Microsoft powerpoint - environmental management in pharmaceutical industry.ppt [compatibility mode]
Environmental Management in
for Environmental Protection
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
CLASSIFICATION OF INDUSTRIES WITH
RESPECT TO PRODUCTION
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
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
PROPOSED SCHEMATIC FLOW DIAGRAM FOR
THE TREATMENT OF EFFLUENT FROM
PROPOSED SCHEMATIC FLOW DIAGRAM FOR
THE TREATMENT OF EFFLUENT FROM BULK
WASTEWATER CHARACTERISTICS OF
BULK DRUGS (SYNTHETIC ROUTE)
WASTEWATER GENERATION FROM AN
ANTIBIOTIC PLANT (FERMENTATION ROUTE)
Range of average
Nature of wastewater and solid
combined effluent, in
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
characteristics in mg/l except
DECISION TREE FOR APPROPRIATE
TREATMENT OF WASTEWATER
STREAM WISE BPT IN BULK DRUG
FORCED EVPORATION FOLLOWED
BY BIOLOGICAL TREATMENT-I
FORCED EVAPORATION FOLLOWED
BY BIOLOGICAL TREATMENT-I
INTEGRATED TREATMENT SCHEME THROUGH
COMBINED EFFLUENT TREATMENT PLANT IN
A CLUSTER OF INDUSTRY
Conventional air pollutants
• SPM, SO2 & NO from utilities like boiler/DG sets
• 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
SOURCES AND QUANTITY OF FUGITIVE
EMISSIONS FROM BULK DRUG INDUSTRY
Pressure relief valves
AIR POLLUTION CONTROL SYSTEMS
SUGGESTED FOR BULK-DRUG INDUSTRIES
SOLID WASTE MANAGEMENT IN BULK-
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
• 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
CHARTER ON CORPORATE
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
Implementation by March 2004 and action plan to besubmitted to SPCB by June 2003.
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.
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.
7. Self-regulation by Industry through
regular monitoring and environmental
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.
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.
9. Optimizing the inventory of hazardous
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
WATER BALANCE SHEET FOR VITAMINS, FOLIC ACID
(Ratio of consumption of process water to total water=0.36)
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.
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