BIOMEDICAL AND PHARMACEUTICAL WASTE MANAGEMENT INTRODUCTION Health care activities are a means protecting health, curing patients and saving lives. But they also generate waste,20 percent of which entail risk either of infection of trauma or chemical radiation exposure. Although the risk associated with hazardous medical waste and the ways and by means of managing that waste1.Pharmaceutical waste can result from many activities and locations in a healthcare facility. Waste produce from pharmacy expired drug, spills, half-used bottles, IV equipment with residual medicine on it and contaminated pharmaceutical product including vaccines and biological product used for therapy. In the past, health care facilities would routinely flush waste pharmaceutical down the drain. As a society we did not know how harmful these drugs would be to the environment. Now biologist have found remaining pharmaceuticals in fish and aquatic ecology, and we understand how bad the unprocessed disposals of drugs are. As responsible citizens and waste managers we need to keep the preventive principle in mind2.Pharmaceutical waste not a single waste streams that can affect the integrity and uniformity of the chemicals that involve pharmaceuticals. Pharmaceutical waste is possibly generated through a wide variety of deeds in health care facility, including but not limited to I.V. preparation, general compounding, breakages, partially used ampoules, needles, IVs, outdated unused preparation, fallow unit doses, personal medication and outdated pharmaceuticals3. Improper management of waste generated in health care facilities causes a direct health impact on the community and health care workers. The waste generated in this institution essentially consist of solid and liquid, which may hazardous, infectious, non-infectious. It has been estimated that up to 85% to 90% of the waste generated in hospitals in non-infectious. It is the remaining 10% to 20% of waste is hazardous and infectious. If waste not treated with right manner would cause environmental pollution affecting the health of the community. Proper handling, treatment and disposal of biomedical waste are elements of health care office infection control programme. Correct procedure will help protect health care workers, patient and local community. Proper collection and segregation of biomedical waste are important. At the same time the quantity of waste generated is equally important. A lesser amount of waste generated means less burden on waste disposal worker, cost saving and more efficient waste disposal system. Hence, health care provider should try to reduce the waste generation in day-to-day work in clinic or at hospitals4. SSBTs, Institute of Pharmacy, Bambhori, Jalgaon. Page 1 BIOMEDICAL AND PHARMACEUTICAL WASTE MANAGEMENT Researc h centres Hospital Lab s Animal research Nursin g home s Chemic al industri es Fig.1. The major sources of Biomedical Waste Fig.2.The minor sources of Biomedical Waste SSBTs, Institute of Pharmacy, Bambhori, Jalgaon. Page 2 BIOMEDICAL AND PHARMACEUTICAL WASTE MANAGEMENT Needs of Biomedical Waste Management in Hospitals: 1. Injuries from sharps leading to infection to all categories of hospitals personnel and waste handler. 2. Nosocomial infection in patients from poor infection control practices and poor waste management. 3. Risk of infection outside hospital for waste handlers and scavengers and at time general public in the vicinity of hospitals. 4. Risk associated with hazardous chemicals, drugs to person handling waste at all levels. 5. Risk of air, water, soil pollution directly due to waste or due to defective incineration emission and ash11 6. Waste management reduces the effect of waste on the environment, health and so on12 7. One of essential aspect of waste management is recycling and when you do it you are helping in the conservation of natural resources by reusing material such as glass, plastics and papers13. SSBTs, Institute of Pharmacy, Bambhori, Jalgaon. Page 3 BIOMEDICAL AND PHARMACEUTICAL WASTE MANAGEMENT BIOMEDICAL WASTE MANAGEMENT PROCESS Mismanagement of hospital waste implies a combination of improper handling of waste during generation, collection, storage, transport