(a themis medicare ltd.,) plot no. phase i, ida,jeedimetla...

M/s. ARTEMIS BIO‐TECH LTD., (A Division of Themis Medicare Ltd.,)

PLOT NO. 1 & 5, Phase I, IDA,JEEDIMETLA VILLAGE, QUTUBULLAPUR MANDAL, RANGAREDDY DISTRICT,

ANDHRA PRADESH

FORM I

Project No. 1113‐21‐01 November 2013

Artemis Bio‐tech Ltd., Plot No. 1 & 5, Phase I, IDA, Jeedimetla, Rangareddy‐500 054. Phone: 040‐23095293/94 Fax: 040‐23095077 E‐mail: [email protected] [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 AND FORESTS,

GOVERNMENT OF INDIA PARYAVARAN BHAVAN, LODHI ROAD, NEW DELHI

Artemis Bio‐tech Ltd., (A Division of Themis Meidcare Ltd.,) Form I

Team Labs and Consultants Page 1

APPENDIX – I (See Paragraph – 6)

FORM I I) Basic Information S.No Item Details

1 Name of the Project/s Artemis Bio‐tech Ltd., 2 S. No in the Schedule 5 f – A category3 Proposed capacity/area/length/tonnage to

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

Area Existing: 4.06 Acres (Expansion within existing land area) Proposed Capacity after Expansion: 15.2TPM (506.6 Kg/day)

4 New/Expansion/Modernization Expansion5 Existing Capacity/Area etc. Existing Capacity: 1.18 TPM

Area Existing: 4.06 Acres 6 Category of Project i.e 'A' or 'B' “A”7 Does it attract the general condition? If yes,

please specify Yes.The Unit is Located in Notified Industrial Estate / Area. Critically Polluted Area of Pattancheru and Bollaram are located at a distance of 8.85 KM’s from the Site.

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

No

9 Location Artemis Bio‐tech Ltd., Plot/Survey/Khasra No. Plot No: 1 & 5 Village Phase – I, IDA, Jeedimetla Village Tehsil Qutubullapur Mandal District Rangareddy District State Andhra Pradesh.10 Nearest railway station/airport along with

distance in kms. Bollaram (S.C Railways) – 7.5 Km – NE.

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

Secunderabad – 12.5 Km

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

Plot No:1 & 5,Phase ‐ I, IDA, Jeedimetla Village, Qutubullapur Mandal, Rangareddy District, Andhra Pradesh Tel. No : 040‐23095293/94

13 Name of the Applicant Artemis Bio‐tech Ltd., 14 Registered Address M/s. Artemis Bio‐tech Ltd.,

Plot No:1 & 5, Phase – I, IDA, Jeedimetla Village, Qutubullapur Mandal, Rangareddy District – 500 054. Tel. No : 040‐23095293/94 Fax: 040‐23095077



15 Address for Correspondence: Name Mr. T. Damodhar Reddy Designation(Owner/Partner/CEO) Vice‐President Address M/s. Artemis Bio‐tech Ltd.,

Plot No:1 & 5, Phase – I, IDA, Jeedimetla Village, Qutubullapur Mandal , Rangareddy District

Pin Code 500 054 E‐mail Email: [email protected]

[email protected] Telephone Number Tel. No : 040‐23095293/94

Mobile: +91 9391306277 Fax No. Fax: 040‐2309507716 Details of alternative Sites examined, if any.

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

‐ NA‐

17 Interlinked Projects ‐NA‐18 Whether separate application of interlinked

project has been submitted? ‐No ‐

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) No24 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



(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 manufacturing capacity in the existing API manufacturing unit.

1.2 Clearance of existing land, vegetation and buildings?

NO Proposed expansion in existing plant area.

1.3 Creation of new land uses? NO Existing land use – Industrial. 1.4 Pre‐construction investigations e.g.

bore houses, soil testing? NO Existing unit.

1.5 Construction works?

YES Construction activity involves creation of additional utilities like Boiler, Chilling Plant etc. There is no addition of production blocks.

1.6 Demolition works? NO1.7 Temporary sites used for

construction works or housing of construction workers?

