An Examination of Waste Management Patterns in Pharmaceutical Industry
An Examination of Waste Management Patterns in Pharmaceutical Industry
An Examination of Waste Management Patterns in Pharmaceutical Industry
Odoja J. N. O.
ABSTRACT
Wastes are of different forms like household rubbish, sewage, sludge, wastes from manufacturing activities,
packaging items, discarded cars, old televisions, garden waste, and old paint containers, among others. Thus, daily
activities may give rise to a large variety of different wastes arising from different sources. Pharmaceutical wastes
are potentially generated through a wide variety of activities in the health care system, including syringes, and
are not limited to intravenous (IV) preparation. With such vast quantities of waste production, it is of vital
importance that these should be managed in such a way that they do not cause any harm to either human health
or to the environment. There are a number of different options available for the treatment and management of
wastes including prevention, minimization, re-use, recycling, energy recovery and disposal. This study examined
the waste management processes in Pharmaceutical industries.
Keywords: Pharmacy, Waste, Management, Environment, Industry
INTRODUCTION
Wastes are the unwanted or unusable materials which can be hazardous to human or the environment hence, they
have to be discarded immediately, or recycled into another useful product(s) [1]. Wastes are of different forms like
household rubbish, sewage, sludge, wastes from manufacturing activities, packaging items, discarded cars, old
televisions, garden waste, old paint containers etc. Thus, daily activities may give rise to a large variety of different
wastes arising from different sources. This might be developed from households, commercial activities (e.g., shops,
restaurants, hospitals etc.), industry (e.g., pharmaceutical companies, clothes manufacturers etc.), agriculture (e.g.,
slurry), construction and demolition projects, mining and quarrying activities and from the generation of energy
[2]. With such vast quantities of waste production, it is of vital importance that these should be managed in such a
way that they do not cause any harm to either human health or to the environment. There are a number of different
options available for the treatment and management of wastes including prevention, minimization, re-use, recycling,
energy recovery and disposal [3]. Pharmaceutical wastes are of different types mainly hazardous wastes and non
hazardous wastes.
Pharmaceutical Wastes
Pharmaceutical wastes are potentially generated through a wide variety of activities in the health care system,
including syringes, and are not limited to intravenous (IV) preparation. Generally Pharmaceutical waste may
include:
Expired drugs
Patients’ discarded personal medications;
Waste materials containing excess drugs (syringes, IV bags, tubing, vials, etc.);
Waste materials containing chemotherapy drug residues;
Open containers of drugs that cannot be used;
Containers that held acute hazardous waste drugs;
© Odoja, 2023
This is an Open Access article distributed under the terms of the Creative Commons Attribution License
(http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.
https://www.eejournals.org Open Access
Drugs that are discarded; and
Contaminated garments, absorbents and spill cleanup material.
Pharmaceutical waste is further classified in 3 categories:-
1. Hazardous waste,
2. Non-hazardous waste,
3. Chemo waste.
Hazardous Wastes: Wastes that are dangerous or potentially harmful to human health or the environment is called Page | 40
hazardous waste. These can be liquids, solids, contained gases, or sludges. Hazardous wastes are divided into two
categories: Listed wastes, and Characteristic wastes. Pharmaceutical wastes come under listed wastes since they
contain commercial chemical products [4]. Characteristic wastes are regulated because they exhibit certain
hazardous properties – ignitability, corrosivity, reactivity and toxicity. Wastes that are not listed and do not exhibit
a characteristic are considered solid waste. Solid wastes should be discarded according to state and/or local
regulations, including regulated medical waste requirements. The objective of the ignitability characteristic is to
identify wastes that either present a fire hazard under routine storage, disposal, and transportation or are capable of
exacerbating a fire once it has started. There are several ways that a drug formulation can exhibit the ignitability
characteristic. Many of the hazardous wastes that pharmacies handle are hazardous because they are ignitable [5].
These wastes often pose the greatest management problems for pharmacies. Ignitable wastes are easily combustible
or flammable [6]. Similarly, corrosive wastes corrode metals or other materials or burn the skin. These liquids have
a pH of 2 or lower or 12.5 or higher. Examples of acids that exhibit a pH of 2 or lower include glacial acetic acid.
Examples of bases that exhibit a pH of 12.5 or higher include Potassium Hydroxide and Sodium Hydroxide.
Generation of corrosive pharmaceutical wastes is generally limited to compounding chemicals in the pharmacy.
