INDICATOR SYSTEMS AND MATERIAL COMPRESSION AND INSERTION DEVICES FOR PREPARING SAME

摘要

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 and for determining the effectiveness of a sterilization procedure. Precise positioning of a plug of compressible material in a container provides flexibility for production of indicator systems that vary in their response to sterilizing conditions. These indicators reflect the efficacy of sterilizers based on different modes of sterilization and reproduceability 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. Upon proper sterilization, 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.