Sterility

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. 

Sterility and sterility suitability tests are part of our scope of accreditation

Applied standard:

  • ISO 11737
  • USP<71>

Method Process:

ROUTINE STERILITY TEST


Sterility testing validation

Protocol generation and validation

  • Bactericidal & fungicidal effect

Extraction

The device is physically placed in the media

Test method

14 days

Results

Sterility PASS / FAIL