Reactive wastes are unstable under "normal" conditions. They can cause explosions, toxic fumes, gases, or vapors
when heated, compressed, or mixed with water. On the other hand, wastes are toxic if they contain toxic organic
chemicals or certain heavy metals, such as chromium, lead, mercury, or cadmium. Approximately 40 chemicals meet
specific leaching concentrations which classify them as toxic. Wastes that exceed these concentrations must be
managed as hazardous waste.
Non Hazardous Wastes: Materials in this category do not have significant hazardous properties. However, [7]
this is not an indication that there are no hazardous components present, only that any such components are below
the threshold for causing harm to human health. Importantly, this non-hazardous state is subject to change and the
addition or removal of specific items from the waste stream may significantly alter the management options available
[5].
Biomedical Wastes: Biomedical wastes can be briefly defined as any solid or liquid waste that is generated in the
diagnosis, treatment of immunization of human beings or animals in research pertaining thereto, or in the production
or testing of biological material. According to World Health Organization (WHO) estimates, 85% of hospital waste
is actually non-hazardous and around 10% is infectious while the remaining 5% is noninfectious but consists of
hazardous chemicals like methyl chloride and formaldehyde. Nevertheless, this study is focused on infectious.
Hospital waste is the transmission of HIV and Hepatitis B or C viruses. In this context, Syringes and needles have
the highest disease transmission potential. Hospital waste, till recently was not being managed but it was simply
‘disposed off’[6, 7, 8]. The disposal of hospital waste can be very hazardous particularly when it gets mixed with
municipal solid waste and is dumped in uncontrolled or illegal landfills such as vacant lots in neighboring residential
areas and slums. This can lead to a higher degree of environmental pollution, apart from posing serious public health
risks such as AIDS, Hepatitis, plague, cholera, etc. The waste produced in the course of health care activities carries
a higher potential for infection and injury than any other type of waste.
Pharmaceutical Waste Management and Disposal
Pharmaceutical waste management is described in the India’s pharmaceutical waste rules which illustrate various
tools for effective management of wastes as follows:
Incineration: Incineration is an effective method used for disposal of wastes, in which solid organic wastes are
subjected to combustion so as to convert them into residue and gaseous products. This method is useful for disposal
of residue of both solid waste management and solid residue from waste water management. This process reduces
the volumes of solid waste to 20 to 30 percent of the original volume. Incineration and other high temperature waste
treatment systems are sometimes described as "thermal treatment". Incinerators convert waste materials into heat,
gas, steam and ash. Incineration is carried out both on a small scale by individuals and on a large scale by industry.
It is used to dispose of solid, liquid and gaseous waste. It is recognized as a practical method of disposing of certain
hazardous waste materials (such as biological medical waste). Incineration is a controversial method of waste
disposal, due to issues such as emission of gaseous pollutants. Incineration is not suitable for such health care wastes
© Odoja, 2023
This is an Open Access article distributed under the terms of the Creative Commons Attribution License
(http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.
https://www.eejournals.org Open Access
as pressurized gas containers, large amounts of reactive chemical wastes, wastes treated with halogenated chemicals,
halogenated plastics such as polyvinyl chloride, wastes with mercury or cadmium (such as broken thermometers,
used lead or mercury batteries), or radiographic wastes. [3], Incinerators that meet the CPCB draft incineration
regulations must have a sophisticated (for example, double- chamber) design and include a scrubber as the air
pollution control equipment. Ash from these incinerators must be disposed of in a secure landfill. Such incinerators
are associated with high investment and operating costs and require highly skilled operating personnel.
