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.
ROUTINE STERILITY TEST
Sterility testing validation
Protocol generation and validation
The device is physically placed in the media
Sterility PASS / FAIL