Patent ID: 6897059

Claim:
A sterilization indicator for testing the effectiveness of a sterilization procedure, comprising: (a) a compressible outer container having at least one opening to allow sterilant to enter the outer container during the sterilization procedure; (b) a source of an active enzyme contained within the outer container, the enzyme having an enzyme activity that is correlated with the survival of at least one test microorganism commonly used to monitor the effectiveness of a sterilization procedure, wherein the enzyme is substantially inactivated by a sterilization procedure that is lethal to the test microorganism, but wherein the enzyme may not be substantially inactivated by a sterilization procedure that is sublethal to the test microorganism; (c) a sterilant-resistant chemical associated with the source of active enzyme in such a manner that the active enzyme is more resistant to inactivation by a sterilization procedure than it would be if it were not associated with the sterilant-resistant chemical; and (d) a breakable inner container within the outer container that is impermeable to the sterilant used in the sterilization procedure and that contains a substrate, wherein the inner container is adapted so that it may be broken by compressing the outer container, to allow the substrate to react with active enzyme to form an enzyme-modified product that provides a detectable indication of the failure of a sterilization procedure.