Pace Analytical Life Sciences (PLS) provides medical device biological indicator testing, or BI testing, for the pharmaceutical, biopharmaceutical and medical device industries.
The test, according to USP <55>, is designed to support:
- Sterilization testing
- Sterilization validation
- Sterilization monitoring
- Steam sterilization effectiveness
- Ethylene oxide (EO) sterilization effectiveness
- Sterility cycle lethality
- Lot release for compliance with testing requirements
The Testing Process
The test consists of spore strips impregnated with several organisms’ spores and then subjected to the client’s sterilization process. The biological indicators’ viability is then an indication of the sterilization process effectiveness. Since spores are especially difficult to sterilize, their absence assures the process is validated and the testing is capable of providing accurate results. The number of strips used during the testing should be based on the usable chamber volume of the sterilizer or on the product load size.
Experts Here To Help
PLS can provide guidance in meeting your medical device biological indicator testing requirements. Our analysts are well trained and qualified in this test to ensure that any chance of a false positive is kept at a minimum. Our lab personnel are experienced in handling a wide range of product types in the pharmaceutical, biopharmaceutical and medical device industries, and our expertise goes beyond the usual to the unique.
We are FDA registered, DEA registered, cGMP compliant and ISO/IEC 17025 accredited.