URS

URS to Process envelope correspondence:  Start the process of obtaining a freeze dryer knowing what the product characteristics are, and then dictate specifications and build a URS that reflects the hardware, software, and performance envelope that will provide the least risk.  Write the specs so that the resultant machine helps to ensure that the product can be successfully processed in this dryer, as specified in the URS.  If you are not able to do this with in-house expertise, allow Applewood Scientific to assist you in this important starting point.

User Requirement Specification

for

Lyophilizers

Table of Contents

1          INTRODUCTION. 4

2          OVERVIEW.. 5

3          OPERATIONAL REQUIREMENTS. 6

3.1       User’s Process Acceptance Criteria. 6

3.2       Technical Data. 7

3.3       Functions. 9

3.4       Power Failure And Recovery. 11

3.5       Emergency Stop. 11

3.6       Alarms and Warnings. 11

3.7       Data & Security. 12

3.8       Interfaces. 12

3.9       Data Collection. 12

3.10     Security Levels. 12

3.11     ENVIRONMENT. 13

3.12     Product 13

3.13     Freeze Drying Process. 13

3.14     Construction Material 14

3.15     Lyophilizer Configuration. 15

3.16     Disaster Recovery. 15

3.17     Data & Security. 15

3.18     Control Alarms. 16

3.19     Data. 16

3.20     Control Interfaces. 17

4          CONSTRAINTS. 19

4.1       Milestones And Timelines. 19

4.2       Compatibility. 20

4.3       Utilities. 20

5          Availability. 20

5.1       Duty. 20

6          maintenance. 21

6.1       Instruction. 21

6.2       Spare parts. 21

7          LIFE-CYCLE. 21

7.1       Development 21

7.2       Testing. 22

7.3       Delivery. 24

7.4       Shipping Requirements. 24

7.5       Documentation. 24

7.6       Support 24

8          GLOSSARY. 26

9          REFERENCES. 27

10         APPROVAL. 28

  • Vacuum Pump Isolation

 

 

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