SY.NO. 219/1(PART), 219/2(PART) AND 221(PART...

23
LAKSHMI PHARMACHEM SY.NO. 219/1(PART), 219/2(PART) AND 221(PART), RAMANNAPALEM VILLAGE, TIRUVURU MANDAL, KRISHNA DISTRICT, ANDHRA PRADESH FORM I Project No. 0218-21-02 February 2018 M/s. Lakshmi Pharmachem 64-9-5A, Flat No 303, Sree Bhaskara Residency, Chennupati Ramakotaiah Street, Patamata Lanka, Vijayawada, Andhra Pradesh – 520 010 Phone No: +91 98491 72280 E-mail: [email protected] STUDIES AND DOCUMENTATION BY TEAM Labs and Consultants B-115-117 AND 509, Annapurna Block, Aditya Enclave, Ameerpet, Hyderabad-500 038. Phone: 040-23748 555/23748616, Telefax: 040-23748666 SUBMITTED TO MINISTRY OF ENVIRONMENT, FOREST AND CLIMATE CHANGE GOVERNMENT OF INDIA INDIRA PARYAVARAN BHAWAN, JOR BAGH ROAD, NEW DELHI

Transcript of SY.NO. 219/1(PART), 219/2(PART) AND 221(PART...

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LAKSHMI PHARMACHEMSY.NO. 219/1(PART), 219/2(PART) AND 221(PART),

RAMANNAPALEM VILLAGE, TIRUVURU MANDAL, KRISHNA DISTRICT,ANDHRA PRADESH

FORM I

Project No. 0218-21-02February 2018

M/s. Lakshmi Pharmachem64-9-5A, Flat No 303, Sree Bhaskara Residency,Chennupati Ramakotaiah Street, Patamata Lanka,Vijayawada, Andhra Pradesh – 520 010Phone No: +91 98491 72280E-mail: [email protected]

STUDIES AND DOCUMENTATION BYTEAM Labs and ConsultantsB-115-117 AND 509, AnnapurnaBlock,Aditya Enclave, Ameerpet,Hyderabad-500 038.Phone: 040-23748 555/23748616,Telefax: 040-23748666

SUBMITTED TOMINISTRY OF ENVIRONMENT, FOREST AND CLIMATE CHANGE

GOVERNMENT OF INDIAINDIRA PARYAVARAN BHAWAN, JOR BAGH ROAD, NEW DELHI

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APPENDIX – I(See Paragraph – 6)

FORM II) Basic Information

S.No. Item Details1 Name of the Project/s Lakshmi Pharmachem2 S. No in the Schedule 5 (f) – A category - Synthetic Organic Chemicals

(Bulk Drugs and Intermediates)3 Proposed capacity/area/length/tonnage to

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

Production Capacity: 4.75 TPDSite Area: 10 acresCapital Cost: Rs. 25 crores

4 New/Expansion/Modernization New5 Existing Capacity/Area etc. Not Applicable6 Category of Project i.e 'A' or 'B' “A”7 Does it attract the general condition? If yes,

please specifyNA

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

No

9 LocationPlot/Survey/Khasra No. Sy. No. 219/1(Part), 219/2(Part) and 221(Part),Village Ramannapalem VillageTehsil Tirvuru MandalDistrict Krishna DistrictState Andhra Pradesh

10 Nearest railway station/airport along withdistance in km.

Madhira Railway station – 34.8 kmGannavarm airport (Vijayawada) - 61 km

11 Nearest Town, City, District Headquartersalong with distance in kms.

Tiruvuru - 5.2 km

12 Village Panchayats, Zilla Parishad, MunicipalCorporation, Local body (complete postaladdress with telephone nos. to be given)

Kakarla

13 Name of the Applicant N. Rama Krishna14 Registered Address Lakshmi Pharmachem

Sy. No. 219/1(Part), 219/2(Part) and 221(Part),Ramannapalem Village, Tiruvuru Mandal,Krishna District, Andhra Pradesh – 521227.

