Waste Management in Pharma

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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

31 Jan 201131 Jan 2011 Waste Mgt Waste Mgt -- Pharma & Bulk DrugPharma & Bulk Drug 22

• 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


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


Spills

28.1 Process / Distillation Residue Incineration

28.1 Pharma Powder Waste Incineration

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Category No.


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


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



Category No.


28.3 Waste / Rejected Pharma powder / Date expired / discarded & Off-specification drugs / medicines

Incineration

28.5 Spent Solvent Incineration


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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Category No.


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


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


– Ignitable

– Toxic

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Waste Hierarchy

Energy recovery with Heat and Power

Recycling

Reuse

Waste Reduction


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;


– 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


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


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


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


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


• 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


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


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


• 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


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)


• 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


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


• 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


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


Bottom HDPE Layer


Top Coverage System


p g y

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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


• 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


• Off Specification Products• Contaminated Soil• Halogenated Organic Pounds / POPs / PCBs

Chemistry of IncinerationOrganic Waste

CCO2H OIncinerationC

HClSN

H2OHClSO2NO2

Incineration

O2


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


er

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Bag Filter Wet Scrubber & ID Fan

Evaporative Cooler


Bag Filter, Wet Scrubber & ID Fan


Fuel supply system – Natural Gas

In-Plant View


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Monitoring by CPCB / NPC / SGS during August 2005


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


g y g


• Monitoring done by BEIL through SGS in November 2006


• CPCB / NPC / SGS have monitored the Common Incineration System in August 2005


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emen

tsge

arr

ange


Stor

ag

Storage arrangements

Heat & Smoke Detectors


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NABL accredited laboratory


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


“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


• Residues after recovery - Captive or Common treatmentsystems are in operation

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Thank you


Waste Management in Pharma

Documents

dioxin level

bio gas plant

common incineration

secured landfill

common facility

cement kiln

disposal facility

hazardous