proposed expansion project for manufacturing of...
TRANSCRIPT
PROJECT PRE-FEASIBILITY REPORT
For
Proposed Expansion project For
Manufacturing of synthetic organic chemicals (Bulk Drugs & drug Intermediates)
AT Plot No. C-1/ 7131, 7132, 7133 & C-1/7102
GIDC Estate Ankleshwar, Dist.: Bharuch.
Project Proponent
M/s. Danopharm Chemicals Pvt. Ltd.
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CONTENTS
CHAPTERS
S. No. Particulars Page No.
1 EXECUTIVE SUMMARY 1-2
2 INTRODUCTION OF THE PROJECT 3-5
2.1 IDENTIFICATION OF THE PROJECT AND PROJECT PROPONENT 3
2.1.1 IDENTIFICATION OF THE PROJECT 3
2.1.2 DETAILS OF PROJECT PROPONENT 3
2.1.3 NATURE OF THE PROJECT 4
2.1.4 NEED OF PROJECT & DEMAND-SUPPLY GAP 4
2.1.5 IMPORTS VS. INDIGENOUS PRODUCTION 5
2.1.6 EXPORT POSSIBILITY 5
2.1.7 DOMESTIC/EXPORT MARKETS 5
3 PROJECT DESCRIPTION 6-20
3.1 TYPE AND LOCATION OF THE PROJECT 6
3.1.1 TYPE 6
3.1.2 LOCATION 6
3.2 DETAILS OF ALTERNATIVE SITE 9
3.3 SIZE & MAGNITUDE OF OPERATION 9
3.4 PROJECT DESCRIPTION WITH PROCESS DETAILS 9
3.5 RAW MATERIAL FOR FINISHED PRODUCT 9
3.6 HAZARDOUS CHEMICALS STORAGE AND HANDLING 11
3.7 RESOURCE OPTIMIZTION & AVAILABILITY 12
3.7.1 LAND & BUILDING REQUIREMENT 12
3.7.2 EQUIPMENT 13
3.7.3 POWER REQUIREMENT 13
3.7.4 FUEL REQUIREMENT 13
3.7.5 WATER REQUIREMENT 13
3.7.6 MAN-POWER REQUIREMENT 14
3.8 QUANTITY OF WASTE TO BE GENERATED 14
3.8.1 WASTE WATER GENERATION & MANAGMENT 15
3.8.2 WASTE WATER CHARACTERISTICS 15
3.8.3 WASTE WATER TREATMENT & DISPOSAL 16
3.8.4 AIR EMISSION & CANTROL 17
3.8.4.1 PROCESS EMISSION 17
3.8.4.2 UTILITY EMISSION 17
3.8.4.3 FUGITIVE EMISSION 18
3.8.5 HAZARDOUS/NON-HAZARDOUS WASTES MANAGEMENT 18
3.8.6 NOISE CONTROL 19
3.9 HEALTH & SAFETY MEASURES 19
3.10 ENVIRONMENTAL HEALTH & SAFETY PLAN 19
3.11 POST PROJECT MONITORING PLAN 20
4 SITE ANALYSIS 21-23
4.1 CONNECTIVITY 21
4.2 LAND FORM, LAND USE & LAND OWNERSHIP 21
4.3 TOPOGRAPHY 21
4.4 SALIENT FEATURES 21
4.5 EXISTING INFRASTRUCTURE 21
4.6 SOIL CLASSIFICATION 21
4.7 CLIMATE & METEROLOGY 22
4.7.1 TEMPERATURE 22
4.7.2 HUMIDITY 23
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S. No. Particulars Page No.
4.7.3 RAINFALL 23
4.7.4 CLOUD COVER 23
4.7.5 WIND PATTERN 23
4.8 SOCIAL INFRASTRUCTURE 23
4.9 EDUCATIONAL FACILITIES 23
4.10 MEDICAL FACILITIES 23
5 PLANNING BRIEF 24-25
5.1 PLANNING CONCEPT 24
5.2 POPULATION PROJECTION 24
5.3 AREA STATEMENT 24
5.4 ASSESMENT OF INFRASTRUCTURE DEMAND (PHYSICAL & SOCIAL)
24
5.5 AMENITIES/FACILITIES 24
5.5.1 DRINKING WATER FACILITIES 24
5.5.2 POWER SUPPLY FACILITIES 24
5.5.3 COMMUNICATION & BANKING FACILITIES 24
5.5.4 TRANSPORT FACILITIES 25
6 PROPOSED INFRASTRUCTURE 26-26
6.1 INDUSTRIAL AREA 26
6.2 RESIDENTIAL AREA 26
6.3 GREENBELT 26
6.4 SOCIAL INFRASTRUCTURE 26
6.5 CONNECTIVITY 26
6.6 DRINKING WATER MANAGEMENT 26
6.7 SEWERAGE SYSTEM 26
6.8 INDUSTRIAL WASTE MANAGEMENT 26
6.9 SOLID WASTE MANAGEMENT 26
6.10 POWER REQUIREMENT & SOURCE OF SUPPLY 26
7 REHABILITATION & RESETTLEMENT ( R& R) PLAN 27-27
7.1 POLICY TO BE ADOPTED 27
8 PROJECT SCHEDULE & COST ESTIMATES 28-28
8.1 TIME SCHEDULE OF THE PROJECT 28
8.2 ESTIMATED PROJECT COST 28
9 ANALYSIS OF PROPOSAL 29-29
9.1 FINANCIAL & SOCIAL BENEFITS 29
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List of Tables
Table No. Topic Page No.
1.1 PROJECT SUMMARY 1
2.1 LIST OF PRODUCTS 3
2.2 LIST OF DIRECTORS 4
3.1 AREA STATEMENT 8
3.2 LIST OF RAW MATERIALS 9
3.3 DETAILS OF HAZARDOUS CHEMICALS/MATERIALS STORAGE AND HANDLING
11
3.4 LIST OF EQUIPMENT/MACHINERIES 12
3.5 CATEGORY WISE FRESH WATER REQUIREMENT (KL/DAY) 13
3.6 MAN-POWER REQUIREMENT 14
3.7 WASTE WATER GENERATION 14
3.8 STREAM WISE EXPECTED CHARACTERISTICS OF WASTE WATER AFTER PROPOSED EXPANSION
15
3.9 EXPECTED CHARACTERISTICS OF COMPOSITE WASTE WATER 15
3.10 DETAILS OF EACH ETP UNIT 17
3.11 DETAILS OF PROCESS EMISSIONS 17
3.12 DETAILS OF UTILITY EMISSIONS 17
3.13 HAZARDOUS AND NON-HAZARDOUS WASTE GENERATION AND ITS MANAGEMENT
18
3.14 SAFETY DETAILS 19
3.15 ENVIRONMENTAL MONITORING PLAN 20
4.1 SALIENT FEATURES OF THE PROJECT SITE 21
4.2 SUMMARY METEOROLOGICAL DATA AT NEAREST IMD STATION- BHARUCH
22
5.1 DISTRIBUTION OF POPULATION 24
8.1 TOTAL CAPITAL COST PROJECTION 28
List of Figures
Sr. No. Description Page No.
3.1 LOCATION OF THE PROJECT SITE 6
3.2 SATELLITE IMAGE OF THE PROJECT SITE 7
3.3 SITE LAYOUT PLAN 8
3.4 WATER BALANCE DIAGRAM (IN KL/DAY) FOR EXISTING SCENARIO 14
3.5 WATER BALANCE DIAGRAM (IN KL/DAY) FOR PROPOSED SCENARIO 15
3.6 FLOW DIAGRAM OF ETP 16
3.7 ORGANOGRAM OF EHS CELL 19
List of Annexures
Sr. No. Description
Annexure 1 Existing CC&A
Annexure 2 Process technology
Annexure 3 Land Possession Documents
Annexure 4 CETP Membership certificate
Annexure-5 BEIL Membership certificate
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CHAPTER – 1
EXECUTIVE SUMMARY The project is summarized in the below table:
Table1.1: Project Summary
PARTICULARS DETAILS NAME OF THE UNIT M/s. Danopharm Chemicals Pvt. Ltd. OCCUPIER Mr. Jayanta Das PRODUCTS The list of products are as follows:
Sr. No.
Products Total Quantity (T/month) Existing After proposed expansion
Existing products1. 2 Amino 5 Nitro
Benzophenone 1.5 3
2. Ofloxacin
9.0
---3. Levofloxacin ---4. Ciprofloxacin ---5 Norfloxacin 156. Ernofloxacin ---Proposed products7. Celecoxib --- 38. CIS Tosylate --- 59. 4- Chloro Phenyl
Hydrazine Hydrochloride --- 10
10. 4,4,4, - Trifluro - 1 - (4-methylphenyl) - Butane - 1.3 – Dione
--- 5
11. Ketoconazole --- 512. Metronidazole Benzoate --- 1513. 4- Sulphonamido Phenyl
Hydrazine Hydrochloride --- 10
14. Carboxy Diphenyl Amine --- 2TOTAL 10.5 73
LOCATION Plot No. C-1/ 7131, 7132, 7133 & C-1/7102 GIDC Estate Ankleshwar, Dist.: Bharuch.
NAME OF PROJECT
Proposed expansion project for manufacturing of synthetic organic chemicals (Bulk drugs & drug intermediates)
RESOURCES Resource type Requirement SourceLand Existing land: 2915.80 m2
No additional land will be required for proposed expansion. Necessary modifications will be done in the existing infrastructure.
The existing site is located in GIDC estate, Ankleshwar.
Water Existing: Total 9.8 kl/day Domestic: 1.0 kl/day Industrial: 8.8 kl/day Gardening: 0.10 kl/day After proposed expansion: Total 75.00 kl/day Domestic: 4.50 kl/day Industrial: 69.00 kl/day Gardening: 1.50 kl/day
The fresh water is/will be supplied by GIDC water supply department.
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PARTICULARS DETAILS Power Existing: 250 kVA
After proposed expansion: 700 kVA The power supply is/will be supplied by Dakshin Gujarat Vij Co. Ltd.
