PDA Midwest Chapter’s Parametric Release Event – A Call to Action
The PDA Midwest Chapter’s event, Parametric Release – A Call to Action, has been developed to raise awareness and address challenges to promote the use of parametric release. The event will take place on September 20 utilizing a hybrid format: in-person attendance will be available in Northbrook, IL, while simultaneous remote streaming will be available around the globe. For colleagues in the Asia Pacific region to participate, a recording of the event will be streamed on September 21, 0:00 to 3:00 GMT, followed by a live Q&A session with available speakers and panelists.
A summary of the history and the current status of parametric release will be presented, serving as a baseline to open this event, which will be followed by a panel discussion. The panel discussion will focus on understanding and effectively addressing the current challenges that exist for the implementation of parametric release.
A survey, entitled 2022 Survey on Parametric Release for Products Terminally Sterilized with Moist Heat, has been developed as an input to drive the panel discussion. The survey will remain open until the start of the event. Whether or not you currently use parametric release, participation in the 2022 Survey on Parametric Release for Products Terminally Sterilized with Moist Heat is strongly recommended for everyone involved in the moist-heat terminal sterilization of medical device, combination and pharmaceutical/biopharmaceutical products to ensure the establishment of an accurate assessment of current parametric release challenges. This is your opportunity to have your specific challenges with parametric release fully addressed!
The panel is composed of global parametric release experts whose collective expertise will be leveraged to highlight effective approaches to address the challenges to implementing parametric release identified from the survey and live-event participant polling. We have just confirmed that Marla Stevens Riley, PhD, Branch Chief, U.S. FDA Division of Microbiology Assessment, and Rick Friedman, Deputy Director, FDA Manufacturing Quality, will participate in this panel discussion.
Action items from this discussion will be utilized by the Kilmer Dry Heat and Moist Heat Sterilization Collaboration Team in partnership with industry organizations to develop future initiatives to drive increased implementation of parametric release. The event will conclude with a forward-looking perspective for possible future applications of the principles of parametric release, including aseptic processing.
It is well recognized that our industry has been slow to adopt Parametric Release, even though it has been in use for nearly 40 years and is recognized as a superior program that employs the sterility test for products that are terminally sterilized with moist heat. The content of this event has been developed to support companies interested in implementing parametric release, to strengthen sterility-assurance programs for companies that already employ parametric release and to consolidate thoughts and ideas for future applications of parametric release.
Further information on participation in the PDA Midwest Chapter’s Parametric Release – A Call to Action event can be found at PDA Midwest: Something New – September Parametric Release Hybrid Event.
Additional Information on Parametric Release
Additional information on the history and current status of parametric release can be found in a recent article, Parametric Release of Moist Heat Sterilized Products: History and Current State, published in the PDA Journal of Pharmaceutical Science and Technology (1).
Information on the upcoming training course for PDA Technical Report No. 30: Parametric Release of Pharmaceutical and Medical Device Products Sterilized with Moist Heat to be held November 30–December 1, 2022, can be found on the PDA website.
Background
The sterility test has been utilized for nearly 90 years to meet regulatory requirements to support the sterile release of products terminally sterilized by moist heat and other sterilization modalities. It is well known that the sterility test is severely limited in its ability to provide a meaningful scientific and statistical basis to support the sterility of finished products (2–5). Accordingly, parametric release was developed as a sterility-assurance release program that defined critical manufacturing-process and sterilization-control parameters essential for sterile-product release, thereby eliminating reliance on the flawed sterility test. The parametric release approach can provide a greater assurance that a batch meets the sterility requirements than the sterility test (2).
Parametric release is defined by PDA TR-30 as “A sterility release program based on effective control, monitoring and documentation of a validated sterile product manufacturing process where sterility release is based on demonstrated achievement of critical operational parameters and performance attributes in lieu of end product sterility testing” (5).
In 1985, the FDA approved the initial submission for a family of parenteral drug products terminally sterilized with moist heat where sterile product release was based on parametric release. Although this approval was granted nearly 40 years ago, our industry has not fully embraced parametric release. In fact, results from the 2020 Kilmer Conference Process Analytical Technology (PAT) and Current Moist Heat Sterilization Practice to Demonstrate Sterility Assurance Survey indicated that 56% of the respondents were exclusively using the Sterility Test Release, 23% of the respondents were exclusively using Parametric Release and 21% of the respondents were using a combination of the Sterility Test Release and Parametric Release (6).
References
- Sadowski, Michael J., and Langille, Stephen E. 2022. “Parametric Release of Moist Heat Sterilized Products: History and Current State.” PDA J Pharm Sci Technol 76(4), July/August 2022. https://doi.org/10.5731/pdajpst.2022.012740.
- U.S. Food and Drug Administration. 2010. Guidance for Industry: Submission of Documentation in Application for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes. February 2010 CMC. U.S. Department of Health and Human Services. Available at https://www.fda.gov/media/71461/download (Accessed 22 Aug 2022).
- United States Pharmacopeial Convention. “USP General Chapter <1222> Terminally Sterilized Pharmaceutical Products-Parametric Release.” In USP 43–NF 38. Rockville, Md.: USP.
- European Commission. 2018. “Annex 17: Real Time Release Testing and Parametric Release.” In EudraLex, Volume 4: EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. Brussels: European Commission. Available at https://www.gmp-compliance.org/files/guidemgr/2018_annex17_en.pdf (Accessed 02 Jun 2022).
- Parenteral Drug Association, Inc. 2012. Technical Report No. 30 (Revised 2012): Parametric Release of Pharmaceutical and Medical Device Products Terminally Sterilized by Moist Heat. Bethesda, Md.: PDA.
- Kilmer Conference. 2020. Survey Results: “Process Analytical Technology (PAT) and Current Moist Heat Sterilization Practice to Demonstrate Sterility Assurance.”
About the Author
Michael (Mike) Sadowski is a Lead Scientist/Senior Director, Sterility Assurance and leads the Sterility Assurance Community of Practice at the Baxter Healthcare Corporation in Round Lake, Illinois. He has over 30 years of experience with drug and device sterilization with a variety of sterilization modalities and is responsible to ensure the continued connection and strengthening of the Sterility Assurance Critical Competency in support of pharmaceutical products and medical devices across the globe.