Freeze-Drying of Pharmaceutical and Food Products addresses both principles and practice.

Features:

• 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

Contents

1. 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

2. Fundamentals of freeze drying

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

3. 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

4. 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

5. 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

6. 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

7. 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

8. Disinfection, sterilization and validation 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

Index

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