FORM-1 - Environmental Clearance

4

FORM-1

for

PROPOSED BULK DRUG & BULK DRUG

INTERMEDIATES MANUFACTURING

PLANT

of

M/s Bonny Chemicals

PLOT NO - J/7015 & J/7016,

GIDC ESTATE, ANKLESHWAR,

DIST - BHARUCH - 393 002,

GUJARAT

5

APPENDIX I

(See paragraph ‐ 6)

FORM 1

Sr. No.

Item Details

1. Name of the project/s M/s.BonnyChemicals2. 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

ProposedCapacity‐60MT/MonthFordetailPleasereferAnnexure–I

4. New/Expansion/Modernization New5. Existing Capacity/Area etc. FordetailPleasereferAnnexure–I6. Category of Project i.e. ‘A’ or ‘B’ B7. Does it attract the general condition? If

yes, please specify.

No

8. Does it attract the specific condition? If

yes, please specify.

No

9. LocationPlot/Survey/Khasra No. PlotNo‐J/7015&J/7016Village GIDCInd.Estate,AnkleshwarTehsil AkleshwarDistrict BharuchState Gujarat

10. Nearest railway station/airport along with

distance in kms.

RailwayStation,Ankleshwar‐3.5kmAirport,Surat‐70km

11. Nearest Town, city, District Headquarters

along with distance in kms.

Ankleshwar‐4km

12. Village Panchayats, Zilla Parishad,

Municipal Corporation, local body

(complete postal address with telephone

nos. to be given)

NotifiedAreaAuthority,Ankleshwar

13. Name of the applicant M/s.BonnyChemicals14. Registered Address PlotNoJ/7015&J/7016,

GIDCIndustrialEstate,Ankleshwar,Dist‐Bharuch‐393002(Gujarat)

6

15. Address for correspondence: PlotNo‐J/7015&J/7016,


Name Mr.JitendrabhaiB.PatelDesignation (Owner/Partner/CEO) PartnerAddress PlotNo‐J/7015&J/7016,


Pin Code 393002E‐mail [email protected] No. (02646)226011Fax No. (02646)226010Mobile No. +91‐9825250427

16. Details of Alternative Sites examined, if

any.

Location of these sites should be shown

on a topo sheet.

NA

17. Interlinked Projects NA18. Whether separate application of

interlinked project has been submitted?

NA

19. If yes, date of submission NA20. If no, reason NA21. 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?

No

22. Whether there is any Government

Order/Policy relevant/relating to the site?

No

23. Forest land involved (hectares) NA24. Whether there is any litigation 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.

NA

Capacity corresponding to sectoral activity (such as production capacity for manufacturing, mining lease area and production capacity for mineral production, area for mineral exploration, length for linear transport infrastructure, generation capacity for power generation etc.,)

7

(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.)

Sr. No.

Information/Checklist confirmation Yes/No Details there of with approximate quantities frates, wherever possible) with source of information data

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

No Proposed project activity iswithin the Ankleshwar GIDCIndustrialEstate.

1.2 Clearance of existing land, vegetation and Buildings?

Yes Minor site clearance activitiesshall be carried out to clearshrubsandweed.

1.3 Creation of new land uses?

No The project site is located onlevel ground, which does notrequireanymajor landfilling forareagradingwork.

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

No

1.5 Construction works?

Yes PleasereferAnnexure– II.

1.6 Demolition works? No Therewillbenotanydemolitionworkatthesite.

1.7 Temporary sites used for construction works or housing of construction workers?

No

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

Yes PleasereferAnnexure– II.

1.9 Underground works mining or tunneling?

No

1.10 Reclamation works?

No

1.11 Dredging?

No

1.12 Off shore structures?

No

1.13 Production and manufacturing processes?

Yes PleasereferAnnexure–III.

1.14 Facilities for storage of goods or materials?

Yes

Rawmaterial&finishedproductsstorageareawillbedeveloped.

8

1.15 Facilities for treatment or disposal of

solid waste or liquid effluents?

Yes For Facilities for treatment ordisposal of liquid effluents isreferredasAnnexure‐V.For Hazardous waste detailpleasereferAnnexure–VI.

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 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? No1.23 Abstraction or transfers of water form

ground or surface waters?

Yes Water requirement will be metthrough Ankleshwar GIDC watersupply.

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 Transportation of personnel orrawmaterialandproductswillbeprimarilybyroadonly.

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 either

temporarily or permanently?

No

1.29 Introduction of alien species? No1.30 Loss of native species or genetic

diversity?

No

1.31 Any other actions? No

9

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):

Sr. No.

Information/checklist confirmation Yes/NoDetails thereof (with approximate quantities /rates, wherever possible) with source of information data

2.1 Land especially undeveloped or agricultural land (ha)

No Proposed project activity will bewithin GIDC Industrial Area,Ankleshwar,Dist‐Bharuch.

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

Yes Water Source: Ankleshwar GIDCWaterSupplyFordetailspleasereferAnnexure–IV.

2.3 Minerals (MT) No

2.4 Construction material ‐ stone, aggregates, and / soil (expected source ‐ MT)

Yes Construction material will berequiredforproposedprojectoffewtypes of equipment. Constructionmaterialslikesteel,cement,crushedstones, sand, rubble, etc. requiredfor the project shall be procuredfromthelocalmarketoftheregion.

2.5 Forests and timber (source ‐ MT) No.

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

Yes POWERREQUIREMENTS:

TotalProposed:Power required fromDGVCL is 500KVA.(Proposed)StandbypowersupplyfromD.G.set(250KVA)inemergencycase.FUELREQUIREMENTS:BriquettesofBioCoal ‐5.0MT/Day(Proposed)HSD‐200Liter/Day(Proposed)

2.7 Any other natural resources (use appropriate standard units)

No

10

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.

Sr. No.

Information/Checklist confirmation Yes/No Details there of (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 PleasereferAnnexure–VIII.

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?

No

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

No

3.5 Any other causes No

4. Production of solid wastes during construction or operation or decommissioning (MT/month)

Sr. No.

Information/Checklist confirmation

Yes/No Details there of (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

4.3 Hazardous wastes (as per Hazardous Waste Management Rules)

Yes PleasereferAnnexure–VI.

4.4 Other industrial process wastes Yes PleasereferAnnexure–VI.4.5 Surplus product No 4.6 Sewage sludge or other sludge from

effluent treatment No

4.7 Construction or demolition wastes No 4.8 Redundant machinery or equipment No 4.9 Contaminated soils or other materials No 4.10 Agricultural wastes No 4.11 Other solid wastes Yes PleasereferAnnexure–VI.

11

5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr) Sr. No.


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

Yes PleasereferAnnexure–VII.

5.2 Emissions from production processes Yes PleasereferAnnexure–VII.

5.3 Emissions from materials handling storage or transport

No

5.4 Emissions from construction activities including plant and equipment

No

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

No

5.6 Emissions from incineration of waste No

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

No

5.8 Emissions from any other sources Yes PleasereferAnnexure–VII.

6.Generation of Noise and Vibration, and Emissions of Light and Heat:

Sr. No.

Information/Checklist confirmation Yes/No Details there of (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 The Noise level will be within theprescribed limit. At noisy areasadequate preventive & controlmeasures will be taken. Nosignificant noise, vibration oremission of light & heat from theunit.

6.2 From industrial or similar processes Yes ‐Do‐

6.3 From construction or demolition No

6.4 From blasting or piling No

6.5 From construction or operational traffic

No

6.6 From lighting or cooling systems No

6.7 From any other sources No

12

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: Sr. No.


7.1 From handling, storage, use or spillage of hazardous materials


7.2 From discharge of sewage or othereffluents to water or the land (expectedmode and place of discharge)

Yes PleasereferAnnexure–V.

7.3 By deposition of pollutants emitted to airinto the and or into water

No

7.4 From any other sources No7.5 Is there a risk of long term build up of

pollutants in the environment from thesesources?

No

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

human health or the environment Sr. No.


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


8.2 From any other causes No 8.3 Could the project be affected by natural

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

No

13

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

(II) Environmental Sensitivity

Sr. No.

Areas Name/ Identity

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

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

NA ProposedprojectsiteiswithintheGIDC Industrial Estate,Ankleshwar.

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

NA

3 Area used by protected, important or sensitive.Species of flora or fauna for breeding, nesting, foraging, resting, over wintering, migration

NA No protected area or sensitivespecies within 5 km from theproposedprojectboundary.

4 Inland, coastal, marine or underground waters

NA Noinland,costalormarinewithin15kmfromtheproject.

5 State, National boundaries NA NA6 Routes or facilities used by the public for

access to recreation or other tourist, pilgrim areas

Yes Publictransportation

Sr. No.


