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US 8,507,248 B2Granted
Genetically engineered biological indicator
AssigneeAmerican Sterilizer Company
InventorsPhillip P. Franciskovich, William A. Yirava, Tricia A. Cregger
Life of this patent
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Abstract
The disclosed technology relates to 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. A process and an apparatus for using the biological indicator are disclosed.
Claims21
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.
9 more elements
A process for determining the effectiveness of sterilization, comprising:
- exposing at least one article to be sterilized and a sterilization indicator comprising a biological indicator to a sterilization medium;
- contacting the exposed sterilization indicator with at least one inducer and at least one enzyme substrate;
- and
- incubating the exposed sterilization indicator with the at least one inducer and the at least one enzyme substrate to determine the effectiveness of the sterilization;
- the biological indicator being in the form of 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.
9 more elements
Dependencies are inferred from the claim text.