1
FORM-I
for
PROPOSED EXPANSION OF BULK DRUGS AND
BULK DRUG INTERMEDIATES IN
EXISTING UNIT
of
M/s. ADARSH DYE CHEM (UNIT-II)
PLOT NO. A-1/3621, OPP. ETL, GIDC ESTATE,
ANKLESHWAR-393002, DISTRICT: BHARUCH, GUJARAT.
Consultant
2
APPENDIX I
FORM 1
(I) Basic Information
Sr.
No.
Item Details
1. Name of the Project/s M/s. Adarsh Dye Chem (Unit-II)
2. S. No. in the Schedule 5 (f)
3. Proposed
capacity/area/length/tonnage to be
handled/command area/lease
area/number of wells to be drilled
For details Refer to Annexure: 2
4. New/Expansion/Modernization Expansion
5. Existing capacity/area etc. Existing capacity: 23 MT/Month
For detail Refer to Annexure: 2
6. Category of project i.e. ‘A’ or ‘B’ ‘B’
7. Does it attract the general condition?
If yes, please specify.
8. Does it attract the specific condition?
If yes, please specify.
Not applicable
9. Location
Plot/Survey/Khasra No. A-1/3621
Village GIDC, Estate
Tehsil Ankleshwar
District Bharuch
State Gujarat
10. Nearest railway station/airport along
with distance in kms.
Nearest Railway Station: Ankleshwar: 2.8 km
Nearest Airport: Surat: 60.0 km
11. Nearest Town, city, District
Headquarters along with distance in
kms.
Nearest town: Ankleshwar: 1.2 km
12. Village Panchayats, zilla parishad,
Municipal corporation, Local body
(Complete postal addresses with
telephone nos. to be given)
Notified Area Authority, Ankleshwar
13. Name of the applicant M/s. Adarsh Dye Chem (Unit-II)
14. Registered address Plot No. A-1/3621, Opp. ETL, GIDC Estate,
Ankleshwar-393 002, District: Bharuch, Gujarat.
Address for correspondence:
Name Mr. Sureshbhai Dobaria
15.
Designation (Owner/Partner/CEO) Partner
3
Address M/s. Adarsh Dye Chem (Unit-II)
Plot No. A-1/3621, Opp. ETL, GIDC Estate,
Ankleshwar-393 002, District: Bharuch, Gujarat
Pin Code 393 002
E-Mail [email protected];
Telephone No. +919904163130
Fax No. 91-2646-253392
16. Details of Alternative Sites examined,
if any location of these sites should be
shown on a topo sheet.
No
17. Interlinked Projects No
18. Whether separate application of
interlinked project has been
submitted?
No
19. If Yes, date of submission Not applicable
20. If no., reason Not applicable
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?
No
22. Whether there is any Government
order/policy relevant/relating to the
site?
No
23. Forest land involved (hectares) No
24. Whether there is any 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.
No
4
(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 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 Proposed expansion is within Existing
Premises.
1.2 Clearance of existing land, vegetation
and buildings?
Yes Minor site clearance activities shall be
carried out to clear shrubs and weed.
1.3 Creation of new land uses? No --
1.4 Pre-construction investigations e.g.
bore houses, soil testing?
No --
1.5 Construction works? Yes Plant layout is attached as Annexure: 1.
1.6 Demolition works? No --
1.7
Temporary sites used for construction
workers or housing of construction
workers?
No --
1.8 Above ground buildings, structures or
Earthworks including linear structures,
cut and fill or excavations
Yes Plant layout is attached as Annexure: 1.
1.9
Underground works including mining
or tunneling?
No --
1.10 Reclamation works? No --
1.11 Dredging? No --
1.12 Offshore structures? No --
1.13 Production and manufacturing Yes List of Products & their capacity is attached
as Annexure: 2 and manufacturing process
is attached as Annexure: 3.
1.14 Facilities for storage of goods or
materials?
Yes Dedicated storage area for storage of Raw
Materials, finished products, solvents, etc.
shall be provided.
1.15
Facilities for treatment or disposal of
solid waste or liquid effluents?
Yes Details of proposed Effluent Treatment
Plant are attached as Annexure: 5.
Details of Hazardous waste generation and
disposal is attached as Annexure: 6.
1.16
Facilities for long term housing of
operational workers?
No --
1.17 New road, rail or sea traffic during
construction or operation?
No --
5
1.18 New road, rail, air waterborne or
other 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, converting,
realignment or other changes to the
hydrology of watercourses or
aquifers?
No --
1.22 Stream crossings? No --
1.23
Abstraction or transfers or the water
form 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?
Yes Transportation of personnel, raw material
and products will be primarily by road only.
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 Direct/Indirect employment shall be
generated after proposed expansion.
1.29 Introduction of alien species? No --
1.30 Loss of native species of genetic
diversity?
No --
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):
Sr.
No.
Information/checklist confirmation Yes/
No?
Details there of (with approximate
quantities/rates, wherever possible) with
source of information data
2.1 Land especially undeveloped or
agriculture land (ha)
No --
2.2 Water (expected source & competing
users) unit: KLD
Yes Water requirement will be met through the
GIDC Water supply.
A detail of water balance is given as
Annexure – 4.
2.3 Minerals (MT) No --
2.4 Construction material -stone, Yes Company shall use Sand, stone, Cement and
6
aggregates, sand / soil (expected
source MT)
Structural Steel for Construction as
required.
2.5 Forests and timber (source - MT) No --
2.6
Energy including electricity and fuels
source, competing users Unit: fuel
(MT), energy (MW)
Yes Power Requirement:
Existing:
Power required from DGVCL is 100 KVA.
Proposed:
Power required from DGVCL will be 250
KVA.
1 DG Set = 100 KVA (for Emergency only)
Fuel Requirement:
Existing: No fuel
Proposed:
Agrowaste = 5 MT/Day
Diesel = 5 Lit./Hr (Only for emergency).
2.7 Any other natural resources (use
appropriates 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.
Sr.
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
Please refer Annexure: 8
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 thereof (with approximate
quantities / rates, wherever possible)
with source of information data
7
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 Please refer Annexure: 6
4.4 Other industrial process wastes Yes Please refer Annexure: 6
4.5 Surplus product No --
4.6
Sewage sludge or other sludge from
effluent treatment
Yes Please refer Annexure: 6
4.7 Construction or demolition wastes Yes Construction waste shall be utilized for
leveling, land filling in the premises.
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 Please refer Annexure: 6
5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr)
Sr.
No.
Information/Checklist confirmation Yes/
No
Details there of (with approximate
quantities/rates, wherever possible) with
source of information data
5.1 Emissions from combustion of fossil
fuels from stationary or mobile sources
Yes Please refer Annexure: 7
5.2 Emissions from production processes Yes Please refer Annexure: 7
5.3 Emissions from materials handling
storage or transport
Yes All liquid raw materials shall be procured
in tankers and shall be transferred through a
closed circuit pipe lines.
Solid raw materials shall be charged
through close pipeline into reactors and the
dust collection hopper shall be connected
to a bag filter and ID fan.
Also all hazardous chemicals storage tanks
will be provided with flame arrestors &
breather valves for safety.
5.4 Emissions from construction activities
including plant and equipment
Yes During construction work, only dust
contamination will be there & water
sprinklers shall be utilized whenever
necessary.
5.5 Dust or odours from handling of
materials including construction
materials, sewage and waste
Yes Dust from drying will be collected in to dust
collector through cyclone separator &
recovered powder will be recycled back to
process. Air Handling Unit will be provided
where ever applicable.
8
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 Please refer Annexure: 7
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 source of information data
6.1
From operation of equipment e.g.
engines, ventilation plant, crushers
Yes There are few activities due to which noise
would be generated. The equipments
resulting in noise generation are machinery
of plant and Diesel generator. Adequate
noise control measures will be provided
whenever required.
Proper and timely oiling, lubrication and
preventive maintenance will be carried out
for the machineries & equipments to reduce
noise generation.
Use of PPEs like ear plugs and ear muffs will
be made compulsory near the high noise
generating machines.
Noise monitoring shall be done regularly in
plant area.
The D.G. Set will be installed in a closed
room and provided with acoustic enclosure.
The unit will increase the plantation species
in the proposed greenbelt within the
premises which will prevent the noise
pollution in surrounding area.
6.2 From industrial or similar processes Yes All machinery / equipment shall be well
maintained, shall have proper foundation
with anti vibrating pads wherever applicable
to keep noise levels within permissible
limits.
Acoustic enclosures shall be provided for DG
set.
6.3 From construction or demolition No --
6.4 From blasting or piling No --
6.5 From construction or operational
traffic No
--
9
6.6 From lighting or cooling systems No --
6.7 From any other sources No --
7. Risks of contamination of land or water from releases of pollutants into the ground or into
sewers, surface waters, groundwater, coastal waters or the sea:
Sr.
No
Information/Checklist confirmation Yes/
No?
Details thereof (with approximate
quantities / rates, wherever possible) with
source of information data
7.1
From handling, storage, use or
spillage of hazardous materials
Yes All the raw material shall be stored
separately in designated storage area with
safety. Bund walls shall be provided around
raw materials storage tanks for containing
any liquid spillage.
Please refer Annexure: 8.
7.2
From discharge of sewage or other
effluents to water or the land
(expected mode and place of
discharge)
Yes Sewage shall be treated in Septic Tank &
Soak Pit.
7.3
By deposition of pollutants emitted
to air into the land or into water
No --
7.4 From any other sources No --
7.5 Is there a risk of long term build up
of pollution in the environment from
these sources?
No --
8. Risks of accident during construction or operation of the Project, which could affect human
health or the environment:
Sr.
No.
Information/Checklist confirmation
Yes/
No?
Details thereof (with approximate
quantities / rates, wherever possible) with
source of information data
8.1 From explosions, spillages, fires etc
from storage, handling, use or
production of hazardous substances
Yes Please refer Annexure: 8
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 --
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
10
activities in the locality
Sr.
