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    Packaging validation tests are conducted to ensure the integrity of medical blisters and pouches. Seal integrity is tested through external visual inspection, dye penetration, aerosol testing to simulate hospital storage, leak testing under vacuum, and calibrated hole testing. More sensitive methods like hydrogen or CO2 tracer gas testing and underwater blue dye testing are used to locate very small holes. Seal strength is evaluated using burst testing and peel testing according to ASTM standards. Shelf life is estimated using accelerated aging tests as per ASTM standards. Finally, transport validation involves simulating shipping using standardized testing like ISTA 2A to ensure resistance to impacts, drops, vibration, heat and humidity.

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    Packaging validation tests are conducted to ensure the integrity of medical blisters and pouches. Seal integrity is tested through external visual inspection, dye penetration, aerosol testing to simulate hospital storage, leak testing under vacuum, and calibrated hole testing. More sensitive methods like hydrogen or CO2 tracer gas testing and underwater blue dye testing are used to locate very small holes. Seal strength is evaluated using burst testing and peel testing according to ASTM standards. Shelf life is estimated using accelerated aging tests as per ASTM standards. Finally, transport validation involves simulating shipping using standardized testing like ISTA 2A to ensure resistance to impacts, drops, vibration, heat and humidity.

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    9 views1 page

    Excellence in Medical Package Testing

    Uploaded by

    ifiedelman
    Packaging validation tests are conducted to ensure the integrity of medical blisters and pouches. Seal integrity is tested through external visual inspection, dye penetration, aerosol testing to simulate hospital storage, leak testing under vacuum, and calibrated hole testing. More sensitive methods like hydrogen or CO2 tracer gas testing and underwater blue dye testing are used to locate very small holes. Seal strength is evaluated using burst testing and peel testing according to ASTM standards. Shelf life is estimated using accelerated aging tests as per ASTM standards. Finally, transport validation involves simulating shipping using standardized testing like ISTA 2A to ensure resistance to impacts, drops, vibration, heat and humidity.

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    Packaging Validation Tests for Medical Blisters

    and Pouches
    Seal Integrity
    External inspection according to ASTM F1886. A relatively simple test regularly used to
    supplement information gleaned from other seal tests.
    Dye penetration according to ASTM F 1929. Dye is injected into sealed packs, ingress
    into seals is then visually inspected for. Suitable for packs with at least one transparent
    web or a porous web.
    Hospital environment aerosol test. This test has been validated internally and shown to find
    channels as small as 0.3mm. It simulates 1 year of storage unprotected on a hospital trolley.
    Leak into a vacuum according to ASTM F-2095. A pressure decay test which is very
    precise, it requires tooling.
    Calibrated hole test. In this test impermeable packs are fitted with laser drilled holes of
    12.5, 25, or 50 micron diameter. Leak from the packs is then measured using a vacuum
    decay method and compared to non-perforated packs. MET uses this test for validation
    and IQ/PQ studies on customer’s own machines.
    Hydrogen or CO2 tracer gas testing. An extremely sensitive test, ideal for 100% testing
    and locating of the tiniest of holes in non-porous packs.
    Under water (Blue Dye) test. An alternative to tracer gas testing for tablet and capsule
    blister packs.

    Seal Strength
    Burst test according to ASTM 1140. A good strength test, which examines the entire seal
    area, locating the weakest point. Suitable for porous and non-porous packs.
    Seal peel (tensile) test to ASTM F88. Measures the force required to peel packs open.

    Shelf Life
    Accelerated ageing according to ASTM F 1980. Storage of packs at elevated
    temperature is used to simulate shelf life ageing in a shorter time period. Suitable for
    porous and non-porous packs.

    Transport System Validation


    A uniform shipping simulation test according to ISTA 2A, testing pack resistance to
    impact, drops, vibration, heat and humidity.

    Medical Engineering Technologies Ltd • Unit 16, Holmestone Road, Dover, Kent CT17 0UF, UK
    t +44 (0)845 458 8924 e solutions@met.uk.com www.met.uk.com
    Registered No. 3295099 VAT No. GB 6838559 76 Certificate No AJAEU/10/11898

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