Pharmaceutical Waste Management PARAS SHAH v Waste Effluents

Pharmaceutical Waste Management PARAS SHAH

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

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

Prescribed Authorities v State : Gujarat Pollution Control Board v Central : Ministry of Environment and Forest , Central Pollution Control Board

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

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

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

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

v Engineered Landfill v Protects loss of chemicals into aquifer v Immobilized best v Direct deposit second best

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

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

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

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

Burning in Open containers v Not for Pharmaceuticals v Paper and cardboard packaging v PVC not burnt

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

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

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

Schedule I Category Type of Material Category No. Human Anatomical Waste 1 (human tissues, organs, body parts) Category No. Animal Waste(animal tissues, organs, body parts carcasses, bleeding parts, fluid, blood 2 and experimental animals used in research, waste generated by veterinary hospitals colleges, discharge from hospitals, animal houses) Category No. Microbiology & Biotechnology Waste(wastes from laboratory cultures, stocks 3 or specimens of microlocal autoclaving/micro-organisms live or attenuated vaccines, human and animal cellwaving/incineration@culture used in research and infectious agents from research and industrial laboratories, wastes from production of biologicals, toxins, dishes and devices used for transfer of cultures) Method incineration@/deep burial Local autoclaving, microwaving or incineration

Category No. 4 Waste sharps Disinfection, (needles, syringes, scalpels, blades, glass, etc. autoclaving, that may cause microwaving, puncture and cuts. This includes both used and mutilation unused sharps) shredding Category No. 5 Discarded Medicines and Cytotoxic drugs Incineration (wastes comprising of outdated, contaminated landfill and discarded medicines) and Category No. 6 Solid Waste Incineration, (Items contaminated with blood, and body fluids autoclaving, including cotton, microwaving dressings, soiled plaster casts, lines, beddings, other material incineration@ contaminated with blood) Category No. 7 Solid Waste (wastes generated from disposable items other than the waste sharps such as tubings, catheters, intravenous sets etc). Disinfection by chemical treatment , autoclaving, microwaving, mutilation and shredding

Category No. Liquid Waste 8 (waste generated from laboratory and washing, cleaning, housedisinfection by chemical keeping and disinfecting activities) Category No. Incineration Ash(ash from incineration of any bio-medical waste) 9 Disinfection by chemical treatment and then discarded in drains Disposal in municipal landfills Category No. Chemical Waste 10 (chemicals used in production of biologicals, chemicals used in disinfection, as insecticides, etc. ) Chemical treatment. Then solids in landfills and liquids in drains.