Fuel Existing: Natural gas: 1200 SCM/day After proposed expansion: Natural gas: 3000 SCM/day
Natural gas is/will be sourced from Gujarat Gas Ltd.
POLLUTION POTENTIAL & MITIGATION MEASURESParameter Potential Mitigation Wastewater Existing:
Total 5.30 kl/day Domestic: 0.7 kl/day Industrial: 4.60 kl/day After proposed expansion: Total 48.50 kl/day Domestic: 3.50 kl/day Industrial: 45.00 kl/day
Domestic waste water is/will be disposed through septic tank/ soak pit system.
The industrial effluent after conforming the standards prescribed by GPCB is/will be discharged through underground GIDC drainage and finally conveyed to M/s. NCTL which ultimately leads to deep sea for final disposal.
Air Emissions Existing: Boilers: Capacity 850 kg/hr x 1 no.
and capacity 600 kg/hr x 1 no. After proposed expansion: Boiler: Capacity 1.5 TPH x 1 no. Thermic fluid heater: Capacity 4
lakh kCal/hr x 1 no.
After the proposed expansion project, existing 2 nos. of boilers having capacity 850 kg/hr and 650 kg/hr will be as stand-by after the installation of boiler having capacity 1.5 TPH.
Hazardous & solid waste
Existing: Residue wastes (Cat. 28.1): 0.015 T/annum Spent carbon (Cat. 28.2): 0.015 T/annum Used oil (Cat. 5.1): 0.017 T/annum Discarded drums/liners (Cat. 33.3): 50 T/annum ETP sludge (Cat. 34.3): 8.9 T/annum After proposed expansion: Residue wastes (Cat. 28.1): 11 T/annum Spent carbon + Hyflow (Cat. 28.2): 1.10 T/annum Used oil (Cat. 5.1): 0.10 T/annum Discarded drums/liners (Cat. 33.3): 2070 T/annum ETP sludge (Cat. 34.3): 60 T/annum
ETP sludge is/will be disposed to TSDF site, BEIL, Ankleshwar.
Residue waste, spent carbon and hyflow is/will be disposed to incineration site.
Used oil is/will be disposed by selling to registered refiners.
Discarded drums/liners is will be reuse/disposed by selling to GPCB authorized vendor after de-contamination/re-used.
Noise Expected levelsWithin the premises During day time <75 dB(A) Durig night time <70 dB(A)
Major noise generation is/will be from pumps, motors and D.G. sets.
Acoustic enclosure will be provided to D.G. sets.
Ear Plugs and Ear muffs provided to the workers in Utility Section.
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CHAPTER – 2
INTRODUCTION OF THE PROJECT
2.1 IDENTIFICATION OF THE PROJECT AND PROJECT PROPONENT
2.1.1 IDENTIFICATION OF THE PROJECT
M/s. Danopharm Chemicals Pvt. Ltd. is located at plot no. C-1/ 7131, 7132, 7133 & C-1/7102 GIDC Estate Ankleshwar, Dist.: Bharuch, Gujarat – 393 002.
The unit has obtained CC&A for its existing plant vide CC&A No.: AWH-66653 dated 03/12/2014 and valid up to 02/05/2019. The copy of existing CC&A is attached as Annexure-1.The list of products are as follows:
Table-2.1: List of products
Sr. No.
Products Total Quantity (T/month) Existing After proposed expansion
Existing products 1. 2 Amino 5 Nitro Benzophenone 1.5 3 2. Ofloxacine
9.0
--- 3. Levofloxacin --- 4. Ciprofloxacin --- 5 Norfloxacin 15 6. Ernofloxacin --- Proposed products 7. Celecoxib --- 3 8. CIS Tosylate --- 5 9. 4- Chloro Phenyl Hydrazine Hydrochloride --- 10 10. 4,4,4, - Trifluro - 1 - (4-methylphenyl) - Butane -
1.3 - Dione --- 5
11. Ketoconazole --- 5 12. Metronidazole Benzoate --- 15 13. 4- Sulphonamido Phenyl Hydrazine Hydrochloride --- 10 14. Carboxy Diphenyl Amine --- 2 TOTAL 10.5 73
(Source: Danopharm Chemicals Pvt. Ltd., Ankleshwar)
2.1.2 DETAILS OF PROJECT PROPONENT
M/s. Danopharm Chemicals Pvt. Ltd. was established in 1986, and is engaged in the manufacturing of bulk drugs and intermediates. M/s. Danopharm Chemicals Pvt. Ltd. has a broad based well-knit professionally managed organization set up with departments headed by exceptionally competent persons. The main complexes for production, research & development and quality assurance are located at G.I.D.C., Ankleshwar, and District. Bharuch. The company has its head office in Mumbai from where it does its marketing of its products locally and internationally.
The plant is well equipped with a full-fledged Research and Development and Quality Control Laboratory. The plant is involved in the state of the art technologies for Hi-tech products.
M/s. Danopharm Chemicals Pvt. Ltd. is backed by a team of dedicated hard working staff having wide experience in the manufacturing and marketing of pharmaceutical products. This enables M/s. Danopharm Chemicals Pvt. Ltd. to grow and continue to fulfill traditional objectives of:
Established high standards of quality by thorough adherence to good manufacturing practices.
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Producing effective products of consistent quality available at the most competitive price.
The company is backed by strong Quality Control department, which take care of all stringent international standard conditions. The QC department’s main objective is to maintain a very strong control on the quality for:
Raw material (input) prior to production.
In process Quality Control
Finished Drug & Intermediates.
It is in the company tradition to send finished products randomly selected from any batch, to accredited laboratories for testing. This provides corroborative assurance that the product of M/s. Danopharm Chemicals Pvt. Ltd. conform to the highest international standards. Research and Development is a full time activity of M/s. Danopharm Chemicals Pvt. Ltd.
A strong quality consciousness and uncompromising attitude within M/s. Danopharm Chemicals Pvt. Ltd. has helped the company establish a very strong clientele base in India and abroad.
M/s. Danopharm Chemicals Pvt. Ltd. is a steady growing company since its incorporation in 1986, in the field of Chemicals. The directors of the company have good experience in handling the production management, financial management and all the allied areas. The detailed list of partners is as under:
Table 2.2: List of Directors
Sr. No. Name of the Directors Address
1 Mr. Satish P. Nachane 1801, Ixora Tower, Hiranandani Meadows, Off. Pokharan Raod No.2, Thane (W)-400610.
2 Mr. Jayanta B. Das G-105 & 106, Palm Project, D-mart, Link Road, Malad (W) Mumbai-400064.
3 Mr. Mehul S. Nachane 1801, Ixora Tower, Hiranandani Meadows, Off. Pokharan Raod No.2, Thane (W)-400610.
4 Mr. Kashi B. Das 102, Sai Trishul, Raviraj Complex, off new Link road, Andheri (W) Mumbai-400053.
5 Mr. Kamlesh B. Das G-1105 & 1106, Palm Project, D-mart, Link Road, Malad (W) Mumbai-400064.
6 Mr. Bimlesh B. Das Flat No.502, Skydeck Co-op Housing Society, off new link road, Andheri (W) Mumbai-400053.
7 Mr. Ramesh Jadhav Anand Regency, Flat No.501-B-Wing, Near Jain Society, Kalatalab, Kalyan (W)-421301
8 Mr. Sabu Daniel 501,E Buldg, New Brahman Complex, Azad Nagar, Thane(W)-400607
(Source: Danopharm Chemicals Pvt. Ltd., Ankleshwar)
2.1.3 NATURE OF THE PROJECT
The proposed expansion project is for manufacturing of synthetic organic chemicals (Bulk drugs and drug intermediates) which is categorized as ‘Category B’ and falls under item no. “5 (f) i.e. Synthetic Organic Chemicals” as per EIA Notification, 2006 (amended from time to time). Due to the applicability of general conditions i.e. located within 5 km distance from Critically Polluted area (Ankleshwar), the proposed expansion project is categorized as ‘category A“ and needs to obtain environmental clearance from MoEF&CC.
2.1.4 NEED OF PROJECT & DEMAND-SUPPLY GAP
Danopharm Chemicals Pvt. Ltd. is a pharmaceutical company, engaged in the manufacture of bulk drugs and intermediates. Being a growing company, it expands to diversify product range and increase
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market share in domestic and export market. Adoption of the latest technology is a part and parcel of this process.
To stay relevant in the pharmaceutical sector, we need to grow, bring in more drugs, more intermediates in our basket and also increase export to foreign countries. The demand for anti-inflammatory and anti-microbial drugs are increasing worldwide. In addition to these drugs, we plan to enter ant-Fungal segment. This will not only helps us to grow financially, but also earn foreign exchange and generate local employment, thus fulfilling our social obligation.
2.1.5 IMPORTS VS. INDIGENOUS PRODUCTION
It is in the company policy to procure indigenously produced raw materials. Only when a particular raw material is not available locally, we Import it.
2.1.6 EXPORT POSSIBILITY
The products are highly influenced by the market demand and market rates of the products and raw materials. Though the company has strong Indian base, all the products are developed keeping the global market into consideration. By virtue of its own infrastructure facility, skilled manpower, and large production capacity, M/s. Danopharm Chemicals Pvt. Ltd. can offer products of international standards at most competitive price on time.
2.1.7 DOMESTIC / EXPORT MARKETS
We cater both domestic and international market. Just two years back our exports was only 2% and today our export is about 54% of our turnover. We are targeting to achieve 70% export in next two years.
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CHAPTER – 3
PROJECT DESCRIPTION 3.1 TYPE & LOCATION OF THE PROJECT 3.1.1 TYPE
The proposed expansion is to be carried out in the existing site itself, so that the existing infrastructure and resources can be utilized for the proposed expansion.
3.1.1.1 LOCATION
The project site is located in the GIDC notified industrial area of Ankleshwar. This region has very good infrastructure facility. The resources are also readily available. Moreover, there is availability of Common Solid Waste Disposal (CSWD) facilities and the Disaster Prevention & Management Centre (DPMC) is located in the GIDC industrial estate.
The location of the project site is provided in figure 3.1, satellite image of the project site is provided in figure 3.2 and the site layout plan of the project site in figure 3.3. The area statement is provided in table 3.1.
