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Pharmaceutical Waste Management

Pharmaceutical Waste Management. PARAS SHAH. Waste & Effluents (E/C PCB). Bio-Medical Waste (Management and Handling) Rules, 1996 Additional precaution for storage and disposal of rejected drugs Records Proper and safe storage of waste materials awaiting disposal.

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Pharmaceutical Waste Management

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  1. Pharmaceutical Waste Management PARAS SHAH

  2. Waste & Effluents (E/C PCB). • Bio-Medical Waste (Management and Handling) Rules, 1996 • Additional precaution for storage and disposal of rejected drugs • Records • Proper and safe storage of waste materials awaiting disposal

  3. Biomedical Waste (Management and Handling) Rules • Duty of Occupier to make sure wastes are handled in a way which does not affect human health and environment • Treated and disposed as per Schedule I as per the standards in Schedule V

  4. Prescribed Authorities • State : Gujarat Pollution Control Board • Central : Ministry of Environment and Forest , Central Pollution Control Board

  5. Records • Annual Report Form II (Annexure III) by 31st January every year. (includes Categories and quantities) • Annual Report sent to CPCB by 31st March. • Authorized person maintains the records related to generation, collection, reception, storage, transportation, treatment, disposal and/or any form of handling of bio-medical waste

  6. Accident Reporting: Authorized person has to report the accident in Form III (Annexure-IV).

  7. Methods of Disposal Return to Donor or mfg. - Near expire goods - Cross-frontier transport

  8. Landfill • Open Uncontrolled non-engineered dump • Not environment friendly • Use only as last resort • Only after immobilization or inertization • Cover with municipal waste • Pollutes aquifer

  9. Engineered Landfill • Protects loss of chemicals into aquifer • Immobilized best • Direct deposit second best

  10. Highly Engineered Sanitary Landfill • Properly Constructed and Operated • Protects aquifer • Isolated pit • Compacted and covered with soil

  11. Immobilization-Encapsulation • Solid block in plastic or steel drum • Filled to 75% capacity • Solid semisolid pharmaceuticals are added, then cement, lime and water are added • Ratio of lime, cement and water 15:15:5 W • Welded and filled

  12. Inertization: • Remove all packaging materials • Ground and mixed with water, cement and lime. • Then disposed with municipal waste • Ratio Pharmaceutical, cement, lime and water is 65:15:15:5

  13. Sewer: • Liquid pharmaceuticals diluted with water flushed into sewers. • Properly diluted and flushed in large and fast moving quantities of sewer. • Hydrogeologist or sanitary engineer may be needed in case of damaged sewer

  14. Burning in Open containers • Not for Pharmaceuticals • Paper and cardboard packaging • PVC not burnt

  15. Medium Temp. Incineration • Operates around 850 degree Celsius • Not for halogen compounds • Material diluted with large municipal waste (1:1000) and then incinerated.

  16. High Temp. Incineration • Cement kilns, Coal fired thermal stations • Higher combustion retention time and expel gas at higher altitude via chimneys. • Remove packaging materials • Burn with fuel • Not more than 5% of fuel at one time. • Fast and large quantities can be disposed

  17. Chemical decomposition • Chemical decomposition followed by landfill. • Tedious and time-consuming • Only for small quantities

  18. Schedule I

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