Water Activity Applications in the Pharmaceutical Industry (single user digital version)

Jun 2009
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PDF Single user
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This book examines the fundamentals and relationships of water activity, ranging from the measurement of moisture content, water activity, and water sorption isotherms, to ways in which water activity affects microorganisms, chemical reaction rates, drug product formulation and processing and physical properties, water activity as a hurdle, and applications of water activity management in the pharmaceutical industry.

Book wrote in 2009.

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Table of Contents

Table of Contents:

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1. Introduction - Historical Highlights of Water Activity Research byAnthony J. Fontana, Jr.
2. Water Activity: Fundamentals and Relationships by Anthony J. Fontana, Jr.
3. Water Activity Determination and Standard-setting Organizations by Anthony M. Cundell
4. Measurement of Water Activity, Moisture Sorption Isotherms, and Moisture Content of Drug Substances, Excipients, and Drug Products by Anthony J. Fontana, Jr.
5. Utilization of Moisture Sorption Data in Pharmaceutics by Leonard N. Bell
6. The Role of Water Activity in Drug Product Development by Roberta Tracy, Michelle Raikes and Christian Meissner
7. Water Activity and Cosmetic Preservation by P.A. Geis and S. L. Schultz
8. Water Activity and Survival of Probiotics by John Coventry and Ross Crittenden
9. Effects of Water Activity on Microorganisms by Anthony M. Cundell
10. Applications of Water Activity Management in the Pharmaceutical Industry by Detlef Werner
11. Use of Water Activity to Support Microbiological Stability by Linda Skowronsky
12. Water Activity and Pharmaceutical Manufacturing: A Regulatory Microbiology Perspective by David Hussong<

Appendix A: Water Activity of Saturated Salt Solutions as a Function of Temperature
Appendix B: List of Water Activity and Moisture Sorption Isotherm Manufacturers
Appendix C: Fundamental Equations: Water Activity Prediction, Electrolyte Solutions, and Moisture Sorption Isotherms
Appendix D: Minimum Water Activity Limits for Growth of Microorganisms
Appendix E: Water Activity Values of Select Pharmaceutical and Consumer Products

About the Authors

About the Editors

Dr Anthony M. Cundell works in the Schering-Plough Research Institute as the Director, Pharmaceutical Sciences Microbiology where he directs a 16-person R&D microbiology laboratory supporting product development. Prior to joining Schering-Plough in February 2006, Dr Cundell was running his own Microbiology consultancy business, and prior to that had a long and distinguished career with Wyeth Pharmaceuticals and The New York Blood Center. Among his many accomplishments, Dr. Cundell was Chair of the PDA Task Force responsible for the publication of the 2000 Technical Report #33 The Evaluation, Validation, and Implementation of New Microbiological Testing Methods. He was re-appointed to the 2005-2010 USP Microbiology and Sterility Assurance Committee of Experts. In 2005 Dr. Cundell was voted by his peers as the Pharmaceutical Technology/Institute of Validation Technology Microbiologist of the Year. He has published extensively in the areas of rapid microbial methods, sterilization processes, microbial identification, and risk assessment. Dr. Cundell has a Ph.D. in Agricultural Microbiology from the Lincoln University, Canterbury, New Zealand as well as a M.Sc.(Hons) degree in Biochemistry from Victoria University of Wellington, New Zealand and a B.Sc. degree in Biochemistry and Chemistry, Victoria University of Wellington, New Zealand.

Dr Anthony J. Fontana Jr. is Technical Director of Chemistry for Silliker, Inc. and has over 15 years of food quality and safety experience. Dr. Fontana received his bachelor degree in Biochemistry from the University of California (Riverside) in 1985 and doctorate in Agricultural and Environmental Chemistry from the University of California (Davis) in 1994. Dr. Fontana possesses an extensive background in food safety and has been an invited presenter at seminars and workshops on water activity for food safety and quality to professional organizations, government agencies, and leading food companies. He has also published many articles in leading industry publications on topics ranging from sample preparation to extending shelf-life in foods. He is an editor and contributor for a new book, "Water Activity in Foods: Fundamentals and Applications," which was released last year. He is an active member of several associations including the Institute of Food Technologists, AOAC International, International Association for Food Protection, American Association for the Advancement of Science, and American Chemical Society.