction 9.6 To wastewater

Cyclohexane 300.0 Cyclohexane Recovered 285.0 Recovered & reused

Iso propyl alcohol(IPA)

250.0 Cyclohexane Loss 3.0 Fugitive Loss

Cyclohexane in Residue 12.0 Solvent in residue IPA Recovered 241.3 Recovered &

reused IPA Loss 5.0 Fugitive Loss IPA in Residue 3.8 Solvent in residue 1,1-dimethyl ethyl -6-(2-

aminoethyl) 4.2 Organic Residue

4-Fluoro -2-methyl-1-oxopropyl

6.5 Organic Residue

Total Input 744.6 Total Output 744.6 Stage II Input Quantity


(Kg/day) Remarks

Acetoxy Atorvastatin ester

174.3 Atorvastatin ester 139.1 To Stage-III

Hydro chloric acid 25.5 Propan-2-one 13.1 To wastewater Water 1137.6 Acetonitrile Recovered 374.0 Recovered &

reused Acetonitrile 400.0 Acetonitrile Loss 6.0 Fugitive Loss Sodium Hydroxide 27.9 Acetonitrile To Wastewater 1.2 To wastewater Acetonitrile in Residue 18.8 Solvent in residue Acetoxy Atorvastatin ester 26.1 Organic Residue Water 1146.1 To wastewater Sodium Chloride 40.9 To wastewater Total Input 1765.4 Total Output 1765.4


Page 9

Stage III Input Quantity


(Kg/day) Remarks

Atorvastatin ester 139.1 Atorvastatin calcium 100.0 Final Product Calcium acetate 51.9 2-Methylproponol 12.8 To wastewater Water 1033.2 Acetonitrile Recovered 727.5 Recovered &

reused Acetonitrile 750.0 Acetonitrile Loss 3.8 Fugitive Loss Hyflow 6.0 Acetonitrile To Wastewater 3.0 To wastewater Sodium hydroxide 6.9 Acetonitrile in Residue 15.8 Solvent in residue Spent Carbon 9.0 Atorvastatin ester 32.7 Organic residue Calcium acetate 4.2 To wastewater Spent Carbon 9.0 Organic residue Calcium acetate 34.0 Inorganic residue Hyflow 6.0 Inorganic residue Water 1033.2 To wastewater Sodium Acetate 14.2 Organic residue Total Input 1996.1 Total Output 1996.1


Page 10

ANNEXURE – II: Wastewater Treatment Facilities

The main sources of effluent generation from the plant are from process, floor washings,

blowing downs from boiler and cooling tower, and domestic effluents. The effluents

generated in the process, separation techniques and during purification contain organic

residues of raw materials, solvents, and products. Some of the raw materials used in the

process are also inorganic in nature. Hence the effluents contain both organics and in-

organics in various quantities leading to high COD and TDS levels respectively. The

quantity of effluents generated and mode of treatment is presented in Table A-5.

Table A-5 Quantity of Effluent Generated and Mode of Treatment

Description Quantity (KLD) Mode of Treatment Permitted After

Expansion HTDS Effluents (TDS & COD> 15000 mg/l)

Process 14.13 49.2 Sent to Stripper followed by MEE and ATFD. Stripper Condensate sent to Cement Plants for Co-Incineration. MEE and ATFD Condensate sent to Biological treatment plant followed by RO. RO rejects sent to MEE and permeate is reused in cooling towers and boiler make-up.

Washings 3 5

Scrubber Effluent 1 3 Sent to MEE followed by ATFD, Biological treatment plant and RO. RO/DM rejects 8

Total - I 18.13 65.2 LTDS Effluents (TDS & COD< 15000 mg/l)

Boiler Blow downs 3 4 Sent to Biological Treatment System followed by RO. RO permeate reused for cooling towers and boiler makeup. RO rejects sent to MEE.

Cooling Tower Blow downs

10

Domestic 2 5 Total - II 5 19 Grand Total (I+II) 23.13 84.2


Page 11

ANNEXURE – III: Water Balance

Water is required for process, scrubbers, washing, cooling tower makeup, steam

generation and domestic purposes. The required water shall be drawn from ground water

sources in addition to reuse of treated wastewater. The total water requirement after

expansion is in the order of 190.9 KLD consisting of 110.9KLD fresh water and 84.2KLD of

recycled water. Total water balance after expansion is presented in Table A-6.

Table A-6 Total Water Balance – After Expansion

Purpose INPUT (KLD) OUTPUT (KLD) Fresh Water Recycled Water Loss Effluent

Process 50.9 49.2 Washings 5 5 Scrubber 3 3 Boiler Feed 30 10 36 4 Cooling Tower 5 70 65 10 RO/DM Plant 8 8 Domestic 6 1 5 Gardening 3 3 Gross Total 110.9 80 105 84.2 Total 190.9 189.2


Page 12

ANNEXURE – IV: Solid Waste

Solid wastes are generated from the process shall be sent to TSDF/ Cement Industries for

Co-incineration. The inorganic residue, evaporation salts from MEE and ATFD and ETP

Sludge shall be sent to TSDF. Total solid waste generated and mode of disposal is

presented in Table A-6.

Table A-6 Total Solid Waste Generated and Mode of Disposal

S.No Description Units Quantity Mode of Treatment/Disposal Permitted After

Expansion 1 Ash from Boiler TPD 9 23 Sold to Brick

manufactures and cement plants

2 Organic residue TPD 0.283 2.33 Sent to TDSF/Cement Plants for Co-incineration

3 Solvent Residue TPD 1.9 Sent to TSDF/Cement Industries

4 Stripper Distillate KLD -- 775 Sent to Cement Industries for Co-incineration. 5 Spent Carbon Kg/day -- 227.7

6 Inorganic Residue Kg/day -- 453.3 Sent to TSDF 7 Evaporation salts TPD 0.8 3 Sent to TSDF 8 ETP Sludge Kg/day 20 150 Sent to TSDF 9 Detoxified containers No.s/Yr 200 700 Sold to authorized

vendors 10 Waste oil LPA 1.6 4 Sent to Authorized

Recyclers 11 Used batteries No.s/Yr 5 12 Sent to Authorized

Recyclers


Page 13

ANNEXURE – V: Stack Emissions Details

The sources of air pollution from the plant are existing 4 TPH Coal fired boiler and Proposed

6TPH Coal fired boiler. DG sets of 380 KVA of existing and proposed 1000 KVA capacity.

The proposed air pollution control equipment for coal fired boiler is Bag filters. DG sets shall

be provided with stack heights based on the CPCB formula for effective stack height.

Stack Emission Details

S. No

Stack Connected to

Stack Ht (m)

Dia of stack at top(m)

Temp. of exhaust

gases (0C)

Exit Velocity (m/sec)

Pollutant Emission Rate (g/sec)

SPM SO2 NOx

Existing 1 4TPH Coal Fired

Boiler 30 0.9 160 18 0.2 0.4 0.5

2 380KVA DG Set 4 0.1 200 10 0.2 0.3 0.4 3 250KVA DG Set 3 0.1 200 10 0.15 0.25 0.4

Proposed 1 6TPH Coal Fired

Boiler 30 1.2 180 20 0.39 0.65 0.9

2 1000KVA DG set 5 0.15 190 18 0.3 0.7 0.95 *DG sets will be used during load shut down by TSPDCL.



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