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.
laities, 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
No Site is having the entire required
infrastructure.
Existing road infrastructure & power supply
are to be utilized.
Local people will be employed and no
housing is required.
Please refer Annexure: 9.
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
--
*(III) Environmental Sensitivity
Sr.
No.
Information/Checklist confirmation Name /
Identity
Aerial distance (within 5 km) Proposed
Project Location Boundary.
1 Areas protected under international
conventions national or local
legislation for their ecological,
landscape, cultural or other related
value
No Proposed expansion project site is within
the GIDC, Ankleshwar.
2 Areas which are important or sensitive
for Ecological reasons - Wetlands,
watercourses or other water bodies,
coastal zone, biospheres, mountains,
forests
No Proposed expansion project site is within
the GIDC, Ankleshwar.
3 Areas used by protected, important or
sensitive species of flora or fauna for
breeding, nesting, foraging, resting,
over wintering, migration
No --
4 Inland, coastal, marine or underground
waters
Yes River Narmada = 7.6 kms
11
5 State, National boundaries No --
6 Routes or facilities used by the public
for to recreation or other tourist,
pilgrim areas.
Yes Public transportation
7 Defense installations No --
8 Densely populated or built-up area Yes Ankleshwar City around 1.2 km from the
proposed expansion project site.
9 Areas occupied by sensitive man-made
land community facilities)
No --
10 Areas containing important, high
quality or scarce resources (ground
water resources, surface resources,
forestry, agriculture, fisheries, tourism,
tourism, minerals)
No
--
11 Areas already subjected to pollution or
environmental damage. (those where
existing legal environmental standards
are exceeded)
Yes Ankleshwar
12 Areas susceptible to natural hazard
which could cause the project to
present environmental problems
(earthquake s, subsidence ,landslides,
flooding erosion, or extreme or
adverse climatic conditions)
No --
IV). Proposed Terms of Reference for EIA studies: Please refer Annexure: 10.
12
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: Nov 06, 2017
Place: GIDC, Ankleshwar
For Adarsh Dye Chem (Unit-II)
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.
13
ANNEXURES
1 PLANT LAYOUT
2 LIST OF PRODUCTS WITH PRODUCTION CAPACITY AND RAW MATERIALS
3 BRIEF MANUFACTURING PROCESS, CHEMICAL REACTION AND MASS BALANCE WITH
FLOW DIAGRAM
4 WATER CONSUMPTION AND EFFLUENT GENERATION
5 DETAILS OF PROPOSED EFFLUENT TREATMENT PLANT
6 DETAILS OF INHOUSE MEE
7 DETAILS OF HAZARDOUS SOLID WASTE MANAGEMENT AND DISPOSAL
8 DETAILS OF STACK & VENTS
9 DETAILS HAZARDOUS CHEMICAL STORAGE FACILITY
10 SOCIO - ECONOMIC IMPACTS
11 PROPOSED TERMS OF REFERENCES
12 GIDC PLOT ALLOTMENT LETTER
13 GIDC WATER SUPPLY LETTER
14 TSDF & CHWIF MEMBERSHIP
15 TOPOSHEET
16 Copy of CCA
17 Copy of EC
14
ANNEXURE: 1
PLANT LAYOUT
15
ANNEXURE: 2
LIST OF PRODUCTS WITH PRODUCTION CAPACITY
Sr
No Existing Product Cas No.
Existing
Capacity
(MT/
Month)
Additional
Capacity
(MT/
Month)
Total
Capacity
(MT/
Month)
End Use
1. 2-Chloro Ethyl Amine
Hydrochloride 0000870-24-6
7.0 --
2. N,N-Bis [(2-Chloro Ethyl)
Amine] Hydrochloride
0000821-48-7
4.0 --
3. 1-(4-Hydroxy Phenyl)
Piperazine Hydrochloride
0056621-48-8
12.0 --
23.0 Pharma
TOTAL ( EXISTING PRODUCTS) 23.0 -- 23.0
Proposed Product
1. Ketoconazole and its intermediates
65277-42-1
a. Cis-Tosylate 154003-23-3
b. Para-Hydroxylphenyl-n-
acetyl piperazine 67914-60-7
c. Cis-Bromobenzoate 61397-56-6
2. Itraconazole and its intermediates
84625-61-6
a. Triazole alcohol --
b. Cis-mesylate 67914-86-7
3. 2-Chloroacetamide 79-07-2
4. Fluconazole and its intermediates
86386-73-4
86404-63-9 a.
1-(2,4-Difluorophenyl)-1-
(1H-1,2,4- triazole-1yl)-
ethanone (DFTA)
b.
2-(2,4-Difluorophenyl)-1-
(1H-1,2,4-triazole-1yl)
2,3Epoxy propane-
Methane sulphonate
(EPOXY MESYLATE)
86386-77-8
5. Trazodone 19794-93-5
a. 1-(3-
chlorophenyl)piperazine 6640-24-0
b.
1-(3-chlorophenyl)-4-(3-
chloropropyl)piperazine
hydrochloride
52605-52-4
6. Aripiprazole 129722-12-9
-- 20.0 20.0 Pharma
16
a. 1-(2,3- Dichlorophenyl)
piperazine hydrochloride 119532-26-2
b. 7-(4-bromobutoxy)-3 4-
dihydro-2(1h)-quinolinone 129722-34-5
7.
1-[2-(2-
Hydroxyethoxy)ethyl]pipe
razine
13349-82-1
TOTAL (PROPOSED PRODUCTS) -- 20.0 20.0
TOTAL ( EXISTING + PROPOSED PRODUCTS) 23.0 20.0 43.0
17
List of Raw Material
Existing Products:
Sr. No. Raw Material Quantity
(MT/MONTH)
Cas No.
1. 1-(4-Hydroxy Phenyl) Piperazine Hydrochloride
Di Ethanol amine 22.6 111-42-2
EDC 14.1 107-06-2
Thionyl Chloride 3.5 7719-09-7
Caustic Lye (40% solution) 42.4 1310-73-2
Methanol 13.6 67-56-1
Acetic Anhydride 21.9 108-24-7
Toluene 7.1 108-88-3
2. 2-Chloro Ethyl Amine Hydrochloride
Monoethanolamine 4.4 141-43-5
Thionyl chloride 9.6 7719-09-7
NaOH 1.1 1310-73-2
EDC 13.1 107-06-2
3. N,N- Bis (2-Chloro Ethyl) Amine Hydrochloride
DiEthanolamine 2.5 111-42-2
Thionyl chloride 5.5 7719-09-7
NaOH 0.625 1310-73-2
EDC 7.5 107-06-2
Proposed Products:
Sr. No. Raw Materials Quantity
(MT/MONTH)
Cas No.
1. KETOCONAZOLE AND ITS INTERMEDIATES
Cis Bromo benzoate 30.6 61397-56-6
Imidazole 13.0 288-32-4
DMF 1.4 68-12-2
Sodium Bicarbonate 5.8 144-55-8
P-toluene sulfonyl chloride 18.2 98-59-9
Methylenechloride 7.6 70110-03-1
18
Sodium carbonate- anhydrous
Monohydrate
decahydrate
12.0
497-19-8
5968-11-6
6132-02-1
Carbon 1.0 7440-44-0
Vacuum salt 0.2 7647-14-5
Sodium hydroxide 6.6 1310-73-2
Hydrochloric acid 6.6 7647-01-0
Acetone 1.6 67-64-1
Toluene 2.6 108-88-3
Sodium methoxide powder 2.8 124-41-4
Dimethyl sulfoxide 2.6 67-68-5.
