WASTE DISPOSAL, SCRAP DISPOSAL PROCEDURES AND RECORDSGUIDED BY : Presented by :Mr.Rajesh Parmar Mehta Pratik S. M.Pharm Sem-1 Roll no: 5 DEPARTMENT OF QUALITY ASSURANCE APMC COLLEGE OF PHARMACEUTICAL EDUCATION & RESEACH, HIMMATNAGAR
Points to be covered:RESPONSIBILITYDEFINATIONREGULATORY BODIES THAT OVERSEEPHARMACEUTICAL WASTE MANAGEMENTTYPE OF WASTEMETHODS OF PRODUCT DISPOSALWASTE PRODUCT DISPOSAL PROCEDURESCALES OF PRODUCT DISPOSALPHARMACEUTICAL WASTE MANAGEMENTGUIDELINESRECORDS.REFFERENCE
RESPONSIBILITY : The responsibility may depend on thefollowing of the peoples in the Pharmaindustry Employees in production unit. Representative of QA. Housekeeping staff.
DEFINATIONS(1)Scrap: Materials like rejected foils, bottles, cans, and tins etc. which have a resale value.• Generated at various stages of manufacturing1)During compression encapsulation coating & packing stages.2)In-process check.3)Rejected printing packing materials.4) From floor sweeping
5) Expired or damaged goods.6) Excess sample in QC after test.7) Product sample from R&D at development stage.(2)Trash: This material is to be discarded or disposed by suitable means and don’t have a resale value. E.g. dust, unsalable materials
(3)Pharmaceutical Waste Pharmaceutical waste is potentially generated thorough a wide variety of activities health care facility general compounding partially used vials syringes, and IV preparation discontinued & unused preparations unused unit dose repacks patients personal medications and outdated pharmaceuticals
Regulatory Bodies that Oversee Pharmaceutical Waste Management Environmental Protection Agency (EPA) Department of Transportation (DOT) Drug Enforcement Administration (DEA) Occupational Safety and Health Administration (OSHA) State Environmental Agencies, State Pharmacy Boards, and Local Publicly Owned Treatment Works (POTW)
Types of wastesA) On the Bases of State1. Solid2. Liquid3. GaseousB) On the Base of Effect1) Hazardous Waste2) Bio hazardous Waste3) Radioactive Hazardous WasteC) WHO categories of health care waste
1) Hazardous WasteA type of solid wastes that contain substantial or potential threats to public health or the environment.Must meet any of the following criteria: – Specifically listed as a hazardous waste by EPA – Exhibits one or more of the characteristics of hazardous wastes (ignitability, corrosiveness, reactivity, and/or toxicity) – Is generated by the treatment of hazardous waste.
Storage Requirements:1)Containers must be in good condition2)Containers must be compatible with waste3)Containers must be handled in a manner to prevent leaks and spills4) Containers must be inspected5) Containers must be labeled “Hazardous Waste ”and / or list the contents of the container
Characteristic of Hazardous wastes Characteristic wastes are regulated becausethey exhibit certain hazardous properties – 1. Ignitability, 2. Corrosivity, 3. Reactivity and 4. Toxicity.
1. Ignitability: The objective of the ignitabilitycharacteristic is to identify wastes that eitherpresent a fire hazard under routine storage,disposal, and transportation or are capable ofexacerbating a fire.There are several ways that a drug formulationcan exhibit the ignitability characteristic
Types of Ignitability with FormulationsIgnitable Properties Formulations1) Aqueous drug formulation a)Erythromycin Gel 2%containing 24% or more b)Taxol Injectionalcohol and having aflashpoint of less than 140 º For 60 º C.2)Liquid drug formulations, a)Flexible collodion usedother than aqueous solutions as a base in wart removerscontaining less than 24 %alcohol, with a flashpoint ofless than 140 º F or 60 ºc.
Types of Ignitability with FormulationsIgnitable Properties Formulations3) Oxidizers or materials a)Amyl nitrite inhalers,that readily supply oxygen used for the rapid relief ofto a reaction in the absence angina painof air. b)Bulk chemicals found in the compounding section of the pharmacy such as potassium permanganate
2. Corrosivity:Any waste which has a pH of less than orequal to 2 (highly acidic) or greater than orequal to12.5 (highly basic) exhibits thecharacteristic of corrosivity and must bemanaged as a hazardous waste.Generation of corrosive pharmaceutical wastesis generally limited to compounding chemicalsin the pharmacy. Compounding chemicalsinclude strong acids, such as glacial acetic acidand strong bases, such as sodium hydroxide.
3. Reactivity:Reactive wastes are unstable under "normal"conditions.They can cause explosions, toxic fumes,gases, or vapors when heated, compressed, ormixed with water.Nitroglycerin is the only drug that ispotentially reactive.
