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 uses a self - containing biological indicator with a biological indicator and media ampule located within a plastic vial . by altering the materials and / or configuration of the scbi a wide range of resistances to sterilant gas processes may be achieved .