Rapid method for determining efficacy of a sterilization cycle and rapid read-out biological indicator
First Claim
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1. A method for rapidly determining the effectiveness of a sterilization cycle, comprising the steps of:
- a) subjecting to said sterilization cycle of a source of active enzyme which provides a detectable amount of said enzyme, said enzyme having sufficient activity following a sterilization cycle which is sublethal to at least one test microorganism commonly used to monitor sterilization, to react with an effective amount of a substrate system for said enzyme to produce a detectable enzyme-modified product within less than twenty-four hours, yet said enzyme having activity which is reduced to "background" following a sterilization cycle which is lethal to said test microorganism;
b) incubating said enzyme, following the completion of said sterilization cycle, with an effective amount of an enzyme substrate system capable of reacting with any residual active enzyme to produce a detectable enzyme-modified product, for a time period and under conditions sufficient to promote reaction of any enzyme remaining active with said substrate.
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Abstract
A rapid method of determining the efficacy of a sterilization cycle, and an indicator adapted to perform such method, comprising subjecting to the sterilization cycle a source of active enzyme having activity which correlates with the viability of a microorganism commonly used to monitor sterilization, and incubating the enzyme source, following the completion of the sterilization cycle, with an effective amount of a substrate system capable of reacting with any residual active enzyme to produce a detectable enzyme-modified product.
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Citations
25 Claims
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1. A method for rapidly determining the effectiveness of a sterilization cycle, comprising the steps of:
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a) subjecting to said sterilization cycle of a source of active enzyme which provides a detectable amount of said enzyme, said enzyme having sufficient activity following a sterilization cycle which is sublethal to at least one test microorganism commonly used to monitor sterilization, to react with an effective amount of a substrate system for said enzyme to produce a detectable enzyme-modified product within less than twenty-four hours, yet said enzyme having activity which is reduced to "background" following a sterilization cycle which is lethal to said test microorganism; b) incubating said enzyme, following the completion of said sterilization cycle, with an effective amount of an enzyme substrate system capable of reacting with any residual active enzyme to produce a detectable enzyme-modified product, for a time period and under conditions sufficient to promote reaction of any enzyme remaining active with said substrate. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25)
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Specification