Para hydroxyl phenyl N-acetyl piperazine 11.2 67914-60-7
Ethyl acetate 7.8 141-78-6
Methanol 2.8 67-56-1
PARA-HYDROXYLPHENYL-N-ACETYL PIPERAZINE
Bis(2-chloroethyl)amine HCL 28.0 821-48-7
Para amino phenol 20.0 123-30-8
Acetic anhydride 20.0 203-564-8
Sodium hydroxide 25.4 1310-73-2
Carbon 0.4 7440-44-0
Methanol 7.6 67-56-1
CIS-BROMO BENZOATE 61397-56-6
2,4-Dichloroacetophenone 13.3 937-20-2
Benzoyl Chloride 12.4 98-88-4
Bromine 12.5 7726-95-6
CS Flakes 4.8 1310-73-2
Glycerin 7.2 56-81-5
Liq. Ammonia 10.0 1336-21-6
Methanol 57.9 67-56-1
N- Butanol 4.0 71-36-3
PTSA ( p-Toluenesulfonic acid)
0.4 104-15-4 6192-52-5
(monohydrate)
Sodium Bicarbonate 0.8 144-55-8
TEBAC 0.3 80904-15-0
19
2. ITRACONAZOLE AND ITS INTERMEDIATES
1-(4-Methoxy) piperidine 20.4 4045-24-3
1H,1,2,4-Triazole 16.6 63598-71-0
2-Bromo butane 7.8 78-76-2
Acetone 1.3 67-64-1
Carbon 1.8 7440-44-0
Cis-Bromobenzoate 26.2 61397-56-6
Dimethyl formamide 10.5 68-12-2
Ethyl acetate 2.8 141-78-6
Formamidine acetate 15.0 3473-63-0
Hydragin hydrate 15.3 7803-57-8
Hydrobromic acid 6.2 10035-10-6
Hydrochloric acid 9.0 7647-01-0
Hydrogen gas 2.4 1333-74-0
Hyflow supercell 1.6 68855-54-9
Methane sulfonyl chloride 9.0 124-63-0
Methanol 6.0 67-56-1
Methylene chloride 3.0 70110-03-1
n-Butanol 0.6 71-36-3
Palladium carbon 0.0 7440-05-3
Paranitro chlorobenzene 16.8 100-00-5
Phenyl chloroformate 18.5 1885-14-9
Potassium carbonate 55.0 584-08-7
Potassium hydroxide 12.2 1310-58-3
Soda ash 20.4 497-19-8
Sodium bicarbonate 16.7 144-55-8
Sodium hydroxide 4.1 1310-73-2
Toluene 2.1 108-88-3
Triethyl amine 9.5 121-44-8
3. 2-CHLOROACETAMIDE
Ammonia solution 48.3 1336-21-6
Methyl 2-chloroacetate
25.0 4755-81-1
20
4. FLUCONAZOLE AND ITS INTERMEDIATES
1,2,4-Triazole 13.2 288-88-0
1,3-Difluorobenzene 16.0 372-18-9
4-Amino-1,2,4-Triazole 13.0 584-13-4
Aluminium Chloride 19.2 7446-70-0
Ammonia Solution 67.2 1336-21-6
Carbon 1.2 7440-44-0
Chloroacetyl chloride 16.8 79-04-9
Citric acid 1.2 77-92-9
Hydrochloric acid 40.4 7647-01-0
Hyflow supercell 1.0 68855-54-9
IPA 63.2 67-63-0
Methylene chloride 96.0 70110-03-1
Potassium Hydroxide 18.8 1310-58-3
Sodium bicarbonate 1.2 144-55-8
Sodium Nitrite 9.4 7632-00-0
Toluene 168.0 108-88-3
Trimethyl sulphoxonium Iodide 26.4 1774-47-6
5. Trazodone Hydrochloride
Diethanolamine 10.3 111-42-2
Ethylene di chloride 21.3 107-06-2
Meta -chloroaniline 12.1 108-42-9
Sodium hydroxide 28.2 1310-73-2
toluene 7.9 108-88-3
IPA- HCl 14.3 7647-01-0
1-bromo-3-chloropropane 8.3 109-70-6
2-chloropyridine 12.9 109-09-1
1, 2, 4-triazolo [4,3-a] pyridine -3-(2H)-one 22.2 6969-71-7
acetone 60.0 67-64-1
Thionyl chloride
23.8
7719-09-7
21
6. Aripiprazole
Diethanolamine 10.3 111-42-2
Ethylene di chloride 21.3 107-06-2
2.3 -Dichloroaniline 15.5 Not available
Sodium hydroxide 12.6 1310-73-2
Xylene 23.7 1330-20-7
DMF 31.7 68-12-2
1,4-dibromo butane 9.9 110-52-1
Tryethylamine 12.9 121-44-8
7-(4-bromobutoxy)-3,4-dihydroquinolin-2(1H)-one 9.9 129722-34-5
Acetone 23.7 67-64-1
Thionyl chloride 20.5 7719-09-7
7. 1-[2-(2-Hydroxyethoxy)ethyl]piperazine
Piperazine 14.3 110-85-0
2- (2-chloroethoxy) ethanol 7.0 628-89-7
Methanol 15.5 67-56-1
Sodium hydroxide 8.7 1310-73-2
22
ANNEXURE: 3
BRIEF MANUFACTRING PROCESS, CHEMICAL REACTION AND MASS BALANCE WITH FLOW
DIAGRAM
Existing Products: [1] 1-(4-Hydroxy Phenyl) Piperazine Hydrochloride
Manufacturing Process:
The mixture of Bis-(2-chloro ethylamine) hydrochloride para amino phenol ,Methanol was heated
to reflux (70-850C) & progress of the reaction was monitored by TLC.On completion the reaction
mass was cooled to 300C and further chilled to 0-5
oC when product crystallizes asoff white crystals
this product taken in reactor with water and methanol than slowly cooled 100C to 15
0C than slowly
addition acetc anhydride and progress of the reaction was monitored by TLC.On completion the
above solid was then dissolved in 30% sodium hydroxide sol. (100 ml) & warmed to 400C when a
clear sol. Was obtained.The sol. was then slowly cooled to 00C when product crystallizes as sodium
salt & thick slurry was obtained.The sodium salt of the product was isolated by filtration and
washed with chilled (00C,200ml) prior to drying at 70
0C under reduced pressure (10mm/Hg) for 12
hrs.
Chemical Reaction:
Cl
N
H
Cl
+
NH
2
HO
+
C
C
CH
3
O
O
O
H
3
C
EDC+Methanol
Bis(2-chloroethyl)amine para amino phenol acetic anydride
C
4
H
9
Cl
2
N .HCl C
6
H
10
NO C
4
H
6
O
3
(178.49) (109.12) (102.09)
N N
HO
CH
3
O
Toluene + Methanol
Sodium hydroxide
NaOH (39.99)
NH
N
+
O
H
3
C
ONa
OH
Para hydroxylphenyl-n-acetyl piperazine 1-(4-hydroxyphenyl) Sodium acetate
piperazine
C
12
H
16
N
2
O
2 (220.12)
C
10
H
14
N
2
O CH
3
COONa
(178.23) (82.03)
23
Mass balance:
INPUT QTY (kg) OUTPUT QTY (kg)
Bis HCL 160 Finish Product 85
PAP 100 Methanol Recovery 275
NaOH 25 Methanol Loss 25
EDC 300 Toluene Recover 45
Acetic anhydride 96 Toluene Loss 5
Methanol 155 Sodium Acetate 451
Toluene 50
TOTAL 886 TOTAL 886
24
[2] 2-Chloro Ethyl Amine Hydrochloride
Manufacturing Process:
In a dry GL fitted with a sealed mechanicals stirrer, an efficient reflux condenser, and addition flask
is placed of Thionyl Chloride and Ethylene Dichloride. Throughout, the entire period of operation,
as the reaction is very exothermic. Monoethanol amine is added through the flask and slow
addition.The cooled mass over a period of an hour, during which time there is a copious evolution
of sulfur dioxide. After all the Diethanol amine has been added, the cooling is stop and the reaction
mixture.
Chemical Reaction:
OH-CH2- CH2-NH2 + SOCl2 Cl-CH2- CH2-NH2.HCl + SO2
Monoethanolamine Thionyl Chloride 2-Chloro ethyl amine HCl Sulphur oxide
Or
NH2
OH
NaOH
EDCMONO ETHANOL AMINE
Cl
NH2
ClH
2-CHLOROETHYLAMINEHCL
+ T C
+NaSO4
2-chloroethanamine
Mass balance:
INPUT QTY (kg) OUTPUT QTY (kg)
Monoethanolamine 100 Finish Product 160
Thionyl chloride 220 EDC Recovery 275
NaOH 25 EDC Loss 25
EDC 300 NaSO4 40
HCl 25 % 145
TOTAL 645 TOTAL 645
EDC (Media)
25
[3] N,N, Bis (2-Chloro Ethyl) Amine Hydrochloride
Manufacturing Process:
In a dry GL fitted with a sealed mechanicals stirrer, an efficient reflux condenser, and addition flask
is placed of Thionyl Chloride and Ethylene Dichloride. Throughout the entire period of operation
the reaction is very exothermic. Diethanol amine is added through the flask and slow addition. The
cooled mass over a period of an hour, during which time there is a copious evolution of sulfur
dioxide after all the Diethanol amine has been added, the cooling is stop and the reaction mixture.
Chemical Reaction:
2(OH-CH2- CH2)NH2 + 2SOCl2 2(Cl- CH2- CH2)NH2 .HCl + SO2
Di Ethanol amine Thionyl Chloride Bis(2-Chloro ethyl)amine HCl Sulphur
oxide
Or
NH
OH
OH
NaOH
EDCDI ETHANOL AMINE
Cl
NH
Cl
ClH
N,N-BIS (2
-CHLOROETHYL)AMINEHCL
+ T C
Mass Balance:
INPUT QTY (kg) OUTPUT QTY
(kg)
DiEthanolamine 100 Finish Product 160
Thionyl chloride 220 EDC Recovery 275
NaOH 25 EDC Loss 25
EDC 300 NaSO4 40
HCl 25 % 145
TOTAL 645 TOTAL 645
EDC (Media)
26
Proposed:
1. Ketoconazole And Its Intermediates:
Manufacturing Process and Chemical Reaction:
KT-I: CBB is reacted with IMD in the presence of DMF as solvent. The reaction mass is quenched in
sodium bicarbonate solution and the product is extracted with toluene. The aqueous layer is
kept for IMD recovery. The organic layer containing the product is reacted with sodim hydroxide
solution. After completion of the reaction, the pH of the mass is adjusted with hydrochloric acid.
The mass is diluted with water and centrifuged. The wet cake is dissolved in ethyl acetate and
treated with carbon. The mass is filtered and the ethyl acetate is distilled off. The residue is
cooled and centrifuged. The mass is dried to produce KT-I
KT-II
KT-I is reacted with PTSC in the presence of sodium carbonate and methylene chloride as
solvent. The reaction mass is diluted and the organic layer separated. Methylene chloride is
distilled off completely from the organic layer and the residue is diluted with methanol and
water. The mass is centrifuges and washed with methanol and water mixture. The mass is dried
to produce Cis-Tosylate (KT-II).
27
KT-III
Cis-Tosylate (KT-II) is reacted with Para hydroxyl phenyl N-acetyl piperazine and sodium
methoxide in the presence of dimethyl sulfoxide as solvent. After completion of the reaction,
sodium hydroxide solution is charged into the reactor and maintained. The mass is centrifuged.
The wet cake is treated with water and further by acetone. The wet cake is taken for next stage.