4. Toxicity:Wastes that exceed these concentrations mustbe managed as hazardous waste.The test that determines the ability of thesechemicals and heavy metals to leach in a landfillenvironment is called the Toxicity CharacteristicLeaching Procedure, or TCLP.If the concentration determined by the TCLPexceeds the stated limits, the waste must bemanaged as hazardous waste.
2) Bio hazardous WasteA solid waste that contains or may reasonably be expected to contain pathogens of sufficient virulence and quantity that exposure to the waste by a susceptible host could result in an infectious disease.This waste includes such materials as used sharps (needles, syringes, blades, pipettes, broken glass, and blood vials), body fluids or materials mixed with body fluids, bandages, or other materials that have come in contact with body fluids
• Storage Requirements:Containers must be clearly labeled with the international biohazard sign and one of the following: "INFECTIOUS WASTE", "BIOMEDICAL WASTE", or "BIOHAZARD“Sharps must be stored in rigid plastic containers. Other wastes may be stored in plastic bags or rigid containers.labeled with a warning sign consisting of the international biohazard sign INFECTIOUS WASTE STORAGE AREA UNAUTHORIZED PERSONS KEEP OUT”
3. Radioactive Waste1) High-level nuclear waste:Means spent reactor fuel assemblies, dismantled nuclear reactor components, and solid and liquid wastes from fuel reprocessing and defense-related wastesDoes not include medical or institutional wastes, naturally-occurring radioactive materials.
2) Low-level radioactive waste:Means waste material which contains radioactive nuclides emitting primarily beta or gamma radiation, or both, in concentrations or quantities which exceed applicable federal or state standards forum restricted release.Does not include waste containing more than 100 Nano curies of transuranic contaminants per gram of material.
WHO categories of health care waste HealthCare waste Examples1)Communal waste (solid Cardboard boxes, paper, foodwastes that are not infectious, waste, plastic and glass bottleschemical, or radioactive)2)Biomedical wastes Cultures, tissues, dressings,Infectious waste (wastes swabs, and other blood soakedsuspected of Containing items; waste from isolationpathogen) wards.3)Anatomical waste Recognizable body parts.4)Sharps Needles, scalpels, knives, blades, broken glass.
HealthCare waste Examples5)Pharmaceutical waste Expired or no longer needed medicines or Pharmaceuticals.6)Genotoxic waste Wastes containing genotoxic drugs and chemicals (used in cancer therapy7)Chemical waste Laboratory reagents, film developer, solvents, expired or no longer needed disinfectants, and organic chemical wastes. (example, formaldehyde, phenol- based cleaning solutions)
HealthCare waste Examples8)Pressurized containers Aerosols9)Radioactive waste Unused liquids from radiotherapy; waste materials from patients treated or tested with unsealed radionuclide
OBJECTIVE OF PHARMACEUTICAL WASTETREATMENTdestruction or recovery for reuse and/or the conversion of these substance to harmless form that are acceptable for uncontrolled disposal
METHODS OF PRODUCT DISPOSAL1. High Temperature Incineration2. Waste Immobilization: Encapsulation3. Waste Immobilization: Inertization4. Discharge to Sewer5. Landfill Deposit6. Chemical Decomposition7. Medium Temperature Incineration8. Open Container Incineration
1. High Temperature IncinerationIncineration is a high temperature dry oxidation process that reduces organic and combustible waste to inorganic, incombustible matter and results in a very significant reduction of waste volume and weight.Incinerators designed especially for treatment of healthcare waste should operate at temperatures between 900 and 1200 C and be equipped with mechanisms to remove toxic byproducts. e.g. Pyrolytic incinerators, and municipal incinerators by product removal mechanisms.
2. Waste Immobilization: EncapsulationEncapsulation involves immobilizing pharmaceuticals in a solid block within a plastic or steel drum.Drums should be cleaned prior to use and should not have contained explosive or hazardous materials previously.They are filled to 75% capacity with solid and semisolid pharmaceuticals. The remaining space is filled with cement, lime, plastic. The drums are sealed, placed at the base of a landfill and covered.
3. Waste Immobilization: InertizationInertization is a variant of encapsulation and involves removing the packaging materials, paper, cardboard and plastic from pharmaceutical products.Pharmaceutical products are ground and a mix of water (5%), cement (15%) and lime (15%) is added to form a homogenous paste. The paste is transported by a concrete mixer truck to a landfill and decanted into the normal urban waste.
4. Discharge to SewerSome liquid pharmaceuticals can be diluted with water and flushed into the sewers in small quantities without serious public health or environmental affect.5. Landfill DepositTo landfill means to place waste directly into a land disposal site without prior treatment or preparation
6. Chemical DecompositionChemical inactivation is tedious and time consuming. If done, stocks of the chemicals used in the treatment must be available at all times.This method may be practical for disposal of a small quantity of anti-neo-plastics drugs7. Medium Temperature IncinerationTemperature ranges between 300-400°C.Used only in the absence of high temperature incinerators.
