Sterilisation processes and survival of bacteria

Question 1

What is the definition of ‘Pharmaceutical Sterilisation’?

Answer 1

Sterilisation is a process of killing or removing micro-organisms

By physical or chemical means or by filtration.

Question 2

What are the 5 Sterilisation processes listed in the European Pharmacopoeia?

Answer 2

Steam (Moist-heat) Sterilisation
Dry Heat
Ionising radiation
Gaseous sterilisation
Filtration

Question 3

What is the test organism for Moist heat?

Answer 3

Bacillus stearothermophilus

Question 4

What is the test organism for Dry heat and Gas?

Answer 4

Bacillus Subtilis

Question 5

What is the test organism for Radiation?

Answer 5

Bacillus Pumilus

Question 6

What is the test organism for Filtration?

Answer 6

Brevundimona Diminuta

Question 7

Moist heat sterilisation

Answer 7

Involves steam
Very effective
Widespread application

Question 8

Dry heat sterilisation

Answer 8

Less effective than moist heat

Question 9

Radiation

Answer 9

Normally used for heat-sensitive products

Mainly for articles in the dried state

Question 10

Gaseous sterilisation

Answer 10

Uses ethylene oxide or formaldehyde

Only used for heat sensitive items (not same SAL as heat)

Question 11

Filtration

Answer 11

0.2-0.22um filters used
The only process that removes microorganisms
Also used for the removal of particulates (both gas and liquid)

Question 12

What factors influence the choice of sterilisation process?

Answer 12

Stability and nature of product
Scale of production
Type and level of contamination
Cost