The ASTM F1929-15 standard, published by the American Society for Testing and Materials (ASTM), describes materials and procedures to detect and locate a leak equal to or greater than a channel formed by 50 µm wire in package edge seals formed between a transparent material and a porous sheet material. defines.
For leaks during the test, a dye penetrating solution is applied locally to the seal edge to be tested. After a period of contact with the dye penetrating solution, the packaging is visually inspected for dye penetration. The full name of this standard is as follows: ASTM F1929-15 Standard test method for detecting gasket leaks in porous medical packaging by dye penetration.
In the test method presented in the ASTM F1929-15 standard, three paint application methods are covered: injection, edge dipping and dropper. These test methods are designed for use in edge-sealed packages formed between a transparent material and a porous sheet material. All three test methods are limited to porous materials that can retain the dye penetrating solution and prevent discoloration of the sealing area for at least 5 seconds. Uncoated papers are particularly sensitive to leakage and should be carefully evaluated for use with each test method.
In the real environment, harmful biological or particulate contaminants enter medical packages through leaks. These leaks are usually found in seals between packaging components of identical or dissimilar materials. Leaks can also be caused by a pinhole on the packaging material. The purpose of this test method is to visually observe the presence of duct defects due to dye leakage.
This dye penetrant test method is only valid for leaks in the package seal. It does not include the presence of other minor leaks in the porous packaging material detected by other methods. These tests are suitable for locating and verifying leakage areas, not quantitative.
With the experience gained over many years, our organization also provides standard testing services to the requesting enterprises, within the framework of laboratory services of the materials with a trained and expert staff, to detect ASTM F1929-15 Dye penetration and seal leaks in porous medical packages.
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