Sterilization is a critical step in the pharmaceutical drug development process to ensure overall safety. Regulations are clear that, whenever possible, products intended to be sterile should be terminally sterilized in their final container. Only if terminal sterilization is not feasible should filtration or aseptic assembly be applied. This webinar will focus on trends in sterility assurance, including the revision of USP <71> and key elements to evaluate before 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 from the perspective of a manufacturer.
- Mitigation strategies for the use of terminal sterilization with radiation, ethylene oxide, and novel modalities.
- Insights into trends in the concept of sterility assurance.
By attending this webinar, participants will gain valuable knowledge and strategies to ensure the sterility and safety of their drug products, aligning with regulatory expectations and industry best practices.