Environmental Management in Pharmaceutical Industry & for Environmental Protection

Transcription

1 Environmental Management in Pharmaceutical Industry & Charter on Corporate Responsibility for Environmental Protection by NKVerma N.K.Verma CEO UPL Environmental Engineers Ltd Awareness Programme on Environment & Hazard Management in Pharmaceutical & Bulk Drug Industry at Ankaleshwar 31 st January, 2011 STATUS OF BULK-DRUGS PRODUCTION IN INDIA Types of drug produced Classification of drugs - 58 (therapeutic classes) Total drugs production - 27,500 tones/year No. of industries in production ~ 300 1

2 CLASSIFICATION OF INDUSTRIES WITH RESPECT TO PRODUCTION Category I : High production with more industries Category II : High production with less industries Category III : Low production with more industries Category IV : Low production with less industries Groups Category No. of therapeutic classes No. of drugs No. of manufacturing units Actual production (tones/year) 1 I II III IV WASTEWATER MANAGEMENT Water consumption and scope of recycling of wastewater Consumption of process water is less than consumption of water for utility (boiler/cooling water bleeding) Utility discharge is relatively cleaner, with renovation it can be reused 2

3 ALTERNATIVES FOR RECYCLING, RECOVERY, RENOVATION AND REUSE OF INDUSTRIAL WASTEWATER RAW WATER WATER FOR UTILITIES INDUSTRIAL PROCESS WATER WW SERVICE AND SANITARY USE RECYCLING COOLING WATER WASTEWATER (WW) D.M. PLANT BOILER ALTERNATIVE TREATMENT HIGH BOD WASTE ENERGY RECOVERY RECOVERY OF METALS UPGRADATION OF WASTE SOLVENT RECOVERY REVERSE OSMOSIS BIO-TREATMENT REUSE FOR AGRICULTURE CHARACTERISTICS OF EFFLUENT TREATMENT TECHNOLOGY AND STANDARDS ISSUES: 1980 S-Objective was to remove BOD. Technology identified end-on-pipe technology Best Practicable Technology (BPT) Compliance of standard, not achievable in respect of TDS & COD 3

4 PROPOSED SCHEMATIC FLOW DIAGRAM FOR THE TREATMENT OF EFFLUENT FROM FORMULATION UNITS Influents Flash Mixer Clariflocculator Cum Skimmer O&G Trap Equalization Neutralization Sedimentation Cum Skimmer Extended Aeration Settlin g Sludge Drying Beds Treated Effluent Chlorine Contact PROPOSED SCHEMATIC FLOW DIAGRAM FOR THE TREATMENT OF EFFLUENT FROM BULK DRUG UNITS Influents O&G Trap Flash Mixer Clariflocculator Cum Skimmer Pump Equalization Regulated Release Neutralization Pre-Aeration Sedimentation Cum Skimmer Trickling Filter Extended Aeration Collection Concentrated Wastewater Settlin g Treated Effluent Chlorine Contact 4

5 PROBLEMS Characteristics of wastewater High salt content (TDS) and High persistent organics (COD) WASTEWATER CHARACTERISTICS OF BULK DRUGS (SYNTHETIC ROUTE) ph COD (mg/l) TDS (mg/l) BOD (mg/l) ,000 1,15,750, 22,000 50,000 8,000 14,800 5

6 WASTEWATER GENERATION FROM AN ANTIBIOTIC PLANT (FERMENTATION ROUTE) S. No Source of Wastewater generation Fermentation block Filtration / Centrifugation Recovery & purification block Nature of wastewater and solid waste Floor and equipment washings, leakages of valves, machines, contaminated batches, cooling waters, laboratory & utility wastes Mycelium cakes, filter washings, floor washings Faecal wastes, acid and alkali wastes (from regeneration of ionexchangers), floor washings and laboratory wastes Range of average characteristics of combined effluent, in mg/l except ph ph 4.0 to 8.0 TSS 10 to 1000 BOD 500 to 6000 BOD Upto 10,000 CN 0.1 to 1 Heavy metals 1 to 5 Oil & Grease 20 to 50 4 Style & finishing block Floor and equipments washings and other utility wastes Phenol (after mycelium cake separation) 1 to 5 WASTEWATER GENERATION FROM A PHARMACEUTICAL (FORMULATION) UNIT S. No. Source of wastewater generation Average flow of wastewater (cum/hr) 1 Sterile products 1.0 to 10 2 Syrup preparation 10 to 25 3 Malt preparation 1 to 5 Range of average effluent characteristics in mg/l except ph BOD 50 to 100 TSS 20 to 260 COD 150 to 2500 Cl - 20 to 150 BOD 300 to 2000 SO to 200 BOD 2000 to Pastilles preparation 10 to 25 Heavy metals 1 to 20 TSS 100 to 300 ph 4.0 to 8.0 6