KT-IV
The wet cake is dissolved in ethyl acetate and methanol, and treated with carbon. The mass is
filtered and the solution distilled off. The residue is cooled and centrifuged. The material is dried
to produce Ketoconazol
28
Flow Diagram:
29
30
31
Mass Balance:
Ketoconazole
Stage-I
Input Output
CBB 780.0 450.0
IMD 693.0
DMF 37.2 IMD (Rec) 360.0
Toluene 2275.5 Toluene (Rec) 2207.0
Sodium Bicarbonate 148.2 Ethyle acetate (Rec) 1620.0
Sodium hydroxide 120.0 Process loss 254.9
Water 1205.0 Aq. Effluent 2099.4
HCL 156.0 Spent carbon 12.0
Ethyl acetate 1706.4 Residue 130.0
Carbon 6.0
Vacuum salt 6.0
Total 7133.3 Total 7133.3
Stage-II
Input Output
KT-I 450.0 KT-II (Cis-tosylate) 600.0
Methylenechloride 3217.5 Methylenechloride (Rec) 3024.0
P-toluene sulfonyl chloride 465.0 Methanol (Rec) 1375.0
Sodium carbonate 307.5 Aq. Effluent 1278.0
Hydrochloric acid 12.0 Residue 120.0
Methanol 1425.0 Process loss 400.0
water 920.0
Total 6797.0 Total 6797.0
Stage-III
Input Output
Cis-tosylate (kt-II) 600.0 KT-III 650.0
Para hydroxyl phenyl n- 285.0
acetyl piperazine
Dimethyl sulfoxide 847.0 Dimethyl sulphoxide (Rec) 779.0
Sodium methoxide powder 70.0 Acetone (Rec) 300.0
Sodium hydroxide 50.0 Aq. Effluent 908.0
Acetone 340.0 Residue 59.0
Methanol 7.0 Process loss 68.0
Water 565.0
Total 2764.0 Total 2764.0
32
Stage-IV
Input Output
KT-III 650.0 Ketoconazole 510.0
Ethyl acetate 2220.0 Ethyl acetate + Methanol (Rec) 2550.0
Methanol 464.0 Process loss 174.0
Carbon 20.0 Spent carbon 40.0
Residue 80.0
Total 3354.0 Total 3354.0
33
a. Para-Hydroxylphenyl-n-acetyl piperazine
Manufacturing Process and Chemical Reaction:
The mixture of bis - (2-chloroethylamine) hydrochloride Para Aminophenol ,Water ,Methanol
was heated to reflux (70-85oC) and progress of the reaction was monitored by TLC. On
completion the reaction mass was cooled to 30oC and further chilled to 0-5oC when product
crystallizes asoff-white crystals.
this product taken in reacter with water and methanol than slowly cooled 10oC to 15
oC than
slowly addition acetic anhydride and progress of the reaction was monitored by TLC. On
completion The above solid was then dissolved in 30 % sodium hydroxide solution (100 mL)
and warmed to 40oC when a clear solution was obtained. The solution was then slowly cooled
to 0oC when product crystallizes as sodium salt and thick slurry was obtained. The sodium salt
of the product was isolated by filtration and washed with chilled water (0oC, 200 mL) prior to
drying at 70oC under reduced pressure (10 mm/Hg) for 12 hours.
Flow Diagram:
34
Mass Balance:
Input Quantity Output Quantity
Para amino phenol 260
BISCEA HCl 364 AHPP 285
Acetic anhydride 260 Waste water 1251
Sodium hydroxide 332 Methanol (Rec) 80
Water 300.5 Spent carbon 8
Methanol 100.5
Carbon 7
TOTAL 1624 1624
35
b. CIS-BROMO BENZOATE:
Manufacturing Process and Chemical Reaction:
Stage-I:
Charge toluene, 2,4-dichloroacetophenone and glycerin onto a stainless steel reactor. Charge
PTSA and water into the reactor, and heat the mass to reflux. Maintain the mass at reflux for 24
hours. After completion of the reaction, cool the mass below 35°C and transfer the mass to a
glass lined reactor. Charge n-butanol in the reactor containing the mass and cool below 15°C.
Slowly add bromine into the reactor and maintain the mass below 15°C. After completion of
the reaction, adjust the pH of the mass to 8 with liquor ammonia. Charge water into the
reactor, stir and settle. Separate the organic layer and wash with water. Meanwhile, charge
water and sodium hydroxide into a stainless steel reactor. Transfer the organic layer from GL
reactor into the SS reactor. Cool the mass and
charge TEBAC. Add benzoyl chloride slowly into the reactor below 20°C and maintain. After
completion of the reaction, settle the mass. Separate the organic layer and wash with sodium
bicarbonate solution followed by water. Distill off toluene completely and dilute the residue
with methanol. Cool the mass and centrifuge. Dry the material at 60 – 65°C to produce Cis-
bromo benzoate.
36
Flow Diagram:
Stage-1:
37
Mass Balance:
Stage-I
Input Quantity Output Quantity
2,4-DCAP 500 Cis-Bromo benzoate 750
Benzoyl Chloride 464
Bromine 468 Methanol (Rec) 1868
Glycerin 271 Aq. HBR (HBR Rec) 1000
Liq. Ammonia 374.5 Spent solvent 465
Methanol 2172.5 Aqueous effluent 1622
N- Butanol 150 Residue 25
PTSA 13.5 Process loss 111
Sodium Bicarbonate 30
TEBAC 9.5
Toluene 1720
Water 1035
Total 7389 Total 7389
38
2. ITRACONAZOLE AND ITS INTERMEDIATES:
Manufacturing Process and Chemical ReactionITR-INT-A
Stage-I:
Charge dimethyl formamide, cis-2[bromomethyl-2-(2,4 dichlorophenyl)1,3 dioxalane-4-yl)methyl
benzoate and 1H-1,2,4 triazole into a reactor. Charge sodium hydroxide solution into the reactor.
Heat to reflux and maintain for 8 hours. After completion of reaction, cool the mass below 35°C
and charge potassium carbonate. Stir the mass for 30 minutes and filter. Charge the filtrate and
distill off DMF completely. Charge water and toluene into the reactor and stir for 30 minutes.
Discard the bottom aqueous layer to ETP. Cool the organic layer to 10-15°C. Centrifuge the material
and wasn with toluene. Dry the material at 60-65°C to produce Cis-[2-(2,4-dichlorophenyl)-2-
(1H,1,2,4-triazol-1yl methyl)1,3 dioxolan-4yl]methanol.
Stage-II:
Charge methylene dichloride, Step-I compound and triethyl amine into a reactor. Slowly add
methane sulfonyl chloride into the reactor at 10-15°C. After completion of the reaction, charge
water and stir for 30 minutes. Separate the layers. Charge organic layer in to the reactor and
charge carbon. Stir for 30 minutes and filter the mass into another reactor. Add hydrochloric acid
into the reactor at 25-30°C. Cool the mass to 10-15°C. Centrifuge and wash with methylene
dichloride. Dry the material at 45-50°C to produce Cis-[2-(2, 4 - dichlorophenyl) - 2 - (1H,1, 2, 4 -
triazol - 1yl- methyl) 1,3-dioxolan-4yl]-methyl methane sulfonate (ITR-INT-A).
39
ITR-INT-B
Stage-I:
Charge dimethyl formamide, potassium carbonate and 1-(4-Methyxy) piperadine into a reactor.
Heat the mass to 60-65°C. Add paranitro chlorobenzene for 3-4 hours at same temperature. After
completion of the reaction distill off the dimethyl formamide completely. Cool the mass and charge
methanol ad carbon into the reactor. Maintain the mass for 30 minutes at 50-55°C and filter into
another reactor. Cool the filtrate to 10-15°C and centrifuge. Wash the material in water. Slurry
wash the cake with acetone to produce 1-(4-Methoxyphenyl)-1-(4-nitrophenyl) piperazine.
Stage-II:
Charge DMF, palladium carbon and 1-(4-Methoxyphenyl)-1-(4-nitrophenyl) piperazine into the
reactor. Heat the mass to 50-55°C. Pass hydrogen gas for 18 hours. After completion of the
reaction, cool the mass below 35°C and filter the mass. Cool the filtrate to 0-5°C and maintain.
Centrifuge the mass to produce 1-(4-Methoxyphenyl)-1-(4-aminophenyl) piperazine.
Stage-III + IV:
Charge Methylene chloride and 1-(4-Methoxyphenyl)-1-(4-aminophenyl) piperazine compound into
a reactor. Heat the mass to 35-45°C. Add phenyl chloroformate for 5-6 hours at same temperature.
After completion of the reaction, charge water into the reactor. Separate the layers. Discard
aqueous layer and charge organic layer. Distill off Methylene chloride completely and charge n-
butanol into the reactor. Heat the mass to 55-60°C. Add hydrazine hydrate into the reactor.
maintain for 4 hours at same temperature and cool the mass. Centrifuge the mass and wash with n-
40
butanol to produce 2,4-Dihydro-4-[4-[(4-methoxyphenyl)-1-piperazinyl] phenyl hydrazine
carboxamide.
Stage-V:
Charge DMF and carboxamide compound into the reactor and heat to 70-75°C. Add formanidine
acetate into the reactor slowly. After completion of the reaction, cool the mass and centrifuge, to
produce 2,4-Dihydro-4-[4-[(4-methoxyphenyl)-1-piperazinyl phenyl]-3H-1,2,4-triazole-3
Stage-VI:
Charge 2-bromobutane, potassium carbonate and triazole compound into a reactor. Heat to reflux
and maintain for 8 hours. After completion of reaction filter the mass and distill off 2-bromebutane
completely. Charge DMF into the reactor and acedify the mass with hydrochloric acid. Centrifuge
the material and wash with DMF to produce 2,4-Dihydro-4-[4-[(4-methoxyphenyl)-1-piperazinyl
phenyl]-2-(1-methylpropyl)-3H-1,2,4-triazole-3-one
41
Stage-VII: Charge hydrobromic acid and stage-VI compound into a reactor and heat the mass to reflux. After
completion of the reaction, distill off HBr completely and charge water into the reactor. Neutralize
the mass with soda ash. Centrifuge the mass and wash with water to produce 2,4-Dihydro-4-[4-[(4-
hydroxyphenyl)-1-piperazinyl] phenyl]-2-(1-methylpropyl)-3H-1,2,4-triazole-3-one (ITR-INT-B)
ITRA-Stage-I/II/III Charge water, potassium hydroxide, Cis-(2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-yl-methyl)-
1,3-dioxalane-4-yl) methyl methane sulfonate and 2,4-Dihydro-4-[4-[(4-hydroxyphenyl)-1-
piperazinyl] phenyl]-2-(1-methylpropyl)-3H-1,2,4-triazole-3-one into the reactor. Heat the mass to
80-85°C and maintain for 6 hours. Cool the mass below 35°C and centrifuge. Charge the cake and
DMF into a reactor and maintain for 1 hour ar room temperature. Centrifuge the mass and wash
with DMF to produce Itraconazole Crude. The crude is treated with toluene, methanol and ethyl
acetate and carbon to produce Itraconazole pure.