NO The 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

1.10 Reclamation works? NO1.11 Dredging? NO1.12 Offshore structures? NO1.13 Production and manufacturing

processes? YES Enclosed in Annexure – I

1.14 Facilities for storage of goods or materials?

YES Common facility for storage of raw materials and solvents will be used.

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

YES Annexure II.

1.16 Facilities for long term housing of operational workers?

NO

1.17 New road, rail or sea traffic during construction or operation?

NO

1.18 New road, rail, air waterborne or other transport infrastructure

NO



including new or altered routes and stations, ports, airports etc?

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? NO1.23 Abstraction or transfers of water

from ground or surface waters? NO

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?

NO

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 expansion shall increase the employment potential.

1.29 Introduction of alien species? NO1.30 Loss of native species or genetic

diversity? NO Proposed expansion in existing plant area.

1.31 Any other actions? NO



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)

NO Existing Unit

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

YES 103 KLD (fresh: 68 KLD + Recycle: 35 KLD)Supplying through road Tankers. (Water Balance Enclosed in Annexure III)

2.3 Minerals (MT) NA2.4 Construction material – stone,

aggregates, sand / soil (expected source – MT)

NO

2.5 Forests and timber (source – MT) NO2.6 Energy including electricity and

fuels (source, competing users) Unit: fuel (MT), energy (MW)

YES The required energy shall be drawn from APTRANSCO. The power shall be drawn from existing DG sets during load shut downs. Backup DG sets of 2 x 500 KVA existing and proposed 1000 KVA shall be provided to cater to energy requirement during load shut downs. The other energy source is proposed Coal Fired Boiler of capacity 2.5 TPH along with existing coal fired boilers of capacity 2 x 2.5 TPH. The required quantity of coal is 27 TPD.

2.7 Any other natural resources (use appropriate standard units)

NO



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 Active Pharmaceutical Ingredients (APIs/Bulk Drugs). Specific measures shall be taken for the storage of hazardous chemicals and solvent shall be stored 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)


4.1 Spoil, overburden or mine wastes NO4.2 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 10 kg/day

4.3 Hazardous wastes (as per Hazardous Waste Management Rules)

YES The quantity of hazardous wastes generated during operation contain salts from evaporators, process residue, and solvent residues, ETP sludge and filtration media etc. Details are enclosed at Annexure IV

4.4 Other industrial process wastes YES Annexure IV4.5 Surplus product NO4.6 Sewage sludge or other sludge from

effluent treatment YES 140 Kg/day sludge generated from

biological effluent treatment plant will



be sent to TSDF. 4.7 Construction or demolition wastes YES Construction activity involves creation

of additional utilities like Boiler, Chilling Plant etc. There is no addition of production blocks.

4.8 Redundant machinery or equipment NO4.9 Contaminated soils or other materials NO4.10 Agricultural wastes NO4.11 Other solid wastes NO Used Batteries 10 No/year

5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr)


5.1 Emissions from combustion of fossil fuels from stationary or mobile sources

YES Coal is used as fuel. Quantity of fuel and emissions details are enclosed in Annexure V

5.2 Emissions from production processes YES Details are enclosed at Annexure VI5.3 Emissions from materials handling

including storage or transport NO Material transfer takes place in closed

pipeline systems. 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

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.

5.6 Emissions from incineration of waste NO5.7 Emissions from burning of waste in open

air (e.g. slash materials, construction debris)

NO

5.8 Emissions from any other sources NO



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 From DG sets, and 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. The nearest residential area is 0.5 km away from the site, hence no significant impact is anticipated.

6.4 From blasting or piling NO6.5 From construction or operational

traffic NO The increased vehicle movement shall not

have any significant impact. 6.6 From lighting or cooling systems NO6.7 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:


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 the hazardous materials is stored on elevated plat form and stored in a closed storage tanks/containers (Liner/MS/GI/HDPE) in a covered shed and no contamination of soil is expected.

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

NO All the wastes from domestic operations are sent to septic tank followed by soak pit.

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, Dust Collectors etc.

7.4 From any other sources NO7.5 Is there a risk of long term build up

of pollutants in environment from these sources?

