Current scenario of pharmaceutical waste management in bangladesh

Pharmaceutical waste management
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Pharmaceutical
Waste
Management
by
Md. Monirul Islam
Pharmacy Discipline
Khulna University
Bangladesh

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1. Introduction
Pharmaceutical products are used in human and veterinary medicine and are a class of
emerging environmental contaminants. These are natural or synthetic chemicals designed to
have a specific mode of action. Worldwide detection of waste pharmaceuticals in the
environment causes risks associated with their introduction into wildlife habitats and is
becoming a serious issue for both regulators and the pharmaceutical industry (Kumari Shalini
et al., 2010)
The discovery of a variety of pharmaceuticals in surface, ground, and drinking waters around
the country is raising concerns about the potentially adverse environmental consequences of
these contaminants. The consistent increase in the use of potent pharmaceuticals, driven by
both drug development and our aging population, is creating a corresponding increase in the
amount of pharmaceutical waste generated.
Water pollution creates serious health hazard for Bangladesh. The dumping of municipal
wastes, hospital wastes and toxic environmental discharges from mostly industries pollute
both surface and ground water sources. The mostly contributing industries for water pollution
are pulp and paper, pharmaceuticals, metal processing, food industry, fertilizer, pesticides,
dyeing and painting, textile, tannery etc. More than 200 rivers of Bangladesh directly or
indirectly receive a large quantity of untreated industrial wastes and effluent. Pharmaceuticals
industry causes water pollution 15.9% per year (Islam Faisal, 2002).
In developed countries people are much more aware about pharmaceutical waste
management. They have adopted many techniques to manage this waste for reducing the
detrimental effect on environment and on human health. In Bangladesh some work has been
done on hospital waste disposal system. But the waste generated by the pharmaceutical
industries the most developed sector in Bangladesh is not in bigger concern.
2. Pharmaceutical Waste
Pharmaceutical waste is a form of medical waste that includes unused medications, over-the-
counter personal care products, and sometimes accessories such as sharps, used test strips,
and other supplies. It is a cause for concern because it poses a threat to human and

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environmental health. Because of the dangers, pharmaceutical waste cannot be disposed of
like conventional waste and requires special handling, whether it comes from a hospital,
clinic, pharmacy, or private household. Other types of medical waste include biohazardous
waste and radiation waste.
Fig: Pharmaceutical wastes
Commercial Pharmaceutical Waste includes pharmaceutical waste from facilities such as
hospitals, pharmacies, convalescent homes, and other institutions. Some pharmaceutical
waste is regulated as hazardous waste. It is the responsibility of the generator to properly
classify their waste as either hazardous waste or non-regulated solid waste
3. Pharmaceutical Waste Classifications
Wastes should be categorized as follows and it is recommended to collect (Charlotte A. 2002)
General waste (e.g. paper, obsolete documents, wrapper, cards, boxes, cartons etc.)
General waste is any waste not classified as being within any of the categories of the clinical
and related waste streams. General waste represents the significant majority of all health
industry wastes. As it is much more economical to dispose of general wastes than of clinical
and related wastes, appropriate segregation practices should be maintained.
Sharps (e.g. e.g. broken glass, needle, blade etc.)
Sharps are discarded objects or devices capable of cutting or penetrating the skin, eg
hypodermic needles, intravenous sets (‘spikes’), Pasteur pipettes, broken glass, and scalpel
blades. Various hard plastic items, such as intact amniotic membrane perforators and broken
plastic pipettes, also contribute to sharps.

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Plastic waste (e.g. infusion bag, polybags, container/drum etc.)
Pharmaceutical waste (Miscellaneous Pharmaceutical products and substances e.g.,
disposed raw materials, intermediate & finished products etc.)
There are many chemical and/or pharmaceutical compounds used in research or in the
treatment of diseases that are also considered to be hazardous wastes when disposed of.
Pharmaceutical waste include-
● Rejected/expired raw & packaging materials
● Spills of raw materials
● Waste generate during manufacturing /processing
● Rejected/ expired/ damaged intermediate and finished drug product etc.
● Hazardous waste ( e.g. solid, liquid, acid- base waste, HPLC waste, organic & inorganic
waste, Karl Fisher waste etc.)
● Biological waste (e.g. Live bacteria/ fungus, culture media, contaminated materials etc.)
4. Nature of Pharmaceutical Waste
The properties that make pharmaceuticals useful are the same properties that make them
hazardous. Pharmaceutical companies invest billions of dollars every year to develop
substances able to affect human metabolism at very low concentrations. This potency does
not change when a material enters the waste stream.
Some pharmaceuticals must be extremely toxic in order to function. Antineoplastic agents
(the type of drug most often used in chemotherapy), for example, are designed to kill dividing
cells. Some radioactive compounds are used for the same purpose.
A few drugs have other properties, unrelated to their intended action that makes them
hazardous. Nitroglycerin, for example, which causes blood vessels to dilate and can be used
to treat chest pain, is also well known for its explosive properties.

