Waste Management in Pharma

Waste Management in Pharmaceutical and Bulk Drug Industry
Awareness Program on Environment & g Hazard Management in Pharmaceuticals & Bulk Drug Industry 31.01.2011, Ankleshwar
Presented by Dr P N Parameswaran Vice President (Environment)
This presentation covers

HW Management regulations Waste categories Treatment captive v/s common Waste hierarchy Solvent Recovery Thermal treatments Secured Landfilling Case Study
Waste Mgt - Pharma & Bulk Drug 2
31 Jan 2011
Waste categorization as per HW Rules 2008

HW generation by Pharmaceuticals / Bulk Drug sector as per Hazardous Waste (Management, H dli & T (M Handling Trans-Boundary M B d Movement) R l 2008 ) Rules Category No. 28.1 28.2 28.3 28.4 28.5 Description Process residues and wastes Spent Catalyst / Spent Carbon Off Specification Products Date-Expired, discarded and Off-Specification Drugs / Medicines Spent Organic Solvents
In addition to above, 34.3 ETP Sludge, 36.2 Incineration Ash etc can be categorized
31 Jan 2011
Waste Mgt - Pharma & Bulk Drug
Types of wastes generated by Pharma / Bulk Drug Industry

HW generation by Pharmaceuticals / Bulk Drug sector as per Hazardous Waste (Management, H dli & T (M Handling Trans-Boundary M B d Movement) R l 2008 ) Rules Category No. 5.1 3.3 28.1 28.1 28.1 Description Used Oil Sludge & Filter contaminated with Oil Waste from containment / clean-up of Spills Process / Distillation Residue Pharma Powder Waste Method of disposal Sale to re-recycler Incineration Incineration Incineration Incineration
31 Jan 2011

HW generation by Pharmaceuticals / Bulk Drug sector as per Hazardous Waste (Management, H dli & T (M Handling Trans-Boundary M B d Movement) R l 2008 ) Rules Category No. 28.1 28.1 28.1 28.1 28 1 B21 (II) 28.2 28.1 Description Cotton Waste Boiler Ash (Carbon Soot) Used PPEs Waste insulation & lining material Asbestos Cement Sheet (Roof Sheet) Off Specification Material Carbon Waste Method of disposal Incineration Secured Landfilling Secured Landfilling Secured Landfilling Secured Landfilling Incineration Incineration
31 Jan 2011

HW generation by Pharmaceuticals / Bulk Drug sector as per Hazardous Waste (Management, H dli & T (M Handling Trans-Boundary M B d Movement) R l 2008 ) Rules Category No. 28.3 Description Waste / Rejected Pharma powder / Date expired / discarded & Offspecification drugs / medicines Spent Solvent Discarded Empty Containers / Liners / Foils (PVC & aluminium) Air (Gas) cleaning residue (Molecular sieves of Nitrogen Plant) Method of disposal Incineration
28.5 33.3 34.1
Incineration Sale to Authorized Traders Secured Landfilling
31 Jan 2011

HW generation by Pharmaceuticals / Bulk Drug sector as per Hazardous Waste (Management, H dli & T (M Handling Trans-Boundary M B d Movement) R l 2008 ) Rules Category No. 34.3 36.2 34.3 28.1 28 1 28.1 Description ETP Sludge Incineration Ash Salt from MEE Residue after process effluent concentration Residue after solvent recovery Method of disposal Secured Landfilling Secured Landfilling Secured Landfilling Incineration Incineration
31 Jan 2011
Hazardous Waste characteristics
HW can be categorized based on CRIT

Criteria i.e.
Corrosive Reactive Ignitable Toxic
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Waste Hierarchy
Waste Reduction Reuse Recycling Energy recovery with Heat and Power Treatment Disposal in landfill
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Waste generation in Pharmaceutical & Bulk Drug sector