9.1 Lead to development of supporting. utilities, 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 industry supply industry other

Yes PleasereferAnnexure–IX.

9.2 Lead to after‐use of the site, which could have an 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

14

7 Defense installations NA

8 Densely populated or built‐up area Yes AnkleshwarCityaround4kmfromtheproposedprojectsite.

9 Area occupied by sensitive man‐made land uses Hospitals, schools, places of worship, community facilities)

No

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 environmental damage. (those where existing legal environmental standards are exceeded)or

No NA

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

No NA

15

IV). Proposed Terms of Reference for EIA studies: Please refer Annexure ‐ X I hereby given undertaking that, the 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 give, if any to the project will be revoked at our risk and cost. Date: 19/03/2019 Place: GIDC, Ankleshwar

For, Bonney Chemicals Signature of applicant (Project Proponent/Authorized Signatory)

NOTE:

1. The projects involving clearance under Coastal Regulation Zone Notification, 1991 shall

submit with the application a C.R.Z. map duly demarcated by one of the authorized agencies,

showing the project activities, w.r.t. C.R.Z. (at the stage of TOR) and the recommendations of

the State Coastal Zone Management Authority (at the stage of EC). Simultaneous action shall

also be taken to obtain the requisite clearance under the provisions of the C.R.Z.

Notification, 1991 for the activities to be located in the CRZ.

2. The projects to be located within 10 km of the National Parks, Sanctuaries, Biosphere

Reserves, Migratory Corridors of Wild Animals, the project proponent shall submit the map

duly authenticated by Chief Wildlife Warden showing these features vis‐à‐vis the project

location and the recommendations or comments of the Chief Wildlife Warden thereon (at

the stage of EC).

3. All correspondence with the Ministry of Environment & Forests including submission of

application for TOR/Environmental Clearance, subsequent clarifications, as may be required

from time to time, participation in the EAC Meeting on behalf of the project proponent shall

be made by the authorized signatory only. The authorized signatory should also submit a

document in support of his claim of being an authorized signatory for the specific project.

16

ANNEXURE - I

LIST OF PRODUCTS AND RAW MATERIALS ALONG QUANTITY

LIST OF PRODUCT & QUANTITY Sr.No. NameoftheProducts CASNo. Quantity

MT/MonthEnd‐useofproduct

1 OrthoChloroBenzoicAcid 118‐91‐2

30.0

Pharma2 ParaChloroBenzoicAcid 74‐11‐3 Pharma3 1,1CyclohexaneDiAceticAcid 4355‐11‐7 Pharma4 1,1 Cyclohexane Di Acetic Acid

Monoamide99189‐60‐3 Pharma

5 1(Aminomethyl) Cyclohexane Di AceticAcid‐HCl

4355‐11‐7 Pharma

6 1,1 Cyclohexane Di Acetic AcidAnhydride

1010‐26‐0 Pharma

7 3‐IsoButylGlutaricAcid 75148‐89‐4 Pharma

8 3‐IsoButylGlutaricAcidMonoamide 181289‐15‐6 Pharma

9 (R)‐(‐),3(Carbamoylmethyl)‐5‐ MethylHexanoicacid

81289‐33‐8 Pharma

10 P‐Chloro(d1)Benzahydrylamine 150700‐52‐0 Pharma

11 n‐pChloro(1)BenzahydrylamineN,H‐pTolueneSulphonylPiperazine

‐‐ Pharma

12 n‐(pChloro(1)Benzahydry)N(2‐HydroxyEthyl)Piperazine

‐‐ Pharma

13 DimethylAmineHydrochloride 506‐59‐2 Pharma

14 IsoPropylAlcoholHydrochloride(IPAHCL)

63659‐19‐8Pharma

15 AtorvastatinCalcium 134523‐00‐5

10.0

Pharma

16 DiclofenacSodium 15307‐79‐6 Pharma

17 PhenylephrineHydrochloride 61‐76‐7 Pharma

Total 40.0

17

LIST OF RAW MATERIAL & QUANTITY:

Sr.No. NameoftheProducts

NameoftheRawMaterials

CASno./CIno.ofRawmaterials.

ProposedQuantity

(MT/Month)1 OrthoChloroBenzoicAcid Ortho Chloro Toluene

(OCT)95‐49‐8 30

NitricAcid(HNO3)60% 7697‐37‐2 75NaOHLye48% 215‐185‐5 10.5

2 ParaChloroBenzoicAcid Para Chloro Toluene(PCT)

106‐43‐4 30

NitricAcid(HNO3)60% 7697‐37‐2 75NaOHLye48% 215‐185‐5 10.5

3 1,1CyclohexaneDiaceticAcid ECA(Ethylcyanoacrylate)

7085‐85‐0 34.5

Cyclohexanone 108‐94‐1 15.3AmmoniaGas 7664‐41‐7 6SulphuricAcid 7664‐93‐9 30.6

4 1,1 Cyclohexane Di acetic acidMonoamide

CDA 28.8Liq.Ammonia 1336‐21‐6 11.7NaOH 215‐185‐5 6HCl 7647‐01‐0 12

5 1‐(Aminomethyl) CyclohexaneDiaceticacid‐HCl

CDM ‐‐ 28.8NaOH 215‐185‐5 17.4Bromine 7726‐95‐6 11.7MDC 75‐09‐2 1.5HCl 7647‐01‐0 16.8Methanol 67‐56‐1 1.2Carbon 7440‐44‐0 0.3Hyflo ‐‐ 0.12

6 1,1 Cyclohexane Di acetic acid

AnhydrideCDA ‐‐ 67.2AcetylChloride 75‐36‐5 13.5

7 3‐IsoButylGlutaricAcid Hexane 110‐54‐3 1.5IsoVeleraldehyde 590‐86‐3 13.8EthylCyanoAcetate 105‐56‐6 18.3DiEthylMelonate 105‐53‐3 25.8HCL 7647‐01‐0 18.6Toluene 108‐88‐3 2.4

18


Name of the RawMaterials

CASno./CIno. of Rawmaterials.

ProposedQuantity(MT/Month)

8 3‐ Iso Butyl Glutaric AcidMonoamide

Hexane 110‐54‐3 1.5IsoVeleraldehyde 590‐86‐3 13.8EthylCyanoAcetate 105‐56‐6 18.3DiEthylMelonate 105‐53‐3 25.8HCL 7647‐01‐0 18.6Toluene 108‐88‐3 2.4Ammonia 7664‐41‐7 16.2CausticFlakes 215‐185‐5 0.3

9 (R)‐(‐),3(Carbamoylmethyl)‐5‐MethylHexanoicacid

Hexane 110‐54‐3 1.5IsoVeleraldehyde 590‐86‐3 13.8EthylCyanoAcetate 105‐56‐6 18.3DiEthylMelonate 105‐53‐3 25.8HCL 7647‐01‐0 18.6Toluene 108‐88‐3 2.4Ammonia 7664‐41‐7 16.2CausticFlakes 215‐185‐5 0.3Chloroform 67‐66‐3 1.5PhenylEthylAmine 64‐04‐0 20.1

10 P ‐ Chloro (d1)Benzahydrylamine

PCBP 134‐85‐0 33.3AF 540‐69‐2 9.9HCl 7647‐01‐0 15.6NaOH 215‐185‐5 5.4

11 n‐pChloro(1)BenzahydrylamineN,H‐pTolueneSulphonylPiperazine

PCBP 134‐85‐0 33.3AF 540‐69‐2 9.9HCl 7647‐01‐0 15.6NaOH 215‐185‐5 5.4IPA 67‐63‐0 0.9TartaricAcid 526‐83‐0 14.4MDC 75‐09‐2 1.5PTSC 98‐59‐9 19.8Soda 497‐19‐8 10.2Bis.CEAHCl ‐‐ 17.4

19




ProposedQuantity

(MT/Month)12 n‐(pChloro(1)Benzahydry)

N(2‐HydroxyEthyl)PiperazinePCBP 134‐85‐0 33.3AF 540‐69‐2 9.9HCl 7647‐01‐0 15.6NaOH 215‐185‐5 0.18IPA 67‐63‐0 0.03TartaricAcid 526‐83‐0 0.48MDC 75‐09‐2 0.05PTSC 98‐59‐9 0.66Soda 497‐19‐8 0.34Bis.CEAHCl ‐‐ 0.58HBr 10035‐10‐6 0.76PHBA ‐‐ 0.39Toluene 108‐88‐3 0.03TEA 121‐44‐8. 0.012ChloroEthanol 107‐07‐3 0.23Acetone 67‐64‐1 0.04