8. Open Container IncinerationOpen-air burning should take place in the pit of final disposal where these solids will be put underground. Processes must be closely supervised by the person responsible for waste management in the heath care facility.The area within which the burning is carried out should be fenced off to prevent animals and unauthorized persons from entering.Burning is generally incomplete, non-uniform and produces large quantities of toxic pollutants.so Restrict use to emergency situations only
WASTE PRODUCT DISPOSALPROCEDURE1) Product disposal:Any product requiring disposal should initially be separated from its packaging if appropriate. For example, any product to be disposed in an approved landfill site should not be left in impermeable glass, plastic, or other containers which would significantly delay destruction.Ideally, INCINERATION procedures have preference over LANDFILL ,where incineration is used, product in plastic or other flammable packaging may not need.
2) Printed packaging disposal:The disposals of printed packaging components include labels, inserts, and cartons possess no health risk.However, ineffective disposal, such as in the public landfill, can give rise to public concern that product may be associated with the packaging. Such materials should preferably be incinerated.
3) General trash and savage:Normal local services will be adequate for sewage and trash. However internal procedures should be sufficiently rigorous and monitored, to ensure that product and the packaging waste does not get intermixed.Containers used within the plant to accumulate waste materials should be clearly marked to denote their designated use.CFR (Code of federal regulation) 211.50 states that “Sewage, trash and other refuse in and from the building and immediate premises shall be disposed of in a safe and sanitary manner
Ten Steps:1. Identifying drugs that must be managed as hazardous waste.2. Determining which non-regulated drugs will be managed as hazardous waste.3. Labeling drugs to facilitate segregation of hazardous waste.4. Preparing and maintaining hazardous waste manifests.5. Determining their hazardous waste generation status and what criteria are used for hazardous waste selection.6. Scheduling regular program reviews.7. Keeping management informed.8. Plan for Emergencies9. Train the Employees10. Keep Records
SCALES OF PRODUCT DISPOSAL Large-scale Destruction Medium-scale Destruction Small-scale Destruction
PHARMACEUTICAL WASTE MANAGEMENTGUIDELINES This Blueprint focuses primarily on three aspects of pharmaceutical waste management: 1) Management of regulated hazardous pharmaceutical waste. 2) Management of non-regulated hazardous pharmaceutical waste. 3) Minimization of pharmaceutical waste.
Schedule M of Drug and Cosmetics Act,gives guidelines in this regard:1)”The disposal of sewage and effluent from manufacturing shall be in conformity with requirement of environmental pollution control Board”2)All biomedical waste shall be destroyed as per provision of bio-medical waste (Manufacturing and Handling) Rules, 1996.3)Additional precaution shall be taken for storage and disposal of rejected drugs. Records shall be maintained for all disposal of waste.
4)Provision shall be made for proper and safe storage of waste materials, awaiting disposal.• Hazardous toxic substance and flammable materials shall be stored in suitably designed and segregated enclosed areas in conformity with central and state legislation.5)The material is generally sold to scrap dealers. Precautions should be taken before selling these materials to scrap dealer
e.g.; 1) Empty solvent containers should be free from residual solvent lying at bottom of drums. 2) Rejected printed packaging materials (Labels, cartons, foils, etc) should be defaced, destroyed before sending to scrap for storage and sale.
WHO guidelines:I. Provision should be made for proper and safe storage of waste materials awaiting disposal. Toxic substance and flammable materials should be stored in suitably designed, separate, enclosed cupboards as required national legislation.II. Waste materials should not allowed to accumulate. It should be collected in suitable receptacles for removal to collection points outsides the building & disposed off safely & in a sanitary manner at regular & frequent interval.
RECORDS:Keep it for at Least 3 Years for followingso License applications (if applicable)o Licenses (if applicable)o Land Disposal Restriction formso Inspection logso Recycled waste shipping paperso Emergency Response recordRecords: Keep Longero Analytical Reportso All data used in evaluationo Training documents
Records: Accesso Copy must be maintained at generator siteo Must be available for inspectiono Paper or Electronic Date of destruction, name of the product to be destroyed, type of destruction, place of destruction, cause of destruction should be included in the relevant record. Quantities rejected and destroyed must be recorded and reconciled in relevant batch documents. Safety precautions taken while carrying out destruction must be included in the records. Signature of the supernatants after completion of the destruction in records
REFERENCE:1)Willing HS, Stoker RJ, ”Good Manufacturing Practices For Pharmaceuticals” Fourth Edition, p. 47-48.2)Potdar AM,”Pharmaceutical Quality Assurance” Nirali Prakashan, First Edition, p.7-8.3)Sharma PP.”How to Practice GMPs”, Vandana Publication, Third Edition, p. 634.