Figure 3.1: Location of the project site
(Source: Google)
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Figure 3.1: Satellite image of the project site
(Source: Google Earth)
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Figure 3.3: Site layout plan
(Source: Danopharm Chemicals Pvt. Ltd., Ankleshwar
Table: 3.1 Area Statement
Sr. No. Description Area (m2)1. Total built-up area 997.412. Greenbelt area 969.523. Open area 589.014. Proposed area 330.55
TOTAL 2915.80(Source: Danopharm Chemicals Pvt. Ltd., Ankleshwar)
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3.2 DETAILS OF THE ALTERNATIVE SITE
The proposed expansion will be carried out on the existing site located in the notified industrial estate of Ankleshwar. Due to the availability of necessary resources, the company has not proposed any alternative site for proposed expansion.
3.3 SIZE & MAGNITUDE OF OPERATION
Total production after the proposed expansion will be 73 T/month.
3.4 PROJECT DESCRIPTION WITH PROCESS DETAILS
The details of process technology is provided in Annexure-2.
3.5 RAW MATERIAL FOR FINISHED PRODUCTS
The list of raw-materials required are as follows:
Table 3.2: List of raw materials
Sr. No.
Product Raw material Requirementkg/kg kg/day
Existing products 1. 2 Amino 5
Nitro Benzophenone
2-Chloro 5-Nitro Benzophenone 64.00 1920.00Liquid Ammonia 108.00 3240.00Acetic Acid 6.00 180.00
2. Ofloxacin Methanol 696.43 20892.86O.Q. Acid 300.00 9000.00N-Methyl Piperazine 96.43 2892.86Caustic Flakes 42.86 1285.71HCl 21.43 642.86
3. Levofloxacin Metanol 696.43 20892.86O.Q.Acid 300.00 9000.00N-Methyl Piperazine 96.43 2892.86Caustic Flakes 42.86 1285.71HCl 21.43 642.86
4. Ciprofloxacin Metanol 696.43 20892.86O.Q.Acid 300.00 9000.00Anhydrous Piperazine 96.43 2892.86Caustic Flakes 42.86 1285.71HCl 21.43 642.86
5 Norfloxacin Methanol 696.43 20892.86O.Q.Acid 300.00 9000.00Anhydrous Piperazine 96.43 2892.86Caustic Flakes 42.86 1285.71HCl 21.43 642.86
6 Enrofloxacin Methanol 696.43 20892.86Enro.Q. Acid 300.00 9000.00N-Ethyl Piperazine 96.43 2892.86Caustic Flakes 42.86 1285.71HCl 21.43 642.86
Proposed products 7 2 Amino 5
Nitro Benzophenone
2-Chloro 5-Nitro Benzophenone 160.00 106.66Liquid Ammonia 270.00 180.00Acetic Acid 10.00 300.00
8 Celecoxib SPHHCL 100.00 68.96Dione 104.00 71.72Toluene 2871.00 1980.00
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Sr. No.
Product Raw material Requirementkg/kg kg/day
Carbon 8.00 5.529 Cis Tosylate Cis Bromo Benzoate (CBB) 555.00 193.92
Imidazole 509.00 177.88DMF 31.00 10.83Toluene 2183.00 762.75Caustic 41.00 14.33MDC 1316.25 459.91Para Toluene Sulphonyl Chloride(PTSC) 228.00 79.66Triethyl Amine (TEA) 106.00 37.03Liq. Ammonia 27.00 9.43Ethyl Acetate 425.00 148.49
10 4- Chloro Phenyl Hydrazine Hydrochloride
HCl 664.00 1383.33Para Chloro Aniline (PCA) 125.00 260.42Sodium Nitrite 76.50 159.37Sodium Bisulphide 5.00 10.42Soda Ash 94.00 195.83Caustic 200.00 416.66NaCl 20.00 41.66
11. Ketoconazole DMSO 200.00 166.661-Acetyl-4-(4-hydroxy Phenyl) Piperazine (AHPP) 90.00 75.00SMO 24.00 20.00CTS 200.00 166.66Acetone 200.00 166.66Hyflow 2.00 1.66Ethyl Acetate 1092.00 910.00Methanol 312.00 260.00Carbon 12.00 10.00
12. Metronidazole Benzoate
Metronidazole 825.00 343.75Beta Picoline 515.00 214.58Soda Ash 11.00 4.58Benzoyl Chloride 680.00 283.33Sodium Bicarbonate 11.00 4.58Methanol 1440.00 600.00Carbon 4.00 1.66Hyflow 2.00 0.83Caustic flakes 25.00 10.42
13 4- Sulphonamido Phenyl Hydrazine Hydrochloride
HCl 806.00 1414.04Sulphanilamide 160.00 280.70Sodium Nitrite 64.80 113.68Sodium Bisulphide 4.00 7.02Soda Ash 88.00 154.38Carbon 3.00 5.26Hyflow 1.00 1.75
14. Carboxy Diphenyl Amine
Ethanol Denatured Toluene 1190.00 223.47Diethyl Malonate 189.00 35.49KOH 72.00 13.52Washing (Ethanol Denatured Toluene) 132.00 24.78Chloro Nitro Diphenyl Amine 248.00 46.571-Chloro Butane 1200.00 225.35PCl 5 98.00 18.40Sodium Bicarbonate solution 105.00 19.72Carbon 5.00 0.94Mix Xylene 65.00 12.21N-Hexane 50.00 9.38
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Sr. No.
Product Raw material Requirementkg/kg kg/day
15 Norfloxacin Methanol 1625.00 9027.78Nor Acid 625.00 3472.22Anhydrous Piperazine 225.00 1250.00Caustic Flakes 50.00 277.77HCl 50.00 277.77
16. 4,4,4, - Trifluro - 1 - (4-methylphenyl) - Butane - 1.3 - Dione
Trifluroacetic Acid 146.00 105.79Sulphuric acid 11.00 7.97Iso Propyl Alcohol 114.00 82.61Toluene 1050.00 760.87SMO 70.00 50.72MAP 139.00 100.72HCl 276.00 200.00
(Source: Danopharm Chemicals Pvt. Ltd., Ankleshwar)
3.6 HAZARDOUS CHEMICAL STORAGE & HANDLING
The list of hazardous chemicals/materials storage, handling and transportation details are as follows:
Table 3.3: Details of hazardous chemicals/materials storage and handling
Sr. No.
Raw Material Source Means of storage
Means of transport
Storage conditions
Max. Qty. to be stored (T)
Press. kg/m2
Temp (ºC)
1 1-Chloro Butane Local Drums-100 kg Truck AP RT 0.1002 2-Chloro 5-Nitro
Benzophenone Local
Bags-40 kg Truck AP RT 0.640
3 Acetic Acid Local Drums-200 kg Truck AP RT 2.5004 Acetone Local Drums-160 kg Truck AP RT 2.2405 Activated Carbon Local Bags-30 kg Truck AP RT 0.3006 AHPP Local Drums-25 kg Truck AP RT 1.0007
Benzoyl Chloride Local/Import
Drums-240 kg Truck
AP RT 10.000
8 Beta Picoline
Local/Import
Drums-200 kg Truck
AP RT 6.000
9 Caustic Flakes Local Bags-50 kg Truck AP RT 10.00010 CBB Local Drums-50 kg Truck AP RT 1.20011 DMF Local Drums-190 kg Truck AP RT 0.38012 DMSO Local Drums-225 kg Truck AP RT 3.00013 Ethyl Acetate Local Drum-210 kg Truck AP RT 5.00014 HCl Local Bulk -10000 kg Tanker AP RT 10.00015 Hyflow Local Bags-25 kg Truck AP RT 0.20016
Imidazole Local/Import
Drums-100 kg & 25 kg. Truck
AP RT 5.000
17 Iso Propyl Alcohol Local Drums-160 kg Truck AP RT 9.00018 Liq. Ammonia Local Drums-200 kg Truck AP RT 1.40019
4-MAP Local/Import
Drums-200 kg Truck
AP RT 4.000
20 MDC Local Drums-250 kg Truck AP RT 3.00021 Methanol Local Bulk-9200 kg Tanker AP RT 9.20022
Metronidazole Local/Import
Drums-25 kg Truck
AP RT 13.000
23 N-Methyl Piperazine
Local/Import
Drums-180 kg Truck
AP RT 4.000
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Sr. No.
Raw Material Source Means of storage
Means of transport
Storage conditions
Max. Qty. to be stored (T)
Press. kg/m2
Temp (ºC)
24 O.Q. Acid
Local/Import
Drums-25 kg Truck
AP RT 4.000
25 PCA Local Bags-50 kg Truck AP RT 3.00026 PTSC Local Drums-50 kg Truck AP RT 1.00027
SMO Local/Import
Drums-110 kg Truck
AP RT 4.400
28 Soda Ash Local Bags-50 kg Truck AP RT 4.00029 Sodium
Bicarbonate Local
Bags-50 kg Truck
AP RT 0.600
30 Sodium Bisulphide Local Bags-50 kg Truck AP RT 6.00031 Sodium Nitrite Local Bags-50 kg Truck AP RT 4.00032 Sulphanilamide Local Bags-40 kg Truck AP RT 10.00033 Sulphuric Acid Local Carboys-40 kg Truck AP RT 0.48034 TEA Local Drums-140 kg Truck AP RT 1.50035 Toluene Local Drums-180 kg Truck AP RT 3.00036
Trifluroacetic Acid Local/Import
Drums-250 kg Truck
AP RT 3.000
(Source: Danopharm Chemicals Pvt. Ltd., Ankleshwar)
3.7 RESOURCE OPTIMIZATION & AVAILABILITY
The main resources for the proposed expansion project will be machineries, raw-materials, power, fuel, water, man-power etc.
3.7.1 LAND & BUILDING REQUIREMENT
The existing land is 2915.80 m2. No additional land will be required for the proposed expansion. Necessary modifications will be done in the existing plant. The plot allotment letter is attached herewith as Annexure-3.