NO



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


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 NA8.3 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. There are no major support industries required for this plant.

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.



(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

NO Dulapalle RF – 1.5 Km – N Gajularamaram RF – 3.5 Km – NW Borampet RF – 6.8 Km – NW Suraram RF – 6.2 Km – NW Pochampalli RF – 7.5 Km – N Gaudavalli RF – 8 Km – N Kotta Cheruvu – 2 Km – NE Amb Cheruvu ‐ 6 KM – W Hussain Sagar – 9.7 Km ‐S

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

NO

5 State, National boundaries NO6 Routes or facilities used by the public

for access to recreation or other tourist, pilgrim areas

NO

7 Defense installations NO8 Densely populated or built‐up area YES Chintal Village with population of

3000 and Jeedimetla Village with population of 2500.

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

NA Place of worship and school at 1.0 Km distance from site.

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 Patancheru and Bollaram Industrial areas at a distance of 8.85Km.

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



(IV) Proposed Terms of Reference for EIA studies Scope of Work of EIA

“...The EIA shall cover the following:Description of the proposed project: The first task:” Description of the proposed project” forms a vital component of the Environmental Impact Assessment (EIA) as it provides the basis for evaluating the likely causes of Environmental Impacts.

Existing Environment and Baseline Conditions: The baseline assessment will be carried out to identify potentially sensitive and critical areas that may be affected by the project in an area of 10 km surrounding the project location. The critical and sensitive targets shall be plotted on land use map of project impact area. The existing environment and baseline conditions should be established from:‐ Analysis of existing information published and secondary data. ‐Consultation with relevant statutory authorities, and Field visits for supplementation of missing gaps.

The key subject areas which the EIA shall address include Ecology and Nature conservation, Air quality, surface and water quality in project impact area, soil quality, cultural heritage, landscape, land use, noise quality, etc. Natural habitats like national parks, wildlife reserves, sanctuaries, sacred grove, protected areas, forests, wetlands, major rivers and waterways if any, shall also be identified and marked.

Assessment of Environmental Impacts: Based upon the results from the review of existing information, field visits, site data collection and consultation, for each component of environment (physical, biological and socio economic) the positive, negative, direct and indirect, temporary and permanent impacts will be evaluated along with an indication of the degree of impact, i.e., whether the impact is significant, moderate, minor or negligible. The degree of impact shall also be quantified by using state of the art air quality impact prediction models based on ISCST3 algorithms.

Environment Management Plan And Mitigation Plan: For each significant negative impact identified, specialist shall work closely with the engineering team/technical consultants to suggest practicable measures to avoid or mitigate the impact. The mitigation of environmental impacts will be by three mechanisms. =>Introduction of mitigation features through the engineering practices. =>Implementation of environmental controls during construction and operation. =>Legislative control involving compliance with Indian environmental laws. The Environmental management plan shall include an estimate of capital and recurring costs of mitigation measures and will identify the institutional framework for implementation.

Monitoring Plan: Having identified the significant environmental impact that is likely to arise as a result of the project, the project team shall specify what monitoring is required during the various phases of the project cycle. The monitoring plan will identify parameters and frequency of monitoring and responsible organization.



I hereby give the undertaking that data and information given in the application and enclosures are true to the best of my knowledge and belief and I am aware that if any part of the data and information submitted is found to be false or misleading at any stage, the project will be rejected and clearance given, if any to the project will be revoked at our risk and cost.

Date:

Place: Jeedimetla

Signature of the applicant With Name and Full Address

(Project Proponent/Authorized Signatory)

T. Damodhar Reddy Vice‐President

M/s. Artemis Bio‐tech Ltd., (A Division of Themis Medicare Ltd.,)

Plot No: 1 & 5, Phase – I, IDA, Jeedimetla Village, Qutubullapur Mandal ,

Ranga Reddy District, Andhra Pradesh. Pin: 500054



ANDHRA PRADESH

ANNEXURES

SUBMITTED TO MINISTRY OF ENVIRONMENT AND FORESTS,

GOVERNMENT OF INDIA PARYAVARAN BHAVAN, LODHI ROAD, NEW DELHI

Artemis Bio‐tech Ltd., (A Division of Themis Meidcare Ltd.,) Form I Annexures

Page1

Loca

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Page2

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Page3

ANNEXURE - I

M/s. Artemis Bio-tech Ltd., (A Division of Themis MedicareLtd.,) obtained consent for

establishment and operation for manufacturing of API’s at vide order no.

