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GLE has gained extensive experience testing equipment as a part of their project activities. GLE offers this experience to Clients as a stand-alone service for the following specific equipment types where GLE will write and execute test procedures (FAT, SAT, IQ & OQ) with or on behalf of a Client:
Vial & Syringe Washing
Vial & Syringe Depyrogenation / Sterilizing Tunnels
Vial & Syringe Filling
Vial Capping
Automatic Vial & Syringe Inspection*
Lyophilizers
Lyophilizer Loading / Unloading System
Vial & Syringe ID & Inspection
GLE also offers supplemental testing programs where specific tests are written and executed to enhance current Client test programs. Supplemental testing is often undertaken after the completion of major equipment modifications or where the technology employed is new and testing is used to establish the limits of the prototype equipment.
As a part of all testing activities, GLE arranges the test execution planning, the test equipment and any specialized test fixtures that may be required.
*GLE assists the Client with the preparation of inspection challenge samples including sample preparation protocols against Knapp standards.
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