Biological indicator for monitoring a low-temperature sterilization process

Abstract

An article and method are provided for assessing the efficacy of a sterilization process. The article comprises an outer container having an interior volume; a dry source of measurable biological activity disposed in the interior volume; and an effective amount of a dry agent for neutralizing a sterilant compound; wherein both the source of measurable biological activity and the agent are in vapor communication with an environment outside the outer container. The method comprises exposing the article to a first sterilant and, optionally, a second sterilant for a period of time and detecting the measurable biological activity.

1 - 16 . (canceled) 
     
     
         17 . An article, comprising:
 an outer container having an interior volume, a first end comprising an opening, and a second end;   a dry source of measurable biological activity disposed in the interior volume; and   an effective amount of a dry agent for neutralizing a sterilant compound, the effective amount being disposed in the interior volume;   wherein both the source of measurable biological activity and the agent are in vapor communication with an environment outside the outer container.   
     
     
         18 . The article of  claim 17 , further comprising a layer that is permeable to the sterilant compound, wherein the layer is coupled to the outer container, wherein the layer is interposed between the source of measurable biological activity and the environment outside the outer container. 
     
     
         19 . The article of  claim 17 , wherein the source of measurable biological activity comprises an enzyme activity or a microorganism capable of reproducing. 
     
     
         20 . The article of  claim 17 , wherein the sterilant compound comprises hydrogen peroxide. 
     
     
         21 . The article of  claim 18 , wherein the source of measurable biological activity comprises an enzyme activity or a microorganism capable of reproducing. 
     
     
         22 . The article of  claim 18 , wherein the sterilant compound comprises hydrogen peroxide. 
     
     
         23 . The article of  claim 19 , wherein the sterilant compound comprises hydrogen peroxide.