3m Innovative Properties Company

Ronald G Lulich

Robert A Asmus

William E Foltz

Sailaja Chandrapati

Kelvin J Witcher

Thomas T Rosenlund

Sterilization indicator test packs for testing the effectiveness of a sterilization procedure are provided. Both non-challenge and challenge-type test packs are disclosed. The non-challenge test packs include generally comprise a tray for holding a sterilization indicator the tray containing an elevated rim surface defining the perimeter of the tray and a recessed trough for receiving a sterilization indicator. The rim surface includes a plurality of spaced-apart grooves along its length extending through the rim to the recessed trough; a sterilization indicator within the recessed trough of the tray; and a lid that forms a plurality of channels with the grooves in the tray such that sterilant can enter the tray through the channels and contact the sterilization indicator. The challenge-type test packs generally include a tray for holding a sterilization indicator, the tray comprising a substantially planar surface, a recessed trough for receiving a sterilization indicator, and a recessed groove of a defined length and cross-sectional area extending through the recessed trough and penetrating the edge of the tray; a sterilization indicator within the recessed trough of the tray; and a lid forming a substantially sterilant-impermeable seal with the planar surface of the tray and forming a lumen path with the recessed groove in the tray.

Sterilization indicator test packs

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.

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Brookings, SD, United States of America

Ronald G Lulich