Join us for an informative webinar that reviews the benefits of parametric release and how to establish a compliant, capable process design in accordance with ISO 11135:2014 standards. This session will address key questions to enhance your understanding of parametric release and its application in the manufacturing process.
The webinar begins by explaining what parametric release is and how it can benefit manufacturers. Parametric release is a method that allows for the release of sterilized products based on the data collected during the sterilization process, rather than relying solely on traditional biological indicators. This approach can lead to more efficient production cycles, reduced costs, and improved product safety and quality.
We will then delve into the current requirements as stated in the ISO 11135:2014 Standard. Understanding these requirements is crucial for ensuring compliance and maintaining the integrity of the sterilization process. The presentation will provide a comprehensive overview of the standard, highlighting the critical elements that manufacturers need to consider.
The session will also cover best practices for setting and challenging parametric limits. Establishing robust parametric limits is essential for achieving a reliable and consistent sterilization process. The presentation will offer practical insights into how to set these limits effectively and the steps to take when challenging them to ensure they are robust and capable of maintaining product sterility.
Key topics covered include:
- The definition and benefits of parametric release for manufacturers.
- An overview of the current requirements outlined in ISO 11135:2014.
- Best practices for setting and challenging parametric limits to ensure process capability and compliance.
This webinar is ideal for professionals involved in quality assurance, regulatory compliance, and process design within the medical device and pharmaceutical industries. Gain valuable insights into parametric release and learn how to implement best practices to enhance your sterilization processes.