Join us for an informative webinar that reviews the benefits of parametric release and the general steps that Sterigenics follows to establish the Parametric Release specifications in accordance with the requirements of ISO 11135:2014 standards. This session will address key questions to enhance your understanding of parametric release and how to successfully set the specifications for a parametric release.
The webinar will begin 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 Parametric Release Study General Process Flow that follows Sterigenics’ best practice to establish the Parametric Release specifications and comply with the requirements of ISO 11135:2014 standards. Understanding the process to establish the specifications is crucial for ensuring compliance and maintaining the integrity of the sterilization process. The presentation will provide a comprehensive overview of ISO 11135:2014, highlighting the critical elements that manufacturers need to consider.
Key topics covered include:
- The definition and benefits of parametric release for manufacturers.
- Parametric Release Study General Process Flow.
- Periodic review.
