DIN EN ISO 13408-7:2015-11

This part of ISO 13408 specifies requirements and provides guidance on alternative approaches to processsimulations for the qualification of the aseptic processing of medical devices and combination products that cannotbe terminally sterilized and where the process simulation approach according to ISO 13408-1 cannot be applied. This part of ISO 13408 describes how risk assessment can be used during the development of an asepticprocess to design a process simulation study for medical devices and combination products in those caseswhere a straightforward substitution of media for product during aseptic processing is not feasible or would notsimulate the actual aseptic process.