초록 ▼

A self-contained biological indicator for evaluating the efficacy of sterilization processes utilizing hydrogen peroxide and hydrogen peroxide/peracetic acid plasma and vapor as the sterilant is disclosed. The self-contained biological indicator includes a translucent, vapor-permeable, container inc

A self-contained biological indicator for evaluating the efficacy of sterilization processes utilizing hydrogen peroxide and hydrogen peroxide/peracetic acid plasma and vapor as the sterilant is disclosed. The self-contained biological indicator includes a translucent, vapor-permeable, container including a source of dormant microorganisms, a sealed ampule containing a culture medium that is capable of promoting the growth of surviving microorganisms, a neutralizing tablet that is capable of decomposing hydrogen peroxide sterilant, and an actuating mechanism that permits mixture of the source of microorganisms, culture medium and the hydrogen peroxide neutralizing tablet to be brought into contact from the exterior of the indicator. In one embodiment the self-contained biological indicator is comprised of a plurality of generally cylindrical, telescoping vials being operable from an unsealed, sterilization test configuration to a sealed and activated configuration for incubation. In the sterilization test configuration the integrity of the enclosure is interrupted by a plurality of openings which permit the flow of sterilant vapor into the indicator during a sterilization cycle. After exposure to the sterilization cycle is complete the indicator is operable to a sealed configuration in which the gas permeable openings are blocked by the telescoping movement of the container vials. After the indicator has been exposed to a sterilization cycle and placed in the sealed condition the deformable container may be actuated by finger pressure to bring the microorganism source, culture medium, and the hydrogen peroxide decomposing tablet into contact.

대표청구항 ▼

[ What is claimed is:] [11.] A method of evaluating the effectiveness of a hydrogen peroxide sterilizer by subjecting a self-contained biological indicator to a sterilization cycle, said indicator being of the type having a deformable container means including a plurality of telescoping vial means a

[ What is claimed is:] [11.] A method of evaluating the effectiveness of a hydrogen peroxide sterilizer by subjecting a self-contained biological indicator to a sterilization cycle, said indicator being of the type having a deformable container means including a plurality of telescoping vial means adapted for sliding engagement one inside another from an unsealed sterilization test configuration to a sealed post-test configuration, said indicator further including source of viable microorganisms, a hydrogen peroxide neutralizing means, and frangible ampule containing a culture medium for promoting growth of said microorganisms, said method comprising steps of:providing said self-contained biological indicator;setting said indicator in said unsealed sterilization configuration;positioning said indicator in said sterilizer;subjecting said indicator to a sterilization cycle;engaging said vial means in said sealed post-test configuration;activating said indicator by applying pressure to said deformable container means to permit said medium, said microorganisms, and said neutralizing means to come into contact; andincubating said indicator for a predetermined time to permit any of said microorganisms surviving said sterilization cycle to grow in said medium thereby providing an indication of the effectiveness of said sterilizer.