MONITORING STERILANT CONCENTRATION IN DIFFUSION-RESTRICTED REGIONS AS A BASIS FOR PARAMETRIC RELEASE

摘要

A method monitors a concentration of an oxidative gas or vapor in a diffusio n- restricted region in fluid communication with a sterilization chamber during a sterilization process. The method includes providing a concentration monitor responsive to the oxidative gas or vapor by generating a parameter corresponding to the concentration of the oxidative gas or vapor. The concentration monitor includes a temperature sensing device coupled to a chemical substance reactive with the oxidative gas or vapor to produce heat. The method further includes placing at least a portion of the concentration monitor comprising the chemical substance within the diffusion- restricted region. The method further includes introducing the oxidative gas or vapor into the sterilization chamber. The method further includes monitoring the parameter generated by the concentration monitor during the sterilization process. -37-