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US 5,770,393 AGranted
Biological indicator for detection of early metabolic activity
AssigneeSTERIS Inc.
InventorsJoseph P. Dalmasso, David A. Freeman
Life of this patent
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AssigneeSTERIS Inc.
InventorsJoseph P. Dalmasso, David A. Freeman
Estimating the term…
A bacteria impermeable container or ampule (10) contains a liquid growth medium and a substrate-indicator complex. The complex includes a substrate component, e.g., starch, and an indicator molecule, e.g., a dye, a fluorescent molecule, or the like, which are tightly bound and complexed, but which are cleavable by a preselected enzyme. A sterilant passes over a carrier (20) for microorganisms which, upon germination, are capable of rapidly generating large quantities of the preselected enzyme. Following the sterilization process, the carrier is immersed in the liquid growth medium. Any viable surviving microorganisms grow, generating the preselected enzyme. The enzymes cleave the bound indicator molecule from the substrate, resulting in a measurable property change in a couple of hours. Typical property changes include fluorescence, a color change, a change in pH which triggers a pH indicator color change, and the like.
A self-contained biological indicator for determining the effectiveness of a sterilization process, the biological indicator comprising:
A self-contained biological indicator for measuring the metabolic activity of indicator organisms that survive an inadequate sterilization cycle including a spore carrier material with spores located on or impregnated in the carrier material, a liquid growth media which is contained separately in a sealed ampule, at a time after exposure to the sterilization cycle, the ampule being broken open and the spore carrier immersed in the liquid growth medium to provide nutrients for the outgrowth of spores not killed in the sterilization cycle, the outgrowth of any spores not killed generating an enzyme, further comprising:
A method for assessing the efficiency of sterilization comprising:
Dependencies are inferred from the claim text.