3.7.2 EQUIPMENT
The list of equipments required for the proposed expansion project are as follows:
Table 3.4: List of equipment/machineries
Sr. No. Equipments/Machineries Quantity (Nos.)A SS Reactors
1) 3 kl 22) 4 kl 13) 5 kl 2
B GL Reactor 1) 3 kl 22) 5 kl 2
C SS Centrifuge 1) 48” 22) 36” 2
D RL Centrifuges 1) 48” 2
E Dryer 1) ANFD 2
F Boiler 1) Thermic fluid heater 1
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(Source: Danopharm Chemicals Pvt. Ltd., Ankleshwar)
3.7.3 POWER REQUIREMENT
The existing power requirement is 250 kVA. It is sourced from Dakshin Gujarat Vij Company Limited. (DGVCL). For the proposed expansion project, the power requirement will be increase to 700 kVA. It will also be sourced from DGVCL.
3.7.4 FUEL REQUIREMENT
For existing operations, natural gas @1200 SCM/day is used as fuel in boilers. After the proposed expansion, natural gas @3000 SCM/day will be used as fuel. Natural gas is/will be sourced from Gujarat Gas Ltd.
3.7.5 WATER REQUIREMENT
Fresh water requirement after the proposed expansion will be @75 kl/day. The fresh water is/will be sourced from GIDC water supply department.
Other than general requirement of water in domestic and utilities, it will also be required in process. The category wise bifurcation of fresh water is given as follows:
Table 3.5: Category wise fresh water requirement
Particulars Existing operation (kl/day) After proposed expansion (kl/day)Domestic 0.90 4.50Gardening 0.10 1.50Industrial Process 3.00 21.50Boiler 1.50 7.50Cooling tower 4.00 31.00Washing 0.10 4.50Scrubber 0.20 4.50Sub: Industrial 8.80 69.00Total 9.80 75.00
(Source: Danopharm Chemicals Pvt. Ltd., Ankleshwar)
3.7.6 MAN-POWER REQUIREMENT
In existing operations, the man-power requirement is 28 persons and after the proposed expansion project it will be 85 persons. The man-power will be employed locally. The bifurcation of man-power is given as below:
Table 3.6: Man-power requirement
Phase of project Type of labour No. of workers (Existing)
No. of workers(Proposed)
During construction Contractual ----- ----- During commissioning Contractual ----- ----- During operations Managerial 5 10
Skilled 8 15 Un-skilled 15 60
(Source: Danopharm Chemicals Pvt. Ltd., Ankleshwar)
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3.8 QUANTITY OF WASTE TO BE GENERATED
The quantity wise bifurcation of waste water is provided below table.
Table 3.7: Waste water generation
Particulars Existing operation (kl/day) After proposed expansion (kl/day)Domestic 0.8 3.50Industrial Process 3.25 26.50Boiler blow down 0.75 3.50Cooling tower blow down 0.50 6.00Washing 0.10 4.50Scrubber 0.20 4.50Sub-total: Industrial 4.60 45.00TOTAL 5.40 48.50
(Source: Danopharm Chemicals Pvt. Ltd., Ankleshwar) The water balance diagram for existing scenario is provided in figure 3.4 and for proposed scenario is provided is provided in figure 3.5.
Figure 3.4: Water balance diagram for existing scenario
(Source: Danopharm Chemicals Pvt. Ltd., Ankleshwar)
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Figure 3.4: Water balance diagram for proposed scenario
(Source: Danopharm Chemicals Pvt. Ltd., Ankleshwar)
3.8.1 WASTE WATER GENERATION & MANAGEMENT
The domestic waste water generated is/will be disposed to septic tank system.
3.8.2 WASTE WATER CHARACTERISTICS
The expected characteristics of composite waste water are as follows:
Table 3.8: Stream wise characteristics of waste water
Sr. No.
Effluent Stream
Expected CharacteristicspH TDS COD BOD
1. Process 6.0-9.0 13000-16000 7000-10000 2100-30002. Cooling Tower Blow down 6.0-9.0 1200-1500 100-200 30-603. Boiler blowdown 6.0-9.0 1200-1500 100-200 30-604. Washing 6.0-9.0 1000-1200 1500-2000 450-6005. Scrubber 6.0-9.0 1800-2300 2000-2500 600-750Note: All units are in mg/l except pH.
(Source: Danopharm Chemicals Pvt. Ltd., Ankleshwar)
Table 3.9: Expected characteristics of composite waste water
Sr. No.
Parameters Expected Characteristics NCTL Discharge NormsExisting –
UntreatedProposed –
Untreated1. pH 6.0-9.0 6.0-9.0 6.0-9.02. Total dissolved solids (TDS) 8000-10000 10000-12000 No limit3. COD 2500-3500 4500-5500 5004. BOD 450-600 1300-1600 100Note: All units are in mg/l except pH.
(Source: Danopharm Chemicals Pvt. Ltd., Ankleshwar)
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3.8.3 WASTE WATER TREATMENT & DISPOSAL
Domestic waste water is/will be disposed through septic tank system. The overflow from septic tank is/will be diverted to aeration tank for further treatment.
In existing operations, the waste water from process, plant washing etc. is diverted to ETP consisting of primary, secondary and tertiary treatment. The treated effluent is discharged through underground GIDC drainage after meeting the prescribed norms given by FETP (Final effluent treatment plant). The membership certificate of FETP is attached herewith as Annexure-4.
After the proposed expansion project, necessary modifications will be done in the existing ETP for the treatment of waste water. The flow diagram of ETP is provided in figure 3.6 and the details of each unit is given in table 3.9.
Figure 3.6: Flow diagram of ETP
(Source: Danopharm Chemicals Pvt. Ltd., Ankleshwar)
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Table 3.10: Details of ETP units
Sr. No. Description Capacity1. Collection Tank 12 m3
2. Neutralization tank 123. Primary settling tank 7.84. Aeration tank 2665. Secondary settling tank 7.86. Clarified water tank 5.27. Pressure sand filter -----8. Activated carbon filter -----9. Sludge drying beds 410. Sludge storage area -----
(Source: Danopharm Chemicals Pvt. Ltd., Ankleshwar)
3.8.4 AIR EMISSIONS & CONTROL
The details of air emissions are given as follows:
3.8.4.1 PROCESS EMISSION
In existing operations, the process emissions is in form of HF, HCl and SO2 gas which is scrubbed using two stage scrubber with water and caustic soda solution. The concentrated solution from scrubber is diverted to ETP for further treatment.
After the proposed expansion, the same process will be done to control process emissions.
The details of process emissions are provided in table 3.10.
Table 3.11: Details of process emissions
Sr. No.
Vent attached to
Probable Pollutant émissions
Air Pollution Control Device (APCD)
Height & Diameter of the Vent (m)
Permissible limit
Existing 1. Reaction
vessel HF
Two stage water and Caustic scrubber
H:12 m Dia.: 0.5 m
4 mg/Nm3
HCl 20 mg/N m3
SO2 40 mg/N m3
Proposed additional No additional vent will be required for the proposed expansion
(Source: Danopharm Chemicals Pvt. Ltd., Ankleshwar)
3.8.4.2 UTILITY EMISSION
In existing operations, the company has already installed 2 nos. of boilers having capacities 850 kg/hr and 600 kg/hr each. Natural gas@95 m3/hr is used as fuel in boilers. After the proposed expansion, the company will install one boiler having 1.5 TPH capacity. Existing boilers will be used as stand-by arrangement.
The details of utility emissions are provided in table 3.11.
Table 3.12: Details of utility emissions
Installation Fuel Fuel Consumption
Details of stack
Pollution Parameters
Emission
Rate
Air Pollution Control System
Existing installations NON IBR Boiler (850 Kg/Hr)
Natural gas
55 m3/hr Common stack
SPM 150 mg/Nm3 ----- SO2 100 ppm
NO2 50 ppm
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Installation Fuel Fuel Consumption
Details of stack
Pollution Parameters
Emission
Rate
Air Pollution Control System
NON IBR Boiler (600 Kg/Hr)
Natural gas
40 m3/hr Height (H): 12 m Diameter (D): 0.1 m
SPM 150 mg/Nm3 SO2 100 ppm NO2 50 ppm
Proposed additional installationsThermic fluid heater 4 lakh k.Cal/hr. 1 no.
Natural gas
50 m3/hr Height (H): 12 m Diameter (D): 0.1 m
SPM 150 mg/Nm3
-----
SO2 100 ppm NO2 50 ppm
IBR Boiler (1.5 TPH)
Natural gas
70 m3/hr Height (H): 12 m Diameter (D): 0.1 m
SPM 150 mg/Nm3 SO2 100 ppm NO2 50 ppm
Note: Existing boilers will be replaced by proposed additional boiler having capacity 1 TPH(Source: Danopharm Chemicals Pvt. Ltd., Ankleshwar)
3.8.4.3 FUGITIVE EMISSION
The fugitive emissions in terms of handling losses of solvent is/will be reduced by proper storage and handling. Solvents is/will be stored in drums in the solvent storage area. They is/ will be transferred to the plant by trolleys. Acids is/will be stored in carboys and the storage area is/ will be provided with acid proof lining. Other RM and Finished goods is/will be stored in their designated areas.
3.8.5 HAZARDOUS/NON-HAZARDOUS. WASTES MANAGEMENT
Hazardous and non-hazardous is/will be generated from the proposed project. All such types of wastes is/will be stored in the proper designated storage areas. The details of hazardous and non-hazardous waste generation and its management are provide in table 3.12. Membership certificate from BEIL, Ankleshwar is attached as Annexure-5.
Table 3.13: Hazardous and non-hazardous waste generation and its management
Sr. No.
Type of waste
Category Quantity Mode of disposal Existing After proposed
expansion 1. Residue
waste 28.1 0.015
T/annum 11 T/annum Collection, storage,
transportation and disposal by incineration.
2. Spent Carbon & Hyflow
28.2 0.015 T/annum
1.10 T/annum Collection, storage, transportation and disposal by incineration
3. Used Oil 5.1 0.017 T/annum
0.020 T/annum Collection, storage, transportation disposal by selling to Registered re-cyclers
4. Discarded drums/ liners
33.3 50 T/annum
2070 T/annum Collection, storage, transportation and disposal by sale it to GPCB authorized vendor after decontamination/ re-used.
