what is sterility assurance level
- probability of one viable microorganism in a certain number of drug products
** -1 log: probability of finding 1 microorganism out of 10 loads of single containers = 10^1
** - 2log: probability of finding 2….. = 10^2
** usually 10^6
what is positive control for suitability test
how much microbe can grow without preservative
what is negative control for suitability test
nothing can grow.
what is the point of growth promotion test
1) ensure growth medium allows microorganism to duplicate/grow
2) ensure medium produce consistent results
what to do before growth promotion test
each medium incubated & assessed for sterility
endotoxin test
1) endotoxin limit concentration (ELC) = max endotoxin dose / max recommended dose
2) max valid dilution (MVD) = ELC / method sensitivity
requirement for sterile product
1) no microorganism
2) endotoxin inside limit
3) no detectable particles
what is the point of aseptic process stimulation
validate aseptic process using microbiological growth medium as substitute for product & employing method that closely approximate those used during drug product process
how does aseptic process stimulation work
- basically just to test every component of sterilisation process
- if test once and approved but change something afterwards = redo process again
what can you use aseptic filtration for
- thermolabile objects
- remove bacteria/mould
- remove protein based products that cannot withstand heat
what is the point of aseptic filtration
remove pyrogens
what can you not use aseptic filtration for
viruses/mycoplasma
lyophilization (freeze drying) - most commonly used for what products
vaccines
lyophilization (freeze drying) - tldr of process
1) quick freezing
2) primary drying (sublimation)
- dry w heat under vacuum + remove aq vapour
- end point = when temperature of sample start rising
3) secondary drying (desorption)
- under vacuum to ensure ice X melt but go from solid to gas
- end point = when water content < 1%
- stoppper vials in low humidity to maintain product stability
what is lypophilisation used for
CHATGPT SAYS its for preservation of sterility