Autoclaving: In autoclaving, saturated steam in direct contact with the biomedical waste in a pressure vessel at Page | 41
time lengths and temperatures sufficient to kill the pathogens are used for sterilization. Minimum temperature,
pressure, and residence time for autoclaves for safe disinfection are specified in the Biomedical Waste Rules. Before
autoclaving, BMWs require shredding to an acceptable size which is an operation that would involve frequent
breakdown. Autoclaving produces a waste that can be land filled with municipal waste. A wastewater stream is
generated that needs to be disposed of with appropriate controls [9]. Autoclave operation requires qualified
technicians, and medium investment and operating cost. Regardless of all the benefits, autoclaving is not suitable
for human anatomical, animal, chemical, or pharmaceutical wastes. Microwaving: Application of an electromagnetic
field over the BMW provokes the liquid in the waste to oscillate and heat up, destroying the infectious components
by conduction. This technology is effective if the ultraviolet radiation reaches the waste material. Before
microwaving, BMWs require shredding to an acceptable size and humidification. Microwaving is not suitable for
human anatomical, animal, chemical, or pharmaceutical wastes, or for large metal parts. Microwaving produces a
waste that can be land filled with municipal waste. The advantages of this treatment technology are its small
electrical energy needs and no steam requirement. The disadvantages include the need for qualified technicians and
frequent breakdown of shredders. This technology requires medium investment and operating costs. Chemical
disinfection: Chemical disinfection is most suitable for treating liquid wastes such as blood, urine, stools, or health
care facility sewage. Addition of strong oxidants-like chlorine compounds, ammonium salts, aldehydes, or phenol
compounds-kills or inactivates pathogens in the BMW. However, microbiological cultures, mutilated sharps, or
shredded solids can also be treated by chemical disinfection. Disinfection efficiency depends on such factors as the
type and amount of chemical used, and the extent and duration of contact between the disinfectant and the BMW.
Deep burial: The Biomedical Waste Rules require that human anatomical and animal wastes in cities with
population less than 500,000 and in rural areas be disposed of by deep burial. Accordingly, the deep burial site should
be prepared by digging a pit or trench of about 2 meters deep in an area that is not prone to flooding or erosion, and
where the soil is relatively impermeable, there are no inhabitants or shallow wells in the vicinity, and the risk to
surface water contamination is remote. The pit should be half-filled with the BMW, and then covered with lime
within 50 cm of the surface, before filling the rest of the pit with soil. On each occasion when BMW is added to the
pit, a layer of 10 cm of soil should be added to cover the waste.
Secure land filling: Secure land filling involves disposal of solid BMWs at a landfill designed and operated to receive
hazardous wastes. The Biomedical Waste Rules require disposal of discarded medicines, cytotoxic drugs, solid
chemical wastes, and incineration ash in secured landfills. Disposing of waste in a landfill involves burying the waste,
and this remains a common practice in most countries. Landfills were often established in abandoned or unused
quarries, mining voids or borrow pits [10]. A properly designed and well-managed landfill can be a hygienic and
relatively inexpensive method of disposing of waste materials. Older, poorly designed or poorly managed landfills
can create a number of adverse environmental impacts such as wind-blown litter, attraction of vermin, and
generation of liquid leachate. Another common byproduct of landfills is gas (mostly composed of methane and carbon
dioxide), which is produced as organic waste breaks down anaerobically. This gas can create odour problems, kill
surface vegetation, and is a greenhouse gas. Design characteristics of a modern landfill include methods to contain
leachate such as clay or plastic lining material. Deposited waste is normally compacted to increase its density and
stability, and covered to prevent attracting vermin (such as mice or rats). Many landfills also have landfill gas
extraction systems installed to extract the landfill gas. Gas is pumped out of the landfill using perforated pipes and
flared off or burnt in a gas engine to generate electricity.
Waste immobilization:
Encapsulation: this involves immobilizing the 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 semi-solid pharmaceuticals, and the remaining space is filled by pouring in a
medium such as cement or cement/lime mixture, plastic foam or bituminous sand. For ease and speed of filling, the
drum lids should be cut open and bent back. Care should be taken to avoid cuts to hands when placing
pharmaceuticals in the drums. [7], Once the drums are filled to 75% capacity, the mixture of lime, cement and water
in the proportions 15:15:5 (by weight) is added and the drum filled to capacity. A larger quantity of water may be
© Odoja, 2023
This is an Open Access article distributed under the terms of the Creative Commons Attribution License
(http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.
https://www.eejournals.org Open Access
required sometimes to attain a satisfactory liquid consistency. Steel drum lids should then be bent back and sealed,
ideally by seam or spot welding. The sealed drums should be placed at the base of a landfill and covered with fresh
municipal solid waste. For ease of movement, the drums may be placed on pallets which can then be put on a pallet
transporter.
Inertization: this is a variant of encapsulation and involves removing the packaging materials, paper, cardboard and
plastic, from the pharmaceuticals. Pills need to be removed from their blister packs. The pharmaceuticals are then
ground and a mix of water, cement and lime added to form a homogenous paste. Worker protection in the form of Page | 42
protective clothing and masks is required as there may be a dust hazard [11]. The paste is then transported in the
liquid state by concrete mixer truck to a landfill and decanted into the normal urban waste. The paste then sets as a
solid mass dispersed within the municipal solid waste. The process is relatively inexpensive and can be carried out
with unsophisticated equipment. The main requirements are a grinder or road roller to crush the pharmaceuticals,
a concrete mixer, and supplies of cement, lime and water.