15 Address for Correspondence:Name N. Rama KrishnaDesignation(Owner/Partner/CEO) ProprietorAddress Lakshmi Pharmachem

64-9-5A, Flat No 303, Sree Bhaskara Residency,Chennupati Ramakotaiah Street, Patamata Lanka,Vijayawada

Pin Code 520 010E-mail [email protected] Number 09849172280Fax No.

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16 Details of alternative Sites examined, if any.Location of these sites should be shown on atopo sheet.

Not Applicable

17 Interlinked Projects Not applicable18 Whether separate application of interlinked

project has been submitted?-NA-

19 If yes, date of submission -NA-20 If no, reason21 Whether the proposal involves

approval/clearance under: if yes, details ofthe 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 GovernmentOrder/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 theproject is propose to be set up?(a) Name of the Court(b) Case No(c) Orders/directions of the Court, if any andits relevance with the proposed project.

No

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(II) Activity

1. Construction, operation or decommissioning of the Project involving actions, which will cause physicalchanges 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 inland use, land cover or topographyincluding increase in intensity ofland use (with respect to local landuse plan)

NO The proposal is a green field project. The total site areaof 10 acres.

1.2 Clearance of existing land,vegetation and buildings?

NO The proposal is a green field project. The total site areaof 10 acres.

1.3 Creation of new land uses? NO1.4 Pre-construction investigations e.g.

bore houses, soil testing?YES Soil test done and soil load bearing capacity

established1.5 Construction works? YES Construction activity involves creation of production

blocks, Utilities, ZLD system.1.6 Demolition works? NO1.7 Temporary sites used for

construction works or housing ofconstruction workers?

NO Construction labor from local villages shall beemployed.

1.8 Above ground buildings, structuresor earthworks including linearstructures, cut and fill or excavations

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

1.9 Underground works including miningor tunneling?

NO No underground works like mining and tunneling.

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 ormaterials?

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

1.15 Facilities for treatment or disposal ofsolid waste or liquid effluents?

YES Effluents are treated in ZLD system.Solid waste is sent to TSDF or authorized recyclers.Details of waste treatment facilities presented inAnnexure II

1.16 Facilities for long term housing ofoperational workers?

NO Operational workers stay in surrounding villages.

1.17 New road, rail or sea traffic duringconstruction or operation?

YES Construction materials shall be transported to the site.The traffic density of the existing connecting road isnegligible.

1.18 New road, rail, air waterborne orother transport infrastructureincluding new or altered routes andstations, ports, airports etc?

NO

1.19 Closure or diversion of existing NO

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transport routes or infrastructureleading to changes in trafficmovements?

1.20 New or diverted transmission lines orpipelines?

NO

1.21 Impoundment, damming, culverting,realignment or other changes to thehydrology of watercourses oraquifers?

NO

1.22 Stream crossings? NO All raw materials, solvents and waste streams arepumped through pipe lines above ground level.

1.23 Abstraction or transfers of waterform ground or surface waters?

YES Total water required shall be met from ground waterusing bore- wells.

Total water required shall be 330 KLD out of which 211KLD shall be drawn from bore well and the balanceshall be recycled water.

1.24 Changes in water bodies or the landsurface affecting drainage or run-off?

NO

1.25 Transport of personnel or materialsfor construction, operation ordecommissioning?

YES The construction material shall be drawn from localsources within 10 km. There is no transport ofpersonnel, as the construction workers shall be drawnfrom local villages.

1.26 Long-term dismantling ordecommissioning or restorationworks?

NO

1.27 Ongoing activity duringdecommissioning which could havean impact on the environment?

NO

1.28 Influx of people to an area in eithertemporarily or permanently?

YES The proposed project shall increase the employmentpotential.

