PREFEASIBILITY REPORT FOR EXPNASION IN BULK-DRUG MANUFACTURING UNIT

Transcription

1 PREFEASIBILITY REPORT FOR EXPNASION IN BULK-DRUG MANUFACTURING UNIT PROJECT PROPONENT: M/s. MAHENDRA CHEMICALS Plot No. B-1/ /2, GIDC, Naroda, Ahmedabad JANUARY 2016 Consultant: EXCEL ENVIRO TECH NABET Accredited EIA Consultant Organization TF-2, Sun House, Old High Court Lane Off Ashram Road, Ahmedabad Tele-fax: , Cell: Website :

2 TABLE OF CONTENTS CHAPTER 1 Introduction to the Project Project Proponents 3 CHAPTER 2 Project Description Product Location Alternate sites considered Products & Raw Material Details Product Details Products Properties Raw Material Details Raw Material Properties Source, Transpiration and Storage of raw materials Manufacturing Process Lindocaine Base USP Lidocaine HCL Utilities Requirement List of Machinery Air Pollution Sources Details of Existing Air Pollution Sources Details of Proposed Additional Air Pollution Sources Water Balance Manpower Requirement 10 Chapter 3 Site Analysis Connectivity Existing Land use Pattern Topography Social Infrastructure Available Details of CSR Activity Emergency Management Services rehabilitation & Resettlement Plan Landuse Breakup 12 Chapter 4 Proposed Environmental Infrastructure Management Of Domestic Water Management Of Industrial Waste Water Air Quality Management Solids & Hazardous Waste Management Hazardous Chemicals Details Waste Minimization Measures Details Of Fire Extinguisher 16 CHAPTER 5 PROJECT SCHEDULE & COST ESTIMATES Proposed Schedule Cost Estimation 17 2

3 CHAPTER 1 Introduction to the Project M/s. Mahendra Chemicals is an existing small scale unit located at Plot No. B1/ /2, GIDC, Naroda, Ahmedabad. The current activity involves manufacturing of; Lidocaine base USP with capacity 2 MT/Month and holds valid Consolidated Consent & Authorization (CC&A) from GPCB. M/s. Mahendra Chemicals is one of the most trusted and leading manufacturers and exporters of Lidocaine drug. Now, looking at prospective market scenario and considering the large market demand of the Product, the company is keen to expand production capacity. It is proposed to manufacture 15 MT/Month of existing product (with addition of one stage HCl if required). This pre-feasibility report contains a basic outline of technical and environmental parameters of proposed activity and forms a part of application for procuring Environment Clearance. M/s. Mahendra Chemicals is an active pharmaceutical manufacturing company focused on the development and synthesis of active pharmaceutical ingredients (API) for the pharmaceutical industry to process. The manufacture of products based on small molecules active pharmaceutical ingredients (API) remains critical to global healthcare. The manufacturing landscape is also filled with challenges and opportunities. This is due to the changing social, economic, environmental and regulatory international emerging markets and expectations quickly. The unit exists to provide affordable and innovative medicines for healthier lives. Patient needs are at the heart of everything, and innovation is the main way to meet these needs. The two core businesses - Pharmaceutical services and active ingredients and products, offering a variety of products and services including active pharmaceutical ingredients (API), custom patented pharmaceutical services. The Top management comprises of experts in various fields of medicine, chemistry and medical research, human resource development, business strategy, finance and economics. Top management and committees appointed by the Board Reviews all major business decisions to focus on specific areas. List of partners is as follows Name of partners Shree Rajnibhai G. Patel Smt. Nirmalaben J. Amin Shree Jayantibhai N. Amin Shree Kalpesh S. Patel Address 12-A, Aarohi Royal Part-II, Nr. Aarohi Homes, Nr. Sobo Center, South Bopal, Bopal, Ahmedabad , Maheshwari Park, Near Nirmal Society, Vatva Road, Maninagar, Ahmedabad , Maheshwari Park, Near Nirmal Society, Vatva Road, Maninagar, Ahmedabad Prerna, Opp. Shashtri Stadium, Anand 3

