Rapid biological sterility detection method and apparatus...

C - Chemistry – Metallurgy – 12 – Q

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150/16.2

C12Q 1/22 (2006.01)

Patent

CA 2031757

- 14 - ABSTRACT: The present invention relates to a method and apparatus for rapidly determining the effectiveness of a sterilization process. A test sample comprising a known quantity of viable sporulated microorganisms is placed into asterilization chamber along with objects to be sterilized. After completion of the sterilization process, the test sample is removed along with the objects being sterilized. The test sample is exposed to a known quantity of a protein nutrientmedium which supports the germination and growth of any remaining viable microorganisms. The microorganisms and nutrient medium are sealed aseptically within a containing means and are incubated for a predetermined period of time to promote the germination and growth of the remaining viable microorganisms. Thereafter, an indicator agent capable of undergoing a detectable change in response to the germination and growth of the microorganisms is introduced into the containing means. The indicator agent detects the presence of end products of the protease enzyme reactions produced by the germinating and growing microorganisms. Thereafter, the containing means is examined for the detectable color change indicating microorganism viability and thus insufficientsterilization.

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