Introduction Flashcards
1
Q
What is the definition of sterile?
A
Free from all living forms of life
2
Q
Sterilisation is a “________” phenomenon
A
All-or-nothing
3
Q
What sort of chemical reaction is sterilisation?
A
First-order
Population decreases exponentially (never reaches zero!)
4
Q
What does SAL stand for?
A
Sterility Assurance Level
5
Q
What does PNSU stand for?
A
Probability of a Non-Sterile Unit
6
Q
What is the definition of Bioburden?
A
Amount of bacteria in the produce BEFORE sterilisation
7
Q
What is the minimum standard for PNSU/SAL of pharmaceutical products
A
10^-6