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

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

1.31 Any other actions? NO

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2. Use of Natural resources for construction or operation of the Project (such as land, water, materials orenergy, especially any resources which are non-renewable or in short supply):

S.No. Information/checklistconfirmation

Yes/No Details thereof (with approximate quantities /rates,wherever possible) with source of information data

2.1 Land especially undeveloped oragricultural land (ha)

YES The proposal is a green field project. The total site area of 10acres.

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

YES Total water required shall be met from ground water.

Total water required shall be 330 KLD out of which 211 KLDshall be drawn from bore well and the balance shall berecycled water. (Water Balance Enclosed in Annexure III)

2.3 Minerals (MT) NA2.4 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 andfuels (source, competing users)Unit: fuel (T), energy (MW)

YES The required energy shall be drawn from AP Transco.Standby DG sets of 2 X 1010 kVA and 2 x 500 kVA isproposed. It is proposed to establish 2 X 8 TPH coal firedboilers to meet the steam requirement for process. It isproposed to keep 1 x 8 TPH coal fired boiler as standby.It is proposed to establish coal based Thermic fluid heater ofcapacity 2 x 2 lac K.cal.Coal consumption is 31.8 TPD.

2.7 Any other natural resources(use appropriate standardunits)

NA

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3. Use, storage, transport, handling or production of substances or materials, which could be harmful tohuman 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, whichare hazardous (as per MSIHC rules) tohuman health or the environment(flora, fauna, and water supplies)

YES Hazardous chemicals shall be used for manufacturingof CMC. MSIHC rules shall be followed duringstorage, transportation and handling of rawmaterials. Hazardous chemicals and solvent shall bestored and handled in closed systems.

3.2 Changes in occurrence of disease oraffect disease vectors (e.g. insect orwater borne diseases).

NO

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

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

3.4 Vulnerable groups of people who couldbe affected by the project e.g. hospitalpatients, children, the elderly etc.,

NO No sensitive receptors are present in the immediatevicinity of the site. The project shall not have anysignificant 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 data4.1 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.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 ofpaints etc. The quantity of hazardous wastesgenerated during operation contain used oil, ETPsludge etc.

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

effluent treatmentYES Sludge from STP and Effluent treatment plant shall be

sent to TSDF.4.7 Construction or demolition wastes NO Construction activities involve creation of production

blocks, Utilities and ZLD system.4.8 Redundant machinery or equipment NO4.9 Contaminated soils or other materials NO All pipe lines including pipe lines of waste streams

are above ground level to eliminate the possibility ofany contamination due to seepage and for ease ofmaintenance.

4.10 Agricultural wastes NO4.11 Other solid wastes YES Enclosed at Annexure IV

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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 data5.1 Emissions from combustion of fossil fuels

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

enclosed in Annexure V5.2 Emissions from production processes YES Gaseous emissions from process are HCl, SO2, are

scrubbed in scrubber and. Hydrogen gas sent toatmosphere through water column.

5.3 Emissions from materials handlingincluding storage or transport

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

5.4 Emissions from construction activitiesincluding plant and equipment

YES Dust may rise during transport of material andconstruction activity. The dust emissions shall bemitigated by water spraying on the roads within thepremises.

5.5 Dust or odors from handling of materialsincluding construction materials, sewageand waste

NO Domestic wastewater sent to STP. Treatedwastewater reused for gardening.

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

air (e.g. slash materials, constructiondebris)

NO

5.8 Emissions from any other sources NO

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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 datawith source of information data

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

YES Material transport and construction equipment shall besource of noise, while transfer pumps, DG sets are thesources 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 NO6.5 From construction or operational

trafficNO The increased traffic 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, surfacewaters, 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 orspillage of hazardous materials

NO All the hazardous materials will be stored in MS drums,in a covered shed and no contamination of soil isexpected. Same philosophy will be followed for theafter expansion

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

NO Sludge from ETP shall be sent to TSDF.

7.3 By deposition of pollutants emittedto air into the land or into water

NO Vents of reactors are connected to common scrubber

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

of pollutants in environment fromthese sources?

