LyoHUB Presentations

Fundamentals of Freeze Drying I: Introduction and Process Overview (Advantages and limitations of freeze drying, Product quality attributes, Process overview: freezing, primary drying, secondary drying) https://pharmahub.org/resources/745

Fundamentals of Freeze Drying II: The Freezing Process (Supercooling and ice nucleation, Characterization of freezing behavior, Establishment of upper product temperature limit during primary drying) https://pharmahub.org/resources/746

Fundamentals of Freeze Drying III: Primary and Secondary Drying (Primary Drying: heat transfer considerations, measurement of the vial heat transfer coefficient, mass transfer considerations, measurement of the resistance of the dried product layer and Secondary Drying: critical process variables during secondary drying, how dry is "dry enough") https://pharmahub.org/resources/747

Fundamentals of Freeze Drying IV: Process Monitoring https://pharmahub.org/resources/748

Fundamentals of Freeze Drying V: Formulation Considerations https://pharmahub.org/resources/749

The Fundamentals of Freeze Drying modules are presented by Dr. Steve Nail, Adjunct Professor, Purdue University, retired Senior Research Scientist at Baxter Biopharma Solutions

Dr. Steven L. Nail is an Adjunct Professor of Industrial and Physical Pharmacy at Purdue University and recently retired from the position of Senior Research Scientist at Baxter Biopharma Solutions, Bloomington, IN. His undergraduate training is in chemical engineering at Purdue University, and his Ph.D. is in pharmaceutics, also from Purdue. From 1975-1991 he worked for The Upjohn Company, Kalamazoo, MI in various capacities, all related to development and manufacture of parenteral products, with a special interest in the science and technology of freeze-drying. In 1991, he became Associate Professor in the School of Pharmacy at Purdue, and was promoted to Professor in 1999. His research interests at Purdue focused on the physical chemistry of freezing and freeze-drying, characterization of frozen systems and freeze-dried solids, stability of proteins as freeze-dried products, pharmaceutical thermal analysis, and pharmaceutical applications of supercritical fluid technology. His teaching responsibilities have included undergraduate pharmacy courses in parenteral pharmaceutical products and graduate courses in pharmaceutical processing.

From 2002 until 2006, he was Research Fellow in the Pharmaceutical Sciences R&D organization at Eli Lilly & Co., Indianapolis, IN. He has served on the USP Committee of Experts in Parenteral Products from 1995 until 2010, and was the Chairman of this committee from 2005-2010. He is a Fellow of the American Association of Pharmaceutical Scientists. In 2007, he received the AAPS Research Achievement Award in Pharmaceutical Technology. He was recognized by the Purdue University School of Pharmacy as a Distinguished Alumnus in 2013.