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13-02-2011 Environmental Management in Pharmaceutical Industry Charter o on Corporate Corporate R esponsibility Responsibility for Environmental Protection N.K.Verma UPL Environmental Engineers Ltd Awareness Programme on Environment & Hazard Management in Pharmaceutical & Bulk Drug Industry at Ankaleshwar 31st January, 2011 STATUS OF BULK-DRUGS PRODUCTION 13-02-2011 CLASSIFICATION OF INDUSTRIES WITH RESPECT TO PRODUCTION Category therapeutic manufacturing production (tones/year) WASTEWATER MANAGEMENT
Water consumption and scope of recycling of
Consumption of process water is less than
consumption of water for utility (boiler/coolingwater bleeding)
Utility discharge is relatively cleaner, with
13-02-2011 ALTERNATIVES FOR RECYCLING, RECOVERY, RENOVATION AND REUSE OF INDUSTRIAL WASTEWATER CHARACTERISTICS OF EFFLUENT TREATMENT TECHNOLOGY AND STANDARDS
1980’S-Objective was to remove BOD.
Technology identified end-on-pipe technology – Best Practicable
Compliance of standard, not achievable in respect of TDS & COD
13-02-2011 PROPOSED SCHEMATIC FLOW DIAGRAM FOR THE TREATMENT OF EFFLUENT FROM FORMULATION UNITS PROPOSED SCHEMATIC FLOW DIAGRAM FOR THE TREATMENT OF EFFLUENT FROM BULK DRUG UNITS 13-02-2011 PROBLEMS WASTEWATER CHARACTERISTICS OF BULK DRUGS (SYNTHETIC ROUTE) 13-02-2011 WASTEWATER GENERATION FROM AN ANTIBIOTIC PLANT (FERMENTATION ROUTE) Range of average Source of Nature of wastewater and solid characteristics of Wastewater combined effluent, in generation mg/l except pH
contaminated batches, cooling waters, laboratory & utility wastes
Style & finishing Floor and equipments washings
WASTEWATER GENERATION FROM A PHARMACEUTICAL (FORMULATION) UNIT Average flow of Range of average effluent Source of wastewater wastewater characteristics in mg/l except generation (cum/hr) 13-02-2011 DECISION TREE FOR APPROPRIATE TREATMENT OF WASTEWATER STREAM WISE BPT IN BULK DRUG INDUSTRIES FORCED EVPORATION FOLLOWED BY BIOLOGICAL TREATMENT-I BIOLOGICAL TREATMENT-II INCINERATION-III SOLVENT/CHEMICAL RECOVERY-IV FORCED EVAPORATION FOLLOWED BY BIOLOGICAL TREATMENT-I BIOLOGICAL TREATMENT-II FORCED EVAPORATION SOLVENT/CHEMICAL RECOVERY-IV 13-02-2011 INTEGRATED TREATMENT SCHEME THROUGH COMBINED EFFLUENT TREATMENT PLANT IN A CLUSTER OF INDUSTRY LARGE INDUSTRY AIR POLLUTANTS Conventional air pollutants
• SPM, SO2 & NO from utilities like boiler/DG sets
Hazardous pollutants odorous compounds
• Solvents from solvent extraction and solvent in
reaction media. HAPs are benzene, carbon tetrachloride, 1-
chloride etc. These are hazardous and confirmcarcinogenic.
• The odorous compounds are mercaptans and
13-02-2011 SOURCES AND QUANTITY OF FUGITIVE EMISSIONS FROM BULK DRUG INDUSTRY Average emission factor (kg/hr/source) Pump seals Compressor seals Pressure relief valves Open-ended lines AIR POLLUTION CONTROL SYSTEMS SUGGESTED FOR BULK-DRUG INDUSTRIES Air pollutant 13-02-2011 SOLID WASTE MANAGEMENT IN BULK- DRUG INDUSTRY Solid waste generated in bulk-drug industry can be classified into three categories:
Engineering solid waste like metals, scrap, glass, plastic,drums/carboys is generally sold out for their further reprocessing.
From the formulation unit & fermentation unit,
Mycelium cake coming out from the fermenter,
Solid waste such as residue and rejected batch material.
Toxic and hazardous waste such as residue, reject batch materialetc. from the process. ENVIRONMENTAL MANAGEMENT AND SELF EVALUATION
• Adoption of ISO standards like ISO 14000, 9000,
regular auditing and development of road mapare components of self-assessment.
• The environmental management system may
technology, appropriate engineering practicesalong with end-on-pipe treatment.