APPCB/HYD/JDM/10004/HO/CFO/2013-2812 dated 08.08.2013, at Plot No. 1 & 5,

Phase – I, IDA, Jeedimetla Village, Qutubullapur Mandal, Rangareddy District, Andhra

Pradesh. It is proposed to expand the manufacturing capacity to meet the increasing

market demands. The expansion entails a capital cost of Rs. 1.5 Cores towards

modernization of zero liquid discharge facility, debottlenecking by way of incorporating

the advanced technology and state of the art equipment. The proposed expansion does

not involve any additional civil construction for manufacturing blocks except utility and

pollution control related works. The existing and proposed manufacturing capacity

presented in Table A-1.

Table A-1 Manufacturing Capacity – Permitted & After Expansion

S.No Name of the Product Capacity Permitted* After Expansion**

Kg/Day TPM Kg/Day TPM 1 Dimethyl Chloro Tetra Cycline 28 0.84 -- -- 2 Simvastatin 3.33 0.1 333.3 10 3 Fumagillin DCH Salt 1.33 0.04 6.7 0.2 4 Lovastatin VSP 6.67 0.2 166.7 5

Total 39.33 1.18 506.67 15 * Only one product will be manufactured at any point of time on campaign basis ** All three products will be manufactured.


Page4

Process Description of Simvastatin

Reaction Scheme: Stage I:

+Hydrogen Iodide

HIMol.Wt. 127.91

CH3

OO

BO

ONH

CH3H3C

O

CH3

H

Lovastatin Boronate (LVB) IntermediateC36H52BNO5,

M.ol Wt: 588.61

Methyl IodideCH3I

Mol.Wt. 141.94

Stage I

+ + Sodium HydroxideNaOH

Mol.Wt. 40

+ WaterH2O

Mol.Wt. 18

+ Methyl AlcoholCh3OH

Mol.Wt. 32

Simvastatin Ammonium SaltC29H48NO5M.ol Wt: 453.6

O

O

O

HO

OH

+O NH4

Stage II:

Simvastatin Ammonium SaltC29H48NO5

M.ol Wt: 453.6

O

O

O

HO

OH

+O NH 4

+ AcetonitrileCH3CN

Mol.Wt. 41.05

+ Hydrochloric AcidHCl

Mol.Wt. 36.5

+ ButylatedHydroxy toluene

C15H24OMol.Wt. 220.4

CH3

H3C

H3C

O

O

O

O

HO

HCH3 CH3

Simvastatin TechC25H38O5

M.ol Wt: 418.6OHO

Stage V

Stage III:

M.ol Wt: 453.6

C H 3

H 3 C

H 3 C

O

O

O

O

H O

H C H 3 C H 3

Simvastatin TechC25H38O5

M.ol Wt: 418.6

Methanol, Ac. Carbon

BHT and Water

C H 3 C H 3

H 3 C

H 3 CH 3 C

O

O

O

O

H O

H

SimvastatinC25H38O5

M.ol Wt: 418.6

Stage VI


Page5

Process Description:

Stage-1

Charge THF, Pyrrolidine in to the reactor and cool to -500C and add n-butyl lithium at -45 to

550C in nitrogen atmosphere and maintain for 2 hours. Charge Lova boronate in to the THF

in another reactor. Cool to -10 to -150C by liquid nitrogen and maintain for 30 minutes.

Transfer the reaction mass in to complex solution reactor at -38 to -400C.

Methylation: Add 90 kgs Methyl iodide at -40 to -250C in 3-4 lots by applying liquid

nitrogen then check the Lovaboronate content by HPCL, it should not more then 1.0% and

maintain the reaction mass at -20 to -250C for 1 hour. Followed by quenching the reaction

mass in THF +n-Hexane, process water into organic layer and separate the aqueous layer.

