PRE-FEASIBILITY REPORT
OF
Sai-Tech pharmaceuticals Pvt. Ltd.
A-145/8,TTC Industrial Area, Khairne,Navi- Mumbai 400-705
1
CHAPTER 1
Executive Summery
Proposed project is an expansion project for downstream products the API at their
existing plant atplot no. A-145/8, Khairane MIDC, TTC Industrial Area, Navi Mumbai. It
has been decided to set up a API the capacity of 72 tons per annum for manufacturing
API of different types and grades.
Sr.
No.
Details Information
1 Site A-145/8,TTC Industrial area, Khairne, Navi- Mumbai
400-705
2 Capacity API: 72 MT / Year
3 Water Requirements 45 m3/Day
4 Power Requirements 500 KVA
5 Fuel Requirements HSD or LDO or FO will be used for boiler & HSD
for D.G. Set
HSD = 0.55 MT/ Day
HSD = 25 Lit/ Hr
6 DG Set Proposed: 250 KVA
7 Manpower 45
8 Project Cost Proposed: 6.58 CRORES
2
CHAPTER 2
Introduction of Project/ Background Information
2.1 Identification of project and project proponent
Saitech pharmaceuticals Pvt.Ltd is research driven leading supplier in the chemicals
and intermediates. We are diversifying in the field of manufacturing Active
Pharmaceutical Ingredients and its formulations which will cater the requirements of
pharmaceutical industry. The factory is located at plot no. A-145/8, Khairane MIDC,
TTC Industrial Area, Navi Mumbai. The project will be a Category 5(f)-B as per the New
EIA Notification dated. 14.09.2006.
2.2 Brief Description of nature of the Project
Proposed project is an expansion project for downstream products the API at their
existing plant at plot no. A-145/8, Khairane MIDC, TTC Industrial Area, Navi Mumbai.
It has been decided to set up a API the capacity of 72 tons per annum for manufacturing
API of different types and grades.
2.3 Need of the project and its importance to the country and or region
Saitech pharmaceuticals Pvt. Ltd is leading supplier in the chemicals and
intermediates. It is diversifying in the field of manufacturing Active Pharmaceutical
Ingredients and its formulations which will cater the requirements of pharmaceutical
industry. Saitech pharmaceuticals, is a leader in the Pharmaceutical industry by
manufacturing quality APIs and its formulations. To provide better services in terms of
quality and timely delivery that exceeds the expectations of our esteemed customers. To
build long term relationship with our customers and provide exceptional services by
pursuing business through innovation and advanced technology.
API industry has been identified as a major foreign exchange earner as the API industry
continues to grow, so does the API industry.
The global API market is driven by factors such as emerging global economy and
changing lifestyles.
Uses of Proposed API:
Sr.
no.
Product Name Therapeutic category
1 Raloxifine Hydrochloride Anti osteoporotic
2 Etoricoxib Anti-inflammatory, analgesic
3 Celecoxib Non steroidal anti-inflammatory
4 Homotaurine Advance intermediate for Acamprosate
5 Zolpidem tartrate Sedative, Hypnotic
6 Butamirate citrate Antitussive
7 Butethamate citrate Antitussive
8 Bupropion hydrochloride Anti-depressive disorder
9 Phenylephrine hydrochloride Mydriatic, Decongestant
10 Bazedoxifene acetate selective estrogen receptor modulator (SERM)
In 2015 estimated consumption of API was as below-
1. Bupropion Hydrochloride
Total Exported quantity from India : USD 2,687,285
3
Total Quantity of Export from India : 31,091
Largest Buyers:
Brazil, import value: USD 2,000,976
Canada, import value: USD 564,162
Taiwan, import value: USD 87,524
Exports By Country Total Value (USD) Total Qty. (Kg)
Brazil 20,00,976 26,335
Canada 5,64,162 3,600