• The sequential chain needs an integrati
production manager, project manager, R & D,quality control and environmental manager
13-02-2011 CHARTER ON CORPORATE RESPONSIBILITY F ENVIRONMENTAL PROTECTION FOR PHARMACEUTICAL SECTOR 1. Segregation of waste streams
Waste streams should be segregated into high CODwaste, toxic waste, low COD waste, inorganic wasteetc, for the purpose of providing appropriate treatment. Implementation by December 31, 2003 and action planto be submitted to SPCB by June 30, 2003. 2. Detoxification and treatment of high COD waste streams High COD streams should be detoxified and treated in ETP
Implementation by March 2004 and action plan to besubmitted to SPCB by June 2003. 13-02-2011 3. Management of solid waste
Proper facilities should be provided for handling andstorage of hazardous waste. For final disposal ofhazardous waste, recycling and reuse should be givenpriority
proper manifest system. In case of incinerable waste,properly designed incinerator should be installed withinthe premises or disposed of outside in a commonfacility. The non-incinerable hazardous waste shouldbe disposed of in properly designed secure-landfilleither within the industry’s
facility-Implementation by December 31, 2003 andaction plan to be submitted to SPCB by June 2003. 4. 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, 2003. 13-02-2011 5. Long term strategies for reduction in
Consent for establishment and consent for operation
under the Water Act will be based on pollution loadand concentration of pollutants. Each industry willsubmit pollution load, concentration of final dischargealong
formulation of strategy-action plan to be submitted toSPCB by June 31, 2003. 6. Control of air pollution
Industry will take up on priority, the control ofhazardous air pollutants (such as benzene, carbontetrachloride, 1-4 dioxane, methanol, toluene, methylchloride etc.) and odorous compounds (mercaptans &hydrogen sulphide) - Implementation by December2004 and action plan to be submitted to SPCB by June2003. 13-02-2011 7. Self-regulation by Industry through regular monitoring and environmental auditing
Industries on their own will carry out monitoring ofenvironmental parameters, audit it at regular intervaland submit the same to SPCB-Implementation by June2003.
Comment on BDMA-There shall be a policy foraccreditating the auditors and the policy guidelinesmay be issued by MoEF. 8. Organizational restructuring accreditation Environmental Manager of Industry
Environment management cell will be created for eachindustry reporting to CEO directly-Implementation byJune 2003.
There should be a certification system for theenvironmental
programme along with SPCB/CPCB-Implementationby March 31, 2004 and action plan to be submitted toSPCB by July 2003. 13-02-2011 9. Optimizing the inventory of hazardous chemicals
The information shall be submitted to SPCB regularl
along with rational-action plan to be submitted toSPCB by May 31, 2003. WATER CONSUMPTION AND WASTE WATER GENERTION PATTERN IN BULK DRUG INDUSTRIES RAW WATER INDUSTRIAL INDUSTRIA 13-02-2011 WATER BALANCE SHEET FOR VITAMINS, FOLIC ACID (Ratio of consumption of process water to total water=0.36) TOTAL WATER 144.25 m3/day UTILITIES SERVICES Air Pollution Gardening Equipment 52 m3/day Preparation R&D LABS Effluent Treatment Plant, 89.5 m3 AWARENESS OF THE FACTORY REGARDING CONSERVATION OF WATER
management practices having ISO certified i.e. ISO9000, ISO
Management System (EMS) consume water with lessvariation in compare to other industries. The water usepattern of such manufacturers is totally controlled,because no variation in material and water input can beallowed without prior approval of USFDA. In those casesthe water consumption for that industry is considered inarriving at guidelines for optimum water consumption. 13-02-2011 CPCB’s GUIDELINES FOR WATER CONSUMPTION IN BULK DRUGS MANUFACTURING INDUSTRY
a 84 drugs covered for different Therapeutic Classes (28 no.): wat
consumption ranging from 2 m3/ton for Diethylcarbamazine citrate (+/-5%) to 1748 m3/ton for Carvedilol.
Adoption of guidelines can reduce water consumption from 15 - 50%depending upon the process followed and the products manufactured.
Joint EFSPI/PSI Meeting: Structured Benefit-Risk Assessment This one-day meeting was informative, enjoyable and smoothly organised. While there is a large amount of recommended reading available online, the clear presentations, with opportunity to hear personal opinions and the subsequent discussion, rewarded any effort made to travel and dedicate the time to understand current thinking in this de
PRESCRIBING INFORMATION MALARONE® (atovaquone and proguanil hydrochloride) Tablets MALARONE® (atovaquone and proguanil hydrochloride) Pediatric Tablets DESCRIPTION MALARONE (atovaquone and proguanil hydrochloride) is a fixed-dose combination of the antimalarial agents atovaquone and proguanil hydrochloride. The chemical name of atovaquone is trans -2-[4-(4-chlorophenyl)cycl
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