Terminal Sterilization
Sterilization by moist heat (heating in an autoclave)
Water-wettable materials only, and aqueous formulations
Temperature, time and pressure monitored
Temperature recorder independent of the controller
Independent temperature indicator
Drain - temperature recorded from this position
Regular leak test when vacuum is part of the cycle
Material allows for removal of air and penetration of steam
All parts of the load in contact with steam
Quality of the steam - no contamination
Sterilization by moist heat (heating in an autoclave)
The method can be used for water-wettable materials only, and aqueous formulations. During sterilization, the temperature, time and pressure should be monitored. The temperature recorder should be independent of the controller. An additional independent temperature indicator can be used.
If the autoclave is fitted with a drain, then the temperature should be recorded from this position.
A regular leak test should be done when vacuum is part of the cycle
Material used to pack materials / product should allow for the removal of air and penetration of steam
All parts of the load has to come in contact with steam to ensure sterilization. You have to check that the manufacturer has procedures, specifications, and test methods to ensure that the quality of the steam used is acceptable and that it cannot be an accidental source of contamination