and treatment. Improper handling comprises several unsafe actions, such as handling without personal protective equipment (PPE), poor storage, use of uncovered containers instead of close plastic bags. There is a big network of health Care Institution in India. The hospital waste like body parts, organ, tissue, blood and body fluids along with soiled linen, cotton, bandage and plaster casts from infected and contaminated areas are very essential to be properly collected, segregated, stored, transported, treated and disposed of in safe manner to prevent nosocomial or hospital acquired infection14. Steps of Biomedical Waste Management: 1. 2. 3. 4. 5. 6. Waste Collection Segregation Transportation and storage Treatment and Disposal Transport to final disposal site Final Disposal 1) Waste Collection: Collection of waste is part of the process of waste management. It is the transfer of solid waste from the point of use and disposal to the point of treatment or landfill. Household Waste Collection Waste collection also includes the curb side collection of recyclable material that technically are not waste, as part of a municipal landfill diversion program17 Fig.3.Household Waste Collection SSBTs, Institute of Pharmacy, Bambhori, Jalgaon. Page 4 BIOMEDICAL AND PHARMACEUTICAL WASTE MANAGEMENT Hospital Waste Collection Hospital Waste is any kind of waste containing infectious material. It may be solid, or liquid generate from biological and medical sources and activities such as the diagnosis, prevention and treatment of disease18. Fig. 4. Hospital Waste Collection 2) Segregation: Biomedical waste generated from health care facility required to be segregated at the point of generation as per colour coding stipulated under Schedule-l of BMWM Rules, 2016. Waste must be segregated at point of generation of source and not in later stage. Point of generation means the location where waste initially generate, accumulate. Adequate number of colour coded bin/ containers and bags should be available at the point of generation of bio-medical waste. Colour coded plastics bags should be in line with the Plastic Management Rules, 2016. Provide PPE kit to biomedical waste handling staff19. 3) Transportation: Transportation is transfer of waste from site of generation to disposal site. Truck mounted refuse compactors the refuse compactor vehicles are the solid waste collection equipment designed for lifting and unloading the garbage from garbage bin to transportation to dumping processing plants. Fig.5.Refuse Compactor Vehicle SSBTs, Institute of Pharmacy, Bambhori, Jalgaon. Page 5 BIOMEDICAL AND PHARMACEUTICAL WASTE MANAGEMENT Storage of waste as per colour Sr. No. Category Type of Waste Colour Type of Container 1. Yellow Category -Discarded or expired medicine -Chemical liquid waste -Soiled Waste -Human Anatomical Waste -Animal Anatomical Waste -Microbiology, Biotechnology and other clinical laboratory waste -Chemical Waste Yellow colour nonchlorinated Plastics Bags and containers 2. Red Category Contaminated Waste (Recyclable) such as tubing, bottles, intravenous tubes, sets, urine bags, gloves, oxygen mask, rubber apron, pipette tips, plastic pipette, vail not containing blood Red Coloured nonchlorinated plastics Bags and containers 3. White Category Waste Sharps including metals needles, syringe with fix needle scalpels, blades, insulin pen needle, surgical stab knife, other sharp object that cause puncture and cuts White coloured translucent, puncture proof, leak proof, Temper proof container SSBTs, Institute of Pharmacy, Bambhori, Jalgaon. Page 6 BIOMEDICAL AND PHARMACEUTICAL WASTE MANAGEMENT 4. Blue Category Glassware Metallic body Implant Puncture Proof, leakproof boxes, and containers 5. Black Category Cytotoxic, expired drug, chemical substance, pharmaceutical waste Black Colour plastic bags and containers Various methods to be adopted for disposal of waste are: 1) Incineration 2) Deep burial 3) Autoclaves 4) Irradiation 5) Microwaving 6) Disposal in Landfill 7) Chemical Treatment SSBTs, Institute of Pharmacy, Bambhori, Jalgaon. Page 7 BIOMEDICAL AND PHARMACEUTICAL WASTE MANAGEMENT Incineration: Incineration is the high temperature burning or rapid oxidation of