Transfer organic layer for concentration.

(Concentration) collect the organic layers in to reactor heat and Concentrate the reaction

mass under vacuum at 35-400C till get the mass volume 200-250lts for 6-8 hours.

(De-Boronation): Charge elute the material with methanol in to concentration reaction mass

and pass through resin column for 30 min and collect the elution. Check the elution for

simva boronate content by TLC, it should be absent. Then receive the organic layer from

receiver distillate at 35-400C under vacuum and concentrate to get the mass volume 500-

550lts. Transfer for Hydrolysis.

(Hydrolysis): Prepare the sodium hydroxide solution (sodium hydroxide + process water)

and charge distilled methanol followed by concentrated mass, heat the mass to reflux at 70-

750C for 8 hours. Check the simva amide content, it should NMT 1.0%.,Cool the mass to 35-

400C.Transfer the reaction mass for final concentration. Heat the mass to 40-500C and distill

the methanol under vacuum at 40-500C till turbidity appears. Charge water in to the

reaction mass, cool to 300C.transfer the mass for extraction, cool to 100C and adjust the mass

pH 5.0-5.5 by using 1.9-2.1N HCl. Charge ethyl acetate in to the reaction mass and charge

and adjust the mass pH 3.5 to 4.0 with HCL at 10-150C. Charge sodium chloride in to the

reaction mass separate the organic layer and extract the aqueous layer with ethyl acetate

and sodium chloride followed by organic layer separation.


Page6

Receive the complete organic layer and cool to 200C and 1st lot of ammonia + methanol (1:1)

quantity at 20-230C in 1 hour and stir the mass at temperature 20-230C for 1 hour. Add 2nd

lot of ammonia + methanol (1:1) quantity in 60 minutes and check the pH should be 9.5 to

9.8 and stir for one hour. Cool the mass 0-50C and centrifuge the mass followed by ethyl

acetate washing and dry the material in RVD at 40-450C and unload the material in double

lined polyethylene bags in HPDE container.

Stage-2 & 3

Charge Simvastatin ammonium salt in to Acetonitrile 414L., BHT (0.285 Kg) charged and

cool the reaction mass temperature to -10 to -120C then add 3.9N – 401N HCL solution in

three lots after completion of the addition, maintain the reaction mass for 2 hours at -10 to -

120C.entrifuged the material and wash with solution mixture (Methanol + purified water +

ammonium solution) after spin drying the material. Wash with purified water till getting

the mother liquid pH 4.5 to 7.0 then spin dry the material. Unload the material.

Purification:

Charge the above obtained wet material and BHT (0.150 Kg.) in to methanol and raise the

temperature up to 480C to dissolve the material in methanol followed by carbon treatment

and filtration through leaf, pressure and micron filter to another reactor in clean room. Cool

the filterate to 28-300C and charge the purified water in to filtrate to precipitate the mass and

cool to 50C and maintain the reaction mass ay 5-80C for 90-120 minutes and followed by

centrifugation of the mass.

Wash the wet cake with 1:1 mixure of methanol and purified water followed by n-hexane

washing. Spin dry. Then dry the material at 45-500C followed by milling and sifting

operation and unload in to the double polyethylene bags and purge with nitrogen, placed in

HDPE container.


Page7

Rec. n-HexaneRec. Toluene

LovastatinToluene

CyclohexylaminePBA

Carbonn-Hexane Residue

Rec. THFRec. MeOHRec. Ethy;l Acetate

Tetra Hydro FuranPyrolidine

Methyl Iodiden-Butyl lithium

Methanolhydrochloric acid(32%)

Ethyl AcetateSodium HydroxideHydroden peroxide

sodium chlorideAmmonia solution

Water Effluent to Treatement SystemResidue

Rec. AcetonitrileRec. n-Hexane

AcetonitrileHydrochloric acid(32%)