4 The business of active pharmaceutical ingredients (API) is to help clients succeed by being the first or among the first few to get products with high IP, technological and regulatory barriers in the market. In doing so, we help to bring affordable and innovative solutions to patients faster medicines. For said expansion, there will not be any requirement of additional land, as the expansion would be carried out in existing premises having well-constructed facility. The capacity increase would be gained by large batch-size and extended hours of operation. The additional investment would be Rs. 50 Lac in addition to Existing Rs. 1 Crore. 4

5 CHAPTER 2 Project Description 2.1 Project Location The Project is located at coordinates 23 o N; 72 o E in GIDC Estate, Naroda, Ahmedabad, Plot No: B1/ /2, about 11 km far from Ahmedabad Junction Railway station and 3.5 km far from Ahmedabad International Airport. Plant is just a 0.65 km away from NH8 that provides a convenient & competitive trade gateway to domestic market transportation. Location of the Project with Surroundings 2.2 Alternate Sites Considered The company has not considered any alternate site; as it already has an existing plant for manufacturing of chemicals at the site. Necessary permissions from State Pollution control Board for existing activities have been obtained. The proposed products are addition of manufacturing capacity in existing products. As the unit is located in notified area of GIDC, the site is having all required infrastructure facilities in form of; water, electricity, fuel (natural gas) and Road available for the existing as well as proposed activities. 5

6 2.3 Products & Raw Material Details Product Details Current Product as per valid Consent is Lidocaine Base USP with capacity of 2.0 MT/Month. In the proposed profile, Lidocaine base and Lidocaine HCl would be manufactured. Total of both shall be 15 MT/Month. The Details of existing and proposed products are given in following table: Name of Product Existing Capacity Proposed Change Proposed total capacity Lidocaine base USP Lidocaine base / Lidocaine HCl 2.0 MT/Month Nil Nil Nil 15.0 MT/Month 15.0 MT/Month Product Properties Sr. No Full name of the products and production capacity 1 Lidocaine base / Lidocaine HCl (15 MT/M) Physical Phase Solid Container detail No 600 Nos. HDPE Drums Main properties (refer MSDS) B.P. C F.P. C LEL /UEL % Specific gravity TLV ppm or mg/m 3 LD 50 mg/kg LC 50 mg/l NA NA NA NA 220 mg/kg Raw Material Details Requirement of Raw materials for Lidocaine base / Lidocaine HCl Kg/Month Sr. No. Name of raw material Proposed total quantity in Kg/Month 1 2,6 Xylidine Chloro Acetyl Chloride Soda Ash Di-ethyl Amine Caustic Soda Toluene Acetone (For Lidocaine HCL) Hydrochloric Acid (For Lidocaine HCL)

7 Raw Material Properties Raw material spec. Chemical name Synonym s Molecular weight Molecular formula Physical form Colour Solubility Melting point, o C Boiling point, o C Specific gravity 2,6 Xylidine 2,6- Dimethy l aniline 2,6XD Chloro Acetyl Chloride Chloro acetyl chloride Chloro Acetic Chloride Soda Ash Sodium Carbonat e Disodium Carbonat e Di-Ethyl Amine Di-ethyl amine Di-ethyl Amine Anhydrou s Caustic Soda Sodium hydroxid e Soda lye Toluene Acetone HCl Toluene Acetone Hydrochlori c Acid Methylbenzo l Propanone Hydrogen chloride g/mole g/mole C 8 H 12 N COCH 2 Cl Na 2 CO 3 C 2 H 5 - NaOH C 6 H 5 CH 3 CH 3 COCH HCl 2 NH 2 -C 2 H 5 3 Liquid Liquid Solid Liquid Solid Liquid. Liquid Liquid Pale yellow or pale red Slightly soluble Colourless Solid powder Colourless White Flakes Soluble NA Soluble soluble Diethyl ether, acetone, ethanol, benzene, chloroform, glacial acetic acid, carbon disulfide Colorless Colourless Colourless At 30 o C Miscible At 30 o C Water soluble C C Not available o o C C o C o C o C Source, Transportation and Storage of raw materials: All the raw materials except 2,6 Xylidine are procured from local suppliers. 2,6 Xylidine is imported which is unloaded at Chemical Zone of Mumbai Port. All the raw materials are transported to site by road. The raw materials which are in solid form are packed and stored in HDPE bags. The other raw materials in liquid form are procured and stored in Plastic carboys. Separate storage area has been provided for storage of raw materials. 2.4 Manufacturing Process: Lidocaine Base USP Stage-1 Take 2.6, Xylidine and soda ash, stirring well maintaining temperature of ⁰C. Then start addition of Chloro Acetyl Chloride under stirring at low temperature. After this, add Toluene to this reaction mass. The mass is filtered to get intermediate product Chloro Acetyl Xylidine. The toluene separated from the filteration stage is recycled back for next batch required make up quantity of Toluene is added. The Chloro Acetyl Xylidine is sent for next stage. 7

