Biologically relevant methods for the rapid determination of sterility

Abstract

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.