NTA Level 6 • Semester 1 • PST06103

Management of Pharmaceutical Wastes

Pharmaceutical Production • Source Session/Topic 25

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Session 25: Management of Pharmaceutical Wastes

Total Session Time: 120 minutes

Pre-requisites

• None

Learning Tasks

By the end of this session students are expected to be able to:

• Define pharmaceutical wastes

• List sources of pharmaceutical wastes

• List types of wastes in pharmaceutical production

• Explain the problems caused by pharmaceutical wastes

• Explain methods used in the disposal of pharmaceutical wastes

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

• LCD projector and computer

SESSION OVERVIEW

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (5 minutes)

READ or ASK students to read the learning tasks and clarify

ASK students if they have any questions before continuing

STEP 2: Definitions (10 minutes)

|Activity: Buzzing (5 minutes) |

| |

|ASK students to pair up and buzz on the following question for 2 |

|minutes |

| |

|What is a pharmaceutical waste? |

| |

|ALLOW few pairs to respond and let other pairs to add on points not |

|mentioned |

| |

|WRITE their response on the flip chart/board |

| |

|CLARIFY and SUMMARIZE by using the content below |

• Wastes are unwanted materials which are no longer used in the

manufacturing process that can eventually turn into hazardous or non

hazardous material to human or the environment or both

• Pharmaceutical wastes are wastes are unwanted materials resulting from

pharmaceutical production processes

• Pharmaceutical wastes are in different forms mainly as expired materials,

manufacturing wastes and others

STEP 3: Sources of Pharmaceutical Wastes (35 minutes)

|Activity: Small Group Discussion (15 minutes) |

| |

|DIVIDE students into small manageable groups |

| |

|ASK students to discuss on the following question |

|What are the sources of waste in pharmaceutical manufacturing? |

| |

|ALLOW students to discuss for 15 minutes |

| |

|ALLOW few groups to present and the rest to add points not mentioned |

| |

|CLARIFY and SUMMARIZE by using the contents below |

• Manufacturing processes

o Wastes generated during pharmaceutical production

▪ by-products from different stages of manufacturing

▪ Spillages

▪ Waste water

• Raw materials

o Unusable/expired/rejected/obsolete raw materials

o Expired/unusable/rejected active pharmaceutical ingredients

• Products

o Rejected finished products

• Packaging materials

o Unusable or damaged packaging materials

• Quality control laboratories

o Used chemical by products

o Spills

o Unused/unusable solvents, chemicals and reagents

o Waste water

• Cleaning and maintenance processes

o Cleaning substances e.g. detergents, soaps

o Waste waster

STEP 4: Types of Wastes Produced in Pharmaceutical Production and their

Problems (30 minutes)

• Pharmaceutical wastes are classified into

o Hazardous wastes

o Non-hazardous wastes

o Hazardous wastes

▪ Hazardous wastes are wastes that are dangerous or potentially

harmful to human health or environment

▪ Hazardous wastes can be liquids, solids, gases or sludges

▪ Hazardous wastes exhibit hazardous properties such as:

Ignitability

▪ Ignitibility is a property of a pharmaceutical waste to present

fire hazard under routine storage, disposal and transportation or

are capable of exacerbating a fire once it has started

▪ Ignitable wastes are easily combustible or flammable

▪ Ignitable wastes include flammable liquids and compressed gases

Corrositity

▪ Corrosive pharmaceutical wastes are wastes capable or corroding

metals or other materials or burn the skin

▪ These have a pH of 2 or lower or 12.5 or higher

Reactivity

▪ Reactive wastes are unstable under normal conditions

▪ They undergo violent changes

▪ They can cause explosions, toxic fumes, gases or vapours when

heated, compressed, or mixed with water

▪ They include glacial acetic acid, sodium hydroxide etc

Toxicity

▪ Wastes that are toxic contain toxic organic chemicals or toxic

heavy metals such as chromium, lead, mercury or cadmium

Infectivity

▪ Ability of waste to cause infection

▪ These are from microbiological laboratories or from production of

vaccines or immunological preparations

o Non-hazardous wastes

▪ Non-hazardous pharmaceutical wastes are those wastes that present

no significant hazardous properties

▪ These wastes are below the threshold of causing harm to human

health

• Problems associated with pharmaceutical wastes

|Activity: Small Group Discussion (15 minutes) |

| |

|DIVIDE students into small manageable groups |

| |

|ASK students to discuss on the following question |

|What are the problems associated with industrial pharmaceutical |

|wastes? |

| |

|ALLOW students to discuss for 15 minutes |

| |

|ALLOW few groups to present and the rest to add points not mentioned|

| |

|CLARIFY and SUMMARIZE by using the contents below |

o Environmental contamination with drug substances

▪ Fumes, dust etc.