NO

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

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

8.1 From explosions, spillages, fires etc fromstorage, handling, use or production ofhazardous substances

YES All Inbuilt Safety precautions will beadopted and there will not be anydamage to environment or humanhealth

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 environmentaleffects 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 approximatequantities/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 impacton 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 socioeconomic status of the area byincreasing the demand for housing,improving the employment.

9.2 Lead to after-use of the site, which could havenimpact on the environment

NO

9.3 Set a precedent for later developments NO9.4 Have cumulative effects due to proximity to other

existing or planned projects with similar effectsNO The baseline environmental status of

the surrounding areas is within theprescribed limits as observed from theSecondary data.

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(III) Environmental SensitivityS.No. Areas Name/

IdentityAerial 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 forecological reasons - Wetlands, watercourses orother water bodies, coastal zone, biospheres,mountains, forests

YES Kakarla RF – W – 50 mEdulla Vagu – S – 4.5 kmKattaleru River Stream – W – 5.2 km

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

NA

4 Inland, coastal, marine or underground waters NO5 State, National boundaries NO6 Routes or facilities used by the public for access to

recreation or other tourist, pilgrim areasNO

7 Defense installations NO8 Densely populated or built-up area YES Nearest habitation from the site is

Ramannapalem at a distance of 3.5 Kmin SE direction

9 Areas occupied by sensitive man-made land uses(hospitals, schools, places of worship, communityfacilities)

NA

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

NO

11 Areas already subjected to pollution orenvironmental damage. (those where existing legalenvironmental standards are exceeded)

NO

12 Areas susceptible to natural hazard which couldcause the project to present environmentalproblems (earthquakes, subsidence, landslides,erosion, flooding or extreme or adverse climaticconditions)

NO

(IV) Proposed Terms of Reference for EIA studies

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LAKSHMI PHARMACHEMSY.NO. 219/1(PART), 219/2(PART) AND 221(PART),

RAMANNAPALEM VILLAGE, TIRUVURU MANDAL, KRISHNA DISTRICT,ANDHRA PRADESH

ANNEXURES

Project No. 0218-21-02February 2018

M/s. Lakshmi Pharmachem64-9-5A, Flat No 303, Sree Bhaskara Residency,Chennupati Ramakotaiah Street, Patamata Lanka,Vijayawada, Andhra Pradesh – 520 010Phone No: +91 98491 72280E-mail: [email protected]

STUDIES AND DOCUMENTATION BYTEAM Labs and ConsultantsB-115-117 AND 509, AnnapurnaBlock,Aditya Enclave, Ameerpet,Hyderabad-500 038.Phone: 040-23748 555/23748616,Telefax: 040-23748666

SUBMITTED TOMINISTRY OF ENVIRONMENT, FOREST AND CLIMATE CHANGE

GOVERNMENT OF INDIAINDIRA PARYAVARAN BHAWAN, JOR BAGH ROAD, NEW DELHI

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M/s. Lakshmi Pharmachem Form I Annexures

Page 1

Fig

A-1

.Loc

atio

n M

ap o

f M

/s. L

aksh

mi P

harm

ache

m.

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M/s. Lakshmi Pharmachem Form I Annexures

Page 3

ANNEXURE - I

M/s. Lakshmi Pharmachem proposes to set up a Synthetic Organic Chemicals (Bulk Drugs

& Intermediates) Unit in an area of 10 acres in at Sy. No. 219/1(Part), 219/2(Part) and

221(Part), Ramanapalam Revenue village, Kakarla Gramapanchayati, Tiruvuru Mandal,

Krishna District, Andhra Pradesh. The proposed list of products and manufacturing

capacity is presented in Table A-1.

