Definition Regulatory Bodies that oversee Pharmaceutical Waste Management Type of Waste Methods of product disposal Waste product Disposal Procedure Scales of product disposal Pharmaceutical Waste Management Guidelines Records

1. Prepared By: Guided By:
Rajpurohit Ganpatsingh Mrs. Falguni Tandel
Roll No:10 Assistant Professor,
M.Pharm QA,1st sem, QA Department
PARUL INSTITUTE OF PHARMACY,LIMDA
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2. Contain
 Definition
 Regulatory Bodies that oversee Pharmaceutical Waste
Management
 Type of Waste
 Methods of product disposal
 Waste product Disposal Procedure
 Scales of product disposal
 Pharmaceutical Waste Management Guidelines
 Records
 Reference
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3. Definition
A. Scrap : Materials like rejected foils, bottles, cans,
and tins etc. Which have a resale value.
 Generated at various stages of manufacturing.
1. 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.9/15/2019 3

4. B. Trash : This material is to be discarded or disposed
by suitable means and don’t have a resale value .
E.g. dust, unsalable materials
C. Pharmaceutical waste : Pharmaceutical waste is
potentially generated thorough a wide variety of
activities.
 Health care facility
 General compounding
 Partially used vials
 Syringes, and IV preparations
 Discontinued & unused preparations
 Unused unit dose repacks
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5.  Patients personal medications and
 Outdated pharmaceuticals
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6. 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)
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7. Type of Waste
A. On the Bases of States
1. Solid
2. Liquid
3. Gaseous
B. On the base of Effect
1. Hazardous Waste
2. Bio hazardous Waste
3. Radioactive Hazardous Waste
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8. 1) Hazardous Waste
 A type of solid waste 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.
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9. Storage Requirements:
 Containers must be in good condition
 Containers must be compatible with waste
 Containers must be handled in a manner to prevent
leaks and spills
 Containers must be inspected
 Containers must be labeled “Hazardous Waste’’ and /
or list the contents of the container
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10. Characteristic of Hazardous wastes
 Characteristic wastes are regulated because they
exhibit certain hazardous properties –
a. Ignitability,
b. Corrosivity,
c. Reactivity and
d. Toxicity.
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11. a. Ignitability :
 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.
 There are several ways that a drugs formulation can
exhibit the ignitability characteristic
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12. Types of ignitability with Formulations
Ignitable properties Formulations
1) Aqueous drug formulation
containing 24% or more alcohol
and having a flashpoint of less
than 140° F or 60° C
1) Erythromycin Gel 2%
2) Taxol Injection
2) Liquid drug formulations,
other than aqueous solutions
containing less than 24 %
alcohol, with a flashpoint of less
than 140°F or 60°c.
1) Flexible collodion used as a
base in wart removers
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13. Ignitable properties Formulations
3) Oxidizers or materials that
readily supply oxygen to a
reaction in the absence of air.
1) Amyl nitrite inhalers, used
for the rapid relief of angina
pain.
2) Bulk chemicals found in the
compounding section of the
pharmacy such as potassium
permanganate
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14. b. Corrosivity :
 Any waste which has a pH of less than or equal to 2
(highly acidic) or greater than or equal to 12.5
exhibits the characteristic of corrosivity and must be
managed as a hazardous waste.
 Generation of corrosive pharmaceutical wastes is
generally limited to compounding chemicals in the
pharmacy. Compounding chemicals include strong
acids, such as glacial acetic acid and strong bases.
Such as sodium hydroxide.
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15. c. Reactivity:
 Reactive wastes are unstable under “normal’’
conditions.
 They can cause explosions, toxic fumes, gases, or
vapors when heated, compressed, or mixed with
water.
 Nitroglycerin is the only drug that is potentially
reactive.
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16. d. Toxicity
 Wastes that exceed these concentration must be
managed as hazardous waste.
 The test that determines the ability of these chemicals
and heavy metals to leach in a landfill environment is
called the toxicity characteristic leaching procedure.
 If the concentration determined the exceeds the stated
limits, the waste must be managed as hazardous
waste.
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17. 2) Bio hazardous waste
 A 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.
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18. 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
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19. 3) Radioactive waste
a. High-level nuclear waste:
Means spent reactor fuel assemblies, dismantled
nuclear reactor components, and solid and liquid
wastes from fuel reprocessing and defense- related
wastes
Does not include medical or institutional wastes,
naturally-occurring radioactive materials.
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20. b. Low-level radioactive waste:
Means waste material which contains radioactive
nuclides emitting primarily beta or gamma
radiation, or both, in concentration 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.
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21. WHO categories of health care waste
Healthcare waste Examples
1. Communal waste (solid wastes that
are not infectious, chemical, or
radioactive)
Cardboard boxes, paper, food waste,
plastic and glass bottles
2. Biomedical wastes infectious
wastes (wastes suspected of
containing pathogen)
Cultures, tissues, dressings, swabs,
and other blood soaked items; waste
from isolation wards.
3. Anatomical waste Recognizable body parts.
4.Sharps Needles, scalpels, knives, blades,
broken glass.
5.Pharmaceutical waste Expired or no longer needed
medicines or pharmaceuticals9/15/2019 21

