The dye penetration test is an important step in the quality control of packaging materials, especially in the field of medical packaging. In accordance with the ASTM F1929 and ASTM F3039 standards, this test is carried out in a standardized manner to detect leaks or weak points in the sealing of packaging.
Testing for impermeability and continuity of the seal
The packaging of medical devices plays a central role, as it must not only protect the contents, but also ensure patient safety by complying with strict legal requirements.
We have specialized in the packaging inspection of medical products. Packaging inspection is an essential step in ensuring the quality and safety of medical devices in accordance with the guidelines.
The leak test of the sealing seams according to ASTM F1929 for porous packaging and ASTM F3039 for non-porous packaging is an important step in the quality control of packaging. The standards describe the procedures and criteria for testing the seal integrity of packaging. The integrity of packaging is an essential prerequisite for preventing contamination of medical devices and avoiding potential risks from leaking packaging.
A dye solution adapted to the respective standard is used to carry out the test. This dye solution is injected into the packaging, for example, and brought into contact with the sealing seam from the inside. A visual check is made to see whether the dye solution penetrates the sealing seams. Each seal seam test sample is covered with the dye solution for 5 seconds and tested. The lower detection limit of the methods presented is a channel size of 50 µm.
ASTM F1929
The test is carried out using a color solution to detect leaks/channels on combinations of porous and non-porous materials, such as Tyvek® or medical paper with films made of PE, for example.
ASTM F3039
The test is carried out in the same way as the method described above. If only non-porous packaging materials are tested (film-film). For opaque materials, the outside of the sealing seam is brought into contact with white filter paper.
The tests are carried out within our accredited scope.
Guidelines
- ASTM F1929 porous packaging
- ASTM F3039 non-porous packaging
We look forward to supporting you in ensuring the quality and safety of your medical devices.
Rely on our expertise to ensure that your medical products retain their quality and safety even after years of storage.
For further information, please contact us at
verpackungspruefung@gfps.de