Biological indicator testing

Pace analytical life sciences llc offers wide range of services which includes biological indicator testing service. It provides 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 test consists of spore strips impregnated with several organisms’ spores. 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. Contact us for more information.