As
per HW Inventory of 31.03.2008 in Gujarat, out of total waste quantity of 17,92,489 MT, Pharma & Bulk Drug sector accounted for 1,21,127 MT i.e. 6.76 % At Ankleshwar TSDF, out of total waste receipt, Pharma / Bulk Drug sector 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 solvents y 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 are p p p
on higher side. Moreover, separate team has to work on treatment and disposal In the common facility, as several waste streams are coming, the TSDF can make waste feed menu and properly treat. The capital cost and operation costs will be reasonable due to higher capacity Moreover in common facility, better incineration system with all components and continuous monitoring can be set up
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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 Unit
need 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 ensure good recovery Solvent vapour adsorption systems to recover and reduce VOC
31 Jan 2011
Secured landfilling
Ultimate disposal of waste after recovery and
treatment 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 Post closure maintenance and maintaining the site for 30 years after closure
31 Jan 2011
Drum decontamination and disposal

Bulk Drug / Pharma industry generates large number of g y g g
used 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 inspected before selling to reprocessors Toxic drums should be detoxified, cut to pieces, be inspected and then 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 with

permission of GPCB When 1 MT of organic waste is fed, proportional coal reduction achieved Constraints in usage
Generation of such waste are in small quantities by large number of generators Cement Companies need large quantity of uniform quality
Waste Management - Issues & concerns

Concern of community Old disposal practices p p Ground water contamination Cost -> capital and operational New norms -> local, national and international Technical constraints and economical viability NGOs role Dioxin Di i -> generation and monitoring ti d it i Future liabilities Lack of recycling facilities
31 Jan 2011
Issues and concerns for Pharma / Bulk Drug sector
For high value products, solvent contribution is not g
significant 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 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 (with air pollution control facilities) can solve the problem The treatment and disposal is costly typically landfilling cost is approximately Rs 800 PMT whereas incineration will cost approximately Rs 18,000 PMT
31 Jan 2011
Hazardous Waste Management Strategy

Reduction of waste generation Recover and Reuse Recycle R l Treatment and disposal Treatment
Inorganic Waste secured landfilling Organic Waste thermal treatment
Acidic waste neutralization Waste with Heavy Metals Stabilization
Solvent Recovery y Usage as fuel in Cement Kiln wherever possible Incineration properly designed system Properly designed and operated Treatment & Disposal Facility consider long term liability Risk coverage post maintenance fund, super fund and contingency insurance policy, third party inspection
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Bharuch Enviro Infrastructure Ltd

ISO 14001 & OHSAS 18001 certified CHWTSDF at Ankleshwar
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Introduction
Bharuch Enviro Infrastructure Ltd is a Company promoted by
industries at Ankleshwar with major share holding by United Phosphorus 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 of National Productivity Council in 1997 Phase # II of Secured Landfill Facility designed by IIT New Delhi and drawings 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 in
March 2007 and coverage provided as per CPCB guideline
Phase # 2 of SLF, operations started in March 2007 and more than 5.28 Lacs MT
of 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 Bhabha
Atomic Research Center (BARC)
BEIL is certified under Environmental Management System Standards ISO 14001

and Occupational Health & Safety Assessment Standards OHSAS 18001
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13
Secured Landfill Facility
Construction of Clay Liner
Bottom HDPE Layer
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Top Coverage System p g y
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14
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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 degradation temperature maintained > 1100

o
thermal
In Secondary Combustion Chamber,

C is
31 Jan 2011
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15
Incineration of different wastes

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
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31
Chemistry of Incineration
Organic Waste C H Cl S N Incineration O2 CO2 H2O HCl SO2 NO2
Two Stage Scrubbing System for Acid Gases (Dry Scrubbing with Lime and Wet Scrubbing with Caustic)
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16
Continuous Monitoring System
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Common Incineration System

Post P Combustion Chamber
Rotary Kiln
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17
Evaporative Cooler
Bag Filter, Wet Scrubber & ID Fan Filter
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35