13 DimethylAmineHydrochloride Dimethylamine 124‐40‐3 33.0DryHCLgas 7647‐01‐0 16.5

14 IsoPropylAlcohol

Hydrochloride(IPAHCL)Isopropylalcohol 67‐63‐0 22.5DryHCLgas 7647‐01‐0 7.5

20




ProposedQuantity

(MT/Month)15 AtorvastatinCalcium (4R,6R)‐Tert‐ Butyl‐6‐

Cyanomethyl‐2,2‐dimethyl‐1,3‐dioxane‐4‐acetate(ATS‐8)(CASNo.125971‐94‐0)

125971‐94‐0

0.63

Methanol 67‐56‐1 12.83AmmoniaGas 7664‐41‐7 0.44RaneyNickel 7440‐02‐0 0.25HydrogenGas 1333‐74‐0 0.132‐[2‐(4‐Fluorophenyl)‐2‐oxo‐1‐Phenylethyl]‐4‐methyl‐3‐oxo‐NPhenylpentanamide(M4) (CAS No.125971‐96‐2)

125971‐96‐2

0.94

Cyclohexane 110‐82‐7 5.00Pivalicacid 75‐98‐9 0.09Tetrabutylmethylether 1634‐04‐4 0.50Isopropylalcohol 67‐63‐0 7.19Acetone 67‐64‐1 45.00Hyflow 61790‐53‐2 5.94Hydrochloricacid 7647‐01‐0 0.13Sodiumhydroxide 1310‐73‐2 0.44Activatedcarbon 7440‐44‐0 0.23Calciumchloride 10043‐52‐4 0.04

16 DiclofenacSodium 1‐(2,6‐dichlorophenyl)2‐Indolinone

15307‐86‐5 1.25

Sodiumhydroxide 1310‐73‐2 0.375Methanol 67‐56‐1 3.75

21




ProposedQuantity

(MT/Month)17 PhenylephrineHydrochloride 3‐Hydroxy

Acetophenone121‐71‐1 1.111

Ethylacetate 141‐78‐6 3.333Toluene 108‐88‐3 11.111Bromine 7726‐95‐6 1.333Aluminiumtrichloride 7446‐70‐0 0.022benzylethylamine 14321‐27‐8 1.833sodiumbicarbonate 144‐55‐8 0.111sodiumsulphate 7757‐82‐6 0.111Isopropylalcohol 67‐63‐0 11.111Hydrochloricacid 7647‐01‐0 1.222Methanol 67‐56‐1 11.11110%Palladiumcharcoal 7440‐05‐3 0.011LiquidAmmonia 1336‐21‐6 3.167L(+)Tartaricacid 87‐69‐4 1.055Aceticanhydride 108‐24‐7 1.000Sulphuricacid 7664‐93‐9 0.500DryHCLgas 7647‐01‐0 7.5

22

ANNEXURE- II

COPY OF PLANT LAYOUT

23

ANNEXURE - III

MANUFACTURING PROCESS, CHEMICAL REACTION & MASS BALANCE

1) Ortho Chloro Benzoic Acid

MANUFACTURING PROCESS

Charge water 2500 Kg and nitric acid 60% 2500 kg , ortho chloro toluene 1000 Kg in Reactor

and start pump caustic solution circulation ans start blower and water circulation start heating

temp 135°C to 140°C and Temp. should maintain for 8 hrs and then cool it to 40°C. And filter

it in nutch filter and collect wet cake and wash with water. Mother liqour will use in next batch

and wet cake dry and packing in 50 Kg bags.

CHEMICAL REACTION

MASS BALANCE

Sr. No.

Input Quantity

(Kg) Output

Quantity (Kg)

1 Ortho Chloro Toluene 1.0 Product 1.00 2 Nitric Acid (60%) 2.5 Wastewater (Reuse in Next batch) 3.30 3 Caustic Lye 0.350 Effluent 3.85 4 Water 4.50 Evaporation Loss 0.20

Total 8.35 Total 8.35

24

2) Para Chloro Benzoic Acid


Charge water 2500 Kg and nitric acid 60% 2500 kg , para chloro toluene 1000 Kg in Reactor

and start pump caustic solution circulation ans start blower and water circulation start heating

temp 135°C to 140 and Temp should maintain for 8 hrs and then cool it to 40°C. And filter it

in nutch filter and collect wet cake and wash with water. Mother liqour will use in next batch

and wet cake dry and packing in 50 Kg bags.

CHEMICAL REACTION

MASS BALANCE

Sr. No.

Input Quantity

(Kg) Output

Quantity (Kg)

1 Para Chloro Toluene 1.0 Product 1.00 2 Nitric Acid (60%) 2.5 Wastewater (Reuse in Next batch) 3.30 3 Caustic Lye 0.350 Effluent 3.85 4 Water 4.50 Evaporation Loss 0.20

Total 8.35 Total 8.35

25

3) 1, 1 Cyclohexane di acetic Acid


➢ Check SS reactor empty, Clean and dry. Charge 225 kgs ECA and 100 kgs

Cyclohexanone.

➢ Cool upto 5 to 10°C and slowly purge 40 kgs. Ammonia gas at 5 to 10°C under stirring.

➢ Stirr for 16 hrs. at 5 to 10°C

➢ Slowly add 300 Itr. Water at 10 to 15°C

➢ Transfer this Mass in the glass line reactor

➢ Cool to 5 to 10°C

➢ Slowly start addition of 200 kgs Sulphuric acid at 10 to 25°C

➢ Heat upto 100°C and maintained for 3 hrs.

➢ Slowly cool upto 25 to 30°C, Centrifuge product and wash by 100 Itr. Water. Speen dry,

unload and dry the product and M.L. send for Ammonium Sulphate solution sales.

CHEMICAL REACTION

26

MASS BALANCE

Amm. Sulphate

27

4) 1, 1 Cyclohexane Di Acetic Acid Monoamide


✓ Check SS reactor empty, Clean and dry. Charge 200 kgs CDA and 81 kgs Liq. Ammonia.

• Slowly heat upto 45°C

• Stirr for 3 hrs. at 45°C.

✓ Slowly Cool, upto 30°C and charge 100 ltr. Water.

✓ Charge 40 kgs. NaOH, Temperature will rise upto 50°C, if rise more than 50°C apply

cooling upto 50°C ✓ Stirr at 50°C upto clear solution (App. 15 to 20 min.).

✓Slowly cool upto 10-15°C and start addition of 85 kgs. HCI at 15 to 20°C.

✓ Slowly cool upto 5 to 10°C, Centrifuge product. Speen dry, unload and dry the product.

CHEMICAL REACTION

28

MASS BALANCE

29

5) 1(Aminimethyl) Cyclohexane Di Acetic Acid HCl


➢ Check SS reactor empty, Clean and dry. • Charge 260 IV. Water and 260 kgs. Caustic

flakes under cooling Cool upto 10°C and slowly add 160 kgs bromine at 10°C

• Stirr for 1 hrs. at 10°C

• Slowly add 396 kgs CDM at 10 to 15°C and maintain for 1 hrs

➢ Heat upto reflux and reflux for 4 hrs. • Cool to 30°C and charge 600 ltr. MDC, Stirr and

Settled for 30 min.

• Separate Organic layer and send it in GLR for MDC recovery and store NaBr by product

separately (752 kgs) ki> In GLR distill out MDC up to 80°C and then cool upto 30 to 35°C

• Charge 230 kgs. HCI and 280 ltr. Water and heat up to reflux. Reflux for 3 hrs. And then

distill out water under vacuum up to max 90°C and then cool upto 30 to 35°C Charge 600 Itr.

Methanol and heat up to clear solution (45 to 50°C) Charge 6 kgs carbon and stir at 45-50°C

for /z hrs. Filter via sparkler filter with 2 kgs hyflo.

• Wash sparkler filter by 100 Its. Methanol. Filtrate charge in other clean reactor.

• Distilled out Methanol and cake will be dried through Spin dryer.

CHEMICAL REACTION

30

MASS BALANCE

31

6) 1, 1 Cyclohexane Di Acetic Acid Anhydride


• Check glass line reactor empty, clean and dry • Charge 200 kgs. CDA and cool upto 20°C

Slowly add 80 kgs. Acetyl Chloride at 20°C Stirr for 1 hrs. at 20°C Distill out Acetyl chloride

acid under vacuum up to 80°C (60 kgs) and then cool up to 30 to 35°C .-- Dump RM in the

200 ltr. Water under stirring.

➢ Stirr for 1 hrs.

➢ Centrifuge product, speen dry and unload.

➢ Dry the product.