42
43
44
45
46
47
48
49
50
Mass Balance:
ITR-INT-A Stage-I
INPUT Quantity OUTPUT Quantity
Cis-Bromobenzoate 111.3 Triazole derivative 95.8
1H,1,2,4-Triazole 70.4 Solvent rec (DMF) 181.7
Potassium carbonate 105.7 Solvent rec (Tol) 153.3
Dimethyl formamide 186.7 Aq. Effluent 324.3
Sodium hydroxide 10.6 Residue 64.5
Toluene 157.4
Water 186.7 Solvent loss 9.1
Total 828.7 Total 828.7
Stage-II
INPUT Quantity OUTPUT Quantity
Triazole derivative 95.8 ITR-INT-A 101.5
Triethyl amine 40.2 Solvent rec (MDC) 187.0
Methane sulfonyl chloride 38.3
Methylene chloride 193.8 Aq.effluent 192.0
Carbon 3.8 Spent carbon 7.7
Sodium hydroxide 6.9 Residue 56.2
51
Water 172.4 Solvent loss 6.8
Total 551.2 Total 551.2
ITR-INT-B
Stage-I
INPUT Quantity OUTPUT Quantity
1-(4-Methyxy) piperadine 86.9 Stage-I 132.4
Paranitro chlorobenzene 71.2 Solvent Rec (Methanol) 198.9
Potassium carbonate 77.1 Solvent Rec (Acetone) 200.2
Dimethyl formamide 101.5 Solvent Rec (DMF) 98.1
Methanol 203.3 Aq. Effluent 176.5
Acetone 205.7 Spent carbon 3.5
Carbon 1.7 Residue 54.8
Water 130.3 Solvent loss 13.3
Total 877.7 Total 877.7
Stage-II
INPUT Quantity OUTPUT Quantity
Stage-I 132.4 Stage-II 118.3
Dimethyl formamide 238.4 Solvent Rec (DMF) 231.4
Palladium carbon 0.1 Gas loss 5.0
Hydrogen gas 10 Residue 19.2
Solvent loss 7.0
Total 380.9 Total 380.9
Stage-III+IV
INPUT Quantity OUTPUT Quantity
Stage-II 118.3 Stage-IV 136.0
Phenyl chloroformate 78.6 Solvent Rec (MDC) 240.0
Sodium bicarbonate 71.0 Solvent Rec (Butanol) 145.2
Methylene chloride 246.0 Aq. Effluent 450.8
Hydragin hydrate 65.0 Residue 41.8
n-Butanol 147.8
Water 295.7 Solvent loss 8.6
Total 1022.4 Total 1022.4
Stage-V
INPUT Quantity OUTPUT Quantity
Stage-IV 136.0 Stage-V 121.2
Formamidine acetate 63.6 Solvent Rec (DMF) 380.3
Dimethyl formamide 390.0 Residue 78.3
Solvent loss 9.7
Total 589.5 Total 589.5
52
Stage-VI
INPUT Quantity OUTPUT Quantity
Stage-V 121.2 Stage-VI 92.9
2-Bromo butane 125.2 Solvent Rec (DMF) 349.7
Potassium carbonate 51.0 Solvent Rec (2-BB) 92.0
Dimethyl formamide 357.0 Residue 148.8
Hydrochloric acid 38.3 Solvent loss 9.4
Total 692.8 Total 692.8
Stage-VII
INPUT Quantity OUTPUT Quantity
Stage-VI 92.9 ITR-INT-B 78.0
Hydrobromic acid 961.9 Hydrobromic acid rec 935.5
Soda ash 86.7 Aq. Effluent 476.6
Water 359.0 Solvent loss 10.4
Total 1500.5 Total 1500.5
Itraconazole
Stage-I
INPUT Quantity OUTPUT Quantity
ITR-INT-B 78 IT-I 125
ITR-INT-A 101.5 Solv. Recovery (DMF) 578
Water 287.5 Aq. Effluent 380.5
N,N-Dimethyl formamide 590 Residue 13.5
Potassium hydroxide 52 Solvent loss 12
Total 1109 Total 1109
Stage-II
INPUT Quantity OUTPUT Quantity
Stage IT-I 125 Itraconazole 85
Toluene 165 Solv. Recovery (Tol) 160
Ethyl acetate 432 Solv. Recovery (EA) 420
Methanol 695.9 Solv. Recovery (Me) 675
Carbon 2.3 Residue 34.1
Hyflow supercell 6.7 Spent Carbon 4.6
Spent hyflow 10.3
Solv. Loss 37.9
Total 1426.9 Total 1426.9
53
3. 2-CHLOROACETAMIDE
Manufacturing Process:
Stage-I:
Charge Ammonia solution into the reactor and cool to 0°C. Add Methyl 2-chloroacetate slowly in
the reactor below 10°C. Maintain and centrifuge the mass. Wash the material with water and dry
to produce 2-Chloroacetamide.
Chemical Reaction:
Flowchart:
54
Mass Balance:
55
4. FLUCONAZOLE AND ITS INTERMEDIATES Manufacturing Process and Chemical Reaction:
Stage-I Charge Methylene dichloride and aluminium chloride into the reactor. Cool the mass to below
5°C. charge 1,3-Difluorobenzene into the reactor. Add slowly chloroacetyl chloride into the
reactor for 4 to 5 hours below 10°C. Charge water into another reactor and cool below 5°C.
Charge the reaction mass to ice and hydrochloric acid, slowly maintaining the temperature
below 10°C. Stir the reaction mass for 4 hours and separate the layers. Wash the organic layer
with sodium bicarbonate solution. Distill off MDC completely below 50°C. Charge isopropyl
alcohol and 4-amino-1,2,4-triazole into the reactor and maintain for 6 hours at 45-50°C. Cool
the reaction mass to 10°C and centrifuge the material and dry to produce 2-(1H-1,2,4-triazole-
1-yl)-2’,4’-difluoroacetophenone salt.
Stage-II 1-(2,4-difluorophenyl)-2-(1H,1,2,4-Triazol-1-yl) ethanone.
Charge water, sodium nitrite and 2-(1H-1,2,4-triazole-1-yl)-2’,4’-difluoroacetophenone into the
reactor and heat to 50-60°C. Slowly add hydrochloric acid at 50-60°C and maintain for 12
hours. Cool the mass below 20°C and neutralize the reaction mass with ammonia solution.
Centrifuge the mass and wash with water. Dry the material to produce 1-(2,4-difluorophenyl)-
2-(1H,1,2,4-Triazol-1-yl) ethanone.
56
Stage-III & IV Charge Toluene, 1-(2,4-difluorophenyl)- 2-(1H,1,2,4-Triazol-1-yl) ethanone, potassium hydroxide,
1,2,4,-Triazole and Trimethyl sulphoxinium iodide into the reactor. Heat to reflux and maintain for
12 hours. Distill off Toluene completely. Cool the reaction mass and charge water into the reactor.
Charge toluene into the reactor and stir for 30 minutes. Settle the mass for 30 minutes. Separate
the layers. Discard the bottom aqueous layer. Cool the mass to 10°C and centrifuge. Dry the
material to produce Flucnazole crude.
Charge water, crude and ammonia solution into the reactor. Check complete dissolution and charge
carbon. Stir for 30 minutes and filter over hyflow bed. Charge toluene and citric acid. Neutralize the
mass with hydrochloric acid. Stir for 30 minutes and settle for 30 minutes. Separate the layers and
discard aqueous layer. Cool the mass. Centrifuge the mass and wash with toluene. Dry the material
to produce Fluconazole pharma.
57
Flowchart:
58
59
60
Mass Balance:
Stage-I
Input Output
1,3-Difluorobenzene 200 Stage-I Compound 480
Aluminium Chloride 240 Solvent Recovery (MDC) 1050
Methylene chloride 1200 Solvent Recovery (IPA) 740
Chloroacetyl chloride 210 Solvent loss 202
4-Amino-1,2,4-Triazole 162 AlCl3 gel for Rec. 1100
IPA 790 Aq. Effluent 490
Sodium bicarbonate 15 Residue 30
Hydrochloric acid 75
Ice & Water 1200
Total 4092 Total 4092
Stage-II
Input Output
Stage-I Compound 480 Stager-II 370
Sodium Nitrite 118
Hydrochloric acid 250
Water 1100 Aq. Effluent 1778
Ammonia Solution 200
Total 2148 Total 2148
Stage-III
Input Output
Stage-II 370 Stage-III 370
Trimethyl sulphoxonium Iodide 330
1,2,4-Triazole 165 Solvent recovery (Toluene) 550
Potassium Hydroxide 235 Aq. Effluent 1170
Toluene 600 Residue 50
Water 500 Solvent loss 60
Total 2200 Total 2200
61
Stage-IV
Input Output
Stage-III Material 370 Fluconazole 250
Toluene 1500 Solvent rec (Tol) 1428
Carbon 15 Aq. Effluent 1478
Citric acid 15 Spent carbon 30
Ammonia solution 640 Spent hyflow 24
Hydrochloric acid (CP) 180 Residue 50
Hyflow supercell 12
Water 600 Solvent loss 72
Total 3332 Total 3332
62
5. Trazodone Hydrochloride
Manufacturing Process and Chemical Reaction:
TH- I
In first part of the process bis-(2-chloroethylamine) hydrochloride (Compound P) is prepared by
chlorination of diethanolamine with thionyl chloride in ethylene di chloride which is then
temperature 65 to 70 C which is then condensed with 3-chloro aniline to get 1-(3-
chlorophenyl)-piperazine hydrochloride
STAGE –II (1-(3-chlorophenyl)-4-(3-chloropropyl) piperazine)
1-(3-chlorophenyl)-piperazine hydrochloride intermediate (Compound Q). This is reacted with
3-bromo-3-chloropropane in alkaline aqueous acetone (50 %) gave various 1-(3-
chlorophenyl)-4-(3-chloropropyl) piperazine intermediate (Compound R)
63
Stage – III
In second part of the process, 1-(3-chlorophenyl)-4-(3-chloropropyl) piperazine is condensed with sodium salt of 1, 2, 4-triazolo [4, 3-a] pyridine-3- (2H)-one (Compound S) 1-(3-chlorophenyl)-4-(3-chloropropyl) piperazine (R) and of Trazodone Hydrochloride (T) reported in the literature and observed in the lab are 84-85%, 72-73%, 84-85% respectively. The intermediate 1, 2, 4-triazolo [4, 3-a] pyridine-3- (2H)-one (S) is obtained in >90 % yield and in desired purity. But the process involves long reaction hours (>12) and elevated temperature (145-150
0C).
