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The Process of Freeze-Drying
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The Process of Freeze-Drying
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A Model to Implement and Run a Compliant Freeze Drying Process
Edition: 1st edition 2014
21 Pages
ISBN: 978-3-943267-89-1
Excerpt from the GMP MANUAL

Freeze-drying is by far the most common unit process for manufacturing drug products which are too unstable to be marketed as ready-to-use liquid dosage forms. In freeze-drying, products are frozen and water is extracted by means of sublimation in a vacuum, until a specified product specific residual moisture is reached. Because the products are usually sterile products which cannot be subjected to heat sterilization, this procedure must be carried out under aseptic conditions. The whole process is quite complex, therefore, the manufacturer should carefully balance product requirements with equipment capabilities.

In this e-book you will find answers to the following questions:
- How is freeze-drying performed?
- What are the relevant process parameters to be measured?
- What are the quality-determining physical principles/processes?
- What are the technical requirements of a freeze-drying system and how is the system qualified?
- How is a freeze-drying cycle validated?

Table of Contents

1 The concept of freeze-drying
1.1 Physical Background
1.2 The freeze-drying cycle phases
2 Freeze dryer design
2.1 Refrigeration system
2.2 Vacuum system
2.3 Product chamber
2.4 Condenser
2.5 Control system
2.6 General aspects
3 Process monitoring and control
3.1 Pressure monitoring and control
3.2 Temperature monitoring and control
4 Qualification and process validation in freeze-drying
4.1 Regulatory background
4.2 Facility requirements
4.3 Qualification
4.4 Validation
5 Author

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Dr. Margit Gieseler, GILYOS GmbH, Würzburg (Germany) CEO
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