With the growing demand for sterilization of medical devices and pharmaceutical products, the industry is increasingly looking to electron beam (e-beam) as a viable alternative to gamma irradiation where appropriate. This webinar will delve into the critical considerations when evaluating the transfer between gamma and e-beam sterilization modalities.
The session will begin with an overview of the key differences between gamma and e-beam sterilization, setting the stage for a detailed discussion on the practical aspects of making this transition. One of the primary topics will be change assessment, focusing on the necessary steps to evaluate the feasibility and implications of switching from gamma to e-beam sterilization.
Participants will learn about the evaluation of process capabilities, understanding how the unique characteristics of e-beam sterilization can impact the overall process. The webinar will also cover the transfer of sterilization dose levels, ensuring that the transition maintains the required levels of sterility assurance.
Product dose mapping will be another critical area of focus, highlighting the methods for accurately mapping dose distribution within products to ensure uniform and effective sterilization. The importance of risk assessment in this context will be emphasized, providing insights into how to identify and mitigate potential risks associated with the transition.
Regulatory guidance from ISO documents 11137 and TIR104 will be used to support the discussion, offering a framework for ensuring compliance and maintaining high standards of quality and safety throughout the process.
Join us to gain a comprehensive understanding of the considerations involved in transitioning from gamma to e-beam sterilization. This knowledge is essential for professionals looking to optimize their sterilization processes and ensure the continued safety and efficacy of their medical devices and pharmaceutical products.