64
Flowchart:
Mass Balance:
Stage-I
Input Output
Diethanolamine 262
Stage-I Compound 308
Ethylene dichloride 540 Solvent Recovery (EDC) 430
Thionyl chloride 604
Sodium hydroxide 305 Sodium sulpate + water 1581
water 562 Residue 60
3-Chloroaniline 308
Solvent loss 202
Total 2581 Total 2581
65
Stage-II
Input Output
Stage-I Compound 308 Stage-II Compound 361
3-bromo-3-chloropropane 209 Solvent Recovery (Acetone) 530
Acetone 604 Sodium bromide + water 136
Sodium hydroxide 205 Sodium chloride + water 557
water 362 Residue 30
Solvent loss 74
Total 1688 Total 1688
Stage-III
Input Output
Stage-II Compound 361 Stage-III Compound 507
1, 2, 4-triazolo 568 Solvent Recovery (Acetone) 730
Acetone 904 IPA 203
Sodium hydroxide 205 Sodium chloride + water 657
IPAHCL 362 Residue 80
Solvent loss 174
Total 2400 Total 2400
66
6. Aripiprazole
Manufacturing Process and Chemical Reaction:
STAGE – I (1-(2,3-Dichlorophenyl)piperazine hydrochloride)
In first part of the process bis-(2-chloroethylamine) hydrochloride (Compound A) is prepared by
chlorination of diethanolamine with thionyl chloride in xylene, which is then condensed with
2,3-dichloro aniline to get 1-(2,3-dichlorophenyl)-piperazine hydrochloride intermediate
STAGE – II (7-(4-bromobutoxy)-3 4-dihydro-2(1h)-quinolinone)
The intermediate, 7-(4- bromobutoxy)-3, 4-dihydro-2(1H)-quinolinone (D) is prepared by
condensation of 7-hydroxy-3, 4-dihydro-2(1H)-quinolinone (Compound C) with dibromobutane
in DMF using potassium carbonate as base.
67
STAGE –III
The yields of 1-(2, 3- dichlorophenyl)-piperazine hydrochloride (B), 7-(4- bromobutoxy)-3,4-
dihydro-2(1H)- quinolinone (D) WITH TRA and NaOH after tempature Aripiprazole
68
Flowchart:
69
PMass Balance:
Stage-I
Input Output
Diethanolamine 262 Stage-I Compound 392
Ethylene dichloride 540 Solvent Recovery (EDC) 430
Tionyl chloride 604
Sodium hydroxide 305 Sodium sulpate + water 1581
Xylene 562 Residue 60
2,3-diChloroaniline 392
Solvent loss 202
Total 2665 Total 2665
Stage-II
Input Output
7-(4-bromobutoxy)-3,4-
dihydroquinolin-2(1H)-one 250 Stage-II Compound 361
1-bromo-3-bromopropane 392 Solvent Recovery (DMF) 730
DMF 804 Sodium bromide + water 236
Potasuim carbonate 205
water 362 Residue 60
Solvent loss 74
Total 2041 Total 2041
Stage-III
Input Output
Stage-I Compound 392 Stage-III Compound 507
Stage-II Compound 361 Solvent Recovery (TEA) 830
Tryethylamine 904
Sodium hydroxide 205 Sodium chloride + water 271
Residue 80
Solvent loss 174
Total 1862 Total 1862
70
7. 1-[2-(2-Hydroxyethoxy)ethyl]piperazine
Manufacturing Process:
Piperazine monohydrochloride prepared with 2- (2-chloroethoxy) ethanol in was added the
reaction solvent, wherein the piperazine monohydrochloride and 2- (2- The molar ratio of
added-chloroethoxy) ethanol was (piperazine 2- (2-chloroethoxy) ethanolthe use of a polar
solvent such as ethanol solvent; and an amount of ethanol is added, in a weight ratio of g / g
operator, is 2- (2-chloroethoxy) ethanol added in an amount of 2.4 times; stirring warmed to 40
° C; in at this temperature for 2 hours. 3) After completion of the reaction, distillation under
reduced pressure below 600C to remove about half of the ethanol 30 g, cooled to 15
0C, filtered ,
and the filter cake was washed with a small amount of ethanol is piperazine dihydrochloride,
500C
7 hours drying after recyclabe. 4) Step 3) The filtrate was filtered slowly heated to 90 ° C,
the0020methanol was removed in vacuo and the residue was distilled under reduced pressure
after the high purity piperazine 1- [2- (2_-hydroxyethoxy) ethyl] piperazine (HEEP) crude. 5)
Step 4) to give 1- [2- (2_-hydroxyethoxy) ethyl] piperazine (HEEP) crude vacuum distillation in
vacuum,
Chemical Reaction:
NH
NH
+Cl
OOH
N
NH
OOH
Na OH
water
piperazine
M.F.= C4H10N2
M.W = 86.13
2-(2-chloroethoxy)ethanol
M.F = C4H9ClO2
M.W.= 124.56
2-[2-(piperazin-1-yl)ethoxy]ethanol
M.F.= C8H18N2O2
M.W.= 174.24
M.W.= 39.99
+ Na Cl + OH2
M.W= 58.44
71
Flow diagram:
Mass Balance:
Stage-I
Input Output
Piperazine 392
1- [2- (2_-hydroxyethoxy) ethyl]
piperazine 507
2- (2-chloroethoxy) ethanol 195 Solvent Recovery 830
water 350 Waste water 271
Sodium hydroxide 205 Residue 80
Methanol 200 Solvent loss 174
Total 1862 Total 1862
72
ANNEXURE: 4
WATER CONSUMPTION AND WASTEWATER GENERATION
WATER CONSUMPTION
WASTEWATER GENERATION
Wastewater Generation (KL/day) Sr.
No.
Usage
Existing Additional Total
1. Industrial
Process Nil 16.0 16.0
Boiler Nil 0.5 0.5
Cooling Tower Nil 0.5 0.5
Washing Nil 1.0 1.0
Total (Industrial) Nil 18.0 18.0
2. Gardening -- -- --
3. Domestic 0.5 1.5 2.0
Total 0.5 19.5 20.0
Water Consumption (KL/day) Sr.
No.
Usage
Existing Additional Total
1. Industrial
Process 1.5 18.0 19.5
Boiler 0.5 1.5 2.0
Cooling Tower 0.5 1.5 2.0
Washing 0.0 1.0 1.0
Total (Industrial) 2.5 22.0 24.5
2. Gardening -- 0.5 0.5
3 Domestic 2.0 2.0 4.0
Total 4.5 24.5 29.0
73
WATER BALANCE DIAGRAM (EXISTING)
All figures are in KL/Day.
Raw Water: 4.5
Domestic:
2.0
Process:
1.5
Boiler:
0.5
Cooling
Tower:
0.5
Gardening:
Nil
Septic Tank
& Soak Pit:
0.5
Nil Nil
Washing:
0.0
Nil Nil
74
WATER BALANCE DIAGRAM (TOTAL = EXISTING + PROPOSED)
All figures are in KL/Day.
Raw Water: 29.0
Domestic:
4.0
Process:
19.5
Boiler:
2.0
Cooling
Tower:
2.0
Gardening:
0.5
Septic Tank
& Soak Pit:
2.0
0.5 0.5
ETP: 18.0
Washing:
1.0
1.0
Inhouse MEE
16.0
MEE salt: MEE salt
will be sent to
common TSDF site of
BEIL, Ankleshwar.
MEE condensate: MEE condensate will
be reused in industrial purpose.
75
ANNEXURE: 5
DETAILS OF EFFLUENT TREATMENT PLANT (ETP)
The details of ETP are as follows.
M/s. Adarsh Dye Chem (Unit-II) shall have an Effluent treatment plant consisting of primary
and advance treatment units. The details of ETP are as follows.
First all wastewater streams from plant shall be collected in Equalization cum Neutralization
tank (ENT-01) where the continuous addition and stirring of Caustic solution is done to maintain
neutral pH of wastewater from Caustic Dosing Tank (CDT-01) as per requirement by gravity.
Mixer is provided in the ENT-01 to keep all suspended solids in suspension and for proper
mixing.
Then, neutralized wastewater shall be pumped to Primary Settling Tank (PST-1). Alum and
Polyelectrolyte shall be dosed from Alum Dosing Tank (ADT-01) and Polyelectrolyte Dosing Tank
(PEDT-01) respectively by gravity into PST-01 to carry out coagulation by using a Mixer. Then
Mixer is stopped and effluent is allowed to settle in Primary Settling Tank (PST-01). After
Primary treatment, Clear supernatant from PST-01 shall be collected in MEE Feed Tank (TES-01)
then sent to in house MEE (MEE-01) for further treatment. MEE condensate will be collected in
Condensate Storage Tank (CST-01) before reuse in plant Slurry. Slurry shall be sent to Dryer Unit
(DU-01) for drying of solids. Salt from Dryer will be sent to common TSDF site of BEIL,
Ankleshwar.
