Manufacturers utilizing ionizing radiation (gamma, electron beam, or X-ray) for sterilization purposes must establish the maximum acceptable dose for their specified products. Compliance with the ISO 11137 standard requires an experimental program that demonstrates that a product treated with the maximum acceptable dose meets its specified functional requirements throughout its defined lifetime. This critical step ensures both the efficacy of sterilization and the preservation of product integrity.
This webinar will provide a comprehensive overview of radiation interaction with materials and the proper design of experiments to establish a product’s maximum acceptable dose. Viewers will gain insights into the complex processes involved and the importance of adhering to regulatory standards. The session will delve into the specifics of how different types of radiation interact with various materials, potentially altering their mechanical properties.
By the end of the webinar, professionals involved in medical device and pharmaceutical manufacturing, quality assurance, and regulatory compliance will have a thorough understanding of the principles and practices for establishing the maximum acceptable dose in radiation sterilization. This knowledge will help them ensure their sterilization processes are effective, reliable, and compliant with industry standards, ultimately safeguarding product quality and patient safety.