Taiwan 87,524 745
2. Raloxifene Hydrochloride
Total Exported quantity from India: USD 604,240
Total Quantity of Export from India: 720 Kg
Largest Buyers:
Canada’s import value: USD 192,562
Oman’s import value: USD 182,756
Algeria’s import value: USD 62,633
Compiled Export data of Raloxifene Hydrochloride
Exports by country Total Value USD Total Qty. (KG)
Canada 1,92,562 200
Oman 182756 219
Algeria 62633 80
3. Celecoxib
Total Exported quantity from India: USD 60,632,075
Total Quantity of Export from India: 122,371,610 Kg
Largest Buyers:
United State Import value: USD 8,974,999
Israel’s Import value: USD 8,193,250
Vietnam’s Import value: USD 4,590,288
4. Etoricoxib
Total Exported Value from India: USD 5,582,124
Total Quantity of Export from India: 16,638 kg
Largest Buyers:
Bangladesh’s Import value: USD 1,384,646
Spain’s Import value: USD 871,066
Lebanon’s Import Value: USD 509,307
5. Butamirate Citrate
Total Exported Value from India: USD 9,796
Total Quantity of Export from India: 45 kg
Largest Buyers:
Argentina’s Import value: USD 5,603
Bangladesh’s Import value: USD 4,193
6. Phenylephrine Hydrochloride
Total Exported Value from India: USD 39,746
4
Total Quantity of Export from India: 212 kg
Largest Buyers: Turkey’s Import value: USD 13,371
Serbia’s Import Value: USD 9,838
Peru’s Import value: USD 8,626
7. Zolpidem Tartrate
Total Exported Value from India: USD 105,301
Total Quantity of Export from India: 240 kg
Largest Buyers: Poland’s Import value : USD 92,225
Canada’s Import Value: USD 9,768
Japan’s Import value: USD 1,976
8. Homotaurine
Total Exported Value from India: USD 41,151
Total Quantity of Export from India: 500 kg
Largest Buyers:
Singapore’s Import value: USD 41,151
2.4 Employment Generation (Direct and Indirect due to project) Project will create direct and indirect opportunities within surrounding region. Unit will
use good faith to employ local people from nearby villages depending upon the
availability of skilled and unskilled manpower surrounding the site.
In operation phase, the proposed project will require significant workforce of non-
technical and technical persons. Migration of highly education and skilled experience will
result in increase of literacy in the surrounding villages.
In addition the proposed expansion of project shall enhance the prospects of employment.
Labour costs are estimated to be 50 lacs per annum.
5
CHAPTER 3
Project Description
3.1 Type of Project Currently M/s Sai-Tech pharmaceutical Pvt Ltd is manufacturing API. Proposed project
API of is for downstream products of below mentioned API.
3.2 Location Sai-Tech pharmaceutical Pvt Ltd proposes to set up this API Plant at company’s existing
plot at plot no. A-145/8, Khairane MIDC, TTC Industrial Area, Navi Mumbai.
3.3 Selection of Site The proposed API plant is an expansion for downstream products. This location is well
connected with internal roads of and the main highway.
3.4 Size/Magnitude of Operation Proposed API plant capacity is 72 Metric Ton Per Annum.
3.5 Project Description
3.5.1 Proposed Products
Sr.
No. Name of Product
Capacity per
annum (MT)
1 Raloxifene Hydrochloride 36 MT
2 Butamirate Citrate 36 MT
3 Celecoxib 36 MT
4 Etoricoxib 36 MT
5 Phenylephrine Hydrochloride 36 MT
6 Bupropion hydrochloride 36 MT
7 Butethamate citrate 36 MT
8 Homotaurine 36 MT
9 Zolpidem Tartrate 36 MT
Maximum two products simultaneously correspond to annul installed capacity:
72 MT/A
6
3.5.2 Production Processes Company intends to manufacture 6 MT /Month of following active pharmaceutical
ingredients in the proposed plant at Khairane MIDC.
