IC9 Flashcards
State 2 sterility tests
- Membrane filtration sterility test
- Direct inoculation sterility test
Size of membrane filter used for membrane filtration sterility test
0.45 μm membrane filter
What does D-value measure?
Time required to reduce bacterial population to 90% or log 10
Significance of D-value
To allow direct comparison of heat resistance btw microorganisms
Parameters for moist heat sterilisation
Steam, pressure, time, temperature (121 to 136 degC)
How does moist heat destroy microorganisms?
Irreversible coagulation; Denatures structural proteins and enzymes
2 basic types of dry-heat sterilisers
- Static-air type
- Forced-air type
Which sterilisation method has the ability to destroy pyrogens?
Dry heat sterilisation
Difference btw endotoxin vs non-endotoxin pyrogen
Endoxin: from gram neg bacteria
Non-endotoxin: from gram pos bacteria/ virus/ yeast/ fungi
Animal-based method & In-vitro method for detection of broad range of pyrogens
Rabbit pyrogen test; Monocyte activation test (MAT)
Animal-based method & In-vitro method for detection of endotoxins only
Bacterial endotoxin test; recombinant factor c (rFC)
Chemicals that can be used for chemical sterilisation
Ethylene oxide, formaldehyde, peracetic acid, hydrogen peroxide
Chemical sterilisation: What is peracetic acid combined with?
Anti-corrosive agent e.g. sulfonate
Gamma radiation: Advantages and disadvantages
(+) Containers and packaging may remain intact
(-) Not good for some heat sensitive products
(-) Not useful for aqueous product containing proteinaceous component e.g. vaccine
(-) Possible oxidation, delamination and cracking in polyethylene
Gamma radiation: Process
Sterilisation by ionising radiation, mainly by cobalt 60 or cesium 137 or electron accelerators
