Patent ID: 6323032
Filing Date: 2001-11-27
Classification: A61L

Abstract:
A sterilant challenge device for use in a sterilizer for determining the efficacy of the air removal stage of a sterilization cycle, the sterilizer having a sterilization chamber for receiving objects to be sterilized, the sterilant challenge device comprising an exterior, walls that define a chamber that defines a remote interior space with a closed end; an opening for the entry of sterilant to the remote interior space, the opening being spaced from the closed end; a heat sink portion which, when the device is in use in a sterilizer, receives heat preferentially from the remote interior space; and a first temperature sensor for detecting the presence of sterilant at a predetermined location within the remote interior space, said predetermined location being spaced from the opening and substantially adjacent the closed end, the walls of the chamber comprising a thermally insulating material which impedes the transmission of heat from within the sterilizer to the remote interior space through the walls of the chamber, wherein the chamber is sized and shaped so that i) the penetration of sterilant from the opening to the predetermined location during a sterilization cycle is inhibited by the accumulation of air and/or non-condensable gas within the remote interior space resulting from the condensation of moisture on the walls of the chamber, and ii) there is a portion of the chamber between the opening and the predetermined location and that portion of the chamber is free of any physical barrier to the passage of the sterilant and/or air, and iii) the portion of the chamber between the opening and the predetermined location resists blockage due to condensate;a second temperature sensor in direct thermal communication with the interior of the sterilization chamber to read the temperature of the sterilization chamber of the sterilizer, andprocessing means for receiving signals from said first and second temperature sensors and for making a determination of the adequacy of the sterilization cycle, based, at least in part, on the signals from said first and second temperature sensors.