2023 PDA Journal Article of the Year
The Frederick Simon Award is presented annually for the best paper published in the PDA Journal of Pharmaceutical Science and Technology. It is named in honor of the late Frederick D. Simon, a previous PDA Director of Scientific Affairs.
Parametric Release of Moist Heat Sterilized Products: History and Current State
Stephen Langille, PhD
Stephen Langille is a senior microbiology consultant with ValSource who specializes in microbiological and visible particulate matter control strategies and solutions.
He received his BS in biology from the University of Massachusetts and his PhD in microbiology from the University of Maryland. He worked for the U.S. FDA for 19 years serving as a Microbiology Reviewer, Branch Chief and Director of the Center for Drug Evaluation and Research’s Division of Microbiology Assessment. He has served on several PDA interest groups and USP expert committees to help develop and improve industry and compendial standards for microbiological and particulate matter quality in injectable products.
Michael Sadowski
Michael (Mike) Sadowski is a Lead Scientist leading the Sterility Assurance Community of Practice at the Baxter Healthcare Corporation. He is responsible for ensuring the continued connection
and strengthening of the Sterility Assurance Critical Competency in support of global pharmaceutical and medical device products.
Mike has 30 years of experience with drug and device sterilization with a variety of sterilization modalities. In addition to his participation on the Task Force for the revision of PDA Technical Report (TR) No. 1 (Revised 2007) Validation of Moist Heat Sterilization Processes Cycle Design, Development Qualification and Ongoing Control, he was the Chair of the Task Force for the revision of the PDA TR No. 30 (Revised 2012) Parametric Release of Pharmaceuticals and Medical Device Products Terminally Sterilized by Moist Heat. Mike previously served as Treasurer, Secretary and Director on the PDA Board of Directors and member of the PDA Scientific Advisory Board and currently serves as Associate Editor for the PDA Journal and Co-Chair of AAMI WG 03 on Moist Heat Sterilization. He has successfully aligned industry and regulatory agencies to shape best practices and continues to actively publish and contribute presentations and training sessions on moist heat sterilization and parametric release. He is frequently sought as an expert speaker by global industry and regulatory Sterility Assurance professionals. Mike received his BS Degree in Microbiology from Purdue University.