waste. It is also known as controlled flam combustion or calcination and is a technology that destroy organic constituents in waste material. It is a treatment process to convert pathological and pharmaceutical waste into ash, flu gases and heat. Incineration is a thermal waste treatment that primary objective of volume reduction and energy recovery from waste. Process of Incineration: - Waste Storage Pre-treatment / Feed Preparation Emission From stack Combustion/ Incineration Heat Recovery Air Pollution Control System Ash Scrubber Water and ash Handling Diesel Biomedical Waste Incinerator: - Product description: Bio Medical Waste Incinerator is an advanced bio medical waste incineration system which can be used for the disposal of biomedical waste such as sharps, syringe, needle, bandage, etc. The incinerator has been developed using latest technologies ad material. This incinerator suitable for hospitals, clinics, laboratories, nursing homes, blood banks, dental offices, veterinary clinics, research institute, etc. Capacity 40kg/batch, Burning Ability300kg/time, Time required 3hrs Feature easy to operate and fast incineration. SSBTs, Institute of Pharmacy, Bambhori, Jalgaon. Page 8 BIOMEDICAL AND PHARMACEUTICAL WASTE MANAGEMENT Deep Burial: A pit or trench should be drug about 2m deep. It should be half filled with waste, and then covered with lime within 50cm of the surface, before filling the rest of the pit with soil. On each occasion, when wastes are added to the pit, a layer of 10cm of soil be added to cover the waste. Burial must be performed under close dedicated supervision. The Pit should be distant from habitation and sited so as no contamination occurs of any surface water or ground water. The location of the site will be authorised by the prescribe authority. Autoclave: Autoclaving is process of steam sterilization and is the most common alternative to incineration. Some autoclave refers as waste converters can operate in the atmospheric pressure range to achieve full sterilization of pathogenic waste. SSBTs, Institute of Pharmacy, Bambhori, Jalgaon. Page 9 BIOMEDICAL AND PHARMACEUTICAL WASTE MANAGEMENT Irradiation: In these process wastes are exposed to ultraviolet or ionizing radiation in an enclosed chamber40. Irradiation disinfects waste by exposing it to gamma rays that are fatal to bacteria. This is same radiation source used for radiation treatment of cancer. In radiation for sterilization of equipment or treatment of waste, the radiation is intended to kill pathogens. Some irradiation treatment system used electron beams42. Microwaving: Microwave irradiation is suitable tool for inactivation of biohazardous solid waste. There are several health care waste treatment systems using microwave commercially available (e.g.,Sanitec systems) with batch or semi-continuous feeding. Microwave technology has advantage that can implement onsite in the site health care facility which generated the hazardous waste avoiding the need of transport43. SSBTs, Institute of Pharmacy, Bambhori, Jalgaon. Page 10 BIOMEDICAL AND PHARMACEUTICAL WASTE MANAGEMENT Disposal in Landfill: A landfill is a facility designed for solid waste disposal into the ground. A well-engineered land fill is safe, minimizes adverse effect to public health44. Sanitary landfills are intended as bioreactor in which microbes will break down complex organic waste into simpler, less toxic compound45. Chemical Treatment: When liquid waste is common biomedical waste disposal method can be chemical disinfectant. Chlorine is a regular choice for this process and is introduce to the liquid waste in order to kill microorganisms and pathogens47. SSBTs, Institute of Pharmacy, Bambhori, Jalgaon. Page 11 BIOMEDICAL AND PHARMACEUTICAL WASTE MANAGEMENT PHARMACEUTICAL WASTE MANAGEMENT Pharmaceutical waste is potentially generated through pharmaceutical industries and health care facility like expired drugs, outer packing, contaminated garments, etc. Pharmaceutical waste categories: A. Hazardous waste B. Non-Hazardous Waste C. Chemo Waste A) Hazardous Waste: Waste dangerous or potentially harmful to human health or environment. These can be liquid, solid, glass, sludges49. (1) Listed Wastes (2) Characteristics Waste 1) Listed Waste: Listed waste appear on one of four list of hazardous waste (F, K, P and U). Pharmaceuticals are found on two of these lists the P and U list which contain commercial chemical product. P-Listed Pharmaceutical waste: P-listed pharmaceutical Waste code Arsenic trioxide Epinephrine Nicotine Nitroglycerine Physostigmine Physostigmine salicylate Warfarin P012 P042 P075 P081 P204 P188 P001 U -listed Pharmaceuticals: U-listed pharmaceutical Waste code Chloral hydrate Paraldehyde Chlorambucil Phenol Cyclophosphamide Reserpine Melphalan U034 U182 U035 U188 U058 U200 U150 SSBTs, Institute of Pharmacy, Bambhori, Jalgaon. Page 12 BIOMEDICAL AND PHARMACEUTICAL WASTE MANAGEMENT 2) Characteristics of waste: The EPA define characteristics of hazardous waste: - a) Ignitability(D001): The objective of the ignitability is to identify waste that either present a fire hazard under routine storage, disposal and transportation or capable of exacerbating a fire once it has started. Many of the waste that pharmacies handles are hazardous because they are ignitable. b) Corrosivity(D002): Corrosive waste damage metals or other material or burn the skin. These liquids have pH of 2 or lower or 12.5 or higher. Generation of corrosive pharmaceutical waste are generally limited to compounding chemical in pharmacy. c) Reactivity(D003): Reactive waste are unstable under normal conditions. They can cause toxic fumes, gases, vapours when heated, compressed or mixed with water. E.g., Clinitest (test tablet to determine sugar in urine) d) Toxicity (Multiple D Codes): Waste are toxic if they contain toxic organic chemical such as heavy metals lead, chromium, mercury. Ingredient Waste Code Regulatory level(mg/l) Arsenic Barium Cadmium Lindane Mercury Selenium Silver D004 D005 D006 D013 D009 D010 D011 5.0 100.0 1.0 0.4 0.2 1.0 5.0 B) Non-Hazardous waste: Certain medical product has no pharmaceutical properties but still controlled and administered by medical staff such as sodium chloride or dextrose solution. These products may become contaminated or mixed with other compound and therefore require assessment for hazardous properties prior to disposal. C) Chemo Waste: Chemo waste is most hazardous waste in the medical field. They are highly toxic and corrosive. They cause damage to natural resources. Trace Chemotherapy waste: Includes vials, syringe, IV bags, gloves, etc. Bulk Chemotherapy Waste: Includes items that used to contain chemotherapy agent. SSBTs, Institute of Pharmacy, Bambhori, Jalgaon. Page 13 BIOMEDICAL AND PHARMACEUTICAL WASTE MANAGEMENT METHODS OF WASTEMANAGEMENT: 1) Waste immobilization: - Encapsulation Encapsulation involve immobilizing the pharmaceuticals in a solid block within a plastic or steel drums. Drums should be cleaned prior to use and should not have contained explosive or hazardous material previously. Care should be taken to avoid cuts to hand when placing pharmaceutical in drum. Waste Immobilization is conversion of waste into waste form by solidification50. 2) Waste Immobilization: - Inertization Inertization is a variant of encapsulation and involves removing the packaging materials, papers, cardboard and plastics from pharmaceuticals. Pills need to be removed from their blister packs. The pharmaceuticals then ground and mix of water cement and lime added homogenous paste. The paste then transported in the liquid state by concrete mixer trunk to landfill and decanted into the normal urban waste.53 Reduction of environment Pollution by minimizing the pharmaceutical waste: SSBTs, Institute of Pharmacy, Bambhori, Jalgaon. Page 14 BIOMEDICAL AND PHARMACEUTICAL WASTE MANAGEMENT 3) Waste Minimization: It is set processes and practice intended to reduce the amount of waste produced. By reducing or eliminating the generation of harmful and persistent wastes, waste minimization supports efforts to promote the more sustainable society.55 a) Reduce: Reduction of the waste which is being generated is an important method of waste management. Waste reduction also known as source reduction it is practice of using less material and energy to minimize waste generation and preserve natural resources. b) Reuse: Reuse means that the product can be