Self-contained biological indicator

Claim 1

A sterility indicator for use with a hydrogen peroxide sterilizer, said sterility indicator comprising a translucent, liquid impermeable outer container, having an opening that is normally closed by a vapor-permeable, microorganism-impermeable closure, and containing: a) a source of viable microorganisms, b) at least one closed inner container containing a liquid culture medium that, with incubation, is capable of promoting growth of the viable microorganisms and an agent for decomposing hydrogen peroxide, c) opening means actuable external to the outer container for opening the at least one closed inner container to permit the source of microorganisms, culture medium, and hydrogen peroxide-decomposing composition to be brought into contact, and d) a detector means contained in at least one of the containers for undergoing a visible change in response to growth of the microorganisms; whereby the sterility indicator may be subjected to a hydrogen peroxide based sterilization procedure in a hydrogen peroxide sterilizer, and whereafter said opening means may be actuated to bring the source of microorganisms, culture medium, and hydrogen peroxide-decomposing composition into contact with one another and with the detector means, and whereby the agent for decomposing hydrogen peroxide will decompose any hydrogen peroxide left in the sterility indicator after said sterilization procedure, and whereafter if any of the microorganisms remain viable they will grow in said culture medium and said detector means will provide a visual indication that said sterilization procedure failed to sterilize all of said microorganisms.