I. Raloxifene Hydrochloride: General Information:Raloxifene is an oral modul selective estrogen receptor (SERM)
that has estrogenic actions on bone and anti-estrogenic actions on the uterus and breast. It
is used in the prevention of osteoporosis in postmenopausal women. It is also used for
reduction of risk and treatment of invasive breast cancer.
Manufacturing process: Hydrolysis of 6-acetoXy-2(4-acetoXyphenyl)-3-[4-(2-
ridinoethoxy) benzoyllbenzo[b]thiophene according to the following operating
conditions:
d1)Treatment of 6-acetoxy-2-(4-acetoxyphonyl)-3-[4-(2-
PiperidinoethoXy) benZoyl]benZo[b]thiophene with alkaline hydroxide in alcohol
solvent,
d2) Acidification of the product obtained in the preceding stage (d1) with a strong acid,
to obtain the corresponding Raloxifene salt.
List of Raw Materials:
• 6-methylsulpholoxy benzothiophene HCl
• Sodium hydroxide
• Acetone, HCl
Process flow chart:
II. Butamirate Citrate:
General Information: Butamirate is a cough suppressant.
Brief manufacturing process: Phenylbutyric acid chloride is treated with
diethylaminoethoy ethanol in toluene ml at reflux Toluene is distilled off to get base.
Citrate salt is prepared in acetone.
List of Raw Materials:
• 2(2-Diethylamino)ethoxy ethanol
• 2-Phenylbutyrylchloride
• Citric acid
Process flow chart:
7
III. Celecoxib: General Information:Celecoxib is a nonsteroidal anti-inflammatory drug. It works by
reducing hormones that cause inflammation and pain in the body. Celecoxib is used to
treat pin or inflammation caused by many conditions such as arthritis, spondylysis and
menstrual pain.
Brief manufacturing process: Solution of 4,4,4-trifluoro-1-[4-(methyl)phenyl]butane-
1,3-dione & 4-sulfonamidophenylhydrazine hydrochloride in Isopropyl alcohol is
refluxed for 24 hrs to obtain Crude Celecoxib which is purified to obtain pure Celecoxib.
List of Raw Materials:
• 1,3 dione
• Sulphonamide
• Isopropyl Alcohol
Process flow chart:
IV. Etoricoxib:
General Information: Etoricoxib is indicated for the treatment of rheumatoid
arthritis, psoriatic arthritis, osteoarthritis, ankylosing spondylitis, chronic low back pain,
acute pain, and gout.
Brief manufacturing process: Solutionof KetoSulphone&Fluorophosphates in Acetic
acid is refluxed for 24 hrs to obtain Crude Etoricoxib which is purified in Isopropyl
Alcohol to obtain pure Etoricoxib
List of Raw Materials:
• 2-chlro-1,3-bis(dimethylamino) Trimethiniumhexafluorophosphate
• 1-(6-methyl pyridine-3yl)-2{(4-methyl) Sulfonyl)phenyl}ethanone
• Pot. Tert. Butoxide
• Acetic acid
Process flow chart:
Reactor
2(2-Diethylamino)ethoxy ethanol
2-Phenylbutyrylchloride
Toluene
Reactor Citric Acid
Butamirate Citrate
Crude Celecoxib
1,3 Dione
Sulphonamide
IPA
Celecoxib
8
V. Phenylephrine Hydrochloride:
Phenylephrine and its salts are most commonly used, either topically or by mouth, for the
symptomatic relief of nasal congestion. They are frequently included in preparations
intended for the relief of cough and cold symptoms
Brief manufacturing process;
MAP Sulphate is taken in water and IPA and maintained and added TEA buffer to adjest
PH 7.Added NADP and Ketoreductage in traces for reduction to get R- Phenylephrine
base in IPA. R- Phenylephrine base IPA solution is acidified with HCl in IPA to filter
PhenylephrineHydocloride Salt.
List of Raw materials:
• MAP Sulphate
• Ketoreductage
• IPA
• HCl
Process flowchart:
VI. Bupropion hydrochloride
General Information:Bupropion hydrochloride is a Antidepresent and used in smoking
cessation.
