Self-contained biological indicator

Chemistry: molecular biology and microbiology – Apparatus – Including measuring or testing

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435 31, 435262, 4352876, 4352882, 422 28, 422 30, 422 58, 422 61, C12M 140

Patent

active

055523200

ABSTRACT:
A self-contained biological indicator includes an outer container that is translucent and liquid impermeable. The container is normally closed by a vapor-permeable, micro-organism-impermeable closure and contains a source of viable microorganisms, a culture medium, a composition that decomposes hydrogen peroxide, and a detector that undergoes a visible change in response to growth of the microorganisms. In operation, the indicator is first subjected to a sterilization cycle in a hydrogen peroxide sterilizer. Without opening the outer container, the microorganism source, culture medium, and hydrogen peroxide-decomposing composition are brought into contact. The indicator is placed in an incubator, after which the detector responds to any microorganism growth, indicative of incomplete sterilization. But for the hydrogen peroxide-decomposing composition, hydrogen peroxide that becomes bound to the microorganism support during sterilization, could kill the microorganisms afterwards, yielding a false indication of complete sterilization.

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