used multiple times same reason pr for different reason without need for reprocessing. Reuse avoid discarding material to waste stream when initial use has concluded. c) Recycling: Recycling is process which involve of substances that recycled to its original form. The recovery of energy from waste materials. Recyclate is a raw material sent to and processed in recycling plant so it can be used in the production of new materials. Regulatory Bodies for Pharmaceutical waste management: 1)The Drug Enforcement Administration (DEA) 2)Environmental Protection Agency 3)Department of Transportation 4) State environmental Protection Agencies 5) Drug Regulatory Authority (DRA) SSBTs, Institute of Pharmacy, Bambhori, Jalgaon. Page 15 BIOMEDICAL AND PHARMACEUTICAL WASTE MANAGEMENT CONCLUSION: In today’s scenario with the growing lifestyle, the need of pharmaceutical compound is also increasing, and they are with environment in extremely large quantity and the system present is not able to control the untreated or partially pharmaceutical waste. The management of waste is an increasing complex task with new waste classification and disposal techniques being developed and released on continual basis. Thus, there need for adopting cost effective system for providing better medical treatment facilities and require the implementation of new system to ensure proper waste management and to reduce the amount of waste generation by awareness and education of all concerned. Modern waste management methods are far safer for people and the environment than past practice. Recycling and composting grown fast in many countries. Proper handling, treatment and disposal of biomedical wastes are important element of health care office infection control programme. Correct procedure will help to protect health care worker, patients and local community. SSBTs, Institute of Pharmacy, Bambhori, Jalgaon. Page 16 BIOMEDICAL AND PHARMACEUTICAL WASTE MANAGEMENT REFERENCES: 1) Medical Waste Management,International committee of the redcross (IoCRC-November 2011), page no.8 2) Shinde A.R., Patil A.P., et.al, Pharmaceutical Waste Management, December 2020; Article No.11, Page:68-74. 3) K. Sreekanth, N. Gupta N.V, et.al, Managing of pharmaceutical waste in Industry, International Journal of PharmTechResearch, vol.6, page no.899. 4) V.N.Kalpana, D. Sathya Prabhu, Journal of chemical and pharmaceutical research,2016, Page no.670-671, www.jocpr.com. 5) https://www.nicepng.com/ourpic/u2q8t4t4q8u2o0i1_red-cross-hospital-logo-hospital-logo-red-cross/ 6)https://www.synocule.in/ 7)https://www.rdworldonline.com/rd-special-focus-plant-science/ 8)https://opinionfront.com/animal-research-pros-cons 9)https://getblogo.com/resources-to-better-understand-your-nursing-field/ 10) https://auto.economictimes.indiatimes.com/amp/news/auto-components/indias-growing-chemistry-with- the-world/91267028 11) DeepikaKanyal, Biomedical waste management in India, Indian Journal of Forensic Medicine and Toxicology, April-June 2021, Vol.15, No.2:109-110. 12) https://www.indiatoday.in/information/story/waste-disposal-and-management-all-you-need-to-know- 1718288-2020-09-04 13) https://www.rapidrivermagazine.com/2021/5-reasons-why-waste-management-is-important/ 14)http://www.medicareenviro.com/process/ 15) https://www.forgerecycling.co.uk/blog/increase-in-domestic-waste-leads-to-councils-burning-recycling/ 16) https://evreka.co/blog/waste-collection-techniques/ 17) https://en.m.wikipedia.org/wiki/Waste_collection 18)https://en.m.wikipedia.org/wiki/Biomedical_waste 19) Guideline for Management of Healthcare Waste as per Biomedical Waste Management rule,2016, Page no.6-22. 20) https://www.tpsmfg.com/solid-waste-management-machinery-equipments.php 21)https://www.trihazsolutions.com/preparing-medical-waste-what-goes-in-the-black-bin/ 22)https://m.indiamart.com/proddetail/20l-biohazard-bio-medical-waste-bin-23739226455.html 23)https://m.indiamart.com/proddetail/yellow-biohazard-bags-13629656248.html 24)https://usbioclean.com/why-are-medical-waste-disposal-bags-red/ 25)https://usbioclean.com/why-are-medical-waste-disposal-bags-red/ SSBTs, Institute of Pharmacy, Bambhori, Jalgaon. Page 17 BIOMEDICAL AND PHARMACEUTICAL WASTE MANAGEMENT 26)https://m.indiamart.com/proddetail/white-garbage-bags-16857168112.html 27)https://m.indiamart.com/proddetail/15-l-bio-medical-waste-bins-21860365073.html 28)https://m.indiamart.com/proddetail/blue-bio-medical-waste-collection-bags-24503363348.html 29)https://www.indiamart.com/proddetail/orchids-bio-waste-dust-bin-15-litres-blue-24056693333.html 30)https://m.indiamart.com/proddetail/20-l-bio-medical-waste-bins-21860451348.html 31) Rekha Trivedi, Biomedical Waste Management, Biomedical Journal of scientific and Technical Research, Volume 43, page no.35003-35004. 