BIOLOGICAL STERILIZATION INDICATOR, SYSTEM, AND METHODS OF USING SAME

摘要

A biological sterilization indicator, system, and methods of determining the effectiveness of a sterilization process. The biological sterilization indicator can include a locus of spores, a reservoir containing a liquid, and a sterilant path positioned to provide fluid communication between ambience and the locus of spores. The reservoir can have a closed state in which the reservoir is not in fluid communication with the locus of spores and an open state in which the reservoir is in fluid communication with the locus of spores. The biological sterilization indicator system can include the biological sterilization indicator and a detection device adapted to be coupled to the biological sterilization indicator. In some embodiments, the method can include assaying the spores for a detectable change in a characteristic, and detecting substantially all of the detectable change.

主权项

1. A biological sterilization indicator comprising:
a housing; a spore reservoir located in the housing, the spore reservoir comprising a locus of spores, the spore reservoir having a volume; a reservoir containing a liquid, the reservoir having a closed state in which the reservoir is not in fluid communication with the spore reservoir and an open state in which the reservoir is in fluid communication with the spore reservoir; and a sterilant path positioned to provide fluid communication between ambience and the spore reservoir when the reservoir is in the closed state and further positioned to provide a vent when the reservoir is in the open state, the sterilant path having a portion located toward the spore reservoir, the portion of the sterilant path having a cross-sectional area; wherein the ratio of the volume of the spore reservoir to the cross-sectional area of the portion of the sterilant path located toward the spore reservoir is at least 25.