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Freeze-drying of pharmaceutical and food products

T-C Hua, B-L Liu, Shanghai University of Science and Technology, China and H Zhang

Woodhead Food Series No. 198

 - addresses the principles and practices used in this important preservation technique
 - explains the fundamentals of heat-mass transfer analysis, modelling and the equipment used
 - discusses the importance of disinfection, sterilization and process validation

Freeze-drying is an important preservation technique for heat-sensitive pharmaceuticals and foods. Products are first frozen, then dried in a vacuum at low temperature by sublimation and desorption, rather than by the application of heat. The resulting items can be stored at room temperature for long periods. This informative text addresses both principles and practice in this area.

The first chapter introduces freeze-drying. The authors then review the fundamentals of the technique, heat-mass transfer analyses, modelling of the drying process and the equipment employed. Further chapters focus on freeze-drying of food, freeze-drying of pharmaceuticals and the protective agents and additives applied. The final chapter covers the important subjects of disinfection, sterilization and process validation.

Freeze-drying of pharmaceutical and food products will be an essential reference for food, pharmaceutical and refrigeration engineers and scientists with an interest in preservation techniques. It will also be of use to students in these fields.

ISBN 1 84569 746 4
ISBN-13: 978 1 84569 746 4
July 2010
280 pages  234 x 156mm  hardback  
£115.00 / US$195.00 / €145.00

Reprinting – not in stock at present

About the authors

Tse-Chao Hua and Bao-Lin Liu have studied in both China and the USA and are currently faculty members at Shanghai University of Science and Technology. Dr Hua has studied preservation technology since 1980. His interests include cryopreservation of cells and tissues, cold storage and freeze-drying of food, pharmaceuticals and living cells. Dr Liu has worked on cryobiology since 1993. He is interested in vitrification, biomedical engineering and freeze-drying technology. Dr Zhang has studied in China and Germany with a particular focus on refrigeration and cryogenics.

Contents

Introduction
 - Brief history of freeze drying technology
 - Basic processes of freeze drying
 - Protecting agents of freeze drying
 - Freeze drying system constitution
 - Applications of freeze drying technology

Fundamentals of freeze drying
 - Properties of water and aqueous solution
 - Freezing process
 - Sublimation drying process
 - Desorption drying process
 - Storage of freeze dried products

Heat-mass transfer analyses and modeling for drying process
 - Restriction of heat- mass transfer and its relative properties
 - Characteristics of drying process in different heating forms
 - Analyses of mass transfer control and heat transfer control sublimation drying
 - Mathematical model and computational analyses of primary and secondary drying stages
 - Thermal properties of freeze dried material
 - Discussion of mathematical model for drying process

Equipment of freeze drying
 - Vacuum requirement of freeze drying
 - Vacuum measurement in freeze drying
 - Vacuum pump for freeze drying
 - Refrigeration system and water vapor condenser in freeze drying
 - Small scale freeze drying devices for laboratory use
 - Intermediate experimental freeze drying equipment
 - Intermittent and continuous freeze drying equipment
 - Food freeze drying equipment
 - Pharmaceutical freeze drying equipment

Freeze drying of food
 - Characteristics of freeze-dried food
 - Techniques for food freeze-drying
 - Examples of food freeze-drying
 - Hazard analysis and critical control point for freeze-drying of food
 - Application of HACCP in food freeze drying

Protective agent and additives for freeze-drying of pharmaceutical products
 - Sugars/polyols-type protective agents
 - Polymer-type protective agents
 - Surfactants and amino acid-type protective agents and other additives
 - Formula issues of the freeze-drying products
 - Examples of formula

Freeze drying of pharmaceuticals
 - Basic issues for pharmaceutical freeze-drying
 - Freeze-drying of Protein and Hormone
 - The freeze drying of Fibrinogen
 - Freeze-drying of liposome
 - Freeze-drying of water-soluble and fat-soluble liposome pharmaceuticals

Disinfection, sterilization and valiation in freeze drying
 - Disinfection and sterilization
 - Validation
 - Cleaning-in-place, sterilization –in-place and validation
 - Process validation of freeze-drying
 - Validation of technical process and the evaluation of validation
 - Daily monitoring, revalidation and retrospective validation