Sources of contamination Flashcards
Name examples of non-viable contaminants
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
Name viable contaminants
Bacteria
Fungi
Viruses
Why is microbial contamination significant?
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
What can contaminated tablets cause?
Salmonella - cause infections in the gut
What can contaminated eye drops cause?
Pseudomonas eye infection
What can contaminated parenteral nutrition cause?
Bacillus cereus
What are examples of viral infections from contaminated tissues/ fluid?
HIV/HepC from infected blood products
Define sterile products
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
Define non-sterile products
Do contain microorganisms
does not effect product quality
examples, include oral, topical, rectal, vaginal initiated preps
How is contamination assessed at the end or start?
Limit risk of contamination at every stage of manufacture
Name the sources of contamination
Air
Water - raw materials
Packaging
Equipment
People
Premises
Name some common microbes in air
Spore formers - e.g. bacillus, clostridium
Non-spore formers e.g. Staphylococcus, Streptococcus
Moulds e.g. penicillium
Yeasts
How can you reduce air contamination?
Filtration (Highly efficient particulate absorbing), UV light and chemicals
Name the common microbes in water
Pseudomonas
E.coli
some gram positives - Micrococcus, Bacillus
Define mains (portable) water and what is it used for
Not sterile
Contains ions, chlorine
Initial washing if rinsed with purified water
Define purified water and what is it used for
Potable water purified by ion exchange, distillation or reverse osmosis
Not sterile - has got rid of some pathogens
Used for washing containers
Define water for infections BP and water for injections in bulk and what is that used for
Distilled water free from pyrogens
Used for final rinse
Solutions to be sterilised
What is sterile water for injections and what is its use
Autoclaved in a suitable container
Used for sterile solutions
How do we decrease bacterial growth in water storage e
Maintain water at 80 degrees
Circulate water at positive pressure
decreased pipeline - limit areas of slow flow
Use appropriate plumbing materials
Include sterilisation systems
Name the three water treatments
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
Define aW
A measure of water content in relation to how water will react with micro-organisms
Define a clean room
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
