Judy K. Hendricks - Albuquerque NM Shaundrea L. Rechsteiner - Lambertville MI Joel R. Gorski - Marrietta GA Adam Lee - Toledo OH Roger Fiske - Findlay OH
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.
Contained Indicators For Determining Sterilizations
MICHAEL J MILLER - ROCHESTER NY, US JUDY K. HENDRICKS - ALBUQUERQUE NM, US
International Classification:
B01J010/00
US Classification:
422/129000
Abstract:
This invention is directed to sterilization indicator systems for determining the effectiveness of sterilization processes. Test indicator devices comprise a container that is open on one end and has liquid impermeable and substantially gas non-absorptive walls which surround the biological or chemical material to be used as the indicator system. the opening contains a barrier that allows fluid such as gas to flow from the outside, through the plug and into the interior chamber containing the indicator system providing the detection. The entire indicator is further contained within a sealed pouch that is liquid impermeable and gas permeable under the conditions of a gas over steam sterilization system. The flexible pouch allows the test indicator to properly function while protecting the indicator from the environment while maintaining reliability of the test results. Although such sterilization indicators can be used in a wide variety of procedures, the indicators of the invention are particularly useful in evaluating the effectiveness of air overpressure sterilization.
Indicator Systems For Determination Of Sterilization
Judy Hendricks - Albuquerque NM, US Shaundrea Rechsteiner - Lambertville MI, US Joel Gorski - Marrietta GA, US
International Classification:
C12Q001/22
US Classification:
435/031000
Abstract:
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.
Contained Indicators For Determining Sterilization
Michael Miller - Rochester NY, US Judy Hendricks - Albuquerque NM, US
International Classification:
C12Q001/22 A61L002/08 B29D022/00
US Classification:
435/031000, 422/026000, 428/035400
Abstract:
This invention is directed to sterilization indicator systems for determining the effectiveness of sterilization processes. Test indicator devices comprise a container that is open on one end and has liquid impermeable and substantially gas non-absorptive walls which surround the biological or chemical material to be used as the indicator system, the opening contains a barrier that allows fluid such as gas to flow from the outside, through the plug and into the interior chamber containing the indicator system providing the detection. The entire indicator is further contained within a sealed pouch that is liquid impermeable and gas permeable under the conditions of a gas over steam sterilization system. The flexible pouch allows the test indicator to properly function while protecting the indicator from the environment while maintaining reliability of the test results. Although such sterilization indicators can be used in a wide variety of procedures, the indicators of the invention are particularly useful in evaluating the effectiveness of air overpressure sterilization.
Indicator Systems For Determination Of Sterilization
Judy K. Hendricks - Albuquerque NM Shaundrea L Rechsteiner - Lambertville MI Joel R. Gorski - Marrietta GA
Assignee:
North American Science Associates - Northwood OH
International Classification:
C12Q 122 C12Q 154 C12Q 132 C12Q 102
US Classification:
435 31
Abstract:
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.
Indicator Systems For Determination Of Sterilization
Judy K. Hendricks - Albuquerque NM Shaundrea L. Rechsteiner - Lambertville MI Joel R. Gorski - Marrietta GA
Assignee:
North American Science Associates, Inc. - Northwood OH
International Classification:
C12Q 122 C12Q 154 C12Q 132 C12Q 102
US Classification:
435 31
Abstract:
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.
Harold A. Biddle - Kansas OH Dale L. Byerly - Toledo OH Judy K. Hendricks - Albuquerque NM
Assignee:
North American Science Associates, Inc. - Northwood OH
International Classification:
B65B 6302
US Classification:
53436
Abstract:
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.