Brief manufacturing process: α-bromo-3’-chloropropiophenone is treated with tert-
butylamine in acetonitrile under reflux to give Bupropion free base followed by
hydrochloride salt preparation by IPA-HCl.
List of Raw Materials:
alpha-bromo-3’-chloropropiophenone
Dichloromethane
tert-Butylamine
• Acetonitrile
• Isopropyl alcohol
Crude Etoricoxib
2-chlro-1,3-bis(dimethylamino)
Trimethiniumhexafluorophosphate
Etoricoxib
1-(6-methyl pyridine-3yl)-2{(4-
methyl) Sulfonyl)phenyl}ethanone
Pot. Tert. Butoxide ,
Acetic Acid
Reactor
Phenylephrine Base
MAP Sulphae
Ketoreductage +NADP
IPA
HCl
Phenylephrine Hydrochloride
9
• IPA-HCl
Process flow chart:
VII. Butethamate citrate: General Information:Butamirate is a cough suppressant.
Brief manufacturing process: Phenylbutyric acid chloride is treated with
diethylaminoethanol in toluene ml at reflux Toluene is distilled off to get base. Citrate
salt is prepared in acetone.
List of Raw Materials:
• diethylaminoethanol
• 2-Phenylbutyrylchloride
• Citric acid0
• Toluene
• Acetone
• Hexane
Process flow chart:
VIII. Homotaurine: General Information: Homotaurine is a Sedative,Hypnotic.
Brief manufacturing process: 3-Aminochloropropane aqueous solution is sulfonated
with the aqueous solution of Sodium sulphite by reflux followed by acidifying by
hydrochloric acid, filtering, and cooling to get crude followed by purification in Methanol
to get pure 3-aminopropanesulfonic acid Homotaurine.
List of Raw Material:
• 3-Aminochloropropane
• Sodium sulphite
Acetonitrile
α-bromo-3’-chloropropiophenone
IPA
Bupropion Base
Bupropion HCl
Tertbytylamine
IPA/HCl
Toluene
(2-Diethylamino) ethanol
2-Phenylbutyrylchloride
Citric Acid
Reactor
Reactor
Butethamate
10
• Methanol
• Conc. HCl
Process Flow Chart:
IX. Zolpidem Tartrate:
General Information:Zolpidem Tartrate is a Sedative,Hypnotic used as deprssent.
Brief manufacturing process: Zolpedemic acidchloride to condensation with
dimethylamine then leads to zolpidem free base, which is converted to its L-(+)- tartrate
(2:1) by treatment with L-(+)-tartaric acid
List of Raw Materials:
• 6-methyl-2-p-toyl-imidazo [1, 2,-a]pyridine-2-yl) acetic chloride (Zolpidemic acid
chloride)
• Dimethyl amine solution. (40%)
• Ethyl Acetate
• IPA
Process Flow Chart:
3.6 Raw Materials
Sr no Raw material Quantity Unit
Bupropion
1 Metachloropropiophenone 1.406 T
2 Bromine 1.322 T
3-Aminochloropropane
Sodium sulphite
Water
Methanol
Reactor
Reactor
Homotaurine
HCl
Zolpedemic acidchloride
Dimethylamine solution
Ethyl Acetate
Zolpidem Base
Crude
Zolpidem
Base
Zolpidem
Tartrate
Methanol
L(+)Tartaric acid
11
3 MDC 2.109 KL
4 tert-Butylamine 2.100 T
5 Acetonitrile 0.183 KL
6 IPA 1.1248 KL
Butamirate
1 2-Phenylbutyryl chloride 0.7040 T
2 2(2-Diethylamino) ethoxy ethanol 0.6195 T
3 Toluene 0.3960 kL
4 Aq. Ammonia 0.5132 kL
6 citric acid 0.648 T
7 Acetone 0.5133 kL
8 Hexane 2.933286 kL
Butethamate
1 2-Phenylbutyryl chloride 0.9 T
2 2-Diethylaminoethanol 0.576 T
3 Toluene 0.48 KL
4 Aq. Ammonia 0.4 KL
