INTRODUCTION

Physicochemical integrators provide some assessment of sterilization process efficacy and may be used in cases where validation of a sterilization process is not required—an exception is the validation and monitoring of radiation sterilization with dosimetry. The physicochemical indicator provides an immediate visual confirmation that an item has been exposed to a sterilization process. Performance standards both within and between lots of physicochemical integrators or indicators from a given manufacturer should be consistent. Integrators or indicators should not interact physically or chemically with any container or product when placed in the sterilizer load, and should not alter the strength, quality, or purity of the sterilized article. The integrator or indicator should be positioned such that it does not alter the effectiveness of the sterilization process. The principal usage of physicochemical integrators and indicators is to provide a rapid means of confirmation of sterilization cycle completion. This is especially important with single door sterilization chambers where a potential mix-up of nonsterilized and sterilized items is more likely. Aside from radiation sterilization where dosimetric data is accepted as definitive they should not be used as the sole proof of cycle efficacy (see Radiation Sterilization 〈1229.10〉).