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ISO 11607 - 1 & 2 Packaging for Terminally Sterilized ...

1 ISO 11607 -1 & 2 Packaging for Terminally Sterilized Medical DevicesJan Gates: Adept Packaging LLC10X Conference, May 201922 Over 35+ years in medical devices, foods, pharmaceutical and detergent industriesPackaging engineering experience in design, material and distribution testing, material and equipment validations, PMA submissions, REACH/RoHS, EU Packaging Waste Directives, and sustainabilitySoCal Institute of Packaging Professionals Chapter, Co-PresidentIoPP Medical Device Packaging Technical Committee, memberASTM F02, Flexible Barrier Packaging memberASTM D10, Rigid/Environmental Packaging and Testing committee member ISO TC122 SC3 TAG Liaison ChairISO TC122 WG5 Covenor VocabularyISO TC122 WG13 (Labels) & WG16 (Controlled Temperature Packaging ) SMEJan GatesPrincipal Packaging Engineer, Adept PackagingVP Client Solutions, West Coast33 Some of My Old Work44 Some of My Current Work555 Package Engineering SummaryDevelop Packaging human factors for users (end and production)Reduce product breakageMinimize sizing to optimize shipping costsGood Packaging is sustainableAssure label legibility with use and timeOptimize Packaging materials for product shelf li

Packaging System Seal Integrity Aseptic Presentation Stability Testing Performance Testing. 10 ... Aging the packaging system is independent of the physical configuration or contents, as long as: The processing is the same, and The contents do not affect the materials

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