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A relevant property of pharmaceuticals unrelated to their function is their water solubility. In
order to administer drugs in liquid form, those that are not sufficiently soluble in water must
be dissolved in some kind of solvent, generally an alcohol-water mixture. This can pose a
flammability hazard.
Pharmaceutical waste is a small fraction of urban municipal waste. There should be a greater
consensus on how much of the waste generated is actually infectious or hazardous. Infectious
or hazardous pharmaceutical waste represents only a small part of total pharmaceutical waste;
yet, because of ethical questions and potential health risks, it is a focal point of public
interest. Most hazardous and toxic waste is coming from clinical and hospital. Only a small
amount is from domestic or industrial sources. According to World Health Organization
(WHO) (BAN & HCWH, 1999) approximately 85% or hospital wastes are actually non-
hazardous, 10% are infectious, and around 5% are non-infectious but hazardous.
5. Potential impacts (risks) associated with Pharmaceutical Waste
Pharmaceuticals in the waste stream can pose several different types of risk. The most
straightforward is that the active ingredients in a discarded drug could act on an unintended
target. But other ingredients in pharmaceutical formulations can present hazards:
Preservatives and other ingredients can pose a toxicity hazard over and above the
effect of the main active ingredient
Some common solvents can pose a fire hazard (ignitability)
A few compounding agents are corrosive, including strong acids with pH less than 2
(such as glacial acetic and carbolic acids) and strong bases with pH greater than 12.5
(such as sodium hydroxide)
Some compounds are radioactive, including certain chemotherapy drugs, and certain
agents that are used as tracers or markers.
Risks from pharmaceuticals in healthcare facilities generally cannot be eliminated by finding
substitute materials, since the risk is often inherent in the function. But the risks can be
minimized and managed.

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6. Type of waste material found from different pharmaceutical industries
From Production floor and Quality Control Lab:
Inorganic solvent
Organic solvent
Halogenated organic solvent
Non halogenated organic solvent
Solid waste/tested sample:
Unused and rejected / expired reagent test samples (e.g. ampoules, vials,
LVP bags, tablets,, capsules, dry suspensions, oral liquids, cream, ointments, gel,
mouthwash, nasal preparation, eye / ear drops Shampoo, and powder for raw / blend
/intermediate / finished stage.)
Packaging wastes: carton, leaflet, label, papers, spoon, cup, rubber, stopper, dropper,
aluminum tube aluminum foil PVC /PVDC etc.
Liquid waste: general washing discharge, used inorganic and organic solvents, HPLC
waste e.g. mobile phase, Karl fisher waste.
Type of waste from Microbiology Lab:
solid waste / tested samples:
Unused and rejected / expired reagents and test sample (e.g. ampoules, vials,
LVP bags, tablets,, capsules, dry suspensions, oral liquids, cream, ointments, gel,
mouthwash, nasal preparation, eye / ear drops Shampoo, and powder for raw / blend
/intermediate / finished stage)etc. used culture media, gloves, centrifuge tubes, culture
bottles, pipette tip, cotton, swabs, Sharps, (needles, syringe, slide broken glass etc.)
biological / Microbiological laboratory waste.

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7. Pharmaceutical waste management
The flow chart of waste management in pharmaceutical industry is given bel
Figure : Flow chart of waste management
7.1 Treatment and Disposal Methods of Solid Pharmaceutical Waste
There is not much treatment of solid pharmaceutical waste. Most of the time solid waste is
disposed of. Separation and reprocessing of some of the solid waste are also done for
recycling purpose. Incineration and land filling of pharmaceutical solid waste is most
common.
The safe and reliable long-term disposal of solid pharmaceutical waste residues is an
important component of integrated waste management. Solid waste residues generated by
pharmaceutical industry:
 components that are not recycled,
 Residues that remain after processing at a material recovery facility, or
 that remain after the recovery of conversion products and/or energy

