Sources of contamination

Question 1

Name examples of non-viable contaminants

Answer 1

Non-living
Product related - e.g. raw materials, the excipient, the container
Foreign material e.g. building, machinery, clothing

Microbial products - toxins, metabolites, pyrogens e.g. LPS

Question 2

Name viable contaminants

Answer 2

Bacteria
Fungi
Viruses

Question 3

Why is microbial contamination significant?

Answer 3

Are a health hazard - contaminating organisms can cause disease
Depends on type of product and susceptibility of patient
Can also cause spoilage - therapeutic breakdowns of actives, excipients, and/or formulation
Patient compliance
Financial implications for manufacturers

Question 4

What can contaminated tablets cause?

Answer 4

Salmonella - cause infections in the gut

Question 5

What can contaminated eye drops cause?

Answer 5

Pseudomonas eye infection

Question 6

What can contaminated parenteral nutrition cause?

Answer 6

Bacillus cereus

Question 7

What are examples of viral infections from contaminated tissues/ fluid?

Answer 7

HIV/HepC from infected blood products

Question 8

Define sterile products

Answer 8

No acceptable level of contamination
Single used sterile packs and terminal sterilisation
OR by aseptic manufacture in a clean room
examples include, injectables, ophthalmic preps
Should pass sterility test and no pyrogens present

Question 9

Define non-sterile products

Answer 9

Do contain microorganisms
does not effect product quality
examples, include oral, topical, rectal, vaginal initiated preps

Question 10

How is contamination assessed at the end or start?

Answer 10

Limit risk of contamination at every stage of manufacture

Question 11

Name the sources of contamination

Answer 11

Air
Water - raw materials
Packaging
Equipment
People
Premises

Question 12

Name some common microbes in air

Answer 12

Spore formers - e.g. bacillus, clostridium
Non-spore formers e.g. Staphylococcus, Streptococcus
Moulds e.g. penicillium
Yeasts

Question 13

How can you reduce air contamination?

Answer 13

Filtration (Highly efficient particulate absorbing), UV light and chemicals

Question 14

Name the common microbes in water

Answer 14

Pseudomonas
E.coli
some gram positives - Micrococcus, Bacillus

Question 14

Define mains (portable) water and what is it used for

Answer 14

Not sterile
Contains ions, chlorine
Initial washing if rinsed with purified water

Question 15

Define purified water and what is it used for

Answer 15

Potable water purified by ion exchange, distillation or reverse osmosis
Not sterile - has got rid of some pathogens
Used for washing containers

Question 16

Define water for infections BP and water for injections in bulk and what is that used for

Answer 16

Distilled water free from pyrogens
Used for final rinse
Solutions to be sterilised

Question 17

What is sterile water for injections and what is its use

Answer 17

Autoclaved in a suitable container
Used for sterile solutions

Question 18

How do we decrease bacterial growth in water storage e

Answer 18

Maintain water at 80 degrees
Circulate water at positive pressure
decreased pipeline - limit areas of slow flow
Use appropriate plumbing materials
Include sterilisation systems

Question 19

Name the three water treatments

Answer 19

Chemical - hypochlorite, and chlorine gas
Filtration - 0.22 um pure size filter and course pre-filters
UV light - 254 nm light for disinfecting water of good optical quality

Question 20

Define aW

Answer 20

A measure of water content in relation to how water will react with micro-organisms

Question 21

Define a clean room

Answer 21

Air lock system between all the rooms can’t just walk through
Controlled environment
filtered recirculated air
Controlled temperature and humidity
Plates to check the air quality constantly