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ADDITIONAL ATTACHMENTS

New Microsoft Office Word Documentenvironmentclearance.nic.in/writereaddata/FormB/TOR/Additional... · List of Products with Quantities Sr. No. PRODUCTS IN EXISTING EC CATEGORY QUANTITY

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ADDITIONAL ATTACHMENTS

ANNEXURE I

(List of Products with Quantities)

List of Products with Quantities

Sr. No.

PRODUCTS IN EXISTING EC

CATEGORY QUANTITY MT/MONTH MT/ANNUM

1 Nevrapine/ Nevrapine Hemihydrate ANTI-RETROVIRAL

1.89 22.68

2 Ziduvudine 0.49 5.88 3 Lamivudine ANTI-VIRAL 0.85 10.22 4 Terbinafine Hydrochloride ANTI-FUNGAL 2.00 24.00 5 Cyproterone Acetate ANTI-ANDROGEN 0.27 3.24 6 Fexofenadine Hydrochloride ANTI-HISTAMINE 0.86 10.26 7 Deferiprone CHELATING AGENT 1.56 18.72 8 Escitalopram Oxalate ANTI-DEPRESSANT 0.18 2.16 9 Citalopram Hydrobromide 3.10 37.20 10 Rosiglitasone Maleate ANTI-DIBETIC 0.65 7.80 11 Estramustine Sodium Phosphate ANTI-NEOPLASTIC 0.67 7.98

Total

12.50

150.00 Sr. No.

PRODUCTS IN EXPANSION

CATEGORY QUANTITY (TARGET) MT/MONTH MT/ANNUM

1 Abacavir Sulfate

ANTI-RETROVIRAL

2.00 24.00 2 Dolutegravir Sodium 2.00 24.00 3 Tenofovir Disoproxil Fumarate 11.67 140.00 4 Tenofovir Alafenamide

Fumarate 1.00 12.00

5 Emtricitabine 0.42 5.00 6 Oseltamivir Phosphate

ANTI-VIRAL 0.50 6.00

7 Valacyclovir Hydrochloride 0.25 3.00

8 Deferasirox CHELATING AGENT 0.50 6.00 9 Exemestane ANTI-NEOPLASTIC 0.03 0.35 10 Dapagliflozin

ANTI-DIBETIC 0.04 0.50

11 Sitagliptine Phosphate 0.04 0.50 12 Empagliflozin 0.04 0.50 13 Levonorgestrel CONTRASEPTIVE 0.00042 0.005 14 Danazol ANTI-

GONADOTROTIN 0.17 2.00

15 Ondesetron Base/HCL ANTI-EMETIC 0.25 3.00 16 Bictegravir INTEGRASE-

INHIBITOR 0.02 0.25

17 Eluxadoline ANTI-SPASMODICS 0.02 0.25 18 Formaterol Fumarate BRONCHODILATOR 0.25 3.00 19 Pramiprexole Dihydrochloride ANTI-

PARKINSONIAN 0.25 3.00

20 R & d Product - 0.20 2.40 Total 19.65 235.76

Total: 11 (Existing) + 20 (Expansion) = 31Nos. of products Note: From above mentioned product list, only 14 products shall be manufactured daily, as per requirement.

ANNEXURE II

(Plot Layout)

ANNEXURE III

(Registration Certificate)

ANNEXURE IV

(MIDC Plot Letter & Change

in Name Certificate)

ANNEXURE V

(Consent to Operate Copy

& Previous EC Letter)

ANNEXURE VI

(Manufacturing Process)

ANNEXURE VII

(Details of Solid Wastes)

Details of Solid Waste generation

Sr. No.

Description Quantity

Disposal Facility EXISTING EXPANSION TOTAL

1. Plastic, Glass, Ferrous, Wooden, Metal Scrap

132.0 MT/Year

18.0 MT/Year

150.0 MT/Year

Sold to Authorized Party

2. Battery Waste 2.5 MT/Year

1.5 MT/Year

4.0 MT/Year

3. E-Waste 2.0 MT/Year

1.0 MT/Year

3.0 MT/Year

4. Discarded containers, drums, carboys etc.

1200 Nos./Year

1000 Nos./Year

2200 Nos./Year

ANNEXURE VIII

(ETP Process Flow Diagram)

CiplaCapacity 150 m3/day Kurkumbh

38 m3/day Unit - III

150 m3/d

Recycle

Condensate

FLOW DIAGRAM OF ETP

(Annexure ENV-L09/A1)

