What is the definition of sterile?
Free from all living forms of life
Sterilisation is a “________” phenomenon
All-or-nothing
What sort of chemical reaction is sterilisation?
First-order
Population decreases exponentially (never reaches zero!)
What does SAL stand for?
Sterility Assurance Level
What does PNSU stand for?
Probability of a Non-Sterile Unit
What is the definition of Bioburden?
Amount of bacteria in the produce BEFORE sterilisation
What is the minimum standard for PNSU/SAL of pharmaceutical products
10^-6