Many single use medical devices are terminally sterilized by ethylene oxide or radiation methods such as gamma or e-beam. Regulatory bodies requires that the sterilization process be validated and these validations typically require a sterility testing.
Before performing a sterility test, it is necessary to verify the suitability of the method. The sterility suitability test is called bacteriostasis and fungistasis testing. It measures whether a device inhibits the growth of bacteria or fungi, which may lead to false negatives during sterility testing.
Applied standard:
Method Process:
ROUTINE STERILITY TEST
Sterility testing validation
Protocol generation and validation
Extraction
The device is physically placed in the media
Sterility PASS / FAIL