[Study of the reproducibility of the sterilization process and proposal of an sterilizer requalification protocol]

Unlike EN 554, and since the publication of ISO 17665-1 standard, the user of autoclaves may use methods other than those indicated in the guidelines. Outsourcing the requalification of sterilizers by an external service provider and after observing from the previous requalification reports that the thermometric data seemed reproducible, we decided to propose and validate a validation method for the reproducibility of the sterilization process. This is to exempt from the study of the repeatability of the EN 554 standard in future requalifications. Reproducibility was studied with the sensors of the sterilization service and from the production cycles. This study was carried out in three parts. First, we checked whether our sensors were reliable. Then we evaluated the sterilization process fidelity of each sterilizer. Finally, we compared our measurements performed by the service sensors with the measurements performed by the service provider during the requalifications of the previous years. This work leads us to describe a new protocol of requalification of our sterilizers.