In-Plant View
Fuel supply system Natural Gas
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36
18
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 The Dioxin Th Di i llevell reported iis 0 014 ng / TEQ / N 3 against permissible li it of 0 1 ng / TEAQ / N 3 t d 0.014 Nm3 i t i ibl limit f 0.1 Nm3 The Dioxin level reported is 0.014 ng / TEQ / Nm3 against permissible limit of 0.1 ng / TEQ / Nm3 The Dioxin level reported is 0.014 ng / TEQ / Nm3 against permissible limit of 0.1 ng / TEQ / Nm3 The Dioxin level reported is 0.014 ng / TEQ / Nm3 against the permissible limit of 0.1 ng / TEQ / Nm3 The Dioxin level reported is 0.0086 ng / TEQ / Nm3 against the permissible limit of 0.1 ng / TEQ / Nm3 The Dioxin level reported is 0.0484 ng / TEQ / Nm3 against the permissible limit of 0.1 ng / TEQ / Nm3 The Dioxin level reported is 0.02 ng / TEQ / Nm3 against the permissible limit of 0.1 ng / TEQ / Nm3 Waste Mgt - Pharma & Bulk Drug 38
Monitoring done by BEIL through SGS in May 2010 Monitoring done by BEIL through Vimta Lab in February 2010 Monitoring done by BEIL through SGS in November 2009 Monitoring done by BEIL through SGS in August 2008 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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31 Jan 2011
Storag arrange ge ements
39
Storage arrangements
Heat & Smoke Detectors
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20
NABL accredited laboratory
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Visit of Mr Jairam Ramesh on 26.09.2009
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21
Visit of Dr K Kasturirangan, Member (Planning Commission), Government of India on 09.12.2009
Very professionally managed waste disposal system The country at large need to emulate this fine example
Conclusion
Waste Management remains a major challenge for all
Pharmaceutical and Drug manufacturing companies
Treatment of waste is considered a vital aspect of

development process
Solvent Recovery-focus area Residues after recovery - Captive or Common treatment

systems are in operation
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22
Thank you
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23

Waste Management in Pharma

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Waste Management in Pharma

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Format Tersedia

Waste Management in Pharmaceutical and Bulk Drug Industry

Presented by Dr P N Parameswaran Vice President (Environment)

This presentation covers

Waste categorization as per HW Rules 2008

Waste Mgt - Pharma & Bulk Drug

Types of wastes generated by Pharma / Bulk Drug Industry

Waste Mgt - Pharma & Bulk Drug

Types of wastes generated by Pharma / Bulk Drug Industry

Waste Mgt - Pharma & Bulk Drug

Types of wastes generated by Pharma / Bulk Drug Industry

28.5 33.3 34.1

Incineration Sale to Authorized Traders Secured Landfilling

Waste Mgt - Pharma & Bulk Drug

Types of wastes generated by Pharma / Bulk Drug Industry

Waste Mgt - Pharma & Bulk Drug

Hazardous Waste characteristics

HW can be categorized based on CRIT

Waste Mgt - Pharma & Bulk Drug

Waste generation in Pharmaceutical & Bulk Drug sector

Waste Mgt - Pharma & Bulk Drug

Captive v/s common treatment systems

Thermal treatment facility can be captive or common facility

Captive v/s common treatment systems

Pharma / Bulk Drug sector norms for Captive Incinerator

Waste Mgt - Pharma & Bulk Drug

Norms for Common Incinerator

Waste Mgt - Pharma & Bulk Drug

Drum decontamination and disposal

Trials conducted with

Waste Management - Issues & concerns

Issues and concerns for Pharma / Bulk Drug sector

For high value products, solvent contribution is not g

Addressing HWM issues & concerns

Hazardous Waste Management Strategy

Acidic waste neutralization Waste with Heavy Metals Stabilization

Bharuch Enviro Infrastructure Ltd

Waste Mgt - Pharma & Bulk Drug

BEIL is certified under Environmental Management System Standards ISO 14001

Waste Mgt - Pharma & Bulk Drug

Secured Landfill Facility

Construction of Clay Liner

Bottom HDPE Layer

Waste Mgt - Pharma & Bulk Drug

Secured Landfill Facility

Top Coverage System p g y

Waste Mgt - Pharma & Bulk Drug

Secured Landfill Facility

Waste Mgt - Pharma & Bulk Drug

Common Incineration Plant

Capacity @ 2.5 MT per hour Suitable to handle various types of

Flexibility is incorporated considering

temperature degradation temperature maintained > 1100

In Secondary Combustion Chamber,

Waste Mgt - Pharma & Bulk Drug

Incineration of different wastes

Waste Mgt - Pharma & Bulk Drug

Continuous Monitoring System

Waste Mgt - Pharma & Bulk Drug

Common Incineration System

Waste Mgt - Pharma & Bulk Drug

Common Incineration System

Bag Filter, Wet Scrubber & ID Fan Filter

Waste Mgt - Pharma & Bulk Drug