5. ETP sludge
34.3 8.9 T/annum
60 T/annum Collection, storage, transportation disposal at common TSDF BElL.
(Source: Danopharm Chemicals Pvt. Ltd., Ankleshwar)
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3.8.6 NOISE CONTROL
The major noise generating installation will be the D.G. Set. It will be installed in a closed room. Acoustic enclosure will be provided around it and ear plugs will also be provided to the operating personnel. Sturdy foundation and suspension will be provided to centrifuge.
3.9 HEALTH AND SAFETY MEASURES
The details of safety measures provided and safety procedure followed at our unit are as below:
Table 3.14: Safety details
Sr. No. Particulars Remarks/ Details1. Safety Officer Safety officer is available 2. Manual call bells Yes 3. Emergency Control Room At main gate security office 4. Emergency Sirens Yes 5. Assembly Point 1 point 6. Ambulance Point Near main gate 7. First Aid facility Provided at prominent places by trained persons. 8. Personal Protective
Equipments Hand gloves, gum boots, safety shoes, dust masks, safety goggles, and apron.
9. Health Check ups Regular health checkup at every six months. 10. Regular Training Provided 11. Safety & Health Records Maintained as per factory act 12. MSDS MSDS available at prominent places for ready references
(Source: Danopharm chemicals Pvt. Ltd., Ankleshwar)
3.10 ENVIRONMENTAL HEALTH & SAFETY PLAN
The company will appoint separate cell setup to keep a close watch on the performance of the pollution control equipments, emissions from the sources and the quality of surrounding environment in accordance with the monitoring program. The cell will also include the safety cell for observing, inspecting and regulating the safety measures inside the plant campus. The cell will be responsible for maintaining records of all the data, documents and information in line with the statutory requirements. Organogram of the E.H.S Management Cell will be as under:
Figure 3.7: Organogram of EHS management cell
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(Source: Danopharm Chemicals Pvt. Ltd., Ankleshwar)
3.11 POST PROJECT MONITORING PLAN
The proposed post-project monitoring plan to ensure effective implementation of EHS Management system is given below:
Table 3.15: Environmental Monitoring Plan
Component Parameter Frequency Air – Ambient SPM, RSPM, SO2, NO2 Quarterly Process Stack monitoring
HCl, SO2 Quarterly
Noise monitoring Noise levels in decibels Quarterly at all noise generating equipments & plant boundary
Work place monitoring
VOC, HF, HCl, SO2 Quarterly
Haz. Waste management
Maintaining records of generation, receipt & disposal in Form-3
Yearly
Filing of annual returns in Form-4 for Haz. Waste handling
Yearly
CC&A Obtaining consent to operate (and renewal) under Air & Water Acts and authorization under HW rules.
Before expiry of validity
Water cess Filing of annual returns for cess incurred on water consumption
Yearly
Environmental Statement
Submission of audit statement in form-V Yearly
Compliance of EC conditions
Submission of compliance reports Half yearly on 1st June & 1st Dec
(Source: Danopharm Chemicals Pvt. Ltd., Ankleshwar)
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CHAPTER – 4
SITE ANALYSIS
4.1 CONNECTIVITY
This proposed expansion project is located at Plot No. C/1- 7131, 7132, 7133 & 7102 GIDC Estate, Ankleshwar, Dist.: Bharuch, Gujarat – 393 002. The site is 3.20 km from National highway. The land and infrastructure is already available. And the raw material is easily available through the easy transport via road connectivity. The nearest Railway station is Ankleshwar railway station which is 4.20 km and Surat Airport is 61.59 km from the project site.
4.2 LANDFORM, LAND USE & LAND OWNERSHIP
The existing land is about 2112 m2. Additional 704 m2 of land will be required for the proposed expansion. The existing plot is located in the industrial estate of GIDC, Ankleshwar designated for the industrial purpose. Hence, there will be no change in the land-use pattern of the area.
4.3 TOPOGRAPHY
The topography of the Ankleshwar is relatively flat terrain with series of deeply incised creeks of river. There are generally levee deposits on the bank of river.
4.4 SALIENT FEATURES
The salient features of the project site is provided in table 4.1.
Table 4.1: Salient Features of the Project Site
Particulars DetailsApprox. site Co-ordinates Latitude:21°61’69.19” , Longitude:73°04’15.87” Village/Town Ankleshwar Taluka/ Tehsil Ankleshwar District Bharuch Nearest Water body River Narmada ≈ 8.58 km (NW) Gulf of Cambay ≈ 47 km
(W) Nearest Highway NH 8 ≈ 3.40 km (N) Nearest Railway station & Railway line Ankleshwar Railway Station ≈ 4.20 (W) Nearest Airport/ Airbase Surat ≈ 61.59 km (SW) State/ National borders Daman ≈ 138.20 km (S) Protected Area/ Sanctuaries No CRZ applicability No Seismicity Seismic Zone – III (Moderate) Note: All the above mentioned distances are the aerial distance from the project site.
4.5 EXISTING INFRASTRUCTURE
The proposed expansion will be done in the existing land. Necessary modifications will be done in the existing infrastructure.
4.6 SOIL CLASSIFICATION
The soil type in the area of Ankleshwar is deep black clayey soils. Most of the area cultivated, some area are non- cultivated under fallow and pasture forest. The surface colour is reddish brown to dark in hilly area, very dark greyish brown to dark brown & dark and yellowish brown in coastal area. Flood plain is alluvial area. Heavy texture is predominantly clay. The soli is Nitrogen – poor, Phosphorus- medium, Potash- medium and medium in N, P high –Potash.
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The soil is mainly black and Yellowish in surface colour. Depth of the soil is moderate too deep about 20 to 25cm. The predominant texture of soil is loamy and clay. The soil fertility is very poor with low nitrogen and phosphorus.
4.7 CLIMATE& METEOROLOGY
The year can be divided into four seasons. Climate is warm and dry from mid-march to June, during season of summer, climate remains warm and dry, while during rainy season, from mid-June to end of September climate is humid and pleasant. From October to November mild warm climate prevails, and from December to February climate is cold.
The Table 4.2 indicates the summary of meteorological pattern at the nearest observatory of IMD, Bharuch published by IMD.
Table 4.2: Summary Meteorological Data at nearest IMD Station –Bharuch
Location: Bharuch Gujarat ( Lat: N 21o42’, Long: E 73o 00’) Aerial Dist from Project Site: Approx. 10 km (NNW) Height of installation: 17 m above MSL. Month Temperature
(oC) Relative
Humidity (%)
Cloud Cover (Oktas)
Mean Wind
Speed(km/h)
Pre-dominant
Wind Direction
Rainfall (mm)
Max. Min. Mor. Eve. Mor. Eve. January 34.5 7.5 71 38 0.8 0.8 6.0 NE 1.2February 37.8 9.7 64 34 0.8 0.5 6.5 NE 1.4March 41.5 13.6 65 29 1.1 0.8 7.3 SW 0.2April 43.3 19.7 66 31 1.4 1.1 9.3 SW 0.5May 43.8 23.0 74 39 1.7 0.6 13.3 SW 9.2June 39.5 23.1 81 58 4.3 3.1 16.3 SW 108.5July 36.1 23.4 89 74 6.6 5.9 14.5 SW 290.4August 34.9 23.2 90 79 6.7 6.1 12.4 SW 279.1September 36.1 22.6 87 68 4.8 4.7 9.4 SW 182.7October 38.2 17.2 76 46 1.5 1.9 6.1 SW 16.8November 37.4 13.1 73 42 1.0 1.0 4.8 NE 21.9December 34.3 9.3 74 44 1.1 1.0 5.4 NE 0.2Seasonal Average Values Period Temperature
(oC) Relative
Humidity (%)Cloud Cover
(Oktas)Mean Wind
Speed(km/h)
Avg. PDW
Direction
Total Rainfall
(mm)Avg. Max.
Avg. Min.
Avg. Mor.
Avg. Eve.
Avg. Mor.
Avg. Eve.
Summer 39.0 22.5 68.3 33.0 1.4 0.8 9.9 SW 9.9Winter 32.1 12.6 69.6 38.6 0.9 0.5 5.9 NE 2.8Monsoon 32.9 25.2 86.7 69.7 5.6 4.9 13.1 SW 860.7Post monsoon 39.0 22.5 68.3 33.0 1.4 0.8 9.9
SW 9.9
Note: Winter: December, January & February, Summer: March, April & May, Monsoon: June, July, August & September, Post monsoon: October & November
(Source: Book “Climatological tables of Observatories in India (1961 - 1990)” published by IMD)
4.7.1 TEMPERATURE
The climate of Bharuch is warm and dry during the summer months but humid and pleasant during the monsoon months. The south-west monsoon from June to September brings copious rain to the territory. The winter months are generally pleasant. May is generally the hottest month with the mean daily maximum temperature recorded at 43.8 oC and mean daily minimum temperature recorded at 23 oC. January is the coldest month with the mean daily maximum temperature as 34.5 oC and mean daily minimum temperature observed as 7.5 oC.
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4.7.2 HUMIDITY
Humidity is usually high during the monsoon months, generally exceeding 86.7%. Humidity decreases during the summer months. For rest of the year i.e. the period of October to February, the relative humidity ranges around 34-76%.
4.7.3 RAINFALL
About 95% of the annual rainfall is received during the southwest monsoon season i.e. from June to September, July being the month with highest rainfall. The average annual rainfall observed from the data is 912.1 mm.
4.7.4 CLOUD COVER
During the South-west monsoon months, the skies are usually heavily clouded or overcast. Cloud cover decreases during the post monsoon months. In the rest of the year the skies are mostly clear.
4.7.5 WIND PATTERN
The annual predominant wind direction comes to South West, followed by North. Winds blows mostly from the South West during summers and Monsoons. The post-monsoon & winter seasons experience a change in the wind blowing from North-east. The wind speed is high during summer and monsoon seasons, slightly moderate during winter and moderate during post-monsoon phase.
4.8 SOCIAL INFRASTRUCTURE
The infrastructure available in the study area denotes the economic well-being of the Ankleshwar Taluka. There are about 56 villages and 10 Towns in the Ankleshwar Taluka.
