Dye penetration test: Testing the sterile barrier of critical medical devices

Do sterile products remain sterile in your packaging?

As soon as a surgeon steps up to the operating table for surgery, the patient can expect that the instruments used are sterile. And that they have not been contaminated during transport.

We verify this expectation with dye penetration tests performed in accordance with ASTM F1929 (Edge Dip Method, Method B) for porous packaging or ASTM F3039 for non-porous packaging.

Farbeindringprüfung nach Dyetest

A channel appearing in blue shows the vulnerability

The test in the variant of method A works as follows: Different packaging variants are tested, mostly consisting of film/foil or film/special paper, which package a sterile product. This can be, for example, surgical scissors, skull nails or implants (hip / knee). The goal is to detect channels larger than 50 µm in the seal seam. If such a channel is found, the test would be failed, because it would mean that the sterile barrier would be violated. To search for these unwanted channels, we use blue colored solution which, as soon as it encounters a channel, makes it clearly visible.

Testing Standards & Equipment

  • ASTM F1929
  • ASTM F3039
Sealing seams or the sterile barrier system must be safe and intact in the hands of the end user (e.g. doctor during an operation) according to DIN EN 11607.
A visual check and a bubble test round off the test. It is particularly important for us to mention that we can offer you everything at our laboratory, because this test can be performed in combination with other integrity tests such as bubble test, seal strength test, transport simulation, climate control and accelerated aging.

The required samples of critical medical devices do not leave our laboratory and do not have to be subcontracted to other testing services. This gives you the assurance of an inclusive result that automatically combines all the tests performed. The integrity of the sealed seam can be demonstrated without further delay.

    Your contacts

    Karolina Behrens
    Karolina Behrens

    Head of Laboratory for Shipping Simulation
    Pharma & Medical

    040 / 5730 944 -27

    Johanna Lipski

    Johanna Lipski
    M. Sc.

    Deputy Head of Laboratory for Shipping Simulation
    Pharma & Medical

    040 / 5730 944 -26

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    ISTA certification helps minimise product damage and optimise resource use through effective packaging design.
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