ASTM WK40866

    New Test Method for Leak Detection in Pharmaceutical Packaging by Vacuum Deflection Method

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    Developed by Subcommittee: F02.40 | Committee F02 | Contact Staff Manager



    WK40866

    1. Scope

    The method can be applied to non porous pharmaceutical blister packs sealed with flexible films. Such packs typically consist of thermoform polymer or cold formed aluminium trays which contain a number of individual pockets into which the tablets or capsules are placed. The trays are then sealed with a paper or foil based flexible laminate lidding material.

    Leaks in blister packs may cause the sealed product to become defective and can arise from imperfections in the packaging material or bond between the sealed surfaces. It is necessary for manufacturers to leak test blister packs to ensure the integrity of packaging and monitor the consistency of the packaging equipment. This method of leak testing is a useful tool as it allows non-destructive and non-subjective leak testing of blisters. It is used in pharmaceutical packaging lines, stability trials, package research and development operations.


    Keywords

    leak; pin hole; seal; integrity; defliection;

    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:
    02-12-2013

    Technical Contact:
    Dorian Dixon

    Item:
    001

    Ballot:
    F02.40 (14-02)

    Status:
    Negative Votes Need Resolution