Sterilization is a pivotal step in the pharmaceutical drug development process to help ensure overall safety is maintained. Regulation is clear that, whenever possible, products intended to be sterile should be terminally sterilized in their final container. Only if terminal sterilization is not possible, filtration or aseptic assembly should be applied. This webinar will focus on trends in the concept of sterility assurance including the revision of USP <71> and elements to evaluate prior to selecting aseptic assembly for the manufacturing of sterile drug products.
What you will get from this webinar:
- A deeper understanding of terminal sterilization and aseptic processing of drug products through a regulatory lens as well as that of a manufacturer
- Mitigation strategies for the use of terminal sterilization with radiation, ethylene oxide and novel modalities
- Trends in the concept of sterility assurance