▪ Antimicrobial resistance when antimicrobial wastes contaminate

the environment

STEP 5: Disposal of Pharmaceutical Wastes (30 minutes)

• Methods for disposal of pharmaceutical wastes;

o Incineration

▪ Incineration is an effective method for disposal of wastes

(solid, liquid and gaseous waste), in which solid organic wastes

are subjected to combustion so as to convert them into residue and

gaseous products (heat, gas, steam and ash) by use of an

incinerator

▪ Is useful for disposal of residue of both solid waste management

and solid residue from waste water management

▪ Reduces the volumes of solid waste to 20 to 30 percent of the

original volume

▪ 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 recognized as a practical method of disposing of certain

hazardous waste materials (such as biological waste)

o Deep burial

▪ Involves 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

o Secure landfill

▪ 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

▪ 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

o Waste immobilization by encapsulation

▪ Encapsulation 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

o Waste immobilization by inertization

▪ Inertization 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

▪ 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

o Sewer

▪ Some liquid pharmaceuticals, e.g. syrups and intravenous (IV)

fluids remains or unusable, 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

o Waste minimization

▪ This is a method of waste management that focuses on prevention

of waste material being created

▪ Involves reuse and recycle whenever possible

STEP 6: Key Points (5 minutes)

• Wastes are unwanted materials which are no longer used in the

manufacturing process that can eventually turn into hazardous or non

hazardous material to human or the environment or both

• Pharmaceutical wastes are in different forms mainly as expired materials,

manufacturing wastes, quality control laboratories, packaging materials,

raw materials and others

• Major classes of pharmaceutical wastes are hazardous wastes and non-

hazardous wastes

• Methods used for disposal of pharmaceutical wastes include incineration,

secure land fill and waste immobilization

STEP 7: Evaluation (5 minutes)

• What is a waste?

• Define pharmaceutical waste?

• Name sources of waste in pharmaceutical production

• What is waste immobilization?

References

Aulton M.E & Kevin M.G, (Eds): (2013) Pharmaceutics: The design and

manufacture of medicines, (4th ed.) Churchill Livingstone

Hugo and Russell (2011), Pharmaceutical Microbiology (8th ed.), Willey-

Blackwel publications

Gennaro, R. A, et al. (Eds) (1995) Remington: The Science and Practice of

Pharmacy, Volume I & II, (19th ed.): Mack Publishing Company, Easton,

Pennsylvania 18042

Liebsch, B., et al. (1988): Tanzania Pharmaceutical Handbook, Dar es Salaam

University Press.

Lund, W. Editor (1994). The Pharmaceutical Codex, Principles and Practice

of Pharmaceutics (12th ed.): The Pharmaceutical Press, London

Polderman, J., (1990) Introduction to Pharmaceutical Production: Novib, The

Hague

Rawlins E.A, Editor: (1977) Bentley’s Textbook of Pharmaceutics, (8th ed.)

Baillie're Tindall. London Kamm, G. and Kohler, B. Editors: (1995)

Manual for Decentralized Infusion Production, Infusion Unit Project

Tanzania

Schmidt, O. (ed) (2000) Pharmaceutical Quality systems, Interpharm Press,

Colorado.

Shayne C et al. (2008), Pharmaceutical Manufacturing Handbook: Production

and processes, John Wiley & Sons

Watson, D. G,. (1999) Pharmaceutical Analysis: A Textbook for Pharmacy

Students and Pharmaceutical Chemists: Churchill Livingstone,

Edinburgh.

———————–

PST 06103 Pharmaceutical Production

NTA Level 6 Semester 1

March 2019

Source: Aulton 2013

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