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7.1.1 Autoclaving
Autoclaving involves the heating of infectious waste by steam under pressure. The
effectiveness of autoclaving depends on the temperature, pressure, exposure time and the
ability of steam to penetrate the container. Confirmation that the required temperature has
been reached is imperative (Clark, 1989).
Autoclaving are used for the bulk of clinical and related wastes. Care must be taken to
exclude body parts, pharmaceuticals, including cytotoxics, and radioactive wastes.
Autoclaved wastes are disposed of by landfill.
7.1.2 Incineration
Incineration is a term used commonly to describe all systems of burning, although only one
standard is considered to be effective. Combustible waste are incinerated provided that an
appropriate incinerator is used. Incinerator residues are generally disposed of in landfills.
Incineration is one of the best techniques for treating hazardous waste because:
 It can be used to recover heat energy
 Use as volume reduction method
 Use for preheating combustion air
 Detoxification of toxic material can be done by destroying the organic
molecular structure through oxidation or thermal degradation
 Long-term cost of land disposal is likely to be greater than the short-term cost
of incineration.
7.1.3 Landfill
Landfills are physical facilities used for the disposal of residual solid wastes in the surface
soils of the earth.. Solid pharmaceutical waste usually incinerated but in some places most of
the solid Pharmaceutical waste is landfilled. Where pharmaceutical and related wastes are
disposed of by landfill, the sites are confirmed as suitable.

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7.2 Treatment of waste water
Wastewater pollution is the main issue of pharmaceutical sector. In pharmaceutical industries
wastewater is mainly generated through the washing activities of the equipment. Though the
wastewater discharged is small in volume, is highly polluted because of presence of
substantial amounts of organic pollutants (Overcash, 1986).
Hence Effluent Treatment Plants or ETPs are used by leading companies in the
pharmaceutical and chemical industry to purify water and remove any toxic and noneffluent-
treatment-plant toxic materials or chemicals from it. These plants are used by all companies
for environment protection.
Figure : Process flow diagram for Effluent Treatment Plant
The effluent treatment plant consists of primary(Chemical treatment), secondary(Biological
treatment) & tertiary(Filtration) treatments which comprises of screening chambers, oil and
grease trap, equalization tank-1, flush mixer, primary settling tank, equalization tank-2
secondary settling tank neutralization tank primary clarifier (PC), MBBR-1, secondary
clarifier, MBBR-2, secondary clarifier-2, pressured sand filter, and activated carbon filter.

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7.3 TestingMethod
Waste water sample collected from the ETP are tested according to standard testing
procedure. The testing procedure of physicochemical parameters which are tested are
described here.
7.3.1 Testing procedure for pH:
Principle:
pH is the usual means of expressing the hydrogen-ion concentration of water. It is defined as
the negative logarithm of the hydrogen ion concentration.
pH = - log 10 [H+]
Procedure:
1. Calibrate the pH meter with the buffer solutions of 10, 7 & 4 as per the Guidelines of
pH meter.
2. Dip the pH electrode in the sample.
3. Note the pH reading.
7.3.2 Testing procedure for Total DissolvedSolid (TDS)
Principle:
Total dissolve solids are determined as the residue left after evaporation of the filtered
sample.
Procedure:
Weigh 100 ml silica dish (D) Filter the sample through filter paper and take 50 ml in silica
dish. Evaporate The sample at 80 – 100 deg C. Take the final weight after cooling in a
desiccator. (E)
Calculation:
TDS (mg/l) =
(E−D) x 106
ml of sample

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7.3.3 Testing procedure for Chemical Oxygen Demand (COD)
Principle:
The Chemical Oxygen Demand (COD) provides a measure of the oxygen to that portion of
the organic matter in a sample that is susceptible to oxidation by a strong chemical oxidant.
Most types of organic matter are destroyed by boiling with a mixture of dichromate and
sulfuric acid. A sample is refluxed with known amount of potassium dichromate and
sulphuric acid and the excess dichromate is titrated with ferrous ammonium sulphate. The
amount of oxidisable organic matter, measured as oxygen equivalent is proportional to the
dichromate consumed.
Procedure:
1. Place 0.4 gms of HgSO4 in refluxing flask. Dissolve it in 5 ml H2SO4 reagent. To
that add 20ml of sample or suitable portion diluted to 20 ml by addition of D/W.
2. Add 10ml std.K2Cr2O7 solution in flask.
3. Slowly add 25ml acid reagent in the flask & add some glass beads.
4. Connect flask to condenser & reflux for 2 hours at above 1000 C temp.
Disconnect condenser and dilute mixture to about 150 ml with distilled water.
5. Cool to room temperature and titrate with FAS using 3-4 drops of Ferroi as
indicator. Take end point the sharp colour change from blue green to reddish brown.
6. Reflux in the same manner a blank consisting of 20ml distilled water together
with reagents.
Calculation:
COD mg/l =
(a−b) x N x 8000
ml sample taken
a = ml of Fe (NH4)2 (SO4)2 used for blank
b = ml of Fe (NH4)2 (SO4)2 for sample
N = Normality of FAS.

