Dennis C Christensen

US Patent:

6653096, Nov 25, 2003

Filed:

Aug 24, 1999

Appl. No.:

09/379682

Inventors:

Dennis Christensen - San Jose CA
R. Daniel Webster - Sunnyvale CA
Harvey A. Markinson - Alameda CA

Assignee:

Process Challenge Devices - Sunnyvale CA

International Classification:

C12Q 122

US Classification:

435 31, 4352874, 4352877, 435808

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. The separation means between the two chambers is capable of being removed on demand after completion of the process thus allowing the culture medium or enzyme substrate to contact the process indicator.

US Patent:

20130230910, Sep 5, 2013

Filed:

Mar 4, 2013

Appl. No.:

13/783844

Inventors:

Dennis E. Christensen - Sunnyvale CA, US
R. Daniel Webster - Sunnyvale CA, US

Assignee:

Process Challenge Devices, LLC. - Sunnyvale CA

International Classification:

C12Q 1/22

US Classification:

4352874, 29592, 294262

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.

US Patent:

59424087, Aug 24, 1999

Filed:

Jul 3, 1997

Appl. No.:

8/887753

Inventors:

Dennis E. Christensen - Hayward CA
R. Daniel Webster - Sunnyvale CA
Harvey A. Markinson - Alameda CA

International Classification:

C12Q 122

US Classification:

435 31

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.