8 Stage-2 Take Chloro Acetyl Xylidine is another reactor and add Diethyl Amine for exothermic reaction, keeping continuous stirring and maintain temperature at 100 to 105 ⁰C for 6 hours. Then add caustic lye to get Crude Lidocaine Base. Later distilled the crude Lidocaine Base under vacuum and re-crystallise by distilled water to get pure Lidocaine Base USP. Filter, wash with chilled water and dry. PRECESS FLOW CHART Xylidine + Soda Ash (20⁰C - 25⁰C) Chloro Acetyl Chloride + + Toluene Diethyl Amine 100 to 105 ⁰C + caustic lye + Crude Lidocaine Base VACUUM DISTILLATION LIDOCAINE BASE - PURE Lidocaine HCl In this process, the formation of Lidocaine Base is first undertaken. The process for all the preceding reaction is same. Dissolve distilled Lidocaine Base in Acetone & acidify with Hydrochloric Acid. Cool the whole content below 5oc to get Lignocaine HCl. The product is the, filtered, washed with cold Acetone to get pure Lidocaine HCl I.P./B.P. The Mother Liquor (ML) is collected and distilled to recover the solvent Acetone. 2.5 Utilities Requirement 8

9 All utilities required for the project would be developed in the existing facility and the utility requirements are as under. Sr. Particulars Consumption Source No. 1 Power Consumption 120 HP UGVCL 2 Proposed total fresh water 16.1 KL/DAY GIDC pipeline Requirement 3 Natural Gas 1000 SCM/Day Adani 2.6 List of machinery Sr. No. Name of Instruments Existing Capacity Existin g No. Proposed additional Capacity Proposed additional Quantity 1. R.O. Plant (Process) 500 LPH Baby Boiler Non IBR Type 300 KG Steam Boiler kg 1 4. Thermic Boiler Non IBR Type 1 Lac kcal/hrs Air Handling Unit With A/C 1200CFM Air Handling with FDV System 1000CFM Cooling Tower S. S. Tank 40 Lit 6 40 Lit 1 9. Oil Ring Vaccum Pump Platform balance-digital 150 kg Platform Balance 300 kg Sintex Storage HDPE Tank 300 liters Air Compressor(ETP) S. S. Transfer Pump (Water) S. S. Sieve Screen Air Curtain 39 x 84 SIZE Overhead HDPE Tank 2500 LITERS Chilling Plant -1 UPTO 1 c Chilling Plant -2 UPTO 1 c RO plant (Effluent) Lit/hour Air Pollution Sources Details of Existing Air Pollution Sources FLUE GAS EMISSION Sr. No. Type of Emission Fuel APCM Details of Stack 1. Thermic Fluid Heater & Boiler(1 Lac Kcal/hr) 2. D. G. Set Diesel Natural Gas m Details of Proposed additional Air Pollution Sources Adequate stack height 9 m 9