Table A-1 Manufacturing CapacityS.No Name Of the Product Cas No Capacity

Kg/Day TPM1 Cis-Bromo Benzoate 61397-56-6 1000 302 2,3-Dimethyl-4--nitropyridine-N-oxide 37699-43-7 750 22.53 Lansoprazole 103577-45-3 300 94 Rabeprazole Sodium 117976-90-6 300 95 Omeprazole 73590-58-6 300 96 3,5-Dimethyl-4-nitropyridine-N-oxide 14248-66-9 500 157 Cis-[[2-(2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-yl-

methyl)-1,3-dioxolan-4-yl]methyl]methane sulfonate67914-86-7 500 15

8 Cis-Tosylate 154003-23-3 500 159 Pantaprazole Sodium Sesquihydrate 138786-67-1 300 9

10 Itraconazole 84625-61-6 200 611 Esomeprazole Magnesium Trihydrate 217087-09-7 200 612 Ketaconazole 65277-42-1 200 613 1-[2-(2-Hydroxy ethoxy)Ethyl]Piperazine 13349-82-1 200 614 2-Hydroxy methyl-3-methyl-4-(3-mothoxy propoxy)

pyridine. Hydrochloride118175-10-3 300 9

15 2-Chloromethyl-3-methyl-4-(3-methoxypropoxy)Pyridine.

153259-31-5 600 18

16 2-[[[4-(3-methoxy propoxy)-3-methyl-2-pyridinyl]methyl] thio]-1H-benzimidazole

117977-21-6 450 13.5

17 2-(Hydroxy methyl)-3-methyl-4-(2,2,2-triflouroethoxy)Pyridine. Hydrochloride

103577-66-8 450 13.5

18 2-(Chloro methyl)-3-methyl-4-(2,2,2-triflouroethoxy)pyridine Hydrochloride

127337-60-4 400 12

19 2-[[[3-methyl-4-(2,2,2-triflouro ethoxy)-2-pyrdinyl]methyl] sulfanyl]-1H-benzimidazole

103577-40-8 400 12

20 2-[[[3-methyl-4-(nitro)-2-pyridinyl]methyl] sulfanyl]-1H-benzimidazole

152402-98-7 400 12

21 4-[4-[4-(4-Hydroxy Phenyl) -1-Piperazinyl]phenyl] 2,4-dihydro-2-(1-Methyl Propyl)-3H-1,2,4-Triazole-3-One

400 12

Total (Worst Case 8 Product on Campaign Product) 4750 142.5

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Page 4

Process Description of Itraconazole

Reaction Scheme

CH 3

C H 3

NN

N

O

N N O M e

NN

N

O

O

C lC l

H 3C O 2S O H 2 C

NN

N

O

O

C lC l

CH 3

C H 3

NN

N

O

N N O

H

2 ,4 -D ih yd ro -4 -[4 -[4 -4 -m e th o xyp h e n yl]1 -p ip e ra z in yl]p h e n yl]-2 -(1 -m e th lp ro p yl)-3 H -1 ,2 ,4 -tr ia zo l-3 -o n e

M .W t: 4 0 7

+

C is -[2 -(2 -,4 -d ich lo ro p h e n yl)-2 -1 H -1 ,2 ,4 -T ra zo l-1 -yl]m e th yl1 ,3 -d io xa la n -4 -yl]m e th yl su lfo n a te

D im e th yl fo rm a m id e

F o rm ic a c idM e th a n o l

Itra c o n a zo le (P h a rm a )

+

M .W t: 4 0 8

M .W t: 7 0 5

M .W t: 9 6+ M .W t: 9 5

H yd ro g e n b ro m id eM .W t: 8 1

M e th a n esu lfo n ic a c id

M e th yl B ro m id e

Process Description:

2,4-Dihydro-4-[4-[4-(4-methoxyphenyl)-1-piperazinyl]phenyl]-2-(1-methoxy propyl)-3H-

1,2,4-triazol-3-one compound react with cis-[2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-

ylmethyl)-1,3-dioxolan-4-yl] methyl-p-toluenesulfonate in the prensence of Dimethyl

formamide, Formic Acid, and Methanol Solvent to gives the Itraconazole. Schematic diagram

of Itraconazole is shown in Fig A.3 and material balance for Itraconazole is presented in

Table A.2.