5 citric acid 0.656 T
6 Acetone 0.48 KL
7 Hexane 0.48 KL
Etoricoxib
1 Ketosulphone 1.365 T
2 2-chloro compound 1.7472 T
3 Potassium tertiary butoxide 0.735 T
4 Toluene 1.26 KL
5 DMF 2.247 KL
6 Acetic acid 2.1 KL
7 Ammonium acetate 0.735 T
8 Formaldehyde solution 0.315 KL
9 Sodium bi carbonate 1.155 T
10 Isopropyl alcohol 2.247 KL
11 Ammonia solution 3.885 KL
12 Isopropyl alcohol 0.336 KL
13 Norrit Charcoal 0.105 T
Raloxifene Hydrochloride
1
6-hydroxy-2-(4-hydroxyphenyl)-benzo(b) thiphene
mesylate 1.4 T
2 4-(2-piperidino ethoxy) benzoyl Chloride 1.5 T
3 MDC 15.4 KL
4 AlCl3 3.9 T
5 Methanol 7.0 KL
6 NaOH 2.8 T
7 Water 9.5 KL
8 Acetone 18.9 KL
10 HCl 4.2 KL
11 Acetone 5.35 KL
12 Water 2.64 KL
13 HCl 0.32 KL
12
14 Methanol 24.8 KL
Celecoxib
1
4,4,4-Trifluoro-1-[4-(methyl)phenyl]butane-1,3-
dione 0.855 T
2 4-sulfonamidophenylhydrazine hydrochloride 0.88065 T
3 Isopropanol 1.71 KL
4 Methylene dichloride 11.4 KL
5 n-Hexane 5.7 KL
Homotaurine
1 3-Chloropropyl Amine 1.275 kg
2 DM water 5.763 KL
3 Sodium sulphite 12.852 T
4 Concentrate HCl 5.304 T
5 Methanol 0.612 T
6 CTH –N-1 1.1645 T
7 D M water 4.658 KL
8 Ammonia solution 0.425 KL
9 Ethanol 1.8632 KL
Zolpidem Tartrate
1 Zolpidic acid 1.1 T
2 Phosphorous oxy chloride 0.902 T
3 Dimethyl amine sol (40%) 3.96 T
4 MDC 14.19 T
5 Ethyl acetate 1.485 T
6 Tartaric acid 0.176 T
7 Methanol 1.353 T
3.6.1 Power & Fuel Requirement Total power requirement for the proposed Project is 500 KVA. The required power will
be sourced from MSEB in construction and operating phase.
DG set of capacity 250 KVA will be used as backup for emergency purpose.
The details of Fuel requirement is as given bellow.
Sr. No. Type of Fuel Quantity T/Day
1 Fuel Oil 30 Kg/Hr
2 HSD 25 Lit / hr.
Consumption of Utilities Electricity: 1500 KW/Hr
Cooling Water: 8 M3
3.6.2 Selection of Technology Manufacturing process with proven technology has been developed in consultation with
specialists from R & D team of Sai-Tech pharmaceuticals Pvt Ltd. No patented process
will be used. Technology tie-up with any process collaborator is not envisaged.
3.7 Resource Optimization
The main raw materials used in proposed API project are from the local market. Existing
plant manufactures the above mentioned range of products.
3.8 Water Requirement & Distribution The water requirement for the proposed project will be met from the MIDC supply. The
daily water requirement is m3/day as detailed in below table.
13
Sr.
No. Purpose Requirement (cmd)
1 Domestic 5
2 Industrial Processing
For Steam Generation 10
For Cooling Tower 5
For Scrubber& ejector make up 2
For Neutrallization 3
Water of Reaction generated in the process. 12
Boiler water make up
Water for DM unit back wash 1
Water for floor washing 1
Water for green belt 6
TOTAL
Less Water of reaction generated in the process 0
Actual water required from MIDC Supply 45
3.9 Waste Water Generation
The waste water generated from proposed project as estimated is given in below table:
Sr.