10 FLUE GAS EMISSION Sr. No. Type of Emission Fuel APCM Details of Stack 1. Steam Boiler (600 kg /hour) Natural Gas m Note: Natural gas is a clean fuel therefore; there is no requirement of APCM. 2.8 Water balance (Category-wise water consumption and wastewater generation) Water Consumption, L/day Waste Water Generation, L/day Sr. Source No Proposed Proposed Existing Addition Existing Addition Total Total 1. Domestic Gardening Process Boiler Cooling Total Manpower Requirement Required specialized man power & talent would be recruited / hired locally and supporting services would be made available from our existing plant. Approximately 10 people will be employed. 10

11 M/s. Mahendra Chemicals CHAPTER 3 Site Analysis 3.1 Connectivity Site and Ahmedabad is well connected by rail, road & air. Road: Linked to the National Highway Network through an extension of NH 8 from Ahmedabad NH-8, an offshoot of NH 8 connects Delhi, Ahmadabad to Mumbai. Rail: Ahmedabad central Railway station is 11.0 km away from factory site Air: Ahmadabad has a fully functional, long airstrip for servicing the needs of private commercial jets which is proposed to be developed as an air cargo hub. Ahmadabad International airport is 3.5 km from Naroda GIDC Ahmedabad. 3.2 Existing Landuse Pattern Currently the land (1258 m2) is occupied by Project Proponent. No agricultural activities are done on this land. The particular plot B1/ /2 is under the possession of the company. There will not be any additional requirement of land. 3.3 Topography The area is flat in nature. It is a build up plot. The average elevation above mean sea level is 55 m. toposheet of the area covering site is as follows: 11

12 3.4 Social Infrastructure Available: The social infrastructure available at Ahmedabad is listed below. Housing colonies Public School ITI center Healthcare Centre Children s Park Community Centers Pharmacy Market And all very well developed urban facilities 3.5 Detail of CSR activity It will be ensured that the unit contributes to the locally arranged Social welfare activities. 3.6 Emergency management services Logistic facility /Tel Nos. Destination Distance km. Nearest Hospital ( ) NIA Hospital 3.0 km Fire Brigade (101) Memco Fire Brigade 6.0 km Nearest Police Station (100) Naroda Police Station 3.0 km Hospital Gov. Hospital (ESI Corp.) 800 meter 3.7 Rehabilitation & Resettlement Plan The land is already in the possession of the project proponent. The NA permission for the land is obtained by GIDC. Therefore, resettlement and rehabilitation is not involved. 3.8 Landuse Breakup This plant will be located in survey No B1/ /2 having an area of 1258 Sq. m. DETAIL OF GREEN BELT DEVELOPMENT Particular Total Land sq. m Existing green belt sq. m Detail 1258 Sq. m 250 Sq. m 12

13 CHAPTER 4 Proposed Environmental Infrastructure Company has already obtained Consent to Operate from Gujarat Pollution Control Board for the existing unit for manufacturing of Bulk-drugs. The company will take into account all environmental aspects for expansion also so that no pollution hazard is ever created in and around the plant. Every effort is being made to keep zero air pollution as well as water pollution. In addition to the above, care has been taken to provide green belt around the plant. 4.1 Management of Domestic Waste Water The domestic effluent (1200 Liter/day) shall be disposed through septic tank/ soak pit. 4.2 Management of INDUSTRIAL WASTE Water The industrial effluent (8200 Liter/day) shall be treated in ETP and Reverse Osmosis Plant. The RO permeate (meeting GPCB norms) would be reused or disposed off to CETP; and reject would be sent to common MEE for evaporation. Treatment scheme: All the effluent generated from manufacturing process along with boiler blow and the discharges drained from cooling system is taken to the collection cum neutralization tank. ph of the effluent is checked and physico-chemical treatment is given to the effluent. Here, necessary adjustment is made in ph with help of chemicals like dilute Hydrochloric acid and/or caustic soda solution. After neutralization effluent is pumped to primary hopper bottom settling tank, Here, solid liquid separation takes place. Settleable solids are allowed to settle at the bottom of the tank and supernatant effluent is overflows to holding tank by gravity. Here effluent from holding tank is pumped to pressure sand filter and activated carbon filter for polishing treatment. After polishing treatment effluent is treated to Industrial Reverse Osmosis Plant. The RO permeate would be reused or sent to CETP set up and operated by Naroda Enviro Projects Limited (NEPL) for further treatment to achieve the norms laid down by statutory authorities. The RO reject would be sent to common MEE for evaporation. Sludge separated from primary settling tank is drained to sludge drying beds. The leachate from the sludge drying beds is send to collection tank for treatment along with raw effluent. The sludge after proper drying is collected in HDPE bags and stored at designated storage area. The dry sludge after proper accumulation is disposed off to approved Treatment Stabilization and Disposal Facility (TSDF) Name and size of the ETP units Sr.No. Name of Unit Size Capacity in m 3 Retention time 1. Collection Cum Equalization Tank 1.6 X 1.8 X hours 2. Hopper Bottom Settling Tank 10 X 1.0 X hours 3. Holding Tank hours 4. Pressure Sand Filter 1.0 dia X 1.25h Activated Carbon Filter 1.0 dia X 1.25h Sludge Drying beds 1.0 X m Reverse Osmosis Plant (Proposed ) Lit/hour 13

