At the 2022 Nelson Labs Virtual Symposium, we will present examples of radiation sterilization for Ready-to-Use (RTU) Small Volume Parenteral Products (SVPP) as well as terminal sterilization of fill/finished items. This session will delve into the critical aspects of validating irradiation processes, focusing on the Process Definition step, which offers significant benefits beyond the default specification of 25 kGy to 40 kGy.
Radiation sterilization is a key method for ensuring the sterility of medical and pharmaceutical products. However, the traditional approach of applying a standard irradiation dose range may not always be optimal. This presentation will explore advanced methods and practices for broadening the irradiation specifications, providing greater flexibility and efficacy in the sterilization process.
Participants will learn about the advantages of moving beyond the default dose range and how customized irradiation parameters can enhance the sterilization outcomes for various products. The discussion will cover the methodologies for defining these specifications and the practical steps involved in implementing them.
By understanding the intricacies of the Process Definition step, attendees will gain insights into optimizing irradiation processes to meet specific product requirements while maintaining compliance with regulatory standards. This knowledge is crucial for professionals involved in the sterilization and validation of pharmaceutical and medical devices, ensuring the highest levels of product safety and quality.
The session will also include real-world examples of radiation sterilization applications, illustrating the successful implementation of these advanced practices. By attending this webinar, participants will be better equipped to enhance their sterilization protocols and achieve more effective and reliable results.