BIOLOGICAL INDICATOR FOR MONITORING A LOW-TEMPERATURE STERILIZATION PROCESS

摘要

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.