Sterilization process challenge device and method

A - Human Necessities – 61 – L

Patent

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

Patent

CA 2725078

A sterilization process challenge device comprising a solid body comprised of walls which define a space, wherein the space can fully contain a sterilization indicator and a volume of gas of at least 5 cubic centimeters and not more than 1000 cubic centimeters; a flow restrictor associated with the solid body such that any flow of the gas out of the space and any flow of a sterilant into the space is restricted; wherein the sterilization indicator indicates whether or not it has been contacted by the sterilant for a time and at a temperature sufficient to sterilize an article; and wherein the walls of the solid body are impervious to the sterilant and have a thickness of at least 0.3 centimeter, methods of using the device and a kit including the device are disclosed.

La présente invention concerne un dispositif de test dun procédé de stérilisation comprenant un corps solide comprenant des parois définissant un espace, l'espace pouvant entièrement contenir un indicateur de stérilisation et un volume de gaz d'au moins 5 centimètres cubes et inférieur ou égal à 1000 centimètres cubes; un restricteur de débit associé au corps solide de sorte que tout courant de gaz hors de l'espace et tout courant d'un agent de stérilisation à l'intérieur de l'espace soient restreints; l'indicateur de stérilisation indiquant s'il a été en contact ou non avec l'agent de stérilisation pendant une durée et à une température suffisante pour stériliser un article; et les parois du corps solide étant imperméables à l'agent de stérilisation et ayant une épaisseur d'au moins 0,3 centimètre. L'invention concerne également des procédés d'utilisation du dispositif et un kit comprenant le dispositif.

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