Rapid read-out sterility indicator

Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving hydrolase

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435 4, 435288, 435291, 435295, 435808, 435810, 435 31, 435 19, 435 21, 435 23, 435 24, 422 55, 422 56, 422 58, 422 60, 422 61, 422 83, 422 86, 422101, 436501, 436805, 935 38, 935 60, 935 76, C12Q 122, C12M 112, C12M 134, C12M 140

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052234010

ABSTRACT:
A unitary sterility indicator and a method for its use, the indicator comprising an outer container having liquid impermeable and gas non-absorptive walls, and having a gas-transmissive, bacteria impermeable opening therein; contained within the outer container, a detectable amount of a source of active enzyme and/or another microorganism commonly used to monitor sterilization; a sealed, openable gas and liquid impermeable inner container containing an aqueous medium and/or a nutrient growth medium, disposed in the outer container; an enzyme substrate system capable of reacting with active enzyme to produce a detectable enzyme-modified product and/or a detector material sensitive to microorganism growth, contained in one of the containers; and means contained within the outer container for restricting the area in which enzyme-modified product and/or growing microorganisms are contained, after the inner container is opened, to an area which is less than the volume of aqueous solution contained in the inner container.

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