CHEMICAL REACTION

MASS BALANCE

32

7) 3-ISO Butyl Glutaric Acid


STAGE — 1:- 2-CYANO-5-METHYLHEX-2-ENOLEACID-ALKYL ESTER Check SS reactor,

Clean and Dry.

✓ Charge 170 Itr Hexane.

✓ Charge 85 kgs. ISO Veleraldehyde at RT.

✓ Charge 113 kgs. Ethyl Cyano Acetate at RT.

✓ Slowly chill upto 5°C and maintain for 2 hrs.

✓ Slowly heat upto 35-40°C and maintain for 1 hrs.

✓ Distill out Hexane upto max 75°C

✓ Cool to RT and unload material in clean containers.

STAGE - 2:- 3-ISO BYTYL GLUTARIC ACID

✓ Check G.L., Reactor, Clean and Dry.

✓ Charge 180 kgs. Stage-1

✓ Charge 160 kgs. Di Ethyl Melonate at RT.

✓ Slowly chill upto 10°C and maintain for 2 hrs. '>=. Charge 115 kgs HCI at 10°C );- Slowly

heat upto reflux.

✓ Reflux for 12 hrs. r Slowly cool upto RT.

✓ Charge 540 Itr. Toluene.

✓ Stir for 1 hrs. and settle for 1 hrs.

✓ Separate organic layer, Aq. Layer in the reactor.

✓ Charge 180 Itr. Toluene.

✓ Stir for 1 hrs. and settle for 1 hrs.

✓ Separate organic layer, Aq. Layer drain and mix both organic layer.

✓ Distill out Toluene upto 119-120°C, At last apply vacuum to remove traces of Toluene.

✓ Cool to RT and unload material in clean containers.

33

CHEMICAL REACTION

34

MASS BALANCE

35

8) 3-Iso Butyl Glutaric Acid Monoamide


STAGE - 1 :- 2-CYANO-5-METHYLHEX-2-ENOLEACID-ALKYL ESTER

Check SS reactor, Clean and Dry. • Charge 170 ltr Hexane. Charge 85 kgs. ISO Veleraldehyde at RT. Charge 113 kgs. Ethyl Cyano Acetate at RT. Slowly chill upto 5°C and maintain for 2 hrs. Slowly heat upto 35-40°C and maintain for 1 hrs. Distill out Hexane upto max 75°C Cool to RT and unload material in clean containers.

STAGE — 2:- 3-ISO BYTYL GLUTARIC ACID

Check G.L., Reactor, Clean and Dry. Charge 180 kgs. Stage-1 Charge 160 kgs. Di Ethyl Melonate at RT. Slowly chill upto 10°C and maintain for 2 hrs. Charge 115 kgs HCI at 10°C Slowly heat upto reflux. for 12 hrs. Slowly cool upto RT. Charge 540 itr. Toluene. Stir for 1 hrs. and settle for 1 hrs. Separate organic layer, Aq. Layer in the reactor. Charge 180 !tr. Toluene. Stir for 1 hrs. and settle for 1 hrs. Separate organic layer, Aq. Layer drain and mix both organic layer Distill out Toluene upto 119-120°C, At last apply vacuum to remove trac Toluene. Cool to RT and unload material in clean containers.

STAGE - 3:- 3-ISO BYTYL GLUTARIC ACID MONOAMIDE

Check S.S, Reactor, Clean and Dry. Charge 185 kgs. Stage-2 Charge 100 kgs. Ammonia at RT. Heat to 45°C and maintain for 3 hrs. Slowly cool upto RT. Charge 185 !tr. Water. Charge 1 to 2 kgs caustic flakes. Stirr upto clear solution at RT. Filter solution to remove foreign particals. To fitrate slowly add app. 50 kgs. HCI at RT. Stir for 1 hrs. at RT. Centrifuge the product. )=- Wash by 185 ltr. Water. • Unload CF.

and dry the product.

36

CHEMICAL REACTION

37

MASS BALANCE

39

9) (R)-(-), 3 (Carbamolymethyl)-5-Methyl Hexanoic Acid


STAGE - 1:- 2-CYANO-S-METHYLHEX-2-ENOLEACID-ALKYL ESTER

Check SS reactor, Clean and Dry. Charge 170 ltr Hexane. Charge 85 kgs. ISO Veleraldehyde at RT. ‘r Charge 113 kgs. Ethyl Cyano Acetate at

RT. Slowly chill upto 5°C and maintain for 2 hrs. Slowly heat upto 35-40°C and maintain for 1 hrs. Distill out Hexane upto max 75°C Cool to RT and unload material in clean containers.

STAGE — 2:- 3-ISO BYTYL GLUTARIC ACID

Check G.L., Reactor, Clean and Dry. Charge 180 kgs. Stage-1 Charge 160 kgs. Di Ethyl Melonate at RT. Slowly chill upto 10°C and maintain for 2 hrs. Charge 115 kgs HCI at 10°C Slowly heat upto reflux. Reflux for 12 hrs. Slowly cool upto RT. Charge 540 Itr. Toluene. Stir for 1 hrs. and settle for 1 hrs. Separate organic layer, Aq. Layer in the reactor.& gs,3“n e Charge 180 ltr. Toluene. A 0 Stir for 1 hrs. and settle for 1 hrs. Separate organic layer, Aq. Layer drain and mix both organic layer. Distill out Toluene upto 119-120°C, At last apply vacuum to remove traces of

Toluene. Cool to RT and unload material in clean containers.

STAGE - 3:- 3-ISO BYTYL GLUTARIC ACID MONOAMIDE

Check S.S, Reactor, Clean and Dry. Charge 185 kgs. Stage-2 ')=- Charge 100 kgs. Ammonia at RT. Heat to 45°C and maintain for 3 hrs. Slowly cool upto RT. Charge 185 Itr. Water. Charge 1 to 2 kgs caustic flakes. • Stir upto clear solution at RT. Filter solution to remove foreign particles. To filtrate slowly add app. 50 kgs. HCI at RT. Stir for 1 hrs. at RT. Centrifuge the product. Wash by 185 Itr. Water. Unload CF. and dry the product.

40

STAGE - 4:- (R) - (-) 3 (CARBAMOYLMETHYL) - 5 -- METHYL HEXANOIC ACID. alpha

PHENYL ETHYL AMINE

Check S.S. reactor, clean and dry. Charge 360 Itr. Chloroform Charge 185 kgs. Stage-3 at RT Charge 122 kgs. R ) — (+) alpha Phenyl ethyl amine at RT. Slowly heat upto 50°C and maintain for 3 hrs. Slowly cool upto RT and maintain for 1 hrs. Unload material in notch filter, suck ML completely. Wash cake product by 30 Itr. Chloroform Suck ML in form of Spent c than distilled it

and recover the chloroform. Unload cake and dry it.

STAGE - 5:- (R) - (1 3 (CARBAMOYLMETHYL) -5- METHYL HEXANOIC ACID.

Check G.L., reactor, clean and dry. Charge 435 ltr. water )=. Charge 290 kgs. Stage-4 at RT Charge 105 kgs. HCI at RT. Stir at RT for 1 hrs. Slowly chill upto 5°C, and maintain for 1 hrs. Centrifuge the product. Wash by 150 ltr. Water. Unload CF. and dry the product.

41

CHEMICAL REACTION

43

MASS BALANCE

46

10) P - Chloro (d1) Benzahydrylamine

MANUFACTURING PROCESS STAGE-1: p CHLORO BENZHYDRYLAMINE FORMIDE

Check S.S. reactor, clean and dry. Charge 250 kgs. p Chloro Benzophenone. Charge 75 kgs. Ammonium formate at RT Slowly heat upto 100°C without stirring. Start stirring after 100°C Slowly take temperature 135°C water distillation 33 to 35 ltr. Maintain temperature 135°C for 10 hrs. Slowly take temperature 80°C with cooling water circulation. Dump material in quenching vessel with 650 Iiter Water. Stir quenching vessel upto RT. • Centrifuge the product. • Wash by 216 ltr Water. Unload CF. and dry the product.

STAGE-2:- p CHLORO (d.1) BENZHYDRYLAMINE

Check G.L. reactor, clean and dry. Charge 366 ltr. Water Charge 263 kgs. stage-1 at RT. Charge 118 kgs. HO at RT. slowly heat upto 90°C Maintain 90°C for 5 hrs. Cool upto RT. Charge 40 kgs. Caustic flakes upto 7.0 pH at RT. Chill to 5°C CF and

wash ltr. Water. Unload product in clean containers.

