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 uses a self-containing biological indicator (SCBI) 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.
Type:
Application
Filed:
March 4, 2013
Publication date:
September 5, 2013
Applicant:
Process Challenge Devices, LLC.
Inventors:
Dennis E. Christensen, R. Daniel Webster
Abstract: A process challenge device tailored to mimic the resistance of a particular product-package combination to a particular biological inactivation, disinfection, or sterilization process. The device is used to challenge the process, thus providing a means to validate the efficacy of the process. In one embodiment, the process indicator includes a biological indicator organism stored on a carrier 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 or enzyme substrate that is separated from the chamber containing the process indicator by a separation means, such as a valve, a clip, or a frangible separation.
Type:
Grant
Filed:
August 24, 1999
Date of Patent:
November 25, 2003
Assignee:
Process Challenge Devices
Inventors:
Dennis Christensen, R. Daniel Webster, Harvey A. Markinson