BIOLOGICAL ARTICLES AND METHODS FOR MONITORING STERILIZATION PROCESSES

摘要

A sterility indicating composition comprising a plurality of sterilization process resistant spores; a germination medium comprising a sub-lethal amount of at least one cell-permeant nucleic acid-interacting fluorescent dye and at least one nutrient for germination of the spores; wherein the at least one cell-permeant fluorescent dye can interact with nucleic acids present in and produced by the plurality of spores during germination or during germination and outgrowth of the spores to produce an increase in fluorescence intensity, indicating that viable spores are present, and wherein the cell-permeant fluorescent dye is sufficiently stable at least at a temperature for incubating the spores to produce the increase in fluorescence intensity, a sterilization process indicator comprising the composition, and a method of determining the effectiveness of a sterilization process using the composition and indicator are disclosed.