Patent ID: 8507248
Filing Date: 2013-08-13
Classification: C12N,C12Y

Abstract:
1. A sterilization process, comprising: exposing an article to be sterilized and a sterilization indicator to a sterilization medium, the sterilization indicator comprising a genetically engineered biological indicator, comprising: at least one test organism and at least one reporter gene suitable for producing an indicator enzyme, the reporter gene being taken up by the test organism; and at least one repressor gene that inhibits expression of the reporter gene until the reporter gene is exposed to at least one inducer; wherein the sterilization indicator further comprises: a first compartment adapted to permit the biological indicator to be brought into contact with a sterilization medium during the sterilization; and a second compartment containing at least one enzyme substrate, the second compartment adapted to maintain the enzyme substrate separate from the biological indicator during the sterilization, and the second compartment being adapted to permit the at least one enzyme substrate to contact the biological indicator after the biological indicator has been exposed to sterilization; following the exposing, contacting the biological indicator with the at least one inducer and the at least one enzyme substrate; incubating the biological indicator with the inducer and the at least one enzyme substrate; and determining whether the sterilization was effective based on the incubating.