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, along with lot release for compliance with testing requirements. 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.
Pace Analytical Life Sciences can provide guidance in meeting your biological indicator testing requirements. At Pace our analysts are well trained and qualified in this test to assure any chance of a false positive is kept at a minimum. Any false positive readings in biological indicator testing require extensive retesting that Pace Analytical Life Sciences quality systems work hard to avoid. Our lab personnel are experienced in handling a wide range of product types in the pharmaceutical, biopharmaceutical and medical device industries. Biological indicator testing can be challenging with certain products due to their design or sterilization requirements. At Pace our expertise goes beyond the usual to the unique and we can offer exceptional support in biological indicator testing based on our experience.
Pace Analytical Life Sciences brings years of experience performing all types of analytical testing on many drug substances, drug products and medical devices. We bring the highest level of quality and attention to detail to our clients to assure that their biological indicator testing will be successfully executed.
We are FDA registered, DEA registered, cGMP compliant and ISO/IEC 17025 accredited.