Validation

Stripfoil machines are designed and intended for use in sterile facilities and have therefore been designed to the best GMP standards, with all component parts being certificated and fully traceable.

The highest attention possible has been paid to the health and safety aspects of the unit, and the result has been fully successful validation on every installation.

Pharma Engineering provides a comprehensive manual with each machine which contains all the information required for the production of a User Requirement Specification, in the event that the client chooses to prepare and execute all validation documents himself.

However Pharma Engineering is able to complete all the validation stages on behalf of a client if required. This is a chargeable service, but one which can augment the client’s own resources, and speed along the process of facilitating the operation of the machine on the production line.

The following stages would comprise a typical validation package:

• User Requirement Specification (URS)
• Functional Design Specification (FDS)
• Factory Acceptance Test (FAT)
• Site Acceptance Test (SAT) and/or Installation/Operation IQ/OQ
• Performance Qualification (PQ)