USER REQUIREMENT SPECIFICATION FOR AMPOULES

The URS is a definition of requirements to fulfil the demands of the process from the Users’ point of view. The success of a GMP clean room design is dependent on a clear and concise User Requirement Specification (URS) to take through a successful Design Qualification (DQ).

1. User Requirement Specification for Automatic External Ampoules Washing, Drying & Self Adhesive Labelling Machine
2. User Requirement Specification for Ampoule Vertical Ultrasonic Washing Machine
3. User Requirement Specification for Ampoule Filling Machine
4. User Requirement Specification for Autoclave cum Bung Processor
5. User Requirement Specification for Clean in Place Sterilization in Place Module
6. User Requirement Specification for Depyrogenation Tunnel
7. User Requirement Specification for High Pressure High Vacuum Sterilizer
8. User Requirement Specification for Leak Testing cum Terminal Sterilizer
9. User Requirement Specification for Shrink Wrapping Machine
10. User Requirement Specification for Manufacturing Vessel (600 L)
11. User Requirement Specification for Manufacturing Vessel (1300 L)