Process challenge device and method

Abstract

A process challenge device tailored to mimic the resistance of a particular product to a particular biological inactivation, disinfection, or sterilization process, and used to challenge the process, thus providing a means to validate the efficacy of the process. The process challenge device is used by subjecting the device containing indicator organisms to an inactivation or sterilization process, and culturing any surviving indicator organisms as a means to assess the efficacy of procedures for the inactivation of microorganisms. The device includes a biological indicator organism stored on a carrier substrate enclosed within a chamber formed by a barrier film material. The specific indicator organism and carrier substrate are chosen for their appropriateness for a given process. The materials comprising the barrier film material of the process challenge device are chosen for the materials' specific resistance to the given process. The process challenge device may also comprise a separate second chamber filled with an appropriate culture medium that is separated from the chamber containing the biological indicator by a separation means, such as a valve, a clip, or a frangible separation. The separation means between the two chambers is capable of being removed on demand after completion of the process thus allowing the culture medium to contact the biological indicator. This initiates the beginning of the culture phase which confirms non-survivability of the organism population and thus process efficacy. The incorporation of the culture medium into the device permits a level of convenience to the user not available in prior art inventions.