CHEMICAL REACTION

47

MASS BALANCE

48

11) n-p Chloro (1) Benzahydrylamine N, H-p Toluene Sulphonyl Piperazine


STAGE-1: p CHLORO BENZHYDRYLAMINE FORMIDE

Check S.S. reactor, clean and dry. Charge 250 kgs. p Chloro Benzophenone. Charge 75 kgs. Ammonium formate at RT.

Slowly heat upto 100°C without stirring. • Start stirring after 100°C. Slowly take temperature 135°C water distillation 33 to 35 ltr. • Maintain temperature 135°C for 10 hrs.

Slowly take temperature 80°C with cooling water circulation. Dump material in quenching vassel with 650 kg Water. Stir quenching vessel upto RT. Centrifuge the product. Wash by 216 ltr Water. Unload CF. and dry the product.

STAGt-2:- p CHLORO (d.1) BENZHYDRYLAMINE •

Check G.L. reactor, clean and dry. Charge 366 ltr. Water Charge 263 kgs. stage-1 at RT. Charge 118 kgs. HCI at RT. Slowly heat upto 90°C Maintain 90°C for 5 hrs. Cool upto RT. Charge 40 kgs. Caustic flakes upto 7.0 pH at RT. Chill to 5°C CF and ltr Water. Unload product in clean containers.

STAGE-3:- p CHLORO (d.1) BENZHYDRYLAMINE TARTAR.

Check S.S. reactor, clean and dry. Charge 430 RT IPA. Charge 225 kgs. stage-2 at RT. Charge 150 kgs L(+) Tartric acid at RT Slowly heat upto 60°C Maintain 60°C for 3 hrs. Slowly cool to RT. Slowly chill to 5°C. Centrifuge the product. • Wash by 108 ltr. IPA Unload CF. and dry the product.

STAGE-4:- n-p TOLUYL SULPHONYL-BIS CHLORO ETHYL AMINE.

Check G.L. reactor, clean and dry. Charge 380 Itr. M.D.C. Charge 204 kgs. Para Toluyl Sulphonyl Chloride at RT. `).-- Charge 106 kgs. soda at

RT. Slowly chill upto 10°C. - Charge 180 kgs. n,n. BIS Chloro Ethyl Amine NCI at 10°C. Slowly heat upto 40-45°C Maintain 40-45°C for 3 hrs & Cool to RT. Charge 480 Itr Water. Stir fro 1 hrs and sattle for 1 hrs. at RT. Separate organic layer. Drain Aq. Layer. Organic layer recharge in same reactor. Distill out M.D.C. completely. Unload residual product in clean containers.

49

STAGE-5:- n-p CHLORO (I) BENZAHYDRYL AMINE N,H-p TOLUENE SULFONYL

PIPERAZINE.

Check S.S. reactor, clean and dry. Charge 900 Itr Water. Charge 374 kgs. stage-3 at RT. Charge 40 kgs. Caustic soda flakes at RT. Slowly heat upto 60°C and maintain for 1 hrs. Cool to RT. Charge 311 kgs. stage-4 at RT. Charge 108 kgs. soda ash at RT. Slowly heat up to 100°C and maintain for 24 hrs. Cool to RT. Centrifuge the product Wash by 180 lb. Water Unload CF and dry the

product.

50

CHEMICAL REACTION:

52

MASS BALANCE

55

12) n-(p Chloro (1) Benzahydry) N (2-Hydroxy Ethyl) Piperazine


STAGE-1: p CHLORO BENZHYDRYLAMINE FORMIDE

Check S.S. reactor, clean and dry. Charge 250 kgs. p Chloro Benzophenone. Charge 75 kgs. Ammonium formate at RT. Slowly heat upto 100°C without stirring. Start stirring after 100°C Slowly take temperature 135°C water distillation 33 to 35 ltr. Maintain temperature 135°C for 10 hrs. Slowly take temperature 80°C with cooling water circulation. Dump material in quenching vessel with 650 kr. Water. Stir quenching vessel upto RT. Centrifuge the product. Wash by 216 hr. Water. Unload CF. and dry the product.

STAGE-2:- p CHLORO (d.1) BENZHYDRYLAMINE

Check G.L. reactor, clean and dry. Charge 366 It% Water Charge 263 kgs. stage-1 at RT. Charge 118 kgs. HCI at RT. Slowly heat upto 90°C Maintain 90°C for 5 hrs. Cool upto RT. Charge 40 kgs. Caustic flakes upto 7.0 pH at RT. Chill to 5°C C:f an Itr. Water. Unload product in clean containers.

STAGE-3:- p CHLORO (d.1) BENZHYDRYLAMINE TARTARATE SALT.

Check S.S. reactor, clean and dry. Charge 430 RI-. IPA. Charge 225 kgs. stage-2 at RT. Charge 150 kgs L(+) Tartric acid at RT Slowly heat upto 60°C Maintain 60°C for 3 hrs. Slowly cool to RT. Slowly chill to 5°C. Centrifuge the product. Wash by 108 'tr. IPA Unload CF. and dry the product.

56

STAGE-4:- n-p TOLUYL SULPHONYL-BIS CHLORO ETHYL AMINE. STAGE-5:- n-p CHLORO(I) BENZAHYDRYL AMINE N,H-p TOLUENE SULFONYL PIPERAZINE.

Check S.S. reactor, clean and dry. Charge 900 Itr. Water. Charge 374 kgs. stage-3 at RT. Charge 40 kgs. Caustic soda flakes at RT. Slowly heat upto 60°C and maintain for 1 hrs. Cool to RT. Charge 311 kgs. stage-4 at RT. Charge 108 kgs. soda ash at RT. Slowly heat up to 100°C and maintain for 24 hrs. Cool to RT. Centrifuge the product. Wash by 180 Itr. Water. A Unload CF. and dry the product.

STAGE-6:- n-p CHLORO(I) BENZAHYDRYL PIPERAZINE.

Check G.L. reactor, clean and dry. Charge 275 kgs. HBr in Acetic acid 30%. Charge 140 kgs. Para hydroxyl benzoic acid at RT. Chill up to 5-10°C. Charge 446 kgs. stage-5 at 5-10°C. Stir at 5-10°C for 2 hrs. Slowly heat up to 50°C and maintain for 12 hrs. Cool to RT. Charge 880 Itr. Water at RT. Stir for 1 hrs. A Centrifuge product, collect M.L. Product wash by 220 !tr. Water, collect M.L. Combine both M.L. in other reactor. Slowly charge 160 kgs. Caustic flakes at RT. After Caustic flakes addition stir for 1 hrs. at RT. Charge 900 !tr. Toluene at RT. Stir for 1 hrs. at RT and settle for 1 hrs. at RT. Separate organic layer. Charge 450 hr. Toluene at RT. Stir for 1 hrs. at RT and settle for 1 hrs. at RT. Separate organic layer. Drain Aq. Layer. Organic layer recharge in same reactor. Distill out Toluene up to Max. 80°C U/Vacuum. Unload product in clean containers.

57

STAGE-7:- n-(p CHLORO(I) BENZAHYDRYL) N (2-HYDROXY ETHYL) PIPERAZINE.

Check S.S. reactor, clean and dry. Charge 570 ltr. Toluene. Charge 285 kgs. Stage - 6 at RT. Charge 105 kgs. Triethyl Amine at RT. Charge 85 kgs. 2 Chloro Ethanol at RT. Slowly heat up to 105-110°C Stir at 105-110°C for 3 hrs. Slowly cool up to 30°C Charge 275 ltr. Water at RT. Stir for 1 hrs. at RT and settle for 1 hrs. at RT. Separate organic layer. Charge 135 Itr. Water at RT. Stir for 1 hrs. at RT and settle for 1 hrs. at RT. Separate organic layer. Collect Aq. Layer for recovery. Organic layer recharge in same reactor. Distill out Toluene completely up to max. 80°C U/Vacuum At last apply high vacuum and remove traces of toluene. Cool to RT. Charge 650 Itr. Acetone, Chill up to 0-5°C. Centrifuge the product. Wash by 150 Its% Chilled acetone. Unload CF. and dry the product.

58

CHEMICAL REACTION

60

MASS BALANCE

65

13) Dimethyl Amine Hydrochloride


Take 40 % solution of DMA in GLR and start Dry HCL gas Purging at Room temperature and adjust pH 5.5 keep 1 hour stirring then distilled Out water from Reaction mixture after water distillation residual Reaction Mass to be Crystallized. Centrifuge and Dry the material till moisture level comes below 0.10 %. Final product will be packed in LDPE Bags having PVC auto sealed Liner inside.

CHEMICAL REACTION

(CH3)2.N + HCl (g) (CH3)2.NHCl

MASS BALANCE

Sr. No.

