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Waste Management in Pharmaceutical and Bulk Drug Industry
Awareness Program on Environment &
Presented by
gHazard Management in Pharmaceuticals
& Bulk Drug Industry
31.01.2011, Ankleshwar
Dr P N Parameswaran
Vice President (Environment)
This presentation covers
• HW Management – regulationsHW Management regulations
• Waste categories
• Treatment – captive v/s common
• Waste hierarchy
• Solvent Recovery
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• Thermal treatments
• Secured Landfilling
• Case Study
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Waste categorization as per HW Rules 2008
HW generation by Pharmaceuticals / Bulk Drug sector as per Hazardous Waste (M H dli & T B d M ) R l 2008(Management, Handling & Trans-Boundary Movement) Rules 2008
Category No.
Description
28.1 Process residues and wastes
28.2 Spent Catalyst / Spent Carbon
28.3 Off Specification Products
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28.4 Date-Expired, discarded and Off-Specification Drugs / Medicines
28.5 Spent Organic Solvents
In addition to above, 34.3 ETP Sludge, 36.2 Incineration Ash etc can becategorized
Types of wastes generated by Pharma / Bulk Drug IndustryHW generation by Pharmaceuticals / Bulk Drug sector as per Hazardous Waste
(M H dli & T B d M ) R l 2008(Management, Handling & Trans-Boundary Movement) Rules 2008
Category No.
Description Method of disposal
5.1 Used Oil Sale to re-recycler
3.3 Sludge & Filter contaminated with Oil Incineration
28.1 Waste from containment / clean-up of Spills
Incineration
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Spills
28.1 Process / Distillation Residue Incineration
28.1 Pharma Powder Waste Incineration
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Types of wastes generated by Pharma / Bulk Drug IndustryHW generation by Pharmaceuticals / Bulk Drug sector as per Hazardous Waste
(M H dli & T B d M ) R l 2008(Management, Handling & Trans-Boundary Movement) Rules 2008
Category No.
Description Method of disposal
28.1 Cotton Waste Incineration
28.1 Boiler Ash (Carbon Soot) Secured Landfilling
28.1 Used PPEs Secured Landfilling
28 1 Waste insulation & lining material Secured Landfilling
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28.1 Waste insulation & lining material Secured Landfilling
B21 (II) Asbestos Cement Sheet (Roof Sheet) Secured Landfilling
28.2 Off Specification Material Incineration
28.1 Carbon Waste Incineration
Types of wastes generated by Pharma / Bulk Drug IndustryHW generation by Pharmaceuticals / Bulk Drug sector as per Hazardous Waste
(M H dli & T B d M ) R l 2008(Management, Handling & Trans-Boundary Movement) Rules 2008
Category No.
Description Method of disposal
28.3 Waste / Rejected Pharma powder / Date expired / discarded & Off-specification drugs / medicines
Incineration
28.5 Spent Solvent Incineration
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33.3 Discarded Empty Containers / Liners / Foils (PVC & aluminium)
Sale to Authorized Traders
34.1 Air (Gas) cleaning residue (Molecular sieves of Nitrogen Plant)
Secured Landfilling
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Types of wastes generated by Pharma / Bulk Drug IndustryHW generation by Pharmaceuticals / Bulk Drug sector as per Hazardous Waste
(M H dli & T B d M ) R l 2008(Management, Handling & Trans-Boundary Movement) Rules 2008
Category No.