API PLANTS

112 m3/day

Neut.tank

2m3

Pri. Clarifier

24m3

Flash mixer

1m3

Eq.Tank

100 m3 x 3 Nos

Bio-I/ Anoxic

576m3

Anoxic tank-1

100m3

DMF

7 m3/hr

Anoxic tank-II

100m3

Reaction Clarifier

24 m3

Sec. Clarifier-

24m3

BioReactor-

II

576m3

UF plant 150 m3/day

Strippercolumn

1 m3/hr

VTFD

165 l/h & 500 l/h

M.E.E

1 m3/hr

Stream E1

Stream E2

Reject

Decanter5m3/hr Sludge for Dewatering

CentrateDewateredSludgeDisposal to CHW-TSDF

Sec. Clarifier- I

24 m3

Sludge for Recirculation

Eq. Tank

50m3x220m3x1

RO Plant (150 m3/day X 2 Nos)

Domestic Effluent

Solid disposal to CHW-TSDF

Spent Solvents to Authorised Party

Treated Effluent Tank

190 m3ROPermeate for Utility

Cipla Unit – III, Effluent Treatment Process Segregation Philosophy:

I) E1 Stream (Weak Stream): COD below 10000 mg/l and TDS below 3000 mg/l.

II) E2 Stream (Strong Stream): COD greater than 10000 mg/l & TDS greater than 3000 mg/l.

I) E1 Treatment Process:- Primary Treatment: It is nothing but removal of floatable, suspended and colloidal particles as well as neutralization and equalization of incoming effluent, so as to feed the homogenized quality effluent to the secondary treatment. The clean effluent without floating matter is than enters in Receiving tank. Neutralization tank the pH of the effluent is maintained in between 7.5 to 8.5 with the help of acid or alkali solution. Equalization tank is homogeneous mixing of effluent. This tank is having Equalization process is helpful for absorbing fluctuation in organic and inorganic effluent load. The equalised effluent is pumped in flash mixer where with the help of dosing system optimum dose of coagulating and flocculating agent solution from chemical dosing tank and is added for the removal of colloidal and suspended impurities. Domestic waste water addition: The domestic waste water is added in equalization tank by pumping through Domestic effluent collection tank. Effluents with high-density flocks are transferred to Primary Clarifier (PC) / Clariflocculator for gravity settling. In PC / Clariflocculator high-density sludge is settled at the bottom. This sludge is called as chemical sludge. This sludge is then removed and transferred to the Decanter / SDB by pumping. The cleared effluent from Decanter / SDB is passed in to Equalization tank. Secondary Treatment: This includes Anaerobic and Aerobic treatment. The Aerobic treatment is Activated Sludge Process. The diffused aeration is provided from bottom of tank to maintain dissolved oxygen. Air source is taken from air blower. The Aerobic type of bacteria is present in the Bioreactor and we maintain the MLSS to absorb shock load of further treatment. If efficiency goes down / shock load observed then doses are increased. Here the oxidation of dissolved organic matter takes place with the help of the aerobic bacteria. Carbon Di-Oxide is evolved from the system as a by-product. Disc type of diffuser is provided for fine aerations. Bio Clarifier-I / Secondary Clarifier-I (SC-I): The effluent carried over from Bioreactor-I is containing microorganisms, this biological sludge is then settled at the bottom of the clarifier tank and recirculated to Bioreactor-I to maintain the MLSS. (If the percentage of bacteria will increase with respect to F:M ratio then this biological sludge

is dewatered through Decanter / SDB. The clear overflow from Bio Clarifier-I pumped to Bioreactor-II. Bio Clarifier-II / Secondary Clarifier-II (SC-II): The effluent carried over from Bioreactor-II is containing microorganisms, this biological sludge is then settled at the bottom of the clarifier tank and recirculated to Bioreactor-II to maintain the MLSS. Overflow goes to the Reactivator Clarifier. Reactivator Clarifier (RC): The coagulating and flocculating agent solution dosing is given to inlet of chemical dosing tank and the suspended solids and coagulated flocks are settled at the bottom of the tank. This sludge is dewatered through Decanter / SDB. The clear treated effluent is then overflowed to polishing tank for further treatment. Polishing Tank: This tank is used as aneffluent collection tank for back washing of PSF, ACF and decanter / SDB filtrate. This effluent is transfer to Main Equalisation tank for further treatment. Tertiary Treatment: The treated effluent from RC is passed through PSF (Pressure Sand Filter) for the removal of suspended and colloidal impurities. PSF back wash is send to Polishing tank. The treated effluent then send to Ultra Filtration (UF) followed by Reverse Osmosis (RO) Plant. The final treated RO Permeate goes to final Permeate storage tank and RO Reject go to Evaporator (MEE & VTFD). Permeate is send to Utility and Boiler. Sludge Handling: The chemical sludge generated from PC / Clariflocculator, SC-I, SC-II and RC are drained into sludge thickener and pumped to Decanter / SDB. The Decanted sludge is further dried in New Poly-House. The dried sludge is send to CHWTSDF for disposal. II) E2 Treatment Process:- This effluent is treated through MEE and VTFD. The generated solid from VTFD is send to CHWTSDF for final disposal and condensate is treated through E1 Stream treatment. Mode of Disposal:

