METHOD AND DEVICE FOR DETERMINING THE STERILIZATION PERFORMANCE OFA PRODUCT/CONTAINER COMBINATION

摘要

Method for determining the sterilization performance of a product/container combination, in which, in a first step, a first closed vessel with a first volume, which first vessel is at least partially filled with a first quantity of the product, passes through a sterilization process, and in which at least a second vessel is filled with the same quantity of product and is then closed, the second volume enclosed by the second vessel being equal to the first volume, after which the second volume is changed by a selected value and the second vessel, in a second step passes through the sterilization process, and, during the first and the at least second step, the pressure in the vessel is measured while it is passing through the sterilization process, and, from the known volumes of the vessels and the measured pressure, the pressure-volume relationship is determined for the quantity of product in the vessels for one or more phases from the sterilization process, and the determined pressure-volume relationship or pressure-volume relationships is/are combined with the properties of the container to give the sterilization performance of the product/container combination.