validation method of a sterilization procedure comprising two successive contamination

摘要

The invention relates to a method of validating an article sterilization procedure which allows to validate the level of sterility assurance achieved with this sterilization procedure. The method according to the invention is characterized by carrying out a first contamination step of a container receiving the article with more than 105 living cells of a microorganism, then carrying out a first sterilization cycle with the chosen procedure, then opening the container to further contaminate it with more than 105 live cells of a micro-organism, then perform a second sterilization cycle with the same procedure, and finally check the sterility of the container after the first cycle and after the second sterilization cycle. . The method according to the invention is applicable in particular to health products and devices.