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
How can you avoid contamination from Raw Materials?
Monitoring
Treatment
How can you avoid contamination from Water?
Monitoring
Treatment
Storage
How can you avoid contamination from Air?
Filtration
How can you avoid contamination from Buildings?
Design
Cleaning
Monitoring
How can you avoid contamination from Equipment?
Design
Cleaning
Monitoring
How can you avoid contamination from Formulation?
Preservatives
How can you avoid contamination from Product?
Monitoring
Standards