1) Treated Effluent: 100% recycling for utilities (Boiler & Cooling tower) 2) Decanted sludge from E1 Stream: Send to CHWTSDF for disposal 3) MEE sludge from E2 Stream: Send to CHWTSDF for disposal.

ANNEXURE IX

(Details of Hazardous Wastes)

DETAILS OF HAZARDOUS WASTE

Sr. No. DESCRIPTION

QUANTITY MODE OF DISPOSAL EXISTING EXPANSION TOTAL

1. Cat.:- 5.1 Used/Spent Oil

300 lit/Month

100 lit/Month

400 lit/Month Sale to

authorized party 2.

Cat.:- 28.6 Spent Solvents

125 Klit/Month

275 Klit/Month

400 Klit/Month

3.

Cat.:- 28.3 Spent Catalyst/ Spent Carbon

7.5 MT/Month

0.0 MT/Month

7.5 MT/Month

Sale to authorized

party/ CHWTSDF

4.

Cat.:- 28.5Date expired, discarded & off-specification drugs/medicines/chemicals

50 kg/Month

50 kg/Month

100 kg/Month CHWTSDF

5. Cat.:- 28.1Spent Mother Liquor 600 m3

/Month 300 m3

/Month 900

m3 /Month

Final residue to

CHWTSDF

6. Cat.:- 28.6Spent Organic Solvents 25

Klit/Month 05 Klit/Month

30 Klit/Month

Sale to authorized

party

7. Cat.:- 33.1Discarded container, barrels/liners used for hazardous waste/chemicals

100 Nos./Month

100 Nos./Month

200 Nos./Month

Sale to authorized

Party

8. Cat.:- 35.3Chemical sludge, Oil & Grease skimming residues from Industrial effluent

5.25 MT/Month

4.0 MT/Month

9.25 MT/Month CHWTSDF

9. Cat.:- 37.1 Sludge from wet scrubber

15 kg/Month

05 kg/Month

20 kg/Month CHWTSDF

10. Cat.:- 35.4Sludge from MEE system

45 MT/Month

25 MT/Month

70 MT/Month CHWTSDF

ANNEXURE X

(CHWTSDF Membership Certificate)

ANNEXURE XI

(WATER BUDGET)

Cipla Ltd., Unit-III, Plot No. D-22, Kurkumbh MIDC, Tal.: Daund, Dist.: Pune.

WATER BUDGET FOR UNIT III

Sr.No.

Description

Existing

Total after Expansion

1 Domestic 35.00 (#30.00+*05.00)

40.00 (#25.00+*15.00)

2 Industrial 2A Process #25.00 #30.00 2B Lab & Washing 17.00

(#5.00+*12.00) 25.00

(#5.00+*20.00) 2C Cooling 55.00

(#10.00+*45.00) 70.00

(#10.00+*60.00) 2D Boiler Feed 23.00

(#15.00+*8.00) 30.00

(#15.00+*15.00) 2E DM Plant #8.00 #10.00 2F Scrubber *2.00 *3.00 2G Utility (ETP) *12.00 *15.00 2H Softner #3.00 #5.00

Industrial Total

145.00 (#66.00+*79.00)

188.00 (#75.00+*113.00)

3 Gardening #20.00

#30.00 4 GRAND TOTAL 200.00

(#116.00+*84.00) 258.00

(#130.00+*128.00) Note- # Fresh water from MIDC water supply Scheme.

* Recycled water.

Cipla Ltd., Unit-III, Plot No. D-22, Kurkumbh MIDC, Tal.: Daund, Dist.: Pune.

EFFLUENT GENERATION FOR UNIT III

Sr.No.

Description

Existing

Total after Expansion

1 Domestic 38.00 38.00 2 Industrial

2a Process 27.00 70.00 2b Lab & Washing 10.00 15.00 2c Cooling 5.00 5.00 2d Boiler Feed 2.50 3.00 2e DM Plant 5.00 5.00 2f Scrubber 2.00 3.00 2g Softner 1.00 1.50

Industrial Total 52.50 102.50 3 Total of Domestic+Industrial 90.50 140.50