No. Source Used
Losses
M3/Day
Effluent
Generation
M3/Day
Remarks
1 Domestic 5 1 4 -
2 Industrial Processing & water
generated from process 14 5 9
-
3 Boiler 10 9 1 -
4 Water for DM unit back wash 1 0 1 -
5 Water for floor washing 1 0.5 0.5 -
6 Water for green belt 6 6 0 -
7 Cooling Tower make up 8 7 1 -
TOTAL 45 28.5 16.5
3.8.1 Efluent Charecteristic & Treatment Scheme:
The total effluent generated is divided in three categories as Industrial Effluent, Utility
Plant Effluent and Domestic Effluent
3.8.1.1 Industrial Effluent
Total effluent generated industrial processing and floor washings will be treated at
Effluent Treatment Plant (ETP). Thus actual load on effluent treatment plant will be 12
m3/ day.
Liquid effluent thus generated is collected separately in a underground tank having
capacity of 10 m3. It is then pumped to Waste Water Treatment Plant.
Treated effluent will be discharged to CETP.
Characteristics of Effluent from Proposed activity:
Sr. No. Parameters Results
1 pH 5.50-6.00
2 TSS 250-300 mg/ml
3 BOD 1400-1600 mg/ml
4 COD 3500-4000 mg/ml
5 TDS 6000-7000 mg/ml
6 Chlorides 700-750 mg/ml
14
Effluent Treatment Scheme:
Solid Waste: 4000 Kg/Month solid waste will be generated and will be sent to Authorized reprocess
or/ TTWM, Navi Mumbai. The solid filter cake generated in process, will be disposed
off to compound of manufacturers.
All uncondensed vapors are directed to Vacuum Ejector System. No harmful, toxic or
uncontrollable gaseous emit out from production process.
3.8.1.2 Utility Plants’ Effluent
• DM plant regeneration water is 1 m3/ day.
Sr No. Parameters Results
1 pH 4-9
2 TDS 5000-6000 mg/l
• Steam Boiler Blow down is 1m3/ day .
• Cooling Tower Blow down is 1 m3/ day.
3.8.1.3 Domestic Waste water:
Domestic waste water will be treated in Septic tank & soak pit. The overflow from the
Septic tank will be used for gardening. This water generated is 4 m3/ day.
Sr No. Parameters Results
1 pH 7-8.5
2 BOD 200-250 mg/l
3 COD 300-400 mg/l
4 TDS 800-900 mg/l
3.8.1.4 Greenbelt Development
Greenbelt will be developed at site to enhance environment quality through limitations
of air emissions, attenuation of noise levels, balancing eco-environment, prevention of
soil erosion. 495 Sq. m. of area is covered with green cover/lawn development in
existing facility.
15
CAPTER – 4
SITE ANALYSIS
4.1 Connectivity:
Sr. No. Particulars Details
1 Nearest Road TTC Industrial, MIDC Road
2 Nearest High Way Thane Belapur Road
3 Nearest Railway Station KoparKhairne 1.5 Km.
4 Nearest Bus Station Turbhe BEST DEPOT
5 Nearest Air Port Chhatrapati Shivaji Air Port, Mumbai.
4.2 Land Form Land Use & Land Ownership
Project pertains to expansion of existing plant within MIDC Chemical zone – hence no
change in land use anticipated
4.3 Existing Land Use & Pattern:
TTC is an industrial suburb in which MIDC has developed all infrastructures and this
MIDC is spread over about 10000 hectors. TTC MIDC is a rapidly growing and
progressing industrial zone only 50 kms from CST and 10kms from Panvel.
4.4 EXISTING INFRASTRUCTURE:
The proposed project is planned in the company’s existing premises i.e. plot area of 3000
sq. met.