14 ETP Process diagram: From Plant Collection cum neutralization tank Settling tank R.O. Treatment Receiving Tank Carbon Filter Sand Filter R.O. Permeate R. O. Rejected CETP Common MEE Proposed Reverse Osmosis Plant: 1000 Lit/hour capacity with % recovery 4.3 Air Quality Management: The source of air pollution is Thermic Fluid Heater & Boiler, which consumes Natural Gas (1000 SCM/Day) and hence can be considered as non-polluting. Plant area has well ventilated, cross air flow and exhaust fans have been provided for extra air flow. 4.4 Solid & Hazardous Waste Management The details of hazardous wastes generation from the proposed project & its management & Handling are listed in the following tables. All the requirements of hazardous waste rules shall be complied with. Details of Hazardous Waste as per 2008 Rules Sr. No Detail of Hazardous Waste Category Existing Quantity Proposed total Management of Waste 1. ETP Sludge Kg/Month 150 Collection, Storage, transportation 14

15 Used oil/spent oil Discarded container Distillation residue Kg/Month No./Month Kg/Month Kg/Month 5.0 Kg/Month 50 No./Month 250 Kg/Month disposal at TSDF approval by board Collection, Storage, transportation disposal by selling to registered reprocess or used as lubricant in plant Collection, Storage, decontamination, transportation disposal by selling to authorised recycler Collection, Storage, transportation disposal at NECL approved by board 4.5 Hazardous Chemicals Details TABLE of MSDS properties for RM and Product Sr No Full name of the raw material 1. 2,6-Xylidine (C8-H11-N) 2. Chloro acetyl Chloride (C 2-H 2-Cl 2-O) 3. Soda Ash (Sodium carbonate) (Na 2CO 3) 4. Di-ethyl Amine (CH 3CH 2) 2NH 5. Caustic Soda (NaOH ) Physical Phase Maxi. storage Liquid 2.5 MT kg Liquid 2.5 MT kg Solid 100 kg 2 50 kg Liquid 1.5 MT 250 kg Solid 1.5 MT 30 bags Container Main properties (refer MSDS) detail No Size B.P. C F.P. C LEL /UEL % % 6.9% 50 kg 6. Toluene Liquid 500 kg kg Specific gravity NA Not available Not available TLV ppm or mg/m Not available Not available 851 NA Not available % 10.1% 0.71 Not available NA mg/m (40 F). (Setaflash) Open Cup: 16 C (60.8 F). 1.1% 7.1% mg/m3 LD 50 mg/kg LC 50 mg/l Acute: 840 mg/kg [Rat]. 707 mg/kg [Mouse]. ORAL (LD50): Acute: 220 mg/kg [Mouse]. 208 mg/kg [Rat]. DERMAL (LD50): Acute: 662 mg/kg [Rat]. Acute oral toxicity (LD50): 4090 mg/kg [Rat]. Acute toxicity of the dust (LC50): 1200 mg/m3 2 hours [Mouse]. ORAL (LD50): Acute: 540 mg/kg [Rat.]. DERMAL (LD50): Acute: 820 mg/kg [Rabbit.]. VAPOR (LC50): Acute: 4000 ppm 4 hour(s) [Rat.]. LD50: Not available. LC50: Not available. ORAL (LD50): Acute: 636 mg/kg [Rat]. DERMAL (LD50): 15

