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URS (User Requirements Specification) For Vial Lyophilization Process

This document outlines the stages and key parameters of the freeze drying process, including freezing, primary drying under vacuum, and secondary drying. It also discusses the necessary equipment components like the refrigeration system, vacuum system, and condenser. Finally, it lists the operational requirements for a freeze drying system, such as specifications for the shelves, condenser, heating/cooling systems, vacuum system, and control systems to monitor and record the process.

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Mike Song
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368 views2 pages

URS (User Requirements Specification) For Vial Lyophilization Process

This document outlines the stages and key parameters of the freeze drying process, including freezing, primary drying under vacuum, and secondary drying. It also discusses the necessary equipment components like the refrigeration system, vacuum system, and condenser. Finally, it lists the operational requirements for a freeze drying system, such as specifications for the shelves, condenser, heating/cooling systems, vacuum system, and control systems to monitor and record the process.

Uploaded by

Mike Song
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as TXT, PDF, TXT or read online on Scribd
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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

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