Sources of contamination Flashcards
What are non-viable contaminants?
‘Non-living’
E.g Particulates, Microbial products (toxins, metabolites, LPS, pyrogens)
What are viable contaminants?
‘Living’
E.g Bacteria, fungi, viruses
What is the significance of microbial contamination?
It’s a health hazard
Can lead to spoilage of products
- Therapeutic breakdown of products
- May affect taste (Patient compliance)
Pseudomonas is commonly found in what?
Eye-drops (and water)
Give examples of sterile products
Injectables
Opthalmic preparations
Products applied to broken skin/mucous membranes
Give examples of non-sterile products
Topical
Oral preparations
Sterile products have to what?
Pass the sterility test
Non-sterile products have a what?
Limit for viable count
What are the limits for viable count for Oral preparations?
<10^2 Fungi
No E.coli
What are the limits for viable count for Topical preparations?
<10^2 Fungi
What are the 6 major sources of contamination?
Air Raw materials (incl water) Packaging Equipment Premises People
What are the 3 types of non-sterile water?
Potable mains water (tap)
Softened water
De-ionised water
What are the 2 types of sterile water?
Distilled water Reverse osmosis (RO) water
How can water be treated?
Chemical (Cl)
Filtration
UV-Light (254nm)
How can you avoid contamination from Personnel?
Health
Hygiene
Training