16 7. Acetone Liquid 1.25 MT kg 8. HCl Liquid 2.5 MT MT 56.2 C C Closed Cup: - 20 C (- 4 F). Open Cup: -9 C (15.8 F) 2.6% 12.8% Acute: mg/kg [Rabbit]. VAPOR (LC50): Acute: mg/m 4 hours [Rat]. 440 ppm 24 hours [Mouse] ppm Acute oral toxicity (LD50): 3000 mg/kg [Mouse]. Acute toxicity of the vapor (LC50): mg/m3 4 hours [Mouse] C NA Not available Acute oral toxicity (LD50): 900 mg/kg [Rabbit]. Acute toxicity of the vapor (LC50): 1108 ppm, 1 hours [Mouse]. Acute toxicity of the vapor (LC50): 3124 ppm, 1 hours [Rat]. 4.6 Waste Minimization Measures Metering and control of quantities of active ingredients to minimize waste. Reuse of by-products from the process as raw materials or as raw material substitutes in other processes. Use of automated filling to minimize spillage. Use of Close Feed system into batch reactors. Venting equipment through vapor recovery system. Use of high pressure hoses for equipment clearing to reduce wastewater generation for reuse. 4.7 DETAIL OF FIRE EXTINGUISHER Sr. No. Type of Fire Extinguishers Capacity Qty 1 Dry Chemical Powder Type (ABC) (IN MFG. AREA) 15.0 kg 1 2. Dry Chemical Powder Type (ABC) (IN MFG. AREA) 5.0 kg 1 3. Dry Chemical Powder Type (ABC) (IN MFG. AREA) 5.0 kg 1 4. Dry Chemical Powder Type (ABC) (IN MFG. AREA) 5.0 kg 1 5. Dry Chemical Powder Type (ABC) (IN MFG. AREA) 5.0 kg 1 6. Dry Chemical Powder Type (ABC) (IN MFG. AREA) 5.0 kg 1 7. Dry Chemical Powder Type (ABC) (IN MFG. AREA) 1.0 kg 1 8. Dry Chemical Powder Type (ABC) (IN Q.C. LAB) 1.0 kg 1 9. Dry Chemical Powder Type (ABC) (IN Q.C. LAB) 5.0 kg 1 16

17 CHAPTER 5 PROJECT SCHEDULE & COST ESTIMATES 5.1 Proposed Schedule The industry seeks Environmental Clearance (EC) and intends to start production activities from February 2016 and final production activities from December Sr. No. Activity Schedule 1 Application for Environmental Clearance February TOR Meeting April Avail Environmental Clearance September Final Project Activities October Procure CtO December Start Production Activities December Cost estimates As the proposed expansion is to be carried out in existing infrastructure, there would not be any requirement of new land of building. New machinery, like large sized vessel and allied large capacity utilities would be procured. New Reverse Osmosis Plant would be installed. Estimated expenditure would be approximately Rs. 50 Lac to be incurred from captive funds. 17

18 ANNEXURE-I CC&A COPY 18

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22 ANNEXURE-II GIDC Allotment LETTER 22

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24 ANNEXURE-III PLANT LAYOUT 24

25 ANNEXURE-IV PROJECT WITH SURROUNDING 2.5 KM RADIUS AREA 25

26 NEPL MEMBERSHIP 26

27 NECL MEMBERSHIP 27

28 HELP MEMBERSHIP 28

29 COPY OF EC(NOT EXECUTED) 29

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