4.9 EDUCATIONAL FACILITIES
As per 2011 Census of India, 70 Primary schools, 6 Secondary Schools. There were no Middle School, senior secondary schools & Training institute found in 56 villages. The female literacy rate is 43%.
4.10 MEDICAL FACILITIES
Out of the 56 villages, Primary health centers in 5 villages and Primary health sub center in 21 villages. There was no Dispensary & hospitals found in 56 villages.
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CHAPTER – 5
PLANNING BRIEF 5.1 PLANNING CONCEPT
The proposed project is located at Plot No. C-1/ 7131 – 7133 & C-1/7102 GIDC Estate Ankleshwar, Dist.: Bharuch, Gujarat – 393 002. The nearest city is Bharuch which is a big hub for chemical & Pharmaceutical Products and also Ankleshwar itself is a big industrial center. The region is well planned with all the basic infrastructural facilities like internal roads, water supply, arrangements for power, streetlights, solid waste disposal sites etc.
5.2 POPULATION PROJECTION
As per census 2011, the average household size is around 4 to 5. The demographic profile is presented below.
Table 5.1: Distribution of population
Sr. No. Particulars Observed values in Ankleshwar taluka 1 Total Population 4320862 No. of Households 959883 Avg. household size (person) 4-54 Male population 2307325 Male population (in %) 53.4%6 Female population 2013547 Female population (in %) 46.6%8 Sex ratio 873
(Source: Primary Census Abstract – Census of India, 2001)
5.3 AREA STATEMENT
The total area of the plot is 2915.80 m2 out of which greenbelt area of the plant is.998.83 m2 which is approx. 34.25 %. The bifurcation of the same is given in chapter-3 table 3.1.
5.4 ASSESMENT OF INFRASTRUCTURE DEMAND (PHYSICAL & SOCIAL)
In this proposed project the company will acquire plant and machinery so there will be some demand of change in physical infrastructure and social infrastructure. As manpower requirement for the proposed project shall be locally fulfilled, employment generation will lead to additional benefits to social infrastructure.
5.5 AMENITIES/FACILITIES 5.5.1 DRINKING WATER FACILITIES
There were no tap water available in 56 villages as per the Census 2011. 24 villages had wells, 21 villages had tanks/pond/lake and 34 had hand pumps. 24 villages had River/Canal passing. Power supply was also available in all the villages.
5.5.2 POWER SUPPLY FACILITIES
As per census 2011, all the villages have power supply facilities in the Ankleshwar Taluka.
5.5.3 COMMUNICATION & BANKING FACILITIES
Out of the 56 villages, Post Office is available in 2 villages, telephone facility exist in all the villages as per the 2011 census.
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5.5.4 TRANSPORT FACILITIES
Bus service is available in the Ankleshwar Taluka and is the most preferable mode of transport in the Ankleshwar Taluka. The villages are well connected with the State Highways. National Highway-8 also passes from Ankleshwar. The Western railway line between Bombay to Ahmedabad passes from the Ankleshwar Taluka and Ankleshwar Town has a railway station on the same.
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CHAPTER – 6
PROPOSED INFRASTRUCTURE 6.1 INDUSTRIAL AREA
The total area of the plot is 2915.80 m2. The existing built-up area is 997.41 m2 (34.20%) and open area is 589.01 m2 (20.20%).
6.2 RESIDENTIAL AREA
In the said proposal no residential area has been proposed for workers and/or for staff.
6.3 GREENBELT
Maximum open land is/will be allotted for green belt development. Greenbelt area is approximately 34.25% of total plot area.
6.4 SOCIAL INFRASTUCURE
Existing infrastructure will be sufficient to accommodate the existing load from the proposed project which is very low.
6.5 CONNECTIVITY
This proposed project is located at Plot No. C-1/ 7131 – 7133 & C-1/7102 GIDC Estate Ankleshwar, Dist.: Bharuch, Gujarat – 393 002. The site is within the GIDC Ankleshwar. The site is 3.20 km from National highway. The land and infrastructure is already available. And the raw material is easily available through the easy transport via road connectivity. The nearest railway station is Ankleshwar railway station which is 4.31 km and Surat Airport is 61.59 km from the project site.
6.6 DRINKING WATER MANAGEMENT
Drinking water will be sourced from GIDC water supply for the proposed project.
6.7 SEWERAGE SYSTEM
Domestic waste water generated from the proposed expansion project will be disposed off through soak pit / septic tank which will be @ 3.50 kl/day.
6.8 INDUSTRIAL WASTE MANAGEMENT
Industrial Effluent will be treated in the Effluent Treatment Plant at the site. Details are explained in Chapter 03, Section 3.7.3
6.9 SOLID WASTE MANAGEMENT
Hazardous wastes generated will be in the form of ETP waste from Effluent Treatment Plant, Used oil from gear boxes of the machineries & D.G. Set, Process residue from manufacturing process, discarded drums & bags from storage of raw materials. Company will provide adequate storage area for proper storage of wastes. Details of solid waste generation are given in table 3.9.
6.10 POWER REQUIREMENT & SOURCE OF SUPPLY
The power requirement will be increase to 700 kVA which will be sourced from Dakshin Gujarat Vij Company Limited.
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CHAPTER – 7
REHABILITATION &RESETTLEMENT (R &R) PLAN
7.1 POLICY TO BE ADOPTED
The existing land is located in the notified industrial estate of GIDC, Ankleshwar designated for industrial use. The proposed expansion will be done on the existing land. Hence, no displacement of any population is proposed for the project. Therefore, detailed Social Impact Assessment studies or R&R action study has not been proposed.
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CHAPTER – 8
PROJECT SCHEDULE & COST ESTIMATES
8.1 TIME SCHEDULE OF THE PROJECT
M/s. Danopharm Chemicals Pvt. Ltd. has obtained Consent to Operate (CC&A) for the existing products as tabulated in Table 2.1, (Copies of the same is attached as Annexure 1, for ready reference)
8.2 ESTIMATED PROJECT COST
Environment Protection has also been considered in planning the cost projection. Green belt development is also considered. The estimated project cost will be approximately 6.55 Crores.
Table 8.1: Total Capital Cost Projection
Sr. No. Purpose Total cost (Rs. In Crores)1. Plot 1.22. Building/Electrification 2.03. AHU 1.24. Equipments 0.85. Microbiology Lab 0.86. Effluent treatment plant 0.57. Greenbelt development 0.05
TOTAL 6.55CSR activities 2.5% of the capital cost
(Source: Danopharm Chemicals Pvt. Ltd., Ankleshwar)
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CHAPTER – 9
ANALYSIS OF PROPOSAL
9.1 FINANCIAL & SOCIAL BENEFITS
M/s. Danopharm Chemicals Pvt. Ltd. is located at Plot No. C-1/ 7131, 7132, 7133 & C-1/7102 GIDC Estate Ankleshwar, Dist.: Bharuch, Gujarat – 393 002.
The project will provide employment opportunity to 85 persons. The man-power required for the project will be employed locally from the nearby areas.
Annexure
Annexure-1 Existing CC&A
(1) 2 AMINO 5 NITRO BENZOPHENONE
Mfg. process for 2 Amino 5 Nitro Benzophenone
Charge 2-Chloro, 5-Nitro Benzophenone and Ammonia in a reactor and reflux
for 5 hrs and then heat it with Ethyl Acetate to form 2-Amino 5-Nitro
Benzophenone.
Chemical Reaction for 2 Amino 5 Nitro Benzophenone
C
O
Cl
NO2
NH3
- HClC
O
NH2
NO2
2 Chloro 5 Nitro Benzophenone
M.W.: 261.66
2 Amino 5 Nitro Benzophenone
M.W.: 241.23
Annexure-2 Process TechnologyExisting Products
Material Balance All values in kg
2-Chloro-5-nitro benzophenone 160
Liq Ammonia 270
Water wash 600 860 To ETP
10 Drying loss
Crude 160
Acetic Acid (Fresh) 15
Acetic Acid (Recycled) 305
Water wash 400 400 To ETP
315 Distillation Acetic acid (Recycled)
305
Residue
10
15 Drying loss
160
Drying
1) 2 Amino 5 Nitro Benzophenone
ANBP (Crude)
430
Reaction
170
Centrifuge
170
Crude ANBP
150
160
ANBP (Crude)
Reaction
Purification
480
165
165
Wet pure
Centrifuge
ANBP (Pure)
Acetic acid ML for
distillation
150
Drying
ANBP (Pure)
2. OFLOXACIN
Mfg. process for Ofloxacin
Stage-I
Charge Methanol in the reactor. To this charge O.Q-Acid and N- Methyl
Piperazine. Maintain the reaction for 10 hours. Check and transfer the reaction
mass to the crystallizer. Add Methanol and chill the reaction to ppt the
product. Centrifuge the material and wash with Methanol. The material is
unloaded and dried.
Recovery of N-Methyl Piperazine
The mother liquor is collected and distilled for the recovery of methanol. The
recovered methanol is used in the subsequent batches. The liquid mass is
made alkaline to 11 pH. Add 1800 Lts. Water. Recover N-Methyl Piperazine,
after recovery, add 4328 Lts. Water to the molten mass. Bring the pH to neutral
to precipitate the II crop material which is then centrifuged. The mother liquor
is sent to the ETP after collection of second crop. Output of final product of
700Kgs. Effluent goes to ETP of 6321 Lts. There is no gaseous emission during
process.
Chemical Reaction for Ofloxacin
+
N-Methyl PiperazineO.Q.ACID
Methanol
Ofloxacin
N
OCH3
F
F
O
O
OH
N
O
F
O
N
NCH3
CH3
CH3
NNH CH3- HF
MW: 281.21 MW: 100.16 MW: 331.38
Material balance for Ofloxacin
3. LEVOFLOXACIN
Mfg process for Levofloxacin
Stage I Charge Methanol in the reactor. To this charge L.Q-Acid and N-Methyl
Piperazine. Maintain the reaction for 10 hrs. Check TLC and transfer the
reaction mass to the crystallizer. Add methanol and chill the reaction to ppt.
the product. Centrifuge the material and wash with methanol. The material is
unloaded and dried.