22. Healthcare waste Examples
6.Genotoxic waste Wastes containing genotoxic drugs
and chemicals (used in cancer
therapy)
7.Chemical waste Laboratory reagents, film developer,
solvents, expired or no longer needed
disinfectants, and organic chemical
wastes.(Ex:formaldehyde,
phenolbased cleaning solutions)
8.Pressurized containers Aerosols
9.Radioactive waste Unused liquids from radiotherapy;
waste materials from patients treated
or tested with unsealed radionuclide9/15/2019 22

23. Objective of pharmaceutical waste treatment
 Destruction or recovery for reuse and /or the
conversion of these substance to harmless from that
are acceptable for uncontrolled disposal
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24. Methods of product disposal
1. High temperature incineration
2. Waste immobilization : Encapsulation
3. Waste immobilization : Inertization
4. Discharge to sewer
5. Landfill Deposit
6. Chemical Decomposition
7. Medium Temperature incineration
8. Open container incineration
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25. 1.High temperature incineration
 Incineration 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 temp between 900
and 1200 °C and be equipped with mechanisms to
remove toxic products.
 E.g. Pyrolytic incinerators, and municipal incinerators
by product removal mechanisms.
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26. 2. Waste immobilization : Encapsulation
 Encapsulation 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.
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27. 3. Waste immobilization : inertization
 Inertization is a variant of encapsulation and involves
removing the packaging materials, paper, carboard
and plastic from pharmaceutical products.
 Pharmaceutical products are ground and a mix of
water (5%), cement (15%) and lime (15%) is added to
forma homogenous paste. The paste is transported by
a concrete mixer truck to a landfill and decanted into
the normal urban waste.
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28. 4. Discharge to sewer
 Some liquid pharmaceuticals can be diluted with
water and flushed into the sewers in small quantities
without serious public health or environmental affect.
5.Landfill Deposit
 To landfill means to place waste directly into a land
disposal site without prior treatment or preparation
6.Chemical Decomposition
 Chemical inactivation is tendious 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 drugs
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29. 7. Medium Temperature Incineration
 Temperature ranges between 300-400°C.
 Used only in the absence of high temperature incinerators.
8.Open Container Incineration
 Open-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
unautorized persons from entering.
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30. Waste product Disposal Procedure
1. 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.
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31. 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 sewage :
 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.9/15/2019 31

32.  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.
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33. Ten steps :
 Identifying drugs that must be managed as
hazardous waste.
 Determining which non-regulated drugs will be
managed as hazardous waste.
 Labeling drugs to facilitate segregation of hazardous
waste.
 Preparing and maintaining hazardous waste
manifests.
 Determining their hazardous waste generation status
and what criteria are used for hazardous waste
selection.
 Scheduling regular program reviews.
 Keeping management informed.9/15/2019 33

34.  Plan for Emergencies
 Train the Employees
 Keep Records
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35. Scales of product disposal
 Large-scale Destruction
 Medium-scale Destruction
 Small-scale Destruction
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36. Pharmaceutical waste management guidelines
 This blueprint focuses primarily on three aspects of
pharmaceutical waste management:
1. Management of regulated hazardous
pharmaceutical waste.
2. Management of non-regulate hazardous
pharmaceutical waste.
3. Minimization of pharmaceutical waste.
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37. Schedule M of drug and cosmetics act, gives
guidelines in this regard:
 “The disposal of sewage and effluent from
manufacturing shall be in conformity with
requirement of environment pollution control
board’’
 All biomedical waste (Manufacturing and Handing
) Rules, 1996.
 Additional precaution shall be taken for storage and
disposal of rejected drugs. Records shall be
maintained for all disposal of waste.
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38. 4. Provision shall be made for proper and safe storage
of waste materials, awaiting disposal.
 Hazardous toxic substance and flammable
material shall be stored in suitably designed and
segregated enclosed areas in conformity with
central and state legislation.
5. The material is generally sold to scarp dealers.
 Precaution should be taken before selling there
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 should
be defaced, destroyed before sending to scrap for
storage and sale.
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39. 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.
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40. Records:
 keep it for at least 3 years for followings
o License applications(if applicable)
o Licenses(if applicable)
o Land Disposal Restriction forms
o Inspection logs
o Recycled waste shipping papers
o Emergency Response record
 Records: keep longer
o Analytical Reports
o All data used in evalution
o Training documents9/15/2019 40

41. Records: Access
o Copy must be maintained at generator site
o Must be available for inspection
o 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.
Safety precautions taken while carrying out
destruction must be included in the records.
Signature of the supernatants after completion of the
destruction in records
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42. REFERANCE:
 Willing HS, Stoker RJ, “Good Manufacturing
practices for pharmaceutical” Fourth Edition, page no:
47-48.
 Potdar AM, “Pharmaceutical Quality Assurance”
Nirali prakashan, First Edition , page no:7-8.
 Sharma PP “How to practice GMPs” Vandana
publication,Third Edition page no:634.
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