W a t e r

W a s t e w a t e r

M e t h y l e n e c h l o r i d e

I t r a c o n a z o l e ( P h a r m a )

C o n d e n s a t i o n

A c t i v a t e d c a r b o n

2 ,4 - D i h y d r o - 4 - [ 4 - [ 4 - 4 - m e t h o x y p h e n y l ]1 - p i p e r a z i n y l ] p h e n y l ] - 2 - ( 1 - m e t h l p r o p y l )- 3 H - 1 ,2 ,4 - t r i a z o l - 3 - o n e

H y d r o b r o m i c a c i d

S o d i u m b i c a r b o n a t e

D i m e t h y l f o r m a m i d e

C i s - [ 2 - ( 2 ,4 - d i c h l o r o p h e n y l ) - 2 - 1 H -1 ,2 ,4 - T r i a z o l - 1 - y l ] m e t h y l 1 ,3 -d i o x a l a n - 4 - y l ] m e t h y l s u l f o n a t e

C a u s t i c p o t a s h f l a k e s

M e t h a n o lF o r m i c a c i d

C a u s t i c p o t a s h f l a k e s

M e t h a n o l

F o r m i c a c i d

M e t h y l e n e c h l o r i d e

A c t i v a t e d c a r b o n

D i m e t h y l f o r m a m i d e

M e t h a n e s u l p h o n i c a c i d

M e t h y l b r o m i d e

Fig A.3 Process Flow Diagram of Itraconazole

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Table A-2 Material Balance of Itraconazole

Input Quantity(Kg/day)

Output Quantity(Kg/day)

Remarks

2,4-Dihydro-4-[4-[4-(4-methoxyphenyl)-1-piperazinyl]phenyl]-2-(1-methoxy propyl)-3H-1,2,4-triazol-3-one

201.4 Itraconazole 200 Final product

cis-[2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methyl-p-toluenesulfonate

202.2 Methane Sulfonic acid 30 Organic residue

Formic acid 90 Methyl Bromide 29 Organic residueSodium hydroxide 48 MDC recovered 1152 Recovered and reusedSodium bicarbonate 70 MDC loss 9.6 Fugitive lossActivate carbon 12 MDC residue 38.4 ResidueWater 2000 Methanol recovered 1425 Recovered and reusedMethanol 1500 Methanol loss 12 Fugitive lossMethylene chloride (MDC) 1200 Methanol to

wastewater15 To Wastewater

Dimethylformamide (DMF) 500 Methanol residue 48 ResidueHydrochloric Acid 43.8 DMF recovered 480 Recovered and reused

DMF loss 2.5 Fugitive lossDMF residue 17.5 ResidueOrganic Residue 144.7 Organic residueFormic acid 90 Recovered and reusedSodium bicarbonate 70 To WastewaterActivate carbon 12 Organic residueSodium Chloride 70.1 To WastewaterWater 2021.6 To Wastewater

Total Input 5867.4 Total Output 5867.4

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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-3.

Table A-3 Quantity of Effluent Generated and Mode of Treatment

Description Quantity(KLD)

Mode of Treatment

HTDS EffluentsProcess 77 Sent to Stripper followed by MEE and ATFD.

Stripper Condensate sent to Cement Plants for Co-Incineration. MEE and ATFD Condensate sent toBiological treatment plant followed by RO. RO rejectssent to MEE and permeate is reused in cooling towers,boilers make-up and scrubbers.

Washings 5Scrubber Effluent 5RO/DM rejects 10

Total - I 97LTDS Effluents

R & D 1 Sent to Biological Treatment System followed by RO.RO permeate reused for cooling towers, boilers make-upand scrubbers. RO rejects sent to MEE.