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7.3.4 Testing procedure for Total Suspended Solid (TSS)
Principle:
TSS of a water sample is determined by pouring a carefully measured volume of water
through a pre-weighed filter of a specified pore size, then weighing the filter again after
drying to remove all water. The gain in weight is a dry weight measure of the particulates
present in the water sample expressed in units derived or calculated from the volume of water
filtered (typically milligrams per litre or mg/l or ppm)
Procedure:
1. Initially weigh the filter paper after drying it for some time.
2. Take 50 ml of the effluent sample whose suspended solids are to be determined in
a measuring cylinder.
3. Filter the effluent sample through the man Filter Paper; allow the water to drain
through the filter paper. Once the sample is filtered, dry the filter paper in oven at around 105
– 108 deg C till drying.
4. After drying, cool the filter paper in dessicator and take the final weight.
Calculation:
TSS in mg/l =
(A – B) x 1000000
ml sample taken
A = Final weight of the filter paper in gms.
B = Initial weight of the filter paper in gms.
.7.3.5 Testing procedure for DissolvedOxygen (DO)
Principle:
The Dissolved Oxygen can be defined as the Oxygen which is dissolved in water, it is
required to the aquatic life for their survival.

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Methods of determination of DissolvedOxygen
1. Collect treated water sample in 300 ml BOD bottle.
2. Add 1 ml each of Manganous Sulfate and Azide –Iodide
3. Stopper and mix by inverting the bottle.
4. When the precipitate settle down, repeat the shaking.
5. after complete settling remove stopper and add 1 ml H2SO4
6. Re-stopper and mix well.
7. The precipitate will get dissolved & colour will change to yellow –orange.
8. Titrate 200 ml of above solution against Na2S2O3 (0.025N) using starch as
indicator.
9. Note the burette reading End point is blue to colorless
Calculation:
DO , mg/l = Burette Reading of Na2S2O3
8. Waste management strategy
All generators of pharmaceuticals and related wastes are responsible for the safe transport
and disposal of these wastes in an environmentally sound manner that minimizes risk to the
community and staff involved in its management.
An organization’s strategy and implementation plan will depend on its location, size,
specialty and access to disposal services. Even within one organization different procedures
may be necessary to cope with the varying volume of waste generated in particular areas.
Nevertheless, procedures should be uniform, wherever possible, within and between
organizations. This will reduce the possibility of confusion and possible accidents when staff
moves between services.

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The strategy should:
Clearly outline management commitment to the principles of responsible waste
management;
Clearly outline management commitment in terms of resource allocation;
Highlight the accountabilities and responsibilities of management, staff and contractors;
Clearly define the various categories of the waste stream;
Clearly articulate appropriate disposal procedures; and
Provide adequate and on-going education.
9. Conclusion
Environmental degradation is an escalating problem owing to the continual expansion of
industrial production and high-levels of consumption. A renewed dedication to a proven
strategy to resolve this problem is needed. Green Productivity (GP) is one such strategy for
enhancing productivity and environmental performance for overall socio-economic
development. It is the application of appropriate productivity and environmental management
tools, techniques, technologies to reduce the environmental impact of organization’s
activities, goods and services. However, further study is required to reveal the overall real
condition of how much this sector polluting our environment and how we can get rid of from
this worst situation.

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10. References
1. Brunner C. Looking at incineration Waste Management and Environment. 1993; 31–34.
2. Bertino JS. Waste generation of drug product sample versus prescriptions obtained
through pharmacy dispensing. Pharmacotherapy. 2000; 20(5):593–598.
3. Clark R. ‘Infectious waste: a survey of handling practices in Lincoln, Nebraska’, Journal
of Environmental Health, 1989; 51(4); 206–208.
4. Clark County (Washington). Clark County and Partners Launch New Program for Safe
Disposal of unwanted or Outdated Medicine, 2003; 34-39.
5. Daughton, C. G., "Cradle-to-cradle stewardship of drugs for minimizing their
environmental disposition while promoting human health. I. Rationale for and avenues
toward a green pharmacy." Environmental Health Perspectives, 2003; 754-774.
6. Daughton. “Pharmaceuticals and Personal Care Products in the Environment: Agents of
Subtle Change?” Environmental Health Perspectives , 1999; 107(5):907-938.
7. Green S. Sewer disposal of pharmaceutical waste. Tri-Tac, 2003; 03–07.
8. Heberer T. Occurrence, fate, and removal of pharmaceutical residues in the aquatic
environment:a review of recent research data. Toxicol Lett, 2002;131(1–2):05–17.
9. Kuspis DA. What happens to expired medications? A survey of community medication
disposal.Vet Hum Toxicol, 1996;38(1):48–49.

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