7 DECISION TREE FOR APPROPRIATE TREATMENT OF WASTEWATER Start Multiple Evaporation and collection of condensate for biological treatment as dilutant Or Use end-of-pipe technology such as RO/ion exchange Yes Identification of waste stream Is TDS due to organic alone No Is it due to inert inorganic No Is it a blending of organic & inorganic No If it is of low BOD, COD & TDS, use it as dilutant for combined disposal of wastewater Yes Yes Is BOD/COD=<0.3 Is it possibly to modify unit operation Treat it biologically No Yes Incinerate the effluent Stream strip followed by incineration or multiple effect evaporator No Yes Do it STREAM WISE BPT IN BULK DRUG INDUSTRIES COD HIGH HIGH BOD LOW TDS TDS HIGH LOW HIGH LOW FORCED EVPORATION FOLLOWED BY BIOLOGICAL TREATMENT-I BIOLOGICAL TREATMENT-II INCINERATION-III SOLVENT/CHEMICAL RECOVERY-IV LOW HIGH BOD TDS HIGH LOW FORCED EVAPORATION FOLLOWED BY BIOLOGICAL TREATMENT-I BIOLOGICAL TREATMENT-II LOW TDS HIGH LOW FORCED EVAPORATION SOLVENT/CHEMICAL RECOVERY-IV 7

8 INTEGRATED TREATMENT SCHEME THROUGH COMBINED EFFLUENT TREATMENT PLANT IN A CLUSTER OF INDUSTRY Multiple evaporator Separation: TDS bearing COD Sewage With high TDS Sewer line/marine i water body Persistent organic CETP Low TDS River/recycling to agriculture First step: Solvent extraction followed by incineration Residual COD after ph adjustment and solvent extraction by SSI Second step: Biological treatment LARGE INDUSTRY AIR POLLUTANTS Conventional air pollutants SPM, SO 2 &NO x from utilities like boiler/dg sets and from unit operation. Hazardous air pollutants (HAPs) and odorous compounds Solvents from solvent extraction and solvent in reaction media. HAPs are benzene, carbon tetra chloride, 1-4 dioxane, methanol, toluene, methyl chloride etc. These are hazardous and confirm carcinogenic. The odorous compounds are mercaptans and hydrogen sulphide. 8

9 SOURCES AND QUANTITY OF FUGITIVE EMISSIONS FROM BULK DRUG INDUSTRY Source Average emission factor (kg/hr/source) Valves Gas Light liquids Heavy liquids Pump seals Light liquids Heavy liquids Compressor seals Gas/Vapor Pressure relief valves Gas/Vapor Flanges Gas/Liquids/Vapor Open-ended lines Gas/Liquids/Vapor AIR POLLUTION CONTROL SYSTEMS SUGGESTED FOR BULK-DRUG INDUSTRIES S. No. Air pollutant Source Control 1 SPM, SO x Utilities Cyclone/multi-clone appropriate stack height with 2 SO x,cl 2,NH 3 Unit operations Scrubbing with liquids Solvent and 3 hazardous air pollutants Fugitive in nature during material flow Standardization of equipment and accessories (engineering standards) 4 Odorous compounds Unit Operations Collection and thermal destruction 9

10 SOLID WASTE MANAGEMENT IN BULK- DRUG INDUSTRY Solid waste generated in bulk-drug industry can be classified into three categories: a) Engineering solid waste like metals, scrap, glass, plastic, drums/carboys is generally sold out for their further reprocessing. b) ETP sludge From the formulation unit & fermentation unit, Mycelium cake coming out from the fermenter, Solid waste such as residue and rejected batch material. c) Toxic and hazardous waste such as residue, reject batch material etc. from the process. ENVIRONMENTAL MANAGEMENT AND SELF EVALUATION Adoption of ISO standards like ISO 14000, 9000, regular auditing and development of road map are components of self-assessment. The environmental management system may comprise in-plant control, right choice of technology, appropriate engineering practices along with end-on-pipe treatment. The sequential chain needs an integration ti of production manager, project manager, R & D, quality control and environmental manager 10

11 CHARTER ON CORPORATE RESPONSIBILITY FOR ENVIRONMENTAL PROTECTION FOR PHARMACEUTICAL SECTOR 1. Segregation of waste streams Waste streams should be segregated into high COD waste, toxic waste, low COD waste, inorganic waste etc, for the purpose of providing appropriate treatment. Implementation by December 31, 2003 and action plan to be submitted to SPCB by June 30, Detoxification and treatment of high COD waste streams High COD streams should be detoxified and treated in ETP or thermally destroyed in incinerator- Implementation by March 2004 and action plan to be submitted to SPCB by June

