The User Requirement Specification is the base upon which rests many of your SOP’s, regulartory submissions, validation protocols, computer system qualification, as well as the installation and operational qualifications.  The URS could be written to allow the specs to contain operational capabilities containing the process envelope that is important to your production, regulatory, and validation programs. When you are starting a new program involving lyophilization, consider starting the process of obtaining a freeze dryer knowing what the product characteristics are, and then allow product, facility, and process requirements, to dictate some of the specifications.  Having this step by step program will allow you to build a URS that reflects the hardware, software, and performance envelope that will provide the least risk to your company.  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.

Typical User Requirement Specification contents:

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