Sludge settled in PST-01 shall be collected in Sludge Drying Beds (SDBs-01-A/B) where,
dewatering shall be carried out before storage in HWSA and ultimate disposal to TSDF.
EXPECTED CHARACTERISTICS OF WASTEWATER BEFORE & AFTER TREATMENT
Characteristics (mg/L) Sr. No. Parameter
Untreated Condensate
1. pH 4-9 6.5-8.5
2. COD < 8000 < 250
3. BOD3 < 2500 < 30
4. TSS < 200 < 30
76
Effluent Treatment Plant (Dimension):
S.N. Name of unit Size (m x m x m)
/Capacity No. MOC/ Remark
Flow 18.0 KLD
1 Equalization cum Neutralization
Tank (ENT-01)
2.6 m x 2.6 m x
(2.5 m+0.5 FB) 1
MOC = RCC M30+A/A
Bk. Lining
2 Primary Settling Tank (PST-01)
2.8 m x 1.2 m x
(2.0 m + 0.5 HB +0.3
FB)
1 RCC M30
3 MEE Feed Tank (MFT-01) 2.6 m x 2.6 m x
(2.0 m+0.5 FB) 1 RCC M30
4 Sludge Drying Beds (SDBs-01-A/B) 3.0m x 2.0 m 2 Bk. Maso. With RCC
Bedding
5 Caustic Dosing Tank (CDT-01) 1000 Lit 1 HDPE
6 Alum Dosing Tank (ADT-01) 500 Lit 1 HDPE
7 Poly Dosing Tank (PEDT-01) 250 Lit 1 HDPE
8 Multiple Effective Evaporator
(MEE)with Dewatering Unit 20.0 m
3/D 1 SS316
9 Condensate Storage Tank (CST-01) 2.6 m x 2.6 m x
(2.0 m+0.5 FB) 1 RCC M30
RCC M30 = REINFORCED CEMENT CONCRETE (M 30 GRADE)
BK.MAS. = BRICK MASONARY
HDPE = HIGH DENSITY POLY ETHELINE
SS 316 = STAINLESS STEEL 316 GRADE
77
Flow Diagram:
78
ANNEXURE: 6
DETAILS OF INHOUSE MEE
Type: Forced circulation 3 stage waste water evaporator
Capacity: 3000 Litre/hr, total
Pressures: 1st stage: 2 kg/cm2g
2nd stage: atm.
3rd stage: 600 mmhgg
Heating medium: Thermic fluid
MOC: All parts in SS 304
Technical details of MEE including evaporation capacity, steam required for evaporation,
adequacy of the proposed boiler to supply steam for evaporation in addition to the steam
required for the process etc.
� EVAPORATION SYSTEM:
List of Equipment for MVR Plant
Sr.
No. Name of Equipment Qty Tag No
Vessels
1 Liquid vapor Separator 1 V-101
2 Moisture Trap for Vacuum System 1 V-102
Pumps
3 MVR Circulation Pump 2 (1+1) P-101 A/B
4 Feed Pump 2 (1+1) P-102 A/B
5 Condensate Transfer Pump 4 (3+1) P-103 A/B/C
6 Vacuum Pump 2 (1+1) P-104 A/B
Compressor
7 Vapor Compressor 1 C-101
Heat Exchanger
8 Condenser 3 HX-101 A/B/C
9 Feed Preheater 1 HX-102
79
� Specification of Equipment for MVR Plant Vessels
Liquid Vapor Separator (V-101)
S.N. Description Specifications
1 Type Vertical Cylindrical with Dished Top and Hopper Bottom
2 Duty To receive circulating effluent through heat exchanger
and separate liquid and vapor phase.
3 Fluid Flow Inlet Liquid flow: 3000 kg/hr
Outlet Vapor flow: 300 kg/hr
Outlet Liquid flow: 2850 kg/hr
4 Operating Temperature 75 deg C, Max
5 Operating / Design
Pressure
560 / 760 mmhg g
5 Density Liquid Density: 950 kg/M3
Vapor Density: 0.1711 kg/M3
6 Tank Dimension Diameter: 1500 mm
Straight Height: 2500 mm
Hopper Height: 750 mm
7 Quantity 1
8 End Top End: Dished type
Bottom End: Hopper type
9 Inside Attachment Distributor for liquid injection / Perforated pipe type
10 Material of
Construction
Shell: MS: 8/10 mm thk (Thk calculation to be provided
for vacuum condition)
Lining: 38 mm thk, AR Tile lining with Furan based
pointing material.
11 Support Supported on lugs provided from shell of vessel
� Moisture Trap for Vacuum System (V-102)
Sr.
No. Description Specifications
1 Type Vertical Cylindrical with baffle wall arrangement
and Dished Top and Bottom End
2 Duty To Leakage Air from the System and separate
entrained liquid droplets from the system
80
3 Fluid Flow -
4 Operating Temperature 45 deg C, Max
5 Operating / Design Pressure 560 / 760 mmhg g
5 Density Vapor Density: 0.1711 kg/M3
6 Tank Dimension Diameter: 500 mm
Straight Height: 1500 mm
7 Quantity 1
8 End Top End: Dished type
Bottom End: dished type
9 Inside Attachment Baffle wall
10 Material of Construction Shell: MS: 6/8 mm thk (Thk calculation to be
provided for vacuum condition)
Lining: Epoxy Painted
11 Support Supported on lugs provided from shell of vessel
� Pumps
MVR Circulation Pump (P-101 A/B)
S. N. Description Specifications
1 Type Horizontal Centrifugal Pump
2 Quantity 2 ( 1 Operating + 1 Standby)
3 Liquid Details Fluid Name Concentrated Waste Water with
Suspended solids
Fluid Composition
TDS: 20% (consisting of chloride and
sulfates)
Water: 80%
(Suspended Solids will be in range of
0.5 to 1%)
pH: above 7.5
Temperature Operating: 70, Design: 80
Density 1000 kg/m3 (For power calculation)
Viscosity 1.1 CP
Vapour Pressure 205 mmhg a (555 mmhg g)
Corrosive Agent Chloride (pH will be maintained above
81
7.5)
Erosive Agent Suspended solids
4 Operating
Condition Duty Continuous
Capacity 3 M3/hr
Suction Head Flooded
Discharge Head 20 MLC
Differential Head 20 MLC
NPSH A 2.3 M
NPSH R *
Self Priming NA
Foot Valve NA
5 Pump
Specification Type Centrifugal, Low NPSH Pump
Stages *
Installation Horizontal
Location Outdoor
Casing Type *
Impeller Type *
Seal Mechanical Seal
Lubrication *
Cooling *
Rotation *
Coupling Direct Coupling
6 Motor/Drive Type Flame Proof
Process Power 7.63 KW
Pump Efficiency *
Shaft Power *
Motor Rating *
Motor RPM *
Voltage 415 V
Frequency 50 Hz
7 Material of
Construction Casing PTDF lined
82
Impeller PTDF lined / SS316
Shaft *
Shaft Sleeve *
Impeller Wear Ring *
Stuffing Box Cover *
Casing Wear Ring *
Bearing Housing *
Coupling *
Coupling Guard *
Base Frame MS with Epoxy painted
Casing Gasket *
Packing *
Mech Seal St Face *
Mech Seal Rot Face *
Casing Screw *
Inducer *
Throat Bush Screw *
Drip Tray *
� Effluent Feed Pump (P-102 A/B)
Sr. No. Description Specifications
1 Type Horizontal Centrifugal Pump
2 Quantity 2 ( 1 Operating + 1 Standby)
3 Liquid Details Fluid Name Waste Water
Fluid Composition
TDS: 1-2% (consisting of
chloride and sulfates)
Water: Balance%
(Suspended Solids will be
in range of < 0.1 %)
pH: above 7.5
Temperature Operating: 35, Design: 50
Density 1000 kg/m3 (For power
calculation)
Viscosity 1 CP
83
Vapour Pressure NA
Corrosive Agent Chloride (pH will be
maintained above 7.5)
Erosive Agent Suspended solids
4 Operating Condition Duty Continuous
Capacity 3, M3/hr
Suction Head Flooded
Discharge Head 20 MLC
Differential Head 20 MLC
NPSH A Flooded
NPSH R *
Self Priming NA
Foot Valve NA
5 Pump Specification Type Centrifugal
Stages *
Installation Horizontal
Location Outdoor
Casing Type *
Impeller Type *
Seal Mechanical Seal
Lubrication *
Cooling *
Rotation *
Coupling Direct Coupling
6 Motor/Drive Type Flame Proof
Process Power 0.16 KW
Pump Efficiency *
Shaft Power *
Motor Rating *
Motor RPM *
Voltage 415 V
Frequency 50 Hz
7 Material of Construction Casing SS316
84
Impeller SS316
Shaft *
Shaft Sleeve *
Impeller Wear Ring *
Stuffing Box Cover *
Casing Wear Ring *
Bearing Housing *
Coupling *
Coupling Guard *
Base Frame MS with Epoxy painted
Casing Gasket *
Packing *
Mech Seal St Face *
Mech Seal Rot Face *
Casing Screw *
Inducer *
Throat Bush Screw *
Drip Tray *
� Condensate Transfer Pump (P-103 A/B)
Sr.
No. Description Specifications
1 Type Pump suitable for transfer of steam condensate generated
from the steam condenser.