Recovery of N-Methyl Piperazine The mother liquor is collected and distilled for the recovery of methanol. The
recovered methanol is used in the subsequent batches. The liquid mass is
made alkaline to 11 pH. Add 1800 Lts. Water. Recover N-Methyl Piperazine,
after recovery, add 4328 Lts. Water to the molten mass. Bring the pH to neutral
to precipitate the II crop material which is then centrifuged. The ML is sent to
the ETP after collection of second crop.
Output of final product of 700Kgs. Effluent goes to ETP of 6321 Lts. There is no
gaseous emission during process
Chemical Reaction for Levofloxacin
+
Levo Q . Acid N-M ethyl P iperazine
Methanol
Levofloxacin
- HF
N
F
F
OCH 3
O
O HO
N
F
OCH 3
O
O HO
N
N
CH 3
NNH CH3
MW: 281.21 MW: 100.16 MW: 361.37
Chemical Reaction for Levofloxacin
4. CIPROFLOXACIN
Mfg. process for Ciprofloxacin
Stage I Charge Methanol in the reactor. To this charge C.Q-Acid and Anhydrous Piperazine. Maintain the reaction for 10 hrs. Check TLC and transfer the reaction mass to the crystallizer. Add methanol and chill the reaction to ppt the product. Centrifuge the material and wash with methanol. The material is unloaded and dried. Recovery of Anhydrous Piperazine The mother liquor is collected and distilled for the recovery of methanol. The recovered methanol is used in the subsequent batches. The liquid mass is made alkaline to 11 pH. Add 1800 Lts. Water. Recover Piperazine, after recovery, add 4328 Lts. Water to the molten mass. Bring the pH to neutral to precipitate the II crop material which is then centrifuged. The ML is sent to the ETP after collection of second crop. Output of final product of 700Kgs. Effluent goes to ETP of 6321 Lts. There is no gaseous emission during process. Chemical Reaction for Ciprofloxacin
+ NHNHMethanol
C.Q.Acid Anhydrous Piperazine Ciprofloxacin
NCl
F O
OHO
N
F O
OHO
N
NH
MW: 281.67 MW: 331.34MW: 86.14
- HCl
Material balance for Ciprofloxacin
5. NORFLOXACIN
Mfg. process for Norfloxacin
Stage I Charge Methanol in the reactor. To this charge NOR-Acid and Anhydrous
Piperzine. Maintain the reaction for 10 hrs. Check TLC and transfer the
reaction mass to the crystallizer. Add methanol and chill the reaction to ppt the
product. Centrifuge the material and wash with methanol. The material is
unloaded and dried.
Recovery of Anhydrous Piperazine The mother liquor is collected and distilled for the recovery of methanol. The
recovered methanol is used in the subsequent batches. The liquid mass is
made alkaline to 11 pH. Add 1800 Lts. Water. Recover Piperazine, after
recovery, add 4328 Lts. Water to the molten mass. Bring the pH to neutral to
precipitate the II crop material which is then centrifuged. The ML is sent to the
ETP after collection of second crop.
Output of final product of 700Kgs. Effluent goes to ETP of 6321 Lts. There is no
gaseous emission during process.
Chemical Reaction for Norfloxacin
+
Anhydrous Piperazine
Methanol
NOR ACID
NHNHN
F
Cl
O
O
OH
CH3N
F
O
O
OH
H2CCH3
N
NH
MW: 269.66 MW: 86.14 MW: 319.33
- HCl
Norfloxacin
Material balance for Norfloxacin
6. ENROFLOXACIN
Mfg. process for Enrofloxacin
Stage- I Charge Methanol in the reactor. To this charge Enro.Q-Acid and N-Ethyl
Piperazine. Maintain the reaction for 10 hours. Check TLC and transfer the
reactions mass to the crystallizer. Add methanol and chill the reaction to
precipitate the product. Centrifuge the material and wash with methanol. The
material is unloaded and dried.
Recovery of N-Ethyl Piperazine The mother liquor is collected and distilled for the recovery of methanol. The
recovered methanol is used in the subsequent batches. The liquid mass is
made alkaline to 11 pH. Add 1800 Lts. Water. Recover N-Ethyl Piperazine, after
recovery, add 4328 Lts. Water to the molten mass. Bring the pH to neutral to
precipitate the II crop material which is then centrifuged. The ML is sent to the
ETP after collection of second crop.
Output of final product of 700Kgs. Effluent goes to ETP of 6321 Lts. There is no
gaseous emission during process
Chemical Reaction for Enrofloxacin
+Methanol
N -Ethyl P iperazine EnrofloxacinC .Q .AC ID
- HClNNH CH 2CH 3
N
O
Cl
FO
O H
N
OF
O
O H
N
N
H 2C
CH 3
MW: 281.67 MW: 359.39MW: 114.19
Material balance for Enrofloxacin
1) 2-Am ino-5-Nitro Benzophenone
Chemical Reaction
+ NH3 H20 Pressure + HCl + H2O
2-Chloro-5-Nitro Benzophenone Liq Ammonia 2-Amino-5-Nitro Benzophenone
M W. 261 M W. 17 M W. 242 36
Proposed Products
Material Balance All values in kg
2‐Chloro‐5‐nitro benzophenone 160
Liq Ammonia 270
Water wash 600 860 To ETP
10 Drying loss
Crude 160
Acetic Acid (Fresh) 15
Acetic Acid (Recycled) 305
Water wash 400 400 To ETP
315 Distillation Acetic acid (Recycled)
305
Residue
10
15 Drying loss
160
Drying
1) 2 Amino 5 Nitro Benzophenone
ANBP (Crude)
430
Reaction
170
Centrifuge
170
Crude ANBP
150
160
ANBP (Crude)
Reaction
Purification
480
165
165
Wet pure
Centrifuge
ANBP (Pure)
Acetic acid ML for
distillation
150
Drying
ANBP (Pure)
CELECOXIB
ROUTE OF SYNTHESIS
so2NH2
IoI
+
l-(4-Methylphenyll -4,4,4-trif luorobuta ne-1,3-dione
Molecular Weight : 230
Molecular Formula CrrHqFsO2
oHzN-!]-0--n
NHNH2. HCL
4-Sulphonamido PhenylHydrazine -HCL
Molecular Weight: 223Molecular Formula CeHrrNsSOzCI
HCL + 2H2O
+36+36
Il- Vcr,):/pCelecoxib
Molecular Weight : 381
Molecular Formula CrzHuFrNrOzS
2)
SPHHCL 100
Dione 104
Water 1400
Washing 200 1624 ML to ETP
Crude 180
Toluene 2871
Carbon 8
10 Carbon
Water wash 100 2989 ML for toluene recovery
15 Drying loss
2989 2825 Recovered toluene
164 Residue
Sparkler Filter
Material Balance All values in kg
1604
Reaction
180
Centrifuge
180
Celecoxib (Crude)
2) Celecoxib
Celecoxib (Crude)
Celecoxib (Pure)
3059
Reaction Purification
ML for toluene recovery
ML for
toluene
recovery
Distillation
3049
3049
Crystallization
160
Centrifuge
145
Drying
Route of Synthesis Cis Tosylate
STAGE I
+ + 2 NaOH
Cis Bromo Benzoate Imidazole Caustic Soda MW 446 MW 68 80 C18H15BrCl2O4 C3H4N2
Toluene Caustic soda flakes + water
+ NaBr + C7H5O2Na + H2O
CIA Sodium Bromide Sodium Benzoate Water MW 329 103 144 18
C14H14Cl2N2O3
____________________________ (Signed)
Date :23.02.2015
Name: C. M. Deshmukh
Designation & Department: Manager (QC/QA)
O
O
NN
Cl
Cl
O
3)
Route of Synthesis Cis Tosylate STAGE II
+ + Triethyl amine
CIA Para Toluene Sulphonyl chloride C14H14Cl2N2O3 C7H7ClO2S
329 MW 190 101
MDC , Ethyl Acetate Triethyl amine, Liq Ammonia , water
+ Triethylamine Hydrochloride
Cis Tosylate MW 483 137
C21H19N2O5Cl2S
____________________________ (Signed)
O
O
NN
Cl
Cl
O
(STAGE I)
CBB 555
Imidazole 509
DMF 31
Toluene 2183
Water 1782
Caustic 41 416 Imidazole Recovered
Water 1759 2043 To ETP
1884 To ETP
1937 Toluene (Distilled
220 ML for recovery
35 Losses
220 199 Recovered Toluene
2 Losses
19 Residue
STAGE‐2
MDC 1316.25
PTSC 228
Stage I 325
TEA 106
Water 650
27
Water 600
65.25 MDC Loss NaOH Soln. 50 1230 To ETP
1251 MDC (Distilled)
425
25 Ethyl acetate (Distilled)
566 379 Recovered Ethyl acetate
187 Residue
13 Losses
4401
Organic Layer
2459
Aqueous Layer
3) CIS TOSYLATE
1095
Reaction
5060
Separation &
Extraction
4401
Separation &
Extraction
Organic Layer Aqueous Layer
2517 1884
1869.25
Reaction
580
Distillation
580
Crystallization
360
Centrifuge
490
Centrifuge
477
Drying
TEA Recovery & Layer
Separation
100
566
1081
Residue
1056
Distillation
1056
Crystallization
656
Distillation
