Indicator systems for determination of sterilization
First Claim
1. A test indicator for determining the effectiveness of a sterilization procedure comprising:
- a container having at least one opening communicating with an interior chamber containing biological material to be used as an indicator of destruction of living organisms by the sterilization procedure;
a cap that provides direct access to the biological material, wherein the cap is positioned on the at least one opening such that movement of gas between the environment surrounding the test indicator and the interior chamber occurs through the cap.
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Accused Products
Abstract
This invention relates to a container and method for detecting a specific environmental parameter or combination of parameters, or for determining the effectiveness of a sterilization procedure. The invention relates to test indicators containing controlled volumes of compressed, gas-permeable materials, and modified caps comprising one or more apertures, sterilant permeable inserts, protruding members, or a combination thereof, and to methods for using test indicators for determining the efficacy of different types of sterilization processes. If proper sterilization conditions are not met, the interactive enzyme system remains active, and a color product forms upon the addition of the remaining components of the enzyme system. If the proper sterilization conditions are met, the sterilant destroys the interactive enzymes and no color product is formed. Inactivation of the enzyme system parallels the inactivation of bacterial spores subjected to the sterilization process. Results are available in from a few seconds to a few hours. The test indicator can also be placed into a container with material such that the design simulates an environmental parameter test of the sterilization process.
24 Citations
31 Claims
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1. A test indicator for determining the effectiveness of a sterilization procedure comprising:
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a container having at least one opening communicating with an interior chamber containing biological material to be used as an indicator of destruction of living organisms by the sterilization procedure;
a cap that provides direct access to the biological material, wherein the cap is positioned on the at least one opening such that movement of gas between the environment surrounding the test indicator and the interior chamber occurs through the cap. - 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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26. A self-contained test indicator for determining the effectiveness, of a sterilization procedure comprising:
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a container having at least one opening communicating with an interior chamber containing biological material to be used as an indicator of destruction of living organisms by the sterilization procedure;
a cap that provides access to the biological material, wherein the cap is positioned on the at least one opening such that movement of gas between the environment surrounding the test indicator and the interior chamber occurs through the cap, and a vessel that contains an indicator solution. - View Dependent Claims (27, 28, 29)
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30. A method for determining the effectiveness of a sterilization procedure comprising:
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exposing a test indicator having at least one opening communicating with an interior chamber containing biological material to be used as an indicator of destruction of living organisms by the sterilization procedure;
a cap that provides access to the biological material, wherein the cap is positioned on the at least one opening such that movement of gas between the environment surrounding the test indicator and the interior chamber occurs through the cap, and a vessel attached to the cap that contains an indicator solution;
exposing the test indicator to the sterilization procedure;
dispensing the indicator solution to the biological material; and
determining the effectiveness of the sterilization procedure. - View Dependent Claims (31)
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Specification