Description Method of disposal
34.3 ETP Sludge Secured Landfilling
36.2 Incineration Ash Secured Landfilling
34.3 Salt from MEE Secured Landfilling
28 1 Residue after process effluent Incineration
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28.1 Residue after process effluent concentration
Incineration
28.1 Residue after solvent recovery Incineration
Hazardous Waste characteristics
• HW can be categorized based on CRITHW can be categorized based on CRITCriteria i.e.– Corrosive
– Reactive
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– Ignitable
– Toxic
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Waste Hierarchy
Energy recovery with Heat and Power
Recycling
Reuse
Waste Reduction
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Disposal in landfill
Treatment
Energy recovery with Heat and Power
Waste generation in Pharmaceutical & Bulk Drug sector• As per HW Inventory of
31.03.2008 in Gujarat, out of totalwaste quantity of 17,92,489 MT,Pharma & Bulk Drug sectoraccounted for 1,21,127 MT i.e.6.76 %
• At Ankleshwar TSDF, out of totalwaste receipt, Pharma / Bulk Drugsector contributes;
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– Incinerable waste @approximately 25 %
– Landfillable waste @approximately 10 %
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Captive v/s common treatment systems
• Captive facilities are required especially for solventsy• Solvent recovery must be an integral part of Pharma / Bulk
Drug Industry• Residual material can be treated or disposed off by
environmentally sound technologies• Thermal treatment options
– Usage of residual material by other industrial sector
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g y– Co-processing in Cement Kiln– Incineration
• Thermal treatment facility can be captive or common facility
Captive v/s common treatment systems
• In the case of captive, the capital and operation costs arep , p pon higher side. Moreover, separate team has to work ontreatment and disposal
• In the common facility, as several waste streams arecoming, the TSDF can make waste feed menu and properlytreat. The capital cost and operation costs will bereasonable due to higher capacity
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reasonable due to higher capacity• Moreover in common facility, better incineration system
with all components and continuous monitoring can be setup
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Pharma / Bulk Drug sector – norms for Captive Incinerator
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Norms for Common Incinerator
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Solvent recovery
• Considering huge consumption of solvents, every UnitConsidering huge consumption of solvents, every Unitneed Solvent Recovery System
• Spent solvents also can be given to solvent recovery units
• Recovery of solvent – above 99 % desired
• Proper condenser and closed handling system will ensuregood recovery
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good recovery
• Solvent vapour – adsorption systems to recover and reduceVOC
Secured landfilling
• Ultimate disposal of waste – after recovery andUltimate disposal of waste after recovery andtreatment
• Waste to meet acceptance criteria• Common TSDF is in operation for more than 12
years, and disposal practice is well established• CPCB Criteria for HW Landfills
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• CPCB Criteria for HW Landfills• Post closure maintenance and maintaining the site
for 30 years after closure
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Drum decontamination and disposal
• Bulk Drug / Pharma industry generates large number ofg y g gused packing materials – like Drums
• Procedures are established for decontamination /detoxification and disposal of drums– Non toxic drums to be decontaminated and sold to reprocessors
after inspection– Chemically contaminated drums to be decontaminated and
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Chemically contaminated drums to be decontaminated andinspected before selling to reprocessors
– Toxic drums should be detoxified, cut to pieces, be inspected andthen to be sold to reprocessors / smelters
Usage of Calorific Value of wastes in Cement Kilns –trial conducted first time in India in 2000
• Trials conducted withpermission of GPCBpermission of GPCB
• When 1 MT of organicwaste is fed, proportionalcoal reduction achieved
• Constraints in usage– Generation of such waste
are in small quantities by
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are in small quantities bylarge number ofgenerators
– Cement Companies needlarge quantity of uniformquality
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• Concern of community• Old disposal practices
Waste Management - Issues & concerns
p p• Ground water contamination• Cost -> capital and operational• New norms -> local, national and international• Technical constraints and economical viability• NGO’s role
Di i ti d it i
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• Dioxin -> generation and monitoring• Future liabilities• Lack of recycling facilities
Issues and concerns for Pharma / Bulk Drug sector
• For high value products, solvent contribution is notgsignificant and at times, neglected
• Lack of common solvent recovery facility• Fire hazard – Highly flammable wastes with low flash points• Accumulation of used solvents after campaigns• Toxicity – waste from certain process generates highly toxic
waste
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waste• Material handling – tarry waste• Batch failure – more predominantly during first batch of
campaign – full batch quantity becomes waste
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Addressing HWM issues & concerns• HWM is comparatively new area• Waste remaining after recovery, has to be properly treated &g y p p y
disposed off• The waste needs to be classified into inorganic and organic• The inorganic waste can be disposed in landfill, once it meets the
disposal criteria• Organic waste disposal – thermal decomposition (incineration,
cement kiln)
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• Properly designed Secured Landfills and Incineration Systems (withair pollution control facilities) can solve the problem
• The treatment and disposal is costly – typically landfilling cost isapproximately Rs 800 PMT whereas incineration will costapproximately Rs 18,000 PMT
Hazardous Waste Management Strategy
• Reduction of waste generation• Recover and Reuse
R l• Recycle• Treatment and disposal• Treatment
– Inorganic Waste – secured landfilling• Acidic waste – neutralization• Waste with Heavy Metals – Stabilization
