1-Introduction

2-Scope

3-Stages of freeze drying

3-1 Freezing (thermal treatment) at atmospheric press

3-1-1 Cooling rate
3-1-2 Freezing temp and time
3-1-3 Normal freezing process for amorphous products

3-2 Primary drying (sublimation) under vacuum

3-2-1 Target product temp
3-2-2 Chamber press
3-2-3 Shelf temp required to achieve target product temp
3-2-4 Overloading of freeze dryer
3-2-5 Primary drying end point

3-3 Secondary drying (desorption) under vacuum

3-3-1 Heating rate and chamber pressure
3-3-2 The shelf temp and secondary drying time
3-4 Stoppering under partial vacuum

4- Monitoring system
4-1 Silicone oil detection
4-2 Moisture content monitoring
4-3 System leak tests

5- Recipe for freeze drying

6- Freeze drying equipment

6-1 Refrigeration system
6-2 Vacuum system
6-3 Condenser

7- Operational Requirements
7-1 Shelves
7-2 Condenser
7-3 Venting system
7-4 N2 feeding system
7-5 Heating & cooling system
7-6 Shelf package
7-7 Door system
7-8 Vacuum system
7-9 Chamber
7-10 Basic technical requirement
7-11 Mechanical work & hygienic piping
7-12 Refrigeration system
7-13 Electrical system
7-14 In–Process control
7-15 Control system
7-15-1 Alarm management
7-16 Batch data display and record printing
7-17 Equipment location and available space
7-18 Required utilities
7-19 Safety Requirement

8- Desired documents

9- Training
10- Transport/ Delivery