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

Do sterile products remain sterile in your packaging?

Start 9 Laboratory 9 Pharmaceutical and medical products 9 Dye penetration test

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.

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
Dipl.-Ing.

Head of Laboratory for Shipping Simulation
Pharma & Medical



040 / 5730 944 -27



behrens@bfsv.de

Johanna Lipski
M. Sc.

Deputy Head of Laboratory for Shipping Simulation
Pharma & Medical



040 / 5730 944 -26



lipski@bfsv.de

We find answers for your questions

We convey competence, put packaging in focus and find answers to your questions - authentically, honestly, competently and without digressing. So that we can answer your questions, examine your products and expand your knowledge of packaging, send us your e-mail address and we will get back to you.
We are already looking forward to your very individual challenge!

Our accreditation & certifications

Accreditation

The German Accreditation Body (DAkkS)
is the national accreditation authority
of the Federal Republic of Germany.

Certification

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

Recognition

DIN CERTCO certifies and assesses the conformity of products and services on the basis of defined standards.

The competence of our testing laboratories for packaging testing is officially recognised:

» Accreditation & certifications