ML for distillation
Aqueous Layer
1280
100
TEA Recovery
100
TEA Layer
Ethyl
Acetate
Liquid
Ammonia
Material Balance All values in kg
Distillation
Organic Layer
1972.25
1975.25
Reaction
2652.25
3252.25
Separation &
Extraction
Reaction PH
Adjustment
325
Drying
ML for
recovery
2-Chloro Phenyl Hydrazine Hydrochl
ori
de
+ NaNO2 + 2HCl
p-Chloro Aniline Sodium Nitrite Hydrochloric Acid 4-Chloro Phenyl Hydrazine Hydrochloride
M W. 127.5 M W. 68.99 M W. 73 M W. 179
+ NaCl + O2
Sodium Sulphate Oxygen M W. 58.5 M W. 32
4)
All values in kg
HCL 224
PCA 125
Water 125
Sodium Nitrite 76.5
Water 95
ICE Water 700
Sod. Bisulphite 5
Soda Ash 94
water 523
HCl 360
Caustic 200
Water 450
2847.5 To ETP
Base 130
Water 600
HCL 80
NaCl 20
Washing 440 1080 To ETP
30 Evaporation loss
Base Formation
130
Centrifuge
Material Balance
474
Reaction Activation
1345.5
Reaction
Diazotization
160
Drying
4) 4-Chloro Phenyl Hydrazine Hydrochloride
830
190
1967.5
Reaction Coupling
Centrifuge
130
Base Formation
4-Chloro Phenyl Hydrazine Hydrochloride (Base Formation)
4-Chloro Phenyl Hydrazine Hydrochloride
Reaction
Hydrochloride
formation
2327.5
Reaction Hydrolysis
2977.5
4-Sulphanamido Phenyl Hydrazine Hydrochloride
+ NaNO2 + 2HCl Methanol
Sulphanilamide Sodium Nitrite Hydrochloric Acid 4-Sulphonamido Phenyl Hydrazine Hydrochloride
M W. 127.5 M W. 68.99 M W. 73 M W. 223.5
+ NaCl + O2
Sodium Sulphate Oxygen M W. 58.5 M W. 32
Material Balance All values in kg
HCl 277
Sulphanilamide 160
Water 160
Sodium Nitrite 64.8
Water 70
Sod. Bisulphite 4
Soda Ash 88
Water 620
Carbon 3
Hyflow 1
6 Carbon & Hyflow
HCl 529
Water wash 100 1850.8 To ETP
Water 110
Crude 220
Methanol Wash 40 110 To ETP
40 For Methanol recovery
30 Drying loss
40 37 Recovered Methanol
0.5 Losses
2.5 Residue
1970.8
Reaction Hydrolysis
220
Centrifuge
4-Sulphonamido Phenyl Hydrazine Hydrochloride (Crude)
597
Reaction Activation
731.8
Reaction
Diazotization
1447.8
Reaction Coupling
5) 4‐Sulphonamido Phenyl Hydrazine Hydrochloride
ML for recovery
190
Drying
Methanol
RecoveryML for Methanol
recovery
220
Wet Cake Crude
4-Sulphonamido Phenyl Hydrazine Hydrochloride (Pure)
330
Reaction Purification
220
Centrifuge
1441.8
Sparkler Filter
ROUTE OF SYNTHESIS ALONG WITH THE NAME OF REAGENTS & SOLVENTS
4,4,4 – Trifluro-1-(4-methylphenyl)-Butane-1-3-Dione
-
CF3COO(CH3)2CH + Isopropyl Ester 4-Methyl Acetophenone
Mol Wt – 156 Mol. Wt. 134
Toluene,IPA SMO,HCL
+ (CH3)2CHOH 4,4,4 – Trifluro-1-(4-methylphenyl)-Butane-1-3-Dione IPA Mol. Wt. 230 + Mol wt 60
Material Balance
Trifluroacetic acid 146
Sulphuric Acid 11
Isopropyl Alcohol 114
102 Kg Recovered IPA
9 Kg Residue
Toluene 1050
SMO 70
MAP 139
Stage I 160
HCL 276
Water 700
1046 To ETP
1010 Toluene for Reuse
58 IPA for Reuse
23 Atmospheric Loss
8 Distillation Residue
20 Drying Loss
230
Drying
1349
Organic Layer
250
Distillation
250
Centrifuge
1419
Reaction
2395
Reaction
1349
Separation & Extraction
4,4,4 –Trifluro-1-(4-methylphenyl)-Butane-1.3-Dione (Stage-2)
6). 4,4,4 –Trifluro-1-(4-methylphenyl)-Butane-1.3-Dione
All values in kg
Reaction Esterification
271
Distillation
160
Product Stage I
ROUTE OF SYNTHESIS ALONG WITH THE NAME OF REAGENTS & SOLVENTS
METRONIDAZOLE BENZOATE
+
Metronidazole Benzoyl Chloride
171 140
+ HCL
Metronidazole Benzoate Hydrochloric Acid
275 36
Material Balance
Metronidazole 825 76 HCl Gas
Beta Picoline 515 4.5 CO2 gas
Soda Ash 11
Benzoyl Chloride 680
Water 1450
Sod. Bicarbonate 11 3422.5 ML for Beta Picoline recovery
Water 1461
ML for Beta Picoline recovery 3422.5 474.5 Recovered Beta Picoline
caustic flakes 25 3048 Water to ETP
Water 75
Methanol (Fresh) 1440
Methanol (Recovered) 0
Water 360
Crude 1450
Carbon 4
Hyflow 2
10 Carbon + Hyflow
1946 ML for Methanol recovery
100 Loss
ML for Methanol recovery 1946 50 Loss
1850 MeOH (Distilled)
1950.5
Reaction
Benzoylation
Metronidazole Benzoate (Crude)
7) Metronidazole Benzoate
All values in kg
Metronidazole Benzoate (Pure)
Distillation
3400.5
Reaction Quenching
1450
Centrifuge & washing
1450
Wet Cake Crude
3256
Reaction Purification
3246
Sparkler filter
1300
Centrifuge & washing
46
Residue
1200
Drying
46
Distillation
'-ry
Route of SYnthesis
Ketoconazole
nrONN{\*J bH* +
\#\,*{-o* ilprr Lo"JLo,^Jd\
clr'\r^clCis TosYlate
L-4cetyl-4-(4-hYd roxYPhe nYl )
Piperazine (AHPP)220
DN{SOI\4ethano1Ettryl acetate
*$ -.r-""ru. -*
l-"0\ ['*Efr, r. \. rt if .,---d':F*nu, ,H*{. }*fl $ ,so
$r# '*r ''*i t #' !:':s
an* man;ionwr L -# + Para Toluene sulphonic Acid
Ketoconazole
531 172
DMSO 200
AHPP 90
SMO 24
CTS 200
Acetone 200
Water 400 800 To ETP
Alkali Wash 408 470 ML for Recovery
32 Evaporation loss
175.50 Recovered DMSO
175.50 Recovered Acetone
10 Losses
109 Residue
Ketoconazole Crude 220
Ethyl Acetate 1092
Methanol 312
Carbon 12
Hyflow 2
15 Carbon
1053 ML of Ethyl acetate & Methanol for Recovery
50 400 ML for recovery
20 Loss
1163 Recovered EA
254 Recovered Methanol
10 Losses
26 residue
Distillation &
Crystallization
220
Drying
8) KETOCONAZOLE
514
Reaction
714
Reaction
252
Centrifuge
KETOCONAZOLE Crude
KETOCONAZOLE Pure
ML for recoveryDistillation
ML for RecoveryDistillation
1453
470
Centrifuge
220
200
Drying
1638
Reaction Dissolution
& Filtration
1623
Filter
570
Wash with Ethyl
Acetate + MeOH
Reaction Scheme
Ethyl Potassium Malonate
+ KOH + C2H5OH Diethyl Malonate Potassium Hydroxide Ethyl Potassium Malonate Ethyl Alcohol 160 56 170 46
Reaction Scheme
CARBO ETHOXY DI PHENYL AMINE
+ + PCL5 M WT 248.66 M WT 170.20 M WT 208.24
+ 2HCL + KCL + H3PO4
73 74.55 98
Material Balance
Stage‐1
Ethanol Denatured Toluene 1190
Diethyl Malonate 189
KOH 72
1001 Ethanol Denatured Toluene
Washing ethanol denature toluene 132 402 ML for distillation
10 Loss
ML for distillation 402 284 Distilled
73 loss
45 Residue
Stage‐2
Chloro nitro diphenyl amine 248
Stage‐1 170
1‐Chloro butane 1200
PCl 5 98
Water 450
563 Aq layer to etp
Sodium Bicarbnate solution 105
105 Aq layer to etp
Carbon 5
8 Carbon
1140 Distilled out chloro butane
Mix Xylene 65
N‐Hexane 50
Washing Xylene + n‐Hexane 40 115 Residue
145 Distilled quantity
9) Carboxy Diphenyl Amine
All values in kg
355
Centrifuge
355
Drying
260
Distillation
1600
Filter
460
Distillation
575
Residue
1708
Org Layer
1603
Separation
1608
Org Layer
1716
Reaction
2166
Quenching
1603
Separation
450
Distillation
1451
Reaction
Distillation
170
Drying
180
Wet cake
180
Centrifuge
NORFLOXACIN
+
Anhydrous Piperazine
Methanol
NOR ACID
NHNHN
F
Cl
O
O
OH
CH3N
F
O
O
OH
H2CCH3
N
NH
MW: 269.66 MW: 86.14 MW: 319.33
- HCl
Norfloxacin
Material Balance All values in kg
Methanol 175 kg.
Nor Acid 625 kg. HCl ‐ 40 kg.
Piperazine(Fresh) 225 kg.
Piperazine(Recovered) 475 kg.
Mass - 1460 kg.
Methanol - 1400 kg.
Mass - 2860 kg.
Methanol Wash - 50 kg. ML for Piperazine recovery - 2170 kg.
Wet Cake - 740 kg.
Ev.Loss - 40 kg.
Norfloxacin (Dry) ‐ 700 kg.
10) Norfloxacin
Reaction
Crystallization
Centrifuge
Drying
Methanol Distilled ‐ 1550 kg.
ML ‐ 2170 kg. Loss - 15 kg.
Org.Layer - 605 kg.
Water - 1825 kg.
Caustic Flakes ‐ 50 kg. Piperazine recovered ‐ 475 kg.
Aqueous Layer - 2005 kg.
Water - 2000 kg.
HCl ‐ 50 kg.
Mass - 4055 kg.
Effluent to ETP - 3943 kg.
Wet Cake ‐ 112 kg.
Ev.Loss - 32 kg.
2nd Crop ‐ 80 kg.
(Recycle for next batch)
Recovery of Piperazine
Distillation
Reaction&
Layer Separation
Reaction
Centrifuge
Drying
Annexure – 3 Plot Allotment Letter
Annexure – 4 Membership Certificate of Eco-Aqua
Annexure – 5 Membership of BEIL