Sterilization indicator with chemically stabilized enzyme

A - Human Necessities – 61 – L

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A61L 2/26 (2006.01) A61L 2/28 (2006.01) C12Q 1/22 (2006.01)

Patent

CA 2333753

A sterilization indicator for testing the effectiveness of a sterilization procedure comprises a source of an enzyme, a sterilant-resistant chemical associated with the enzyme, and a substrate that reacts with the enzyme to form a detectable enzyme-modified product that provides an indication of the failure of the sterilization procedure. The sterilant-resistant chemical may be a polyglycerol alkyl ester, polyglycerol alkyl ether, an ethoxylated polyhydric alcohol ester, or a polyhydric alcohol ether. The indicator may be used to test the effectiveness of a hydrogen peroxide plasma sterilization procedure and may be provided with a non-challenge test pack or a lumen- challenge test pack.

L'invention concerne un indicateur de stérilisation destiné à tester l'efficacité d'un procédé de stérilisation et comprenant une source d'enzyme, un produit chimique résistant aux stérilisants associé à l'enzyme et un substrat entrant en réaction avec l'enzyme pour former un produit modifié par l'enzyme pouvant être détecté pour indiquer l'échec du procédé de stérilisation. Le produit chimique résistant aux stérilisants peut être un ester d'alkyle polyglycérolique, un éther d'alkyle polyglycérolique un ester d'alcool polyhydrique éthoxylé ou un éther d'alcool polyhydrique. On peut utiliser l'indicateur pour tester l'efficacité d'un procédé de stérilisation au plasma de peroxyde d'oxygène et l'indicateur peut comprendre un ensemble de test sans provocation ou un ensemble de test de provocation dans une lumière.

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