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Shelf life of packaging materials for medical device products

  • 1.  Shelf life of packaging materials for medical device products

    Posted 01-05-2023 14:17
    Hi MDPTC members!
    Recently, my team has faced challenges regarding declaring shelf life for packaging materials which are purchased from suppliers and used for packaging medical device (non-sterile) products, i.e., multi-layer bags, paperboard boxes, etc.. The bags for example are sealed on three sides and once filled at our location are sealed on the last side for final packaging and sale. We've encountered suppliers reticent to declare more than a one year shelf for the bags and have been in a position to do our own shelf life testing to increase shelf life to allow for larger inventory stocks that do not expire in one year. Does anyone have a better way of addressing the shelf life claim with the supplier or otherwise to increase without the need for testing each time a new package is developed?

    Thanks! 
    Michaela Kim
    Staff Pkg Eng
    Illumina, Inc.
    mkim1@illumina.com

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    Michaela Kim CPP
    Senior Packaging Engineer
    Illumina, Inc.
    San Diego CA
    (858) 218-4028
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