The invention is directed to biological processes and apparatus for determining the efficacy of a sterilization cycle based upon the recovery of activity of interactive enzyme systems comprising enzymes, coenzymes, catalysts, cofactors, substrates or any other necessary reagents. The invention provides a vital process for expediting sterility verification before utilization of the articles thought to be sterilized. The invention involves the rapid detection of any surviving interactive enzymatic activity which directly relates to the probability of any biological spores surviving in a test sample. An absence of a change indicates that the sterilization process had inactivated the enzyme system thereby preventing the interactive reaction from taking place which is a rapid equivalent to directly detecting the survivability of bacterial spores in a similar test. The methods and apparatus of the invention are useful in the health care industry such as in hospitals, laboratories, and research institutions, in food and environmental technology, and in all technologies which utilize sterilization in manufacturing, production or waste disposal.

Document Type


Primary Class


Secondary Class

206/528; 206/530; 206/534; 422/86; 422/88; 422/562; 435/4; 435/25; 435/26; 435/29; 435/287.4; 435/810; 435/832; 435/842; 435/920

Application Number


Filing Date

January 1995

Patent Number



Medical College of Ohio

Publication Date


Patent Country





The University of Toledo


University of Toledo Libraries

Digital Publisher

Digital Initiatives


These materials are free of copyright restrictions and are in the public domain within the United States only. The USPTO reserves the right to assert copyright protection internationally.



Rights Statement

Rights Statement

No Copyright - United States. URI: http://rightsstatements.org/vocab/NoC-US/1.0/
The organization that has made the Item available believes that the Item is in the Public Domain under the laws of the United States, but a determination was not made as to its copyright status under the copyright laws of other countries. The Item may not be in the Public Domain under the laws of other countries. Please refer to the organization that has made the Item available for more information.