– Organic Waste – thermal treatment• Solvent Recovery
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y• Usage as fuel in Cement Kiln wherever possible• Incineration – properly designed system
• Properly designed and operated Treatment & Disposal Facility – consider long termliability
• Risk coverage – post maintenance fund, super fund and contingency insurancepolicy, third party inspection
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Bharuch Enviro Infrastructure LtdISO 14001 & OHSAS 18001 certified CHWTSDF at Ankleshwar
Introduction• Bharuch Enviro Infrastructure Ltd is a Company promoted by
industries at Ankleshwar with major share holding by UnitedPhosphorus Ltd
• BEIL has set up Common Hazardous Waste Treatment, Storage &Disposal Facility with Secured Landfill, Common Incineration System,Bio Gas Plant and other infrastructure
• GIDC have given land at concessional rate• Central / State Government provided financial assistance
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• Phase # I – Secured Landfill Facility started under guidance ofNational Productivity Council in 1997
• Phase # II of Secured Landfill Facility designed by IIT New Delhi anddrawings approved by Gujarat Pollution Control Board
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Introduction
• Common Incineration System set up in 2004
• Phase # 1 of SLF, after disposing 6 Lacs MT of landfillable wastes, was capped inMarch 2007 and coverage provided as per CPCB guideline
• Phase # 2 of SLF, operations started in March 2007 and more than 5.28 Lacs MTof landfillable wastes disposed off so far
• Total quantity of landfillable wastes disposed off at site is 11,28,790 MT
• Total quantity of wastes incinerated is 57,218 MT
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q y ,
• Bio Gas Plant for treatment of kitchen waste set up with technology of BhabhaAtomic Research Center (BARC)
• BEIL is certified under Environmental Management System Standards ISO 14001and Occupational Health & Safety Assessment Standards OHSAS 18001
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Secured Landfill Facility
Construction of Clay Liner
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Bottom HDPE Layer
Secured Landfill Facility
Top Coverage System
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p g y
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Secured Landfill Facility
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Common Incineration Plant• Capacity @ 2.5 MT per hour
• Suitable to handle various types of
wastes - solid / liquid / sludge
• Flexibility is incorporated considering
various types of wastes
• High temperature thermal
degradation
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• In Secondary Combustion Chamber,
temperature > 1100 o C is
maintained
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Incineration of different wastes
• Liquid Waste / Solid Waste / Semi Solid Waste /Liquid Waste / Solid Waste / Semi Solid Waste /Tarry Waste etc
• Distillation Residues• Spent Solvents• Expired Bulk Drugs / Pesticides
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• Off Specification Products• Contaminated Soil• Halogenated Organic Pounds / POPs / PCBs
Chemistry of IncinerationOrganic Waste
CCO2H OIncinerationC
HClSN
H2OHClSO2NO2
Incineration
O2
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Two Stage Scrubbing System for Acid Gases(Dry Scrubbing with Lime and Wet Scrubbing with Caustic)
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Continuous Monitoring System
Common Incineration System
P
Rotary Kiln
Post Com
bustion Cham
b
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er
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Common Incineration System
Bag Filter Wet Scrubber & ID Fan
Evaporative Cooler
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Bag Filter, Wet Scrubber & ID Fan
Common Incineration System
Fuel supply system – Natural Gas
In-Plant View
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Monitoring by CPCB / NPC / SGS during August 2005
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Dioxin monitoring results• Monitoring done by BEIL through Vimta Lab in September 2010
– The Dioxin level reported is 0.00144 ng / TEQ / NM3 against permissible limit of 0.1 ng / TEAQ / Nm3
• Monitoring done by BEIL through SGS in May 2010
Th Di i l l t d i 0 014 / TEQ / N 3 i t i ibl li it f 0 1 / TEAQ / N 3– The Dioxin level reported is 0.014 ng / TEQ / Nm3 against permissible limit of 0.1 ng / TEAQ / Nm3
• Monitoring done by BEIL through Vimta Lab in February 2010
– The Dioxin level reported is 0.014 ng / TEQ / Nm3 against permissible limit of 0.1 ng / TEQ / Nm3
• Monitoring done by BEIL through SGS in November 2009
– The Dioxin level reported is 0.014 ng / TEQ / Nm3 against permissible limit of 0.1 ng / TEQ / Nm3
• Monitoring done by BEIL through SGS in August 2008
– The Dioxin level reported is 0.014 ng / TEQ / Nm3 against the permissible limit of 0.1 ng / TEQ / Nm3
• Monitoring done by BEIL through SGS in October 2007
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g y g
– The Dioxin level reported is 0.0086 ng / TEQ / Nm3 against the permissible limit of 0.1 ng / TEQ / Nm3
• Monitoring done by BEIL through SGS in November 2006
– The Dioxin level reported is 0.0484 ng / TEQ / Nm3 against the permissible limit of 0.1 ng / TEQ / Nm3
• CPCB / NPC / SGS have monitored the Common Incineration System in August 2005
– The Dioxin level reported is 0.02 ng / TEQ / Nm3 against the permissible limit of 0.1 ng / TEQ / Nm3
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emen
tsge
arr
ange
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Stor
ag
Storage arrangements
Heat & Smoke Detectors
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NABL accredited laboratory
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Visit of Mr Jairam Ramesh on 26.09.2009
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Visit of Dr K Kasturirangan, Member (Planning Commission), Government of India on 09.12.2009
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“Very professionally managed waste disposal systemThe country at large need to emulate this fine example”
Conclusion
• Waste Management remains a major challenge for allWaste Management remains a major challenge for allPharmaceutical and Drug manufacturing companies
• Treatment of waste is considered a vital aspect ofdevelopment process
• Solvent Recovery-focus area
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• Residues after recovery - Captive or Common treatmentsystems are in operation
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Thank you
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