Input Qty. per Batch (Kg)

Output Qty. per Batch (Kg)

1 Dimethyl amine 650 Dimethylamine HCL 750

2 Dry HCL gas 100

Total 750 Total 750

14) Iso Propyl Alcohol Hydrochloride (IPA HCL)


Dry HCL gas is injected to IPA to get IPA HCl and monitoring the Assay by Keeping Law temperature of Reaction mass. After achieving Desired Results material is packed in HDPE Drums and sealed with Plaster of Paris.

CHEMICAL REACTION

(CH3)2.CHOH + HCl(g) CH3.CH2.CH2.OH .HCl

MASS BALANCE

Sr. No.

Input Qty. per Batch (Kg)

Output Qty. per Batch (Kg)

1 Iso propyl alcohol 1200 Iso propyl alcohol HCl 1600

2 Dry HCL gas 400

Total 1600 Total 1600

66

15) Atorvastatin Calcium


Stage 1: Hydrogenation ATS‐8 converted into ATS‐9 in presence of Hydrogen gas and Raney nickel catalyst at high pressure. Stage 2: Condensation ATS‐9 and M4 condensed in Cyclohexane media at high temperature and liberate water to form L2 Base and purified using isopropyl alcohol and water. Stage 3: Purification L2 is purified in acetone to form highly pure substance L3 Note: In case of purification only purity of substance change but there is no change in chemical formula. Stage 4: salt formation L3 is dissolved in methanol at 45 to 55 C and treated with dilute hydrochloric acid. Reaction mass is then cool to 30‐400C and treated with sodium hydroxide solution. pH of reaction mass is adjusted to 8‐8.5 with dilute hydrochloric acid. Reaction mass is added with calcium chloride solution to form Atorvastatin calcium.

67

CHEMICAL REACTION

N

O O

CH3CH3

O

OCH3

CH3

CH3

O O

CH3 CH3

O

OCH3

CH3

CH3

NH2

CH3

CH3

NH

O

O

O

F

O O

CH3 CH3

O

OCH3

CH3

CH3

NH2

+

4-Fluoro-alpha-[2-methyl-1-oxopropyl]-gama-oxo-N,beta-diphenylbenzene butanamide

CAS No.: 125971-96-2

Mol Wt: 417.484

NH

N

OCH3

CH3CH3

O

O

O

CH3

CH3

OCH3

CH3

F

(4R-Cis)-1,1-dimethylethyl-6-[2-[2-(4-fluorophenyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrol-1-yl]ethyl]-2,2-dimethyl-1,3-dioxane-4-acetate

CAS No: 125971-95-1

Mol Wt: 654.81

NH

N

OCH3

CH3CH3

O

O

O

CH3

CH3

OCH3

CH3

F


CAS No. 125971-95-1

Mol Wt: 654.81

NH

N

O

OHOH

O

CH3

CH3

F

O-

Ca2+

NH

N

OCH3

CH3CH3

O

O

O

CH3

CH3

OCH3

CH3

F

NH

N

OCH3

CH3CH3

O

O

O

CH3

CH3

OCH3

CH3

F

Acetone

(4R-Cis)-1,1-Dimethylethyl-6-Cynomethyl-2,2-dimethyl-1,3-dioxane-4-acetate

CAS No: 125971-94-0

Mol Wt: 269.34

(4R,6R)-Tert-Butyl-6-(2-aminoethyl)-2,2-dimethyl-1,3-dioxane-4-acetate

CAS No: 125995-13-3

Mol Wt: 273.37

(4R,6R)-Tert-Butyl-6-(2-aminoethyl)-2,2-dimethyl-1,3-dioxane-4-acetate

CAS No.: 125995-13-3

Mol Wt: 273.37


CAS No. 125971-95-1

Mol Wt: 654.81


CAS No. 125971-95-1

Mol Wt: 654.81

NaOH/HClMethanol

Calcium chloride

Atorvastatin calcium Trihydarte

CAS No.: 344423-98-9

Mol Wt: 1209.0

OH23

CyclohexaneIsopropyl alcohol

80-90 °C

(--- 2H2O)

hh

2

HydrogenationAmmonia gas

Ni/H2 Methanol

68

MASS BALANCE

Sr. No. Input MT Output MT

1.

(4R,6R)‐Tert‐ Butyl‐6‐ Cyanomethyl‐2,2‐dimethyl‐ 1,3‐dioxane‐4‐acetate (ATS‐8) (CAS No. 125971‐94‐0)

0.29 Atorvastatin calcium 1

2. Methanol 12.83 Methanol +Ammonia recover 3.52

3. Ammonia Gas 0.44 Methanol +Ammonia Loss 0.38

4. Raney Nickel 0.25 Raney Nickel 0.25

5. Hydrogen Gas 0.13 Hydrogen gas use 0.13

6.

2‐[2‐(4‐Fluorophenyl)‐2‐oxo‐1‐Phenylethyl]‐4‐methyl‐3‐ oxo‐N Phenylpentanamide (M4) (CAS No.125971‐96‐2)

0.94 Cyclohexane +Terbutyl methyl ether recovery

5.23

7. Cyclohexane 5.00 Cyclohexane +Terbutyl methyl ether Loss

0.28

8. Pivalic acid 0.09 Isopropyl alcohol recovery 12.49

9. Tetrabutyl methyl ether 0.50 Isopropyl alcohol loss 0.7

10. Isopropyl alcohol 13.19 Acetone recovery 5.63

11. Water 35.00 Acetone Loss 0.31

12. Acetone 5.94 Methanol recovery 9.06

13. Hyflow 0.13 Methanol Loss 0.31

14. Hydrochloric acid 0.44 Activated Carbon 0.04

15. Sodium hydroxide 0.23 Hyflow 0.13

16. Activated carbon 0.04 Effluent 30.0

17. Calcium chloride 0.16 Residue 0.14

TOTAL 69.92 TOTAL 69.92

69

16) Diclofenac Sodium

MANUFACTURING PROCESS:

Manufacturing Process:

1‐(2,6‐dichlorophenyl)‐2‐indolinone is hydrolyzed in presence of caustic soda solution at reflux temperature to produce Diclofenac sodium.

CHEMICAL REACTION

MASS BALANCE

Sr.

No. Input MT Output MT

1. 1‐(2,6‐dichlorophenyl)2‐Indolinone

1.25 Diclofenac sodium 1

2. Sodium hydroxide 0.38 Methanol recover 3

3. DM Water 21.00 Methanol loss 0.75

4. Methanol 3.75 Effluent 21.48

Residue 0.15


ClN O

Cl

Sodium hydroxide

Water

Cl NH

Cl

O

O

Na

1-(2,6-dichlorophenyl)-2-indolinone Diclofenac sodium

70

17) Phenylephrine Hydrochloride

MANUFACTURING PROCESS:

Stage 1: Into a SS reactor charge Ethyl acetate an 3‐Hydroxy acetophenone. Reaction mass is chilled to 0‐50C and added with Liquid bromine solution in ethyl acetate in presence of Aluminium chloride as catalyst. After completion of reaction Toluene is added and washed with Sodium bicarbonate solution. Water wash is given and water is removed by treating with sodium sulphate. Organic layer is chilled and benzyl ethyl amine is added. Reaction mass is acidified with IPA. HCl. Precipitated material is filtered through centrifuge and dried at 50‐600C. Stage 2: Phenylephrine Base Into a Hydrogenator stage I and methanol is added and apply hydrogen pressure in presence of 10 % palladium carbon. Reaction mass is filtered to remove catalyst. Filtrate is charged into the reactor and distilled out methanol under vaccum. Water is added into the reaction mass and basify with ammonia solution to get phenylephrine base. Stage‐3: L‐Phenylephrine Base Phenylephrine base is treated with L(+) tartaric acid in Isopropyl alcohol and water. Salt formed is break with ammonia solution to get D‐Phenylephrine base. Filtrate from salt is basify with ammonia and filtered to get L‐Phenylephrine base. Stage‐4: D‐ Phenylephrine base to L‐Phenylephrine base D‐Phenylephrine base is charged in reactor with water, sulfuric acid and acetic anhydride. Acetic acid formed during reaction is recovered at high temperature. After completion of reaction , liquid ammonia is added. Reaction mass is filtered and dried at 50‐600C to get L‐Phenylephrine base. Stage‐5: Phenylephrine Hydrochloride L‐Phenylephrine base is reacted with hydrochloric acid in isopropyl alcohol to form

Phenylephrine hydrochloride.