Sewer: Some liquid pharmaceuticals, e.g. syrups and intravenous (IV) fluids, can be diluted with water and flushed
into the sewers in small quantities over a period of time without serious public health or environmental affect. Fast
flowing watercourses may likewise be used to flush small quantities of well-diluted liquid pharmaceuticals or
antiseptics. The assistance of a hydro geologist or sanitary engineer may be required in situations where sewers are
in disrepair or have been war damaged.
Hazardous Waste Management Strategy
Waste minimization: An important method of waste management is the prevention of waste material being created,
also known as waste reduction. Methods of avoidance include reuse of secondhand products, repairing broken items
instead of buying new, designing products to be refillable or reusable, encouraging consumers to avoid using
disposable products, removing any food/liquid remains from cans, packaging, and designing products that use less
material to achieve the same purpose.
Reuse: Re-use means the use of a product on more than one occasion, either for the same purpose or for a different
purpose, without the need for reprocessing. Re-use avoids discarding a material to a waste stream when its initial
use has concluded. It is preferable that a product be re-used in the same state e.g., returnable plastic pallets, using
an empty glass jar for storing items and using second hand clothes. Reuse is normally preferable to recycling as
there isn't the same requirement for the material to have gone through a detailed treatment process thus helping to
save on energy and material usage.
Recycling: this involves the treatment or reprocessing of a discarded waste material to make it suitable for
subsequent reuse, either for its original form or for other purposes. It includes recycling of organic wastes but
excludes energy recovery. Recycling benefits the environment by reducing the use of virgin materials.
CONCLUSION/RECOMMENDATION
Pharmaceutical waste management is a challenge to the medical personnel who work in the recycling industries,
government administrations, policy planning’s, quality assurance, etc. For the effective waste management therefore,
new classification for medical wastes for their easy removal and effective technique have to be developed in a
continuous manner and it has to be ensured that these can decrease the cost of the waste management.
REFERENCES
1. Pratyusha K, Nikita M, Gaikwad AA, Phatak PD, Chaudhari. Review On: Waste Material Management
In Pharmaceutical Industry. Int. J Pharm. Sci. Rev. Res. 2012; 16(2):nᵒ 27, 121-129
2. Sreekanth K, Vishal Gupta N, Raghunandan HV, Nitin Kashyap U. A Review on Managing of
Pharmaceutical Waste in Industry. International Journal of PharmTech Research. 2014; 6(3):899 907.
3. Sharma Natasha, Agharwal Dilip, Khinchi Mahaveer G, Gupta MK, Bisht shradha. Pharmaceutical waste
management: A challenge to make environment ecofriendly. International Journal Research in Ayurveda
and Pharmacy. 2010; 1(2):332-338.
4. Ngwuluka, Ndidi C, Ochekpe Nelson A, Odumosu Patricia O. An assessment of pharmaceutical waste
management in some Nigerian pharmaceutical industries. African Journal of Biotechnology 2011;
10(54):11259-11264.
5. Waste Watch: A Model for Managing Discarded Pharmaceuticals, Health Facilities Management
Magazine, March, 2006.
6. Waste minimization opportunity assessment manual, USEPA, Hazardous Waste Engineering Research
Laboratory, Cincinnati, Ohio. EPA/625/7- 88/00, 1988.
7. A Guide on Hazardous Waste Management for Florida's Pharmacies, For Solid and Hazardous Waste
Management, 1-21.
© Odoja, 2023
This is an Open Access article distributed under the terms of the Creative Commons Attribution License
(http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.
https://www.eejournals.org Open Access
8. Government of India, Ministry of Environment and Forests Gazette notification New Delhi, 1998;
460:10-20.
9. Park K. Hospital Waste Management, Park’s Textbook of Preventive and Social Medicine, M/s
Banarasidas Bhanot Publications, New Delhi, 18th Edition, 2005, 595- 598
10. Singh VP, Biswas G, Sharma JJ, Biomedical Waste Management - An Emerging Concern in Indian
Hospitals, 2007, 1(1).
11. Sharma N. Pharmaceutical Waste Management: A Challenge to Make Environment Eco-Friendly, 2010, Page | 43
332-338.
© Odoja, 2023
This is an Open Access article distributed under the terms of the Creative Commons Attribution License
(http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.