North American Science Associates, Inc.

3m Innovative Properties Company

Joel R Gorski

Judy K Hendricks

Shaundrea L Rechsteiner

Roger Fiske

Adam Lee

John R Bealing

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.

Indicator systems for determination of sterilization

The invention relates to indicator ink compositions that contain a water-based dispersion of a phenol-formaldehyde resin, at least one colorant and an amine-terminated catalyst. These indicator ink compositions are fixed to a surface, such as by drying, and respond to specific conditions of time, temperature, humidity, pressure and the presence or absence of certain chemicals by changing color. Compositions provide a means for detecting exposure to a predetermined condition and can be fixed or otherwise attached to nearly any article or designed into patterns on materials. Exposure of the indicator ink to the specific condition, the indicator ink provides a permanent detectable record of the event. Further, by varying the amount of amine-terminated catalyst in the formulation, the specific conditions at which the indicator composition will change color can be altered. Such compositions are specifically useful for determining the effectiveness of a sterilization process.

Indicator ink compositions

This invention relates to novel apparatus and methods for inserting and positioning a compressible material into a container and for using the container for detecting a specific environmental parameter or combination of parameters, or for determining the effectiveness of a sterilization procedure. Precise positioning of a plug of compressible material in a container has been discovered to provide flexibility necessary for production of indicator systems that vary in their response to sterilizing conditions to reflect the efficacy of sterilizers based on different modes of sterilization and reproduceability necessary for accurate monitoring of each mode. The invention also relates to test indicators containing controlled volumes of compressed, gas-permeable materials and to methods for using test indicators for determining the efficacy of different types of sterilization processes. The test indicator consists of a plurality of interactive enzymes in a container with at least one opening. The opening is filled with a compressed cylindrical foam insert and the test indicator is placed into the sterilization chamber. The foam insert regulates the amount of sterilant such as steam, gas, chemicals or plasma entering the test indicator. After the sterilization cycle is complete, the foam insert is removed and the remaining components of the enzyme system are combined. If the proper sterilization conditions were 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 were 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 designs simulates an environmental parameter test of the sterilization process.

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Marrietta, GA, United States of America

Joel R Gorski