71

CHEMICAL REACTION

3-hydroxy Acetophenone

CAS No. 121-71-1

Mol Wt: 136.15

benzyl phenylephrone HCl

CAS No. 71786-67-9

Mol Wt: 291.77

+

N-Methyl benzyl amine

CAS No. 103-67-3

Mol Wt: 121.18

Phenylephrine Base

CAS No. 59-42-7

Mol Wt: 167.21

OH

CH3ONH

CH3

N

CH3O

OH

ClH

Ethylacetate/Toluene/Bromine

Sodium bicarbonteIPA.HCl

N

CH3O

OH

benzyl phenylephrone HCl

CAS No. 71786-67-9

Mol Wt: 291.77

NH

CH3OH

OHPalladium Charcoal

Hydrogen/ Methanol

NH

CH3OH

OH +

L(+) tartaric acid

CAS No.: 87-69-4

Mol Wt: 150.09

OH

O

O

OH

OH

OH

Phenylephrine Base

CAS No. 59-42-7

Mol Wt: 167.21

NH

CH3OH

OH

OH

O

O

OH

OH

OH

Phenyephrine Tartrate Salt

NH

CH3OH

OH

OH

O

O

OH

OH

OHNH

CH3OH

OH

Phenyephrine Tartrate Salt L- phenylephrine Base

Liq. Ammonia

NH

CH3OH

OH+ ClH

Isopropyl alcohol

MethanolNH

CH3OH

OH

ClH

L- phenylephrine Base Phenylephrine Hydrochloride

CAS No. 61-76-7

Mol Wt: 203.67

NH

CH3OH

OH

D-Phenylephrine Base

+CH3 O CH3

O O

Acetic anhydride

CAS No:108-24-7

Mol Wt: 102.09

Sulphuric acidNH

CH3OH

OH

L-Phenylephrine Base

72

MASS BALANCE

Sr. No. Input MT Output MT

1. 3‐Hydroxy acetophenone 1.11 Phenylephrine hydrochloride 1

2. Ethyl acetate 3.33 Ethyl acetate recover 3

3. Toluene 11.11 Ethyl acetate loss 0.33

4. Bromine 1.33 Toluene recover 10.56

5. Aluminium trichloride 0.02 Toluene loss 0.56

6. benzyl ethyl amine 1.83 Benzyl ethyl amine recover 1.17

7. sodium bicarboante 0.11 Isopropyl alcohol recover 9.67

8. sodium sulphate 0.11 Isopropyl alcohol loss 1.44

9. Isopropyl alcohol 11.11 Methanol recover 10.56

10. Hydrochloric acid 1.22 Methanol loss 0.56

11. water 28.89 L(+) Tartaric acid recovery 0.89

12. Methanol 11.11 Acetic acid recover 1.89

13. 10 % Palladium charcoal 0.01 Effluent 35.17

14. Liquid Ammonia' 3.17 residue 0.26

15. L(+) Tartaric acid 1.06

16. Acetic anhydride 1.00

17. Sulphuric acid 0.50


73

ANNEXURE - IV

DETAILS OF WATER CONSUMPTION / WASTEWATER GENERATION &

WATER BALANCE DIAGRAM

DETAILS OF WATER CONSUMPTION & WASTE WATER GENERATION

Sr. No.

Usage Water

Consumption (KL/Day)

Waste Water Generation

(KL/Day)

1 Industrial Process 12.3 12.0

Boiler 5.0 0.5

Cooling 5.0 0.5

Washing 1.0 1.0

Scrubber 1.5 2.0

Total Industrial (A) 23.3 16

2 Domestic (B) 2.0 1.8

3 Gardening (C) 2.0 0.0

Total (A+B+C) 27.3 17.8

Mode of Disposal:-

Industrial :- 14 KL (5.3 KL High COD primary treated process effluent shall be Send to

Common MEE of M/s. ACPTCL, Ankleshwar and 6.7 KL Low COD & Utility

primary treated effluent shall be send to common CETP of M/s. AWML,

Ankleshwar)

2.0 KL Scrubbing Media Reuse in plant Premises and Sell to end user.

Domestic :- 1.8 KL domestic waste from the unit is disposed through underground septic

tank/soak pit.

74

WATER BALANCE DIAGRAM

Note:- All figure in KL/Day

Total Water 27.3

Domestic 2.0

Gardening 2.0

Industrial 23.3

To Septic tank / Soak pit

1.8

Process12.3

Washing 1.0

Boiler 5.0

Cooling 5.0

Process 12

Washing 1

Boiler 0.5

Cooling 0.5

5.3 Send to Common MEE

of M/s. ACPTCL, Ankleshwar

Scrubber 1.5

2.0

Scrubbing Media Reuse

in plant Premises and

Sell to end user

ETP 6.7

6.7 Send to Common CETP

of M/s. AWML, Ankleshwar

Domestic Utility

Low COD Stream

4.7

High COD Stream

5.3

ETP 5.3

75

ANNEXURE - V

DETAILS OF EFFLUENT TREATMENT PLANT M/s. Bonny Chemicals shall proposed primary treatment plant for industrial effluent. The

details of ETP are as follows.

High COD Effluent :-

The process effluent from unit shall be brought to the treatment plant via a series

of pipelines. The effluent shall be collected in the collection cum equalization tank-

1. The equalized effluent shall be pumped into flash mixer for addition of

chemicals like lime. From the flash mixer the waste water flows into the flocculator

where chemical flocks are formed by coagulation and flocculation by addition of

Alum/Ferrous sulphate and polyelectrolyte. These flocks shall be removed in the

primary tube settler.

This primary effluent shall be sent to Common MEE, M/s. ACPTCL, Ankleshwar

for further treatment and final disposal.

Low COD & Utility Effluent :-

The utility effluent from unit shall be brought to the treatment plant via a series of

pipelines. The effluent shall be collected in the collection cum equalization tank-2.

The equalized effluent shall be pumped into flash mixer for addition of chemicals

like lime. From the flash mixer the waste water flows into the flocculator where

chemical flocks are formed by coagulation and flocculation by addition of

Alum/Ferrous sulphate and polyelectrolyte. These flocks shall be removed in the

primary tube settler.

The clear overflow shall be taken into primary treated storage tank. Now primary

treated effluent shall be passed through Dual Media Filter and collected at final

treated collection tank and it will be send to common CETP of M/s AWML,

Ankleshwar for final treatment & disposal.

76

Technical Specification of ETP Plant

Sr. No.

Equipment Name Qty. Specification

1. Oil & Grease Trap 1 Type : Rectangular Channel Size : 1.0 m x 1.0 m x 1.0 m MOC : RCC M25+A/A Bk. Lining.

2. Collection Tank Cum Equalization Tank - 1 (High COD)

1 Type : U/G Rectangular Tank Size : 2.5 m x 2.0 m x 1.0 m Capacity : 5 m3 MOC : RCC M25+A/A Bk. Lining

3. Collection Tank Cum Equalization Tank - 2 (Low COD & Utility)

1 Type : U/G Rectangular Tank Size : 2.5 m x 2.0 m x 1.0 m Capacity : 5 m3 MOC : RCC M25+A/A Bk. Lining

4. Chemical Dosing Tanks 3 Type : Circular Tank Capacity : 0.2 m3 MOC : HDPE

5. Flash Mixer Tank 1 Type : Cylindrical Tank Size: 0.8 m x 1.0 m MOC : MSEP

6. Flocculation Tank 1 Type : Cylindrical Tank Size: 1.0 m x 1.25 m MOC : MSEP

7. Primary Tube Settler 1 Type :Rectangular Tank with hopper bottom Size : 2.0 m x 2.0 m x 1.0 m Capacity : 4 m3 MOC : MSEP

8. Primary treated storage tank 1 Type : Circular Tank Capacity : 5 m3 MOC : HDPE

9. Dual Media Filter 1 Type : Cylindrical Tank Capacity : 2 m3/hr MOC : FRP

10. Final Treated Storage Tank 1 Type : Round Tank Capacity : 5 m3 MOC : HDPE

11. Sludge Drying Beds 1 Size : 1.0 m x 1.5 m x 1.5 m (0.5 m filter media) Total Capacity : 1.5 m3 MOC : R.C.C.

77

ETP FLOW DIAGRAM OF PROCESS EFFLUENT

ETP FLOW DIAGRAM OF UTILITY EFFLUENT

78

CHARACTERISTICS OF PROCESS WASTEWATER BEFORE & AFTER TREATEMENT

(For Common MEE)

Sr. No.

Parameter High COD

Stream (5.3 KL/Day)

Characteristics(mg/L)

Untreated

1 pH 3-9 3-9 2 TDS 28000 28000 3 COD 22050 22050 4 BOD3 5000 5000

CHARACTERISTICS OF WASTEWATER

(Utility i.e. Low COD, Boiler, Cooling Tower and Washing)

Sr. No.

