This webinar will inform you about the current status of the revision regarding changes and enhancements in the field of sterilization and sterile filtration. As an example, the filter test is mentioned. “The integrity of the sterilized filter should be checked before use” is stated in Annex 1. In this context, the requirement for the Pre-Use-Post-Sterilization Integrity Test (PUPSIT) is made to avoid “blinded” filter errors in the pure post-filtration test. For this purpose, it was discussed whether the risk of not using PUPSIT was lower than the risk of the integrity test negatively affecting the performance of the sterile filter. Accordingly, the webinar deals with the following topics:
- Definitions
- Requirements
- Validation
- PUPSIT - Pre-Use-Post-Sterilization Integrity Test