Support

Support Options

Report a problem

About you
About the problem
Close

Tools and Educational Presentations

Training tools:

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, Senior Research Scientist at Baxter Biopharma Solutions

Dr. Steven L. Nail is the 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.

Interactive online tools:

for modeling and analysis of lyophilization/freeze-drying:

1. Interactive Lyocalculator 

LyoCalculator https://pharmahub.org/resources/lyocalculator

Lyocalculator models product temperature and sublimation rate during primary drying for specified chamber pressure, shelf temperature and container/product properties. 

 

Excel-based lyocalculator (Courtesy Dr. Serguei Tchessalov/Pfizer): Lyocycle_design_and_transfer_template_Breckenridge_workshop--Pfizer_Original.xls (2 MB)

 

Abridged version for training by Dr. Tong Zhu: 170727-Lyo-Calculator_Training-Added_Macro_Solver.xls (66 KB

2. Pressure Variation Calculator  https://pharmahub.org/resources/pressurevar

Lyo Chamber Pressure Variation Calculator 

simulate variation of pressure within product chamber for specified chamber pressure, shelf size and drying rate rate. 

 

Best Practices Papers:

1) LyoHUB's Best Practices Paper, "Recommended Best Practices for Process Monitoring Instrumentation in Pharmaceutical Freeze Drying"   can be accessed at http://link.springer.com/article/10.1208/s12249-017-0733-1

Presentations:

1. Developing Transferable Freeze Drying Protocols Using Accuflux® and a MicroFD®

Authors: TN Thompson (Millrock Technology, Inc.), Quiming Wang (Millrock Technology, Inc.), Cindy Reiter (Millrock Technology, Inc.)

FDProtocols.pdf (4 MB) narrated presentation: https://www.youtube.com/watch?v=Gw84GkDUD20

2) "Progress in Vacuum Pressure Measurement" Talk by Dr. Martin Wuest (Inficon) https://pharmahub.org/resources/756

ABSTRACT: For many years standard vacuum pressure measurement sensors consist of capacitance diaphragm gauges, Pirani heat transfer gauges as well as ionization gauges. Development has progressed from passive gauges with a detached controller to combination gauges with integrated electronics. Market demand from industry continues to force the development of smaller, cheaper and better process sensors. Better in this context means the sensors must survive the harsh industrial process conditions for longer, measure faster and with better reproducibility. In the area of vacuum pressure metrology new developments are occurring in national measurement institutes and universities. The pressure is determined by measuring the refractive index. I will present some of the recent developments.

 

3) "Continuous Freeze Drying" Talk by Jos Corver (RheaVita)  https://pharmahub.org/resources/792

ABSTRACT: The guidelines of FDA’s PAT mention the need for continuous processing in pharma to achieve a mechanism of 100% control of process and product quality. Freeze-drying is one of the ‘missing links’ in the chain of pharmaceutical manufacturing. Current Freeze-drying is a very slow process and in order to achieve a continuous process there is a need for drastic increase of process speed. RheaVita developed a route towards such increase and also developed physical prototypes to demonstrate and further develop the scientific background. Throughout the development exercises, a scientific way of working has been adopted involving modeling and experimental verification. From the earlier phases onwards, PAT tools have been developed and employed, finally leading to a concept where all process steps are in closed-loop control. The presentation will illustrate some highlights of this effort which started effectively in 2013.