Common use of Packaging Design Verification Clause in Contracts

Packaging Design Verification. Design Verification related to packaging are the impacted TDI’s related to the packaging configuration (tray, pouch, sheath extrusion (length change), carton) only. The only TDIs that Cordis will be tested as part of the Design Verification for packaging are: • Product Migration • Product Visual Inspection • Packaging Integrity Test (Visual Inspection) • Package Challenge Test (Bubble Test) • Dye Penetration Test • Seal Pull Test DV & PQ for the packaging will be combined. DV/PQ units will be subjected to three EtO sterilization cycles. No aging testing will be performed by Cordis for the 36 new Carotid Stent Delivery System catalogs - 57cm length project. Cordis Quality System is used by Cordis.