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Microsoft powerpoint - environmental management in pharmaceutical industry.ppt [compatibility mode]

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
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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
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PROBLEMS
WASTEWATER CHARACTERISTICS OF
BULK DRUGS (SYNTHETIC ROUTE)
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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)
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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
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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
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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.
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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.
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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
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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.
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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.

Source: http://www.hrdp-net.in/live/hrdpmp/hrdpmaster/hrdp-asem/content/e8451/e8981/e31428/e32044/e32111/eventReport32118/EnvironmentalManagementinPharmaceuticalIndustry.pdf

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