A study on waste disposal in the pharmaceutical areas. the chapter deals with types of waste, how the waste is disposed, the procedure of waste disposale and the regulatory guidelines.

1. Ms. TENY SARA THOMAS
MOUNT ZION COLLEGE OF PHARMACEUTICAL SCIENCES AND
RESEARCH, ADOOR, KERALA
ASSISTANT PROFESSOR
B.PHARM SIXTH SEMESTER
PHARMACEUTICAL QUALITY ASSURANCE

2. Waste includes all items that people no longer have
any use for, which they either intend to get rid of
or have already discarded.
Pharmaceutical waste potentially generated
includes:-
 Expired drugs
 Patients discarded personal medications
 Contaminated garments, absorbents
 Syringes, vials, iv bags, tubings
 Waste materials containing chemotherapy drug
residues.
 Open containers of drugs that cannot be used.

3. TYPES
OF
WASTE
HAZARDOUS
NON -
HAZARDOUS
CHEMO WASTE
BIOHAZARDOUS
INERT
WASTE
RADIOHAZARDOUS

4. A) HAZARDOUS WASTE
 Potentially dangerous to human health or environment.
 Hazardous wastes can be of two types –
characteristic waste and listed waste.
 Characteristic waste – are waste which may have the
following characters :-
 Ignitability – identify waste that either present a fire
hazard under routine storage, disposal, and
transportation. E.g. Erthromycin gel.
 Corrosivity – any waste which has a pH of less than or
equal to 2 or greater than or equal to 12.5 exhibits the
characteristic of corrosivity. E.g. – glacial acetic acid
 Reactivity – waste which can cause explosion, toxic
fumes, gases when heated, compressed etc. E.g. –
nitroglycerine
 Toxicity – if the waste leaches in a landfill environment
and the determined level exceeds the stated limits

5.  Listed hazardous waste :- wastes from
common manufacturing and industrial process.
These can be of four type :- P, U, F & K.
Pharmaceuticals comes under the P and U list
 P list and U list wastes – are chemicals that are
acutely hazardous under Resource Conservation
and Recovery Act. . P listed waste are toxic and
cause death or irreversible illness at low dose.
U- listed waste are identified as toxic wastes.

6. B) NON - HAZARDOUS WASTE
 Presents significant hazardous characteristics.
 No hazardous components present.
 Pharmaceutically inert
C) BIOHAZARDOUS WASTE
 Contain pathogens of sufficient virulence and
quantity that exposure to the waste by a
susceptible host could result in an infectious
disease.
 Waste includes needles, syringes, pipettes, vials
that may have come in contact with body fluids.
 Container must be clearly labelled with
“biomedical”, “infectious waste”
 Stored in rigid plastic containers.

7. D) RADIOACTIVE WASTE
 High level nuclear waste – reactor fuel
assemblies, solid and liquid waste from fluid
reprocessing.
 Low level nuclear waste – that contains
radioactive nuclides emitting beta or gamma
radiation.
E) INERT WASTE
 Materials that do not have any therapeutic effect
but they are used for supportive nutrition. E.g.
sodium chloride solution.
 They may become mixed with other chemicals.
 Checked for hazardous properties before
disposal

8. F) CHEMO WASTE
 Classified as Trace Chemotherapy and Bulk
Chemotherapy
 Trace Chemotherapy Wastes include;-
1. gowns, gloves, wipes, associated with
routine handling, preparation and administration
of chemotherapy
2. wipes and other materials used during
cleaning and decontamination of a biological.
 Bulk Chemotherapy Waste – any
chemotherapy waste that is not deemed RCRA
empty.
E.g. any item used to clean up a chemo spill.

9. DISPOSAL
OF WASTE
INCINERATION
CHEMICAL
DISINFECTION
MICROWAVING
AUTOCLAVING
SECURE LAND
FILLING
DEEP BURIAL
IMMOBILISATION
INERTIZATION
SEWER
TREATMENT

10. 1. INCINERATION
 Solid organic waste are incinerated or burnt
to convert them into gaseous products and
a solid residue in the form of ash
 Best ways to dispose hazardous wastes
 Suitable for highly reactive chemicals like
halogens.
 Ash produced after incineration must be
disposed into a secure landfill.
 Arrangements for preventing air pollution
from the gas produced during the process.

11. 2.WASTE IMMOBILISATION -
ENCAPSULATION
 Encapsulation involves immobilising
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 by spot welding, placed
at the base of a landfill and covered with fresh
solid waste.