4.5 Climatic Conditions
The weather of the area is typical coastal sultry and humid. The average rainfall records
from 1,500mm to 2,000mm. The place experiences the onset of the monsoon in the
month of June and experiences monsoon till the end of September. The average
temperature recorded varies from 25 to 42 degrees.
16
CHAPTER 5
PLANNING BRIEF
5. Planning Brief
5.1 Planning Concept In existing unit atplot no. A-145/8, Khairane MIDC, TTC Industrial Area, Navi Mumbai.
Sai-Tech pharmaceuticals manufactures API with the production capacity of 72 MT/
Annum This unit is situated in notified industrial area i.e. MIDC Khairne
5.2 Man Power Requirement During the operating phase manpower requirement for proposed plant operation is
estimated as 72. The details of man power requirement are as given in table below.
Most of the employees will be recruited from local areas.
Category SI Title Requirement for
Operations
Company 1 Vice President 1
2 General managers 2
3 Engineering Manager 1
4 Administration 1
5 Production Plant Executive 4
6 Asst. Managers 2
7 QC Chemist 3
8 EHS 1
9 Utility Operators 3
10 Plant Operator 12
Contractual 11 Labours 10
12 Security In Charge 5
Total Per annum for Operations 45
5.2.1 Land Use Planning
Sr.
No.
Description Proposed Area
(Sq. Met)
1 Plant and Machinery Area 632
2 Canteen
Security Area
Workers Change Room 79
3 Utility Area: Boiler, Chilled water, DG Unit 44
4 MCC Room 66
Transformer 15
Control Room 18
5 ETP/ By Product recovery & Storage, Residue
Storage
22
6 Road
Storm Water Drain 670
7 Godown (Finished products Drums storage)
Finished product Storage Tanks 93
8 Bulk Storage tank yard 46
17
9 Administrative Office, QC Lab 204
10 Ware House 78
11 Raw Water Storage 28
TOTAL USED AREA
12 Open Space 1504
13 Total Green Belt Area 495
5.3 FACILITIES PROVIDED
5.3.1 Landscaping and Green belt Development Adequate land is embarked as open spaces and other non building purposes. 495 Sq. m.
of area is covered with green cover/lawn development in existing facility. No additional
green belt area is envisaged. Varieties are planted with adequate spacing and density for
their fast growth and survival.
5.3.2 Fire Fighting System The existing facility already has the adequate fire Hydrant system with fire water storage
tank. The proposed Project design and development has been planned with utmost care
and all provisions have been made for the safety and security of the plant and personnel.
Flammable and hazardous chemicals like Methanol and IPA are being used in the
manufacturing of process which poses explosion/ Fire Hazard. HSD as fuel for DG set as
a fire hazard.
For protection of the facility against fire, all the blocks and yards are equipped with any
one or a combination of the following fire fighting systems:
• Hydrant System:
• Fire Detection and Alarm System; and
• Different types of Fire Extinguishers.
Fire water storage facilities are as provided given below:
Main water storage tank: 10 KL
Sources of water supply: MIDC
In order to provide easy access to the fire tenders to extinguish fire in case of fire
accidents, the fire tender tracks have been provided at the building blocks. The warning
signs for prevention of fire and plans showing the exit paths for escape from fire shall be
displayed in the working places and corridors of the buildings.
5.3.3 Storm Water Collection and Disposal
Storm water drains will be provided and Storm water from the entire plot will be collected
through network of storm drains (RCC).
18
CHAPTER 6
PROPOSED INFRASTRUCTURE
Particulars Details
1 Existing Industrial Area 3000 Sq. m
Proposed for this project 3000 Sq. m
2 Connectivity Nearest Highway: NH4
Nearest Road: MIDC Road
Nearest Railway Station: Kopar-Khairne
3 Green Belt No additional green belt is envisaged for the
expansion
4 Power Management Source: MSEB, 500 KVA
5 Waste Water Effluent will be treated in the primary treatment
plant and transferred to CETP drainage system.