32) N. Nishad Fathima, J. Raghava Rao, Balachandran unni Nair, chemical laboratory Council of scientific and industrial research, Adyar, Chennai, India. page no.595 33) Rucha V. Moharir, Pratibha Gautam, Sunil Kumar, Waste Treatment Process/ Technologies for Energy Recovery, Current development in Biotechnology and Bioengineering, Chapter-4, page no.65. 34) https://www.envmart.com/diesel-bio-medical-waste-incinerator-capacity-40-kg- batch/cp10348penv10c433b 35) https://vikaspedia.in/energy/environment/wastemanagement/bio-medical-waste-management/treatment- of-bio-medical-waste#:~:text=Deep%20Burial,wire%20meshes%20may%20be%20used 36) https://www.intechopen.com/chapters/78663 37)https://en.m.wikipedia.org/wiki/Waste_autoclave 38) https://www.bertin-medical-waste.com/products/biohazardous-waste-management-systems/sterilwave- 100/ 39) https://www.news-medical.net/Autoclave-for-Medical-Waste-Management-from-Bondtech 40) https://vikaspedia.in/energy/environment/waste-management/bio-medical-waste-management/treatment- of-bio-medical-waste#section5 41) Treating Medical Waste with Microwaves, and Irradiation https://www.malsparo.com/treat2.htm 42) Placido Alfredo Lanza, Department of Engineering, University of Palermo, Italy. Healthcare Waste Treatment by Microwave :Critical Parameter and Future Perspective, American Journal of Biomedical Science and Research,ISSN:2642-1747,Vol-5. 43) https://www.disposingmedicalwaste.com/biohazard-infectious-waste-disposal-equipment/57643782.html 44)https://www.malsparo.com/landfill.htm#:~:text=There%20are%20two%20types%20of,of%20air%20by %20anaerobic%20bacteria 45) https://en.m.wikipedia.org/wiki/Landfill 46) https://bio.libretexts.org/Courses/Bakersfield_College/Introduction_to_Environmental_Science/16%3A_ Solid_Waste_Management/16.04%3A_Waste_Disposal 47) Types of Biomedical Waste Disposal | BWS SSBTs, Institute of Pharmacy, Bambhori, Jalgaon. Page 18 BIOMEDICAL AND PHARMACEUTICAL WASTE MANAGEMENT https://bwaste.com/resources/the-knowledge-center/articles-insights-and-updates/types-biomedical-wastedisposal 48) B. Kiranmayi, Swarupa A, et al. Review article pharmaceutical waste management Journal of pharma research, vol.8, issue 10,2019, ISSN:2319-5622. 49) Muhammed jaseem, Promod Kumar, RemyamariamJohn, Waste Management in pharmaceutical Industry, The Pharma Innovation Journal 2017;6(3):158-161. 50) C. M. Jantzen, Radioactive waste conditioning, immobilization and encapsulation process and technologies, published by Woodhead publishing limited, 2013,175. 51) K. Pratyusha, Review article on Waste material management in pharmaceutical industry, international journal of pharmaceutical science review and research, ISSN:0976-044X,121-129. 52) https://www.malsparo.com/encap.htm 53) Hospital waste inertization system - Chemical Empowering AG https://www.ce.eco/en/products/our-embedded-systems/hospital-waste-inertization-system 54) Waste minimisation – Wikipedia https://en.m.wikipedia.org/wiki/Waste_minimisation 55) Waste Reduction | Encyclopedia.com https://www.encyclopedia.com/earth-and-environment/ecology-and-environmentalism/environmentalstudies/waste-reduction 56) Recycling – Wikipedia https://en.m.wikipedia.org/wiki/Recycling 57) https://stlcityrecycles.com/reduce-%F0%9F%9A%AB-reuse-%F0%9F%94%82-recycle-%E2%99%BB 58) https://www.stericycle.com/en-us/solutions/regulated-waste-disposal/epa 59)Hazardous Waste Compliance In Health Care Settings https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4315112/ 60)Notification on collection of Pharmaceutical waste | Drug Regulatory Authority https://dra.gov.bt/?p=1252 SSBTs, Institute of Pharmacy, Bambhori, Jalgaon. Page 19