Patent ID: 8333933

Claim:
A process challenge device for a high-pressure steam sterilizer, comprising: a plurality of steam permeable bodies formed by a steam permeable material; an indicator changeable in appearance on exposure to a predetermined temperature history; and a holder, wherein the steam permeable bodies comprise at least one end steam permeable body and a plurality of intermediate steam permeable bodies, wherein the steam permeable bodies are stacked with the end steam permeable body arranged at at least one end, the intermediate steam permeable bodies each having an opening, the openings of the intermediate steam permeable bodies being communicated with one another to form a cavity, the cavity being closed at at least one end by the end steam permeable body, the indicator being contained in the cavity, and wherein the holder holds the stacked steam permeable bodies having therein the indicator in a stacked fashion, wherein the holder has a plurality of discrete holes therethrough strategically located with respect to the steam permeable bodies to controllably pass steam to the steam permeable bodies, wherein the intermediate steam permable bodies each has a positioner, whereby a direction of the intermediate steam permable bodies is adjusted in being stacked to thereby facilitate alignment of the openings in the intermediate steam permable bodies consistently in a predetermined manner.