12 3. Management of solid waste Proper facilities should be provided for handling and storage of hazardous waste. For final disposal of hazardous waste, recycling and reuse should be given priority, either within the premises or outside with proper manifest system. In case of incinerable waste, properly designed incinerator should be installed within the premises or disposed of outside in a common facility. The non-incinerable hazardous waste should be disposed of in properly designed secure-landfill either within the industry s premises or inacommon facility-implementation by December 31, 2003 and action plan to be submitted to SPCB by June Minimum scale of production to afford cost of pollution control For new industries which are not connected with CETP & TSDF and which do not have the economics to install treatment facilities may not be considered for granting consent to establishment. Industry association shall submit proposal to SPCB/CPCB-Implementation by December 31, 2003 and action plan to be submitted to SPCB by June 30,

13 5. Long term strategies for reduction in waste Consent for establishment and consent for operation under the Water Act will be based on pollution load and concentration of pollutants. Each industry will submit pollution load, concentration of final discharge along with water balance to SPCB/CPCB for formulationofstrategy-actionplantobesubmittedto SPCB by June 31, Control of air pollution Industry will take up on priority, the control of hazardous air pollutants (such as benzene, carbon tetrachloride, 1-4 dioxane, methanol, toluene, methyl chloride etc.) and odorous compounds (mercaptans & hydrogen sulphide) - Implementation by December 2004 and action plan to be submitted to SPCB by June

14 7. Self-regulation by Industry through regular monitoring and environmental auditing Industries on their own will carry out monitoring of environmental parameters, audit it at regular interval and submit the same to SPCB-Implementation by June Comment on BDMA-There shall be a policy for accreditating the auditors and the policy guidelines may be issued by MoEF. 8. Organizational restructuring and accreditation of Environmental Manager of Industry a) Environment management cell will be created for each industry reporting to CEO directly-implementation by June b) There should be a certification system for the environmental managers at individual level and common facility level. BDMA may evolve the programme along with SPCB/CPCB-Implementation by March 31, 2004 and action plan to be submitted to SPCB by July

15 9. Optimizing the inventory of hazardous chemicals The information shall be submitted to SPCB regularly along with rational-action plan to be submitted to SPCB by May 31, WATER CONSUMPTION AND WASTE WATER GENERTION PATTERN IN BULK DRUG INDUSTRIES RAW WATER Loss in UTILITY SERVICE POTABLE INDUSTRIAL Evaporation Cooling Tower DM Plant Floor Washing Fire APCD Gardening Canteen Gardening CT Blow Down Boiler Boiler Blow down Steam to process ETP DISPOSAL 15

16 WATER BALANCE SHEET FOR VITAMINS, FOLIC ACID (Ratio of consumption of process water to total water=0.36) TOTAL WATER m 3 /day UTILITIES 35 m 3 PROCESS 52 m 3 /day SERVICES Air Pollution Gardening 24 m 3 Equipment 30 m Preparation m 3 Boiler, Cooling 50 m 3 Tower, 40 m 3 52 m 3 35 m 3 20 m 3 Wastewater B/D B/D 24 m m 3 10 m 3 Effluent Treatment Plant, 89.5 m 3 R&D LABS 1 m 3 Wastewater 1.0 m 3 AWARENESS OF THE FACTORY REGARDING CONSERVATION OF WATER The industries which have a best environment management practices having ISO certified i.e. ISO 9000, ISO 14000, approved by adrug control authority like USFDA and other certified Environment Management System (EMS) consume water with less variation in compare to other industries. The water use pattern of such manufacturers is totally controlled, because no variation in material and water input can be allowed without prior approval of USFDA. In those cases the water consumption for that industry is considered in arriving at guidelines for optimum water consumption. 16

17 CPCB s GUIDELINES FOR WATER CONSUMPTION IN BULK DRUGS MANUFACTURING INDUSTRY S.No. Therapeutic Class/Name of drug Total water m 3 /ton (+/- 5%) Analgescis 1 Diclofenac sodium 58 2 Ibuprofen 50 3 Naproxen Paracetamol 29 5 Pentazocine 352 Total 84 drugs covered for different Therapeutic Classes (28 no.): water consumption ranging from 2m 3 /ton for Diethylcarbamazine citrate (+/- 5%) to 1748 m 3 /ton for Carvedilol. Adoption of guidelines can reduce water consumption from 15-50% depending upon the process followed and the products manufactured. THANK YOU 17