Risk assessment paradigm: an opportunity for rationalizing the choice of biological indicator during the validation of isolator biodecontamination cycles.

The use of biological indicators is integral to the validation of isolator decontamination cycles. The difficulty in setting up the initial qualification of the decontamination cycle and especially the successive requalifications may vary as a function of not only the installation to be qualified and the sterilizing agent and generator used, but also as a function of the type of biological indicators used. In this article the manufacture and control of biological indicators are analyzed using the hazard analysis and critical control point (HACCP) approach. The HACCP risk analysis, which must take into account the application of the isolator being qualified or requalified, is an efficient simplification tool for performing a decontamination cycle using either hydrogen peroxide gas or peracetic acid in a reliable, economical, and reproducible way.