12. 3.WASTE IMMOBILISATION -
INERTIZATION
 Inertization 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 concrete mixer
truck to a landfill and decanted into the
normal urban waste.

13. 4. CHEMICAL DISINFECTION
 Treating waste materials with chemicals
that will inactivate the chemicals or
biological materials present in the liquid
waste.
 Effectiveness of the process depends on the
type of chemical used, its concentration,
and nature of contact between disinfectant
material and waste.

14. 5. MICROWAVING
 Includes the use of microwave radiation
and can destroy the infectious materials in
the biological waste.
 Electricity requirement is less and steam is
not needed.
 Waste materials required to be shredded
prior to microwaving in order to allow the
radiation to come into contact with the
waste material.

15. 6. AUTOCLAVING
 Saturated steam is passed through the
waste in the autoclave for a duration and at
a temperature sufficient to destroy the
pathogens.
 Commonly used for biomedical waste
disposal and waste generated from the
microbiological testing laboratory.
 After autoclaving, the waste is disposed by
land filling.
 Not best for chemical and drug product
waste.

16. 7. DEEP BURIAL
 Waste is buried in deep pits that are at least 2
metres deep.
 One must ensure that the soil is impermeable
in these areas and that there are no shallow
wells in the area to avoid the risk of water
contamination.
 Half the pit is covered with the biomedical
waste and rest is filled with lime, stopping
50cm below ground surface.
 Final layer of the pit is made up of soil to
cover the waste.
 Such burial should be done in area not prone
to flooding.

17. 8. SECURE LAND FILLING
 Waste are disposed by burying in landfills
that has been designed to contain
hazardous wastes.
 If not properly designed and operated, the
landfill may lead to liquid leaching into the
ground water, attraction of vermin etc.
 Also gas extraction systems must be
available for the removal of carbon dioxide
and methane that has produced by the
anaerobic breakdown of the waste.

18. 9. SEWER TREATMENT
 Some liquid pharmaceuticals can be diluted
with water and flushed into the sewers in
small quantities without serious public
health or environmental affect.

19. WASTE MANAGEMENT
STRATEGY
 Waste Minimization
 Reuse
 Recycling
 Energy Recovery

20. WASTE MINIMIZATION
 Prevention of waste material from being created –
waste reduction.
 There are limitations of substituting hazardous
substances with lesser hazardous substances as the
hazardous substances are of more therapeutic effect.
 Priming and flushing IV lines with saline solution.
 Maximising the use of open chemotherapy vials.
 Replacing pre-packaged unit dose liquids with patient
specific oral syringes.
 Reuse of second hand products, repairing broken items,
designing products to be refillable or reusable.
 Develop a detailed organisation’s approach to
identifying drugs that must be managed as hazardous
waste.
 Training the staff about minimizing wastage.

21. REUSE
 Use of a product on more than one occasion, either for
same or different purpose.
 Avoids discarding a material to waste stream when its
initial use has concluded.
 E.g. returnable plastic pellets
 Using empty glass jar for storing items
 Using second hand clothes.
RECYCLING
 Involves treatment or reprocessing of a discarded waste
material to make it suitable for subsequent reuse either
for its original or for other purposes.
 Recycling benefits the environment by reducing the use
of virgin materials.
 In the European Union, 13% waste is recycled.

22. ENERGY RECOVERY
 Energy content of waste products can be harnessed
directly by using them as direct combustion fuel.
 Thermal treatment ranges from using waste as a fuel
source for boilers to generate steam and electricity.
 Waste materials are heated to high temperatures with
limited oxygen availability.

23. WHO GUIDELINES
 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.
 Waste materials should not be allowed to
accumulate. It should be collected in suitable
hollow object for removal from collection
points outside the building and disposed off
safely and in a sanitary manner at regular and
frequent interval.

24. WASTE PRODUCT DISPOSAL
PROCEDURE
1. Any product requiring disposal should initially be
separated from its packaging.
2. Identify drugs that must be managed as hazardous
waste.
3. Determining which non-regulated drugs will be
managed as hazardous waste.
4. Labelling drugs to facilitate segregation of
hazardous waste.
5. Preparing and maintaining hazardous waste
manifests.
6. Determining their hazardous waste generation
status and what criteria are used for hazardous
waste selection.
7. Scheduling regular program reviews and keeping
management informed.

25. RECORDS
Keep it for at least 3 years for following:-
 License applications
 Licenses
 Land disposal restriction forms
 Inspection logs
 Recycled waste shipping papers
 Emergency response record
 Analytical reports
 All data used in evaluations
 Training documents