Ammonia Solution(18%) Effluent to Treatement Systemn-Hexane Residue

WaterRec. MeOHRec. n-Hexane

MethanolCarbon

n-hexane Effluent to Treatement SystemWater Residue

Solvent Recovery

Simvastatin

Solvent Recovery

Stage - I

Stage - II

Solvent Recovery

Stage - III

Solvent Recovery

Stage - IV

Process Flow Diagram of Simvastatin


Page8

Table A-2 Material Balance for Simvastatin Stage I Input Quantity

(Kg/day) Output Quantity

(Kg/day) Stage I 560.6 Simva Ammonia Salt 390.9 Tetra Hydro Furan 1500 Solvent: Pyrolidine 150 Tetra Hydro Furan Recovery 1467 Methyl Iodide 150 Tetra hydro furan loss 33 n-Butyl lithium 190 Methanol recovery 1960 Methanol 2000 Methanol Loss 40 hydrochloric acid(32%) 100 Ethyl Acetate Recovery 1548.8 Ethyl Acetate 1600 Ethyl Acetate Loss 51.2 Sodium Hydroxide 120 Methyl Iodide Recovery as ML 650 Hydroden peroxide 200 Liquid Waste: sodium chloride 60 High TDS Effluent 2849.3 Ammonia solution 26 Organic Residue: 36.4 Water 2370 Total Input 9026.6 Total Output 9026.6 Stage II Input Quantity


(Kg/day) Simava Ammonia Salt 390.9 Crude 345.42 Acetonitrile 1000 Solvent: Hydrochloric acid(32%) 500 Acitonitrile Recovery 980 Ammonia Solution(18%) 10 Acitonitrile Loss 20.0 n-Hexane 200 n-Hexane Recovery 194 Water 2400 n-Hexane Loss 6 Low TDS 2940.3 Organic Residue: 15.15 Total Input 4500.9 Total Output 4500.9 Stage III Input Quantity


(Kg/day) Crude 345.4 Pharma 333.3 Methanol 2000 Solvent: Carbon 20 Methanol Recovery 1972 n-hexane 200 Methanol Loss 28 Water 2000 n-Hexane Recovery 194 n-hexane Loss 6.0 Liquid Waste Low TDS Effluent 2012 Solid Waste: Spent carbon 20 Total Input 4565.4 Total Output 4565.3


Page9

ANNEXURE – II: Wastewater Treatment Facilities

The effluent generated is mainly from process, washings, and scrubbers, cooling towers &

boiler blow downs and domestic effluent. Total Effluent generated permitted and

proposed and mode of treatment is presented in Table A-3 and A-4 respectively.

Table A-3 Quantity of Effluent Generated - Permitted

Description Quantity (KLD)

Mode of Treatment

HTDS Effluents Process & Wash Effluents 3 Sent to Stripper, MEE and ATFD.

Salts from ATFD sent to TSDF. Condensate from MEE and ATFD sent to RO along with LTDS effluents.

Total HTDS Effluents 3 LTDS Effluents

Process & Washings 14.5 Sent to RO Plant. Permeate reused for cooling towers/boilers. Rejects sent to MEE.

DM Wash Water 2.5 Cooling & Boiler Blow Downs 3

Total LTDS Effluents 20 Domestic Effluents 5 Sent to Septic tank followed by Soak

Pit.

Table A-4 Quantity of Effluent Generated – After Expansion (Tentative)

Description Quantity (KLD)

Mode of Treatment

Process 18.5 Treated in effluent treatment plant consisting of Stripper, MEE, ATFD, Biological treatment and RO. RO permeate reused for cooling tower makeup. RO rejects sent to MEE.

Washings 5 Scrubber Effluent 2

Boiler Blow downs 3 Sent to Biological Treatment System along with MEE and ATFD condensate followed by RO. RO permeate reused for cooling tower makeup. RO rejects sent to MEE.

Cooling Tower Blow downs 8 Domestic 5

Total 41.5


Page10

ANNEXURE – III: Water Balance

The total water requirement after proposed expansion shall be 103 KLD out of which 68

KLD shall met from tankers and balance shall be recycled water. The water balance for

daily consumption before and after expansion is presented in Table A-5 & A-6.