Boiler Blow downs 6Cooling Tower Blowdowns

20

Domestic 8 Sent to Sewage Treatment Plant and treated wastewaterreused for gardening..

Total - II 35Grand Total (I+II) 132

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Page 7

ANNEXURE – III: Water Balance

Water is required for process, scrubbers, washing, R&D, 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 is in the

order of 330 KLD consisting of 211 KLD fresh water and the remaining of recycled water.

Total water balance is presented in Table A-4.

Table A-4 Total Water Balance (Tentative)

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

Process 70 77*Washings 5 5R&D Lab 1 1Scrubber 2 3 5Boiler Feed 42 36 6Cooling Tower 70 108 158 20DM Rejects 10 10Domestic 9 1 8Gardening 2 8 10Gross Total 211 119 205 132Total 330 337* Process effluents contain soluble raw materials, byproducts, solvents etc.

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Page 8

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-5.

Table A-5 Total Solid Waste Generated and Mode of Disposal (Tentative)

S.No Description Units Quantity Mode of Treatment/Disposal

1 Ash from Boiler TPD 18 Sold to Brick manufactures and cementplants

2 Organic residue TPD 2.5 Sent to TDSF/Cement Plants for Co-incineration

3 Solvent Residue TPD 4 Sent to TSDF/Cement Industries4 Spent Solvent KLD 50 Recovered within plant premises and

reused5 Mixed Solvent KLD 10 Sent to authorized recovery

units/Cement plants for co-incineration6 Stripper Distillate KLD 2 Sent to Cement Industries for Co-

incineration.7 Spent Carbon Kg/day 60 Sent to Cement Industries for Co-

incineration.8 Inorganic Residue TPD 1 Sent to TSDF9 Evaporation salts TPD 7 Sent to TSDF

10 ETP Sludge TPD 1.2 Sent to TSDF/ Cement plants for co-incineration

11 Detoxified containers No.s/Yr 10000 Sold to authorized vendors12 Waste oil KLPA 10 Sent to Authorized Recyclers13 Used batteries No.s/Yr 300 Sent to Authorized Recyclers

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Page 9

ANNEXURE – V: Stack Emissions Details

The sources of air pollution from the plant are proposed 2 x 8 TPH Coal fired boilers, 2 x 2

lac k.cal theric fluid heaters and proposed DG sets of 2 x 1010 KVA and 2 x 500 KVA. 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. The

emission rates of SO2, NOx and PM from each stack are presented in Table A-6.

Table A-6 Stack Emission Details

S. No Stack Connected to StackHt (m)

Dia ofstack attop(m)

Temp. ofexhaust

gases (0C)

ExitVelocity(m/sec)

Pollutant EmissionRate (g/sec)

PM SO2 NOx

1 2 x 8 TPH CoalFired Boiler*

40 1.2 180 10 0.3 1.2 1.88

2 2 x 2 Lakh KcalThermic FluidHeaters

15.2 0.4 180 6.5 0.04 0.08 0.12

3 2 X 1010 KVA DGset#

10 0.4 200 11 0.037 0.13 0.19

4 2 x 500 KVA DGset#

7 0.2 170 10.9 0.01 0.035 0.05

* 1 x 8 TPH boiler shall be kept as Standby#DG sets will be used during load shut down by .

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LAKSHMI PHARMACHEMSY.NO. 219/1(PART), 219/2(PART) AND 221(PART),

RAMANNAPALEM VILLAGE, TIRUVURU MANDAL, KRISHNA DISTRICT,ANDHRA PRADESH

STUDIES AND DOCUMENTATION BYTEAM Labs and ConsultantsQCI: MoEANDF OM, List A-1, S.No.25.(An ISO 9001:2008, ISO 14001:2004 ANDOHSAS 18001:2007 Certified Organization)B-115, Annapurna Block, Aditya EnclaveAmeerpet, Hyderabad-500 038.Phone: 040-23748 555/616,Telefax: 040-23748666Email: [email protected]