2 Quantity 2 ( 1 Operating + 1 Standby)
3 Liquid Details Fluid Name Steam condensate
Fluid Composition 100% Water with
traces of salts
Temperature Operating: 70,
Design: 80
Density < 1000 kg/m3 (For
power calculation)
Viscosity < 1 CP
Vapour Pressure Equivalent to
85
Temperature
Corrosive Agent Steam condensate
Erosive Agent NIL
4 Operating
Condition Duty Continuous
Capacity 2, M3/hr
Suction Head Flooded
Discharge Head 20 MLC
Differential Head 20 MLC
NPSH A *
NPSH R *
Self Priming NA
Foot Valve NA
5 Pump Specification Type Suitable for transfer
of steam condensate
Stages *
Installation *
Location Outdoor
Casing Type *
Impeller Type *
Seal Mechanical Seal
Lubrication *
Cooling *
Rotation *
Coupling Direct Coupling
6 Motor/Drive Type Flame Proof
Process Power 7.63 KW
Pump Efficiency *
Shaft Power *
Motor Rating *
Motor RPM *
Voltage 415 V
Frequency 50 Hz
7 Material of Casing *
86
Construction
Impeller *
Shaft *
Shaft Sleeve *
Impeller Wear Ring *
Stuffing Box Cover *
Casing Wear Ring *
� Compressors
Vapor Compressor (C-101)
Sr.
No. Description Specifications
1 Tag number C-101
2 Equipment Name Vapor Compressor
3 Type and arrangement Centrifugal Fan
4 Duty To compress Steam (Vapor)
5 Quantity 1
8 Inlet Gas Pressure -560 mmhgg / -7368 mmwcg (200 mmhga /
2632 mmwc b)
9 Outlet Gas Pressure -500 mmhgg / -6579 mmwcg (260 mmhga /
3421 mmwc b)
10 Differential Head 60 mmhg / 790 mmwc (Design 850 mmwc)
11 Inlet gas temperature Operating: 67
12 Outlet gas temperature * (Calculated 73)
Inlet Gas Details Flow,Nm3/hr
Operating: 1517.30
Design: 1805.57
Flow, Kg/hr Operating: 1218.50
Design: 1450
Flow, Am3 /hr
Operating: 7117.41
Design: 8470
Density, kg/M3 0.1712
Gas Composition 100% Steam / water
87
Mol wt 18 kg/kmol
13 Dust Content < 50 mg/NM3
14 Barometric Pressure *
16 Blower Type Centrifugal
17 Impeller Type *
18 Casing Type *
19 Bearing Type *
20 Seal Mechanical Seal (Zero Air Leakage)
21 Lubricant type *
22 Coupling Directly coupled
23 Casing Position *
24 Suction Connection *
25 Discharge Connection *
26 Base Frame Common for Blower and Motor
27 Location Outdoor, mounted on RCC Footing
� Heat Exchanger
Condenser (HX-101 A/B/C)
Sr.
No. Description Required as per Specifications
1 Type Shell and Tube Type Surface Condenser - 3
Nos in series
2 Duty To condense steam from compressor by
heating circulating waste water in tube side
3 Installation Horizontal
4 Operating Parameters (All
together for 3 nos) Tube Side Shell Side
Fluid Circulating Waste
Water Steam
Fluid Composition Salts: 20%,
Balance Water 100% Water
Flow, kg/hr 3000 300
Inlet Temperature, C 66.44 72.48
Outlet Temperature, C 70.61 72.48
88
Specific Heat, Kcal/kg-C 1 Condensing
Heat Load, Kcal/hr 677328 Kcal/hr
5 MOC Shell MS, 8 mm thk
Tube SS316 Ti
Tube Sheet SS316
Inlet and Outlet
Head SS316
Baffles MS
Baffles MS
Nut/Bolts SS316
Gaskets *
6 Nozzle details Shell side in/out AS per GAD
Tube side in/out As per GAD
Shell drain/vent As per GAD
Tube drain/vent As per GAD
7 Support Lug support (Min 3 for vertical
arrangement)
89
ANNEXURE: 7
DETAILS OF HAZARDOUS WASTE MANAGEMENT AND DISPOSAL
Sr.
No
Category
No.
Type of
waste Existing Additional Total
Disposal Method
1 33.1 Discarded
Containers
Bags: 50
Nos/Month
Drums: 30
Nos/Month
Bags: 125
Nos/Month
Drums: 45
Nos/Month
Bags: 175
Nos/Month
Drums: 75
Nos/Month
Collection, Storage,
Transportation,
Decontamination &
Disposal by selling to
registered recycler
2 5.1
Used/
Spent Oil
1
Lit./Month
1
Lit./Month
2
Lit./Month
Collection, Storage,
Transportation &
Disposal by selling to
registered recycler
3 35.3 ETP Sludge -- 2
MT/Month
2
MT/Month
4 35.3 MEE Salt -- 25
MT/Month
25
MT/Month
5 -- Spent
Hyflow --
0.1
MT/Month
0.1
MT/Month
Collection, Storage,
Transportation and
disposal in common
TSDF site of BEIL,
Ankleshwar.
6 28.1 Residue -- 1
MT/Month
1
MT/Month
7 28.3 Spent
Carbon --
0.1
MT/Month
0.1
MT/Month
Collection, Storage,
Transportation &
sent to cement
industries for co-
processing or
incineration in CHWIF
of BEIL, Ankleshwar.
8 --
Sodium
Sulphate
(30%
Solution)
30
MT/Month --
30
MT/Month
Collection, Storage,
Transportation and
sale to end user or
disposal in common
TSDF site of BEIL,
Ankleshwar.
90
ANNEXURE: 8
Details of Stack & Vents
EXISTING:
1. Details of Flue Gas Stack; Stack Attached To Boiler,
There shall be no use of fuel; hence there shall be no flue gas emission from the
manufacturing process and other ancillary operations.
2. Details of Process Vent
Sr.
No.
Stack attached
to
Stack
Height
Air Pollution
Control System
Parameter & Permissible
Limit
1 Process Vent-1 10 m Alkali & Water
Scrubber
SO2 < 40 mg/Nm3
Chlorine < 9 mg/Nm3
PROPOSED:
(1). Details of Flue Gas Stack; Stack Attached To Steam Boiler
SOURCES OF GASESOUS EMISSIONS STACK
Fuel Used Agrowaste
Capacity 1.5 T/Hr
Type of Emissions SO2 NOx SPM
Permissible Limits 100 ppm 50 ppm 150 mg/Nm3
Stack Height 18 meter
Stack Diameter at the Top 0.3 meter
Air Pollution Control Measures Multicyclone Separator and Bag Filter
91
2. Details of Flue Gas Stack; Stack Attached To D.G. Set
Sources of Gaseous Emissions D.G. Set (100 KVA)
Fuel Used Diesel
Stack Height 11 meter
Stack Diameter at The Top 0.2 meter
Type of Emissions SO2 NOx SPM
Permissible Limits 100 ppm 50 ppm 150 mg/Nm3
(2). Details of Process Vent
Sr.
No.
Stack attached
to
Stack
Height
Air Pollution
Control System
Parameter Permissible
Limit
1 Process Vent - 2 11 m Two Stage Scrubber HCl 20 mg/Nm3
2 Process Vent - 3 11 m Two Stage Scrubber SO2 40 mg/Nm3
3 Process Vent - 4 11 m Two Stage Scrubber NH3 175 mg/Nm3
92
ANNEXURE: 9
DETAILS HAZARDOUS CHEMICAL STORAGE
Sr.
No.
Name of the
Hazardous
Chemicals
Type of
Hazard
No of
Vessels
Vessel
Capacity
Maximum
Storage
(MT)
Type of
Storage &
MOC
1. Toluene Toxic/Flammable 15 200 Lit 3.0 Drums
2. Ethyl Acetate Toxic/Flammable 1 200 Lit 0.2 Drums
3. HCl Corrosive 6 200 Lit 1.2 Drums
4. Bromine Toxic 70 3 kg 0.2 Bottle
5. Hydrogen gas Flammable 1 90 kg 0.09 Cylinder
6. Methanol Flammable 7 200 Lit 1.4 Drums
7. Acetic anhydride Flammable 2 200 Lit 0.4 Drums
8. Dimethyl
Formamide Toxic/Flammable 4 200 Lit 0.8 Drums
9. Acetone Toxic/Flammable 8 200 Lit 1.6 Drums
10. Hydrobromic
Acid Corrosive 2 50 kg 0.10 Carboy
11. Thionyl Chloride Toxic 4 200 Lit 0.8 Drums
12. Liq. Ammonia Toxic 1 200 Lit 0.2 Drums
13. Xylene Toxic/Flammable 2 200 Lit 0.4 Drums
14. Ethylene
dichloride Flammable 4 200 Lit 0.8 Drums
15. Methylene
chloride Toxic 1 200 Lit 0.2 Drums
16. Benzoyl Chloride
Toxic/Flammable 1 200 Lit 0.21 Drums
17. IPA
Toxic/Flammable 5 200 Lit 1.05 Drums
18. Ammonia
solution
Toxic 10 200 Lit 1.93 Drums
93
ANNEXURE: 10
SOCIO - ECONOMIC IMPACTS
1) EMPLOYMENT OPPORTUNITIES
The manpower requirement for the proposed project is 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 project 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 project is not expected to make any significant change in the
existing status of the socio - economic environment of this region.
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ANNEXURE: 11
PROPOSED DRAFT TERMS OF REFERENCE
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.
• Water source and utilization including proposed water balance.
• Product spectrum (proposed products along with production capacity) and process
• 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 5 km
area.
• Existing environmental status Vis a Vis air, water, noise, soil in 5 km area from the project site.
For SPM, RSPM, SO2, NOx.
• Ground water quality at 5 locations within 5 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.
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.
5. Environmental Management Plan
• Details of pollution control measures
• Environment management team
• Proposed schedule for environmental monitoring including post project
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6. Risk Assessment
• Objectives 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 through occurrence & evaluation of incidents
• 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
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Annexure-12
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GIDC Plot Allotment Letter
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Annexure-12
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GIDC Plot Allotment Letter
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Annexure-13
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GIDC Water Supply Letter
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Annexure-14
__________________________________________________________________________
TSDF & CHWIF membership Letter
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Annexure-15
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Toposheet
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Annexure-16
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Copy of CCA
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Annexure-16
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Copy of EC
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