Table A-5 Total Water Balance – Permitted

Description Input (KLD)

Description Output (KLD)

Process & Washings 25 Process Effluent 17.5 Loss 8

DM Water 2.5 DM Water Effluents 2.5 Boiler & Cooling Towers Make-up

27.5 Blow down 3 Loss 24.5

Domestic 5 Domestic Effluent 5 Green belt 2 Gardening - Loss 2 Total 62 Total 62

Table A-5 Total Water Balance – After Expansion (Tentative)

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

Process 18 18.5 Washings 5 5 Scrubber 2 2 Boiler Feed 30 27 3 Cooling Tower 5 35 32 8 Domestic 6 1 5 Gardening 2 2 Gross Total 68 35 62 41.5* Total 103 103.5

*Industry proposed to treat entire effluents and recycle in the unit itself and not disposing outside.


Page11

ANNEXURE – IV: Solid Waste Generation and Mode of Disposal

Solid Waste Details – Permitted S.No Description Units Quantity Mode of Treatment/Disposal

1 Process Residues (Mycellia) TPM 10 Sent to TSDF, Dundigal, Rangareddy District for incineration.

2 Spent Carbon TPM 0.5 3 ETP Sludge TPM 1.5 4 Distilled Bottom residue Lts/Month 450 5 Mixed Spent Solvents KL/Month 3.5

Solid Waste Details – After Expansion (Tentative) S.No Description Units Quantity

After Expansion

Mode of Treatment/Disposal

1 Ash from Boiler TPD 12 Sold to Brick manufactures 2 Solvent residue TPD 0.12 Sent to TDSF/Cement Plants for Co-

incineration 3 Process Organic

residue TPD 0.18 Sent to TDSF/Cement Plants for Co-

incineration 5 Filter Aid TPD 0.24 Recovered within the plant premises

and resued. 6 Spent Carbon Kg/day 30 Sent to TDSF/Cement Plants for Co-

incineration 7 Spent Solvents KLD 10 Recovered within the plant premises. 8 Mixed Solvents KLD 4.2 Sent to authorized recovery

units/Cement plants for co-incineration 9 Stripper Distillate KLD 0.3 Sent to Cement Industries for Co-

incineration. 10 Evaporation salts TPD 0.4 Sent to TSDF 11 ETP Sludge TPD 0.14 Sent to TSDF 12 Detoxified containers No.s/Yr 70 Sold to authorized vendors 13 Waste oil LPM 50 Sent to Authorized Recyclers 14 Used batteries No.s/Yr 10 Sent to Authorized Recyclers


Page12

ANNEXURE – V: Air Pollution Details

The sources of air pollution from the plant are from proposed 2.5 TPH coal fired boiler

and existing 2 x 2.5 TPH coal fired Boiler, and DG set of 2 x 500KVA existing and

proposed 1000 KVA capacity. The proposed air pollution control equipment for coal fired

boiler is multi cyclone separators. DG sets shall be provided with effective stack height.

DG sets shall be provided with stack heights based on the CPCB formula for effective

stack height. Carbondioxide shall be released from process and same shall be let out into

atmosphere safely through standard operating procedure.

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)

Polluant Emission Rate (g/sec)

SPM SO2 NOx

Existing 1 2 x 2.5 TPH Coal Fired

Boiler 20 1 180 5 0.7 0.04 0.13

2* 2 x 500 KVA DG Sets 5 0.1 160 8.5 0.06 0.1 0.21 Proposed

1 2.5 TPH Coal Fired Boiler

20 1 180 5 0.7 0.04 0.13

2* 1000 KVA DG Set 7 0.2 170 10 0.09 0.25 0.38 *DG sets will be used during load shut down by APTRANSCO.



ANDHRA PRADESH

STUDIES AND DOCUMENTATION BY TEAM Labs and Consultants QCI: MoE&F OM, List A‐1, S.No.25. (An ISO 9001:2008, ISO 14001:2004 & OHSAS 18001:2007 Certified Organization) B‐115, Annapurna Block, Aditya Enclave Ameerpet, Hyderabad‐500 038. Phone: 040‐23748 555/616, Telefax: 040‐23748666 Email: [email protected]

(a themis medicare ltd.,) plot no. phase i, ida,jeedimetla...

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