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

Do sterile products remain sterile in your packaging?

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.

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.

Johanna Lipski
M. Sc.

Deputy Head of Laboratory for Shipping Simulation