2022 Survey on Parametric Release for Products Terminally Sterilized with Moist Heat

Parametric Release was initially approved for products terminally sterilized with moist heat in 1985.  Since that time, Parametric Release has not been fully embraced for pharmaceutical, biopharmaceutical and medical device products for many reasons.  The purpose of this survey is to:

1.  Understand the current state regarding the use of Parametric Release

2.  Identify the reasons and challenges that have prevented implementation of Parametric Release

3.  Identify potential opportunities to increase the implementation of Parametric Release

This survey was developed by the Kilmer Process Analytical Technology/Parametric Release Collaboration Team.  For the purposes of this survey, Parametric Release is defined as "The release of sterile product based on the achievement of parameters that are critical to the assurance of sterility with no requirement to complete the test for sterility".  The Team will analyze the survey results and partner with industry organizations to execute on initiatives to promote the implementation of Parametric Release.

The survey consists of multiple choice, checkbox and short answer questions-all responses are completely anonymous.  You can return to update your responses to the survey from your same device (e.g., computer, iPAD, etc.) at any time until the survey closes.  Since many companies are global, we recommend that a separate survey be completed for each global region (e.g., Africa, Asia Pacific, Europe, North America and South America) when your company's practices or use of Parametric Release differs across the globe, if possible--this is not mandatory but highly recommended.  For example, if a company commercializes product in North America and Europe and employs differing practices related to Parametric Release in these two regions, it would be appreciated if two independent surveys could be completed, if possible. 

Note for Consultants participating in the survey:  Please select “No” as your answer to the questions that ask “Do you terminally sterilize medical devices or combination products with moist heat?”, “Do you terminally sterilize pharmaceutical or biopharmaceutical products with moist heat?” and “Do you purchase sterile containers or closures externally for use in aseptic processing?”.   Please answer all other questions based on your experiences including support of your clients.

If you have any questions on the survey, please contact Mike Sadowski (mike_sadowski@baxter.com)