6 Solid Waste Management
solid waste
Solid waste will be sent to TTCWMA Thane.
7 Hazardous Waste Hazardous waste will be sent to TTCWMA,Thane
CHAPTER 7
REHABILATION AND RESETTLEMENT PLAN Since project is located in notified industrial area i.e. MIDC Khairne, R & R is not
applicable to this project.
CHAPTER 8
PROJECT SCHEDULE
PROJECT SCHEDULE
8.1 PROPOSED SHEDULE AND APPROVAL FOR IMPLEMENTAION The proposed project shall be established in 6 months period after getting the
environmental clearance from the SEIAA and consent from MPCB
8.2 PROJECT COST ESTIMATION Estimated cost estimation for the proposed project will be as below:
Sr. No. Item Amount (In Crores)
1 Infrastructure cost 4.78
2 Working Capital 1.80
Total 6.58
19
CHAPTER 9
ANALYSIS OF PROPOSAL
Project will create direct and indirect employment opportunities in surrounding region.
Unit will use good faith efforts to employ local people from nearby villages depending
upon skilled and unskilled man power from surrounding the project site.
In operation phase the proposed project would require significant force of technical as
well as non-technical persons.
Migration of highly education and skilled experience will result in increase of literacy in
the surrounding villages.
In addition, the proposed expansion project shall enhance the prospects of employment.
Additional government revenue expected from royalty, taxes, duties and other fees. The
added benefit to the proposed project will result in considerable growth of stimulating the
industrial and commercial activities in the state.
20
CHAPTER 10
ENVIRONMENTAL MANAGEMENT SYSTEM (EMS)
1. Safety: Operational controls related to safety, such as issuing of work permits, handling
and storage of hazardous chemicals, use of tools and protective equipment,
transportation, working in laboratories, working in special conditions etc. are included
under Safety Manual.
The MSDS for all hazardous chemicals are maintained. Adequate first aid facilities are
maintained to deal with the situations of accidental chemical exposure.
Due precautions are taken by chemists while handling the chemicals. The personal
protective equipments are provided to avoid accidental exposures.
The residue samples/ chemicals, expired chemicals are disposed off in the most
environment friendly way. The residue samples of approved finished products, are
collected and fixed in final product.
2. Waste Management: Sai-Tech Pharmaceuticals Pvt. Ltd. uses an ETP manual to control
the storage and disposal of wastes. This manual indicates the source, quantification,
storage and disposal of all categories of hazardous and solid wastes. Possibility of waste
recycling is explored. The HSE & TS function identifies possibilities for external reuse of
wastes generated.
3. Wastewater Quality Management: Wastewater generation and treatment is regulated
through ETP Manual. The operation of the Effluent Treatment Plant and accessories is
controlled to avoid incidents of non-compliance.
4. Air Quality Management: The departmental procedure for the operation of boilers and
diesel generator sets include the control over EMS impacts in the form of emissions from
stacks. Emission of solvent vapors is minimized through various control measures during
storage, handling and operation.
5. Soil Management: Pollution of the soil is avoided through liquid tight provisions,
measures to prevent leakage and overfilling and inspection of process installations above
ground.
6. Energy Management: Wherever possible, energy saving measures would be put in place
and process equipment modified.
EMERGENCY PREPAREDNESS AND RESPONSES
The organization has established emergency plan to ensure appropriate responses to
unexpected and accidental incidents. A procedure has been established for preventing and
mitigating the impacts of such emergency situation. The organization shall review and
revise its emergency preparedness and response procedures after the occurrence of
accidents or emergency situations where necessary. The requirement of mock drills for
testing and verification of implementation of these procedures have been documented in
the procedure.
In an emergency, in line with Sai-Tech Pharmaceuticals Pvt. Ltd. on-site emergency
plans, the various responsible personnel carry out their assigned functions. Emergency
services are made available and can be alerted through alarms and communications in the
event of an emergency.