ASTM WK57656

    New Guide for determining minimum seal strength for Medical Device Packaging

    (What is a Work Item?)

    Developed by Subcommittee: F02.50 | Committee F02 | Contact Staff Manager



    WK57656

    1. Scope

    to provide guidance on determining minimum seal strength for terminally sterilized peel-able medical device packaging.


    Keywords

    minimum peel strength, seal strength

    Rationale

    For many years in Medical Device Packaging there has been an arbitrary seal strength minimum value of 1.0 lbs./in. width. It is often perceived as a regulator requirement and it is not. No one knows where the value came from and it is inappropriate for many types of packaging. It is too low for large and/or heavy devices and too high for some small and/or light weight devices. Because of these reasons it is inappropriate to apply a single arbitrary minimum value to all packaging applications. Many Packaging Engineers have been faced with challenges stemming from the perception and a guidance document would help clarify and define a more appropriate way.

    The title and scope are in draft form and are under development within this ASTM Committee.

    Citing ASTM Standards
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    Work Item Status

    Date Initiated:
    02-02-2017

    Technical Contact:
    Geoffrey Pavey

    Item:
    001

    Ballot:
    F02.50 (20-03)

    Status:
    Negative Votes Need Resolution