Parameter

Low COD

Stream

Boiler blow down

Cooling Tower blow down

Washing

Characteristics(mg/L)

Untreated CETP Inlet

Norms

1 pH 3-9 8 - 8.5 8 - 8.5 5.5 - 8.5 7.5 6.5 - 8.5 2 TSS 800 50 50 100 80 100 3 COD 2500 80 100 600 1550 2000 4 BOD3 1400 500 700 800 350 400

79

ANNEXURE - VI DETAILS OF HAZARDOUS WASTE GENERATION, STORAGE & DISPOSAL

Sr. No.

Type/Name of Hazardous

waste

Source of generation

Category and Schedule as

per HW Rules.

Quantity (MT/Annum)

Disposal Method

1 ETP Sludge ETP SCH-I/35.3 5 Collection, Storage, Transportation and Disposal at common TSDF site.

2 Discarded Drums/Bags/ Liners

Raw Materials/ Products

SCH-I/33.1 24 Collection, Storage, Transportation, Decontamination & Sale to GPCB approved vendors.

3 Used/ Spent Oil

Machineries/ Utility

SCH-I/5.1 0.1 Collection, Storage, Transportation & Sale to GPCB registered re-processor.

4 Distillation Residue

Distillation SCH-I/20.3 72 Collection, Storage, Transportation and sent for co-processing in cement industries or Disposal at common incineration site.

5 Spent Solvent Process SCH-I/28.6 1450 Collections, Storage, distill and reuse in plant premises.

6 Organic waste Process SCH-I/28.1 95 Collection, Storage, Transportation and sent for co-processing in cement industries or Disposal at common incineration site.

7 Spent Carbon Process (Product No.

15)

SCH-I/28.3 15 Collection, Storage, Transportation and sent for co-processing in cement industries or Disposal at common incineration site.

8 Spent Catalyst Process (Product No.

15)

SCH-I/28.2 30 Collection, Storage, Transportation and send to regenerator

9 Ammonia Sulphate

Process (Product No.

3)

SCH-I/28.1 95 Collection, Storage, Transportation and Sell to end user who is having Rule-9 Permission.

10 NaBr (25%) Process (Product No.

5)

SCH-I/28.1 660 Collection, Storage, Transportation and Sell to end user who is having Rule-9 Permission.

11 Liq. Ammonia Scrubber SCH-I/28.1 300 Collection, Storage and reuse in plant premises. (Requirement of Liq. Ammonia in Product No 4 &15 - 140 MT/Year) & remaining sell to end user who is having Rule-9 Permission.

12 Dil. HCl (30%) Scrubber SCH-II/B15 365 Collection, Storage and reuse in plant premises. (Requirement of HCL in Product No. 7 - 223 MT/Year) & remaining sell to end user who is having Rule-9 Permission.

13 Off Specification Products

From mfg. Process (Batch failure)

SCH-I/28.4 5.0 Collection, Storage, Transportation and sent for co-processing in cement industries or Disposal at common incineration site.

80

ANNEXURE – VII

DETAILS OF AIR EMISSION (FLUE GAS EMISSION / PROCESS GAS VENT)

Flue Gas Emission:-

Sr. No. Particulars

Stack height

Fuel used with Qty.

Parameter Permissible

Limit APCM

1 Boiler

(Cap.: 1.5 MT/Hr) 30 m

Briquette of Bio Coal

5 MT/Day SPM SO2 NOx

150 mg/Nm3

100 ppm 50 ppm

Multicyclone Separator with

Bag Filter

2 D.G Sets - Stand by

(Cap.: 125 KVA) 9 m

HSD 200 Liter/Day

Adequate Stack Height

Process Gas Vent:-

Sr. No.

Stack attached to Stack Height

Air Pollution Control System

Parameter Permissible

Limit

1 Process Vent - 1

(Product No. 10,11,12-HCl))

11 m Two Stage Water

Scrubber HCl 20 mg/Nm3

2

Process Vent - 2 (Product No.

4,8,9,10,11,12 – NH3)

11 m Two Stage Water

Scrubber NH3 175 mg/Nm3

81

ANNEXURE - VIII

DETAILS OF HAZARDOUS CHEMICALS STORAGE

Sr. No.

Name of the Hazardous Substance

Maximum Storage

(MT)

Actual Storage (MT)

Mode of Storage

Possible type of Hazards

1 Acetone 11.5 250 Liter x 30 Drum Flammable /

Toxic

2 Ammonia Gas 4.0 50 Kg x 50 Cylinder Toxic

3 Bromine 2 3 Kg x 650 Bottle Toxic

4 Dry HCL gas 4.25 50 Kg x 50 Bottle Corrosive /

Toxic

5 Ethyl Acetate 1 200 Liter x 5 Drum Flammable /

Toxic

6 Hydrochloric Acid (HCl)

5.0 200 Liter x 15 Drum Corrosive /

Toxic

7 Hydrogen Gas 0.13 60 kg x 1 Bank Explosive

8 Hexane 0.5 200 Liter x 2 Drum Flammable

9 Iso propyl alcohol 5.75 200 Liter x 25 Drum Flammable /

Toxic

10 Methanol 3.5 200 Liter x 15 Drum Flammable /

Toxic

11 Nitric Acid (HNO3) 19 200 Liter x 50 Drum Corrosive /

Toxic

12 Sulphuric Acid (H2SO4)

8 200 Liter x 15 Drum Corrosive /

Toxic

13 Sodium Hydroxide(NaOH)

2.0 50 Kg x 40 Bag

Corrosive

14 Toluene 3.0 200 Liter x 15 Drum Flammable /

Toxic

82

ANNEXURE - IX

SOCIO - ECONOMIC IMPACTS

1) Employment Opportunities

The manpower requirement for the proposed project is being expected to generate some

permanent jobs and secondary jobs for the operation and maintenance of plant. This will

increase direct / indirect employment opportunities and ancillary business development to

some extent for the local population.

This phase is expected to create a beneficial impact on the local socio-economic

environment.

2) Industries

Required raw materials and skilled and unskilled laborers will be utilized maximum from

the local area. The increasing industrial activity will boost the commercial and economical

status of the locality, to some extent.

3) Public Health

The company regularly examines, inspects and tests its emission from sources to make

sure that the emission is below the permissible limit. Hence, there will not be any

significant change in the status of sanitation and the community health of the area, as

sufficient measures have been taken and proposed under the EMP

4) Transportation and Communication

Since the existing factory is having proper linkage for the transport and communication,

the development of this project will not cause any additional impact.

In brief, as a result of the proposed there will be no adverse impact on sanitation,

communication and community health, as sufficient measures have been proposed to be

taken under the EMP. The proposed scenario is not expected to make any significant

change in the existing status of the socio - economic environment of this region.

83

ANNEXURE - X

PROPOSED TERMS OF REFERENCE FOR EIA STUDIES

1. Project Description

Justification of project.

Promoters and their back ground

Project site location along with site map of 5 km area and site details providing

various industries, surface water bodies, forests etc.

Project cost

Project location and Plant layout.

Existing infrastructure facilities

Water source and utilization including proposed water balance.

List of Products & their capacity

Details of manufacturing process of proposed products

List of hazardous chemicals

Mass balance of each product

Storage and Transportation of raw materials and products.

2. Description of the Environment and Baseline Data Collection

Micrometeorological data for wind speed, direction, temperature, humidity and rainfall

in 10 km area.

Existing environmental status Vis a Vis air, water, noise, soil in 10 km area from the

project site.

Ground water quality at 8 locations within 10 km.

Complete water balance

3. Socio Economic Data

Existing socio-economic status, land use pattern and infrastructure facilities available

in the study area were surveyed.

84

4. Impacts Identification And Mitigatory Measures

Identification of impacting activities from the proposed project during construction and

operational phase.

Impact on air and mitigation measures including green belt

Impact on water environment and mitigation measures

Soil pollution source and mitigation measures

Noise generation and control.

Solid waste quantification and disposal.

Control of fugitive emissions

5. Environmental Management Plan

Details of pollution control measures

Environment management team

Proposed schedule for environmental monitoring including post project

6. Risk Assessment

Objectives, Philosophy and methodology of risk assessment

Details on storage facilities

Process safety, transportation, fire fighting systems, safety features and emergency

capabilities to be adopted.

Identification of hazards

Consequence analysis

Recommendations on the basis of risk assessment done

Disaster Management Plan.

7. Information for Control of Fugitive Emissions

8. Post Project Monitoring Plan for Air, Water, Soil and Noise

9. Information on Rain Water Harvesting

10. Green Belt Development plan

FORM-1 - Environmental Clearance

Documents

Transcript of FORM-1 - Environmental Clearance