STERILIZATION INDICATORS INCLUDING A NEUTRALIZER AND METHODS

摘要

Sterilization indicators that include a neutralizer, such indicators useful for testing the effectiveness of a sterilization procedure by measuring the activity of an active enzyme whose activity is correlated with the survival of microorganisms.

主权项

1. A method for testing the effectiveness of a sterilization procedure, the method comprising:
providing a sterilization indicator comprising:
a carrier;biological material comprising a source of an active enzyme, wherein the source of active enzyme is supported by the carrier; wherein the active enzyme has 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 source of an active enzyme is inactivated by a sterilization procedure that is lethal to the test microorganism, but wherein the source of an active enzyme is not inactivated by a sterilization procedure that is sublethal to the test microorganism;wherein one or more components of the sterilization indicator retains residual oxidizing sterilant;a neutralizer disposed within the indicator in an amount effective to neutralize residual oxidizing sterilant, wherein the neutralizer is not an enzyme and not a metal catalyst; andan enzyme substrate that reacts with the active enzyme to form an enzyme-modified product, which has a detectable signal, upon failure of a sterilization procedure; subjecting the source of active enzyme to a sterilization procedure; combining the enzyme and the substrate to form an enzyme-modified product; determining whether the enzyme-modified product, which has a detectable signal, is present or absent; and correlating the presence of the detectable signal with failure of the sterilization procedure and the absence of the detectable signal with success of the sterilization procedure.