Terminal Sterilization
Sterilization by dry heat
For non-aqueous liquids, dry powders
Air circulation in the chamber
Positive pressure in chamber to prevent entry of non-sterile air
HEPA filtered air supplied
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When removing pyrogens, challenge tests
- validation (using endotoxins)
Sterilization by dry heat
This method is used mainly for non-aqueous liquids and dry powders. Air is circulated in the chamber and there should be a positive pressure in chamber to prevent entry of non-sterile air.
The air should be filtered through a HEPA filter
When removing pyrogens (e.g. sterilization and depyrogenation of glass ampoules), challenge tests have to be done. The validation includes the use of endotoxins.