ASTM-F describes the standard test method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration. The current test method is ASTM F dye penetration. • It has been used for many years for testing seal integrity of sterile barrier systems. • Round robin. While the traditional ASTM F Dye. Penetration standard is Triton-X used in dye penetration testing is a non-ionic surfactant with both a hydrophilic.
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ASTM-F – Medical Package Testing
The dye solution used in penetration testing will wick through any porous material over time, but normally not within the suggested maximum time. Please keep this in mind when developing your studies and validations. Refer to Appendix X1 for details on wicking and guidance ;enetration the observance of false positives. The test methods are limited to porous materials which can retain the dye penetrant solution and prevent it from discoloring the seal area for a minimum of 5 seconds.
Either is to be regarded as standard.
Overview of ASTM F1929 Dye Penetration Integrity Test
These leaks are frequently discovered at seals between package components of the same or dissimilar materials. Along the extended unsealed area beyond outer seal edgethe transparent material is separated from the porous peentration with use of a finger, paperclip, etc.
Water already in the seal due may render them undetectable with a dye penetrant. As a guide, each Test Method above recommends observing each seal for a maximum of 5 seconds on a 4-sided package 20 seconds total. The dye will have discolored the surface of the material. Leaks t1929 also result from a pinhole in the packaging material.
A dye penetrant solution is applied locally to the seal edge to be tested for leaks. Leaks may also result from a microscopic pinhole in the packaging material that is invisible to the human eye.
No indication of leak size can be inferred from these tests. Learn more about the different testing services provided at each location.
Here is a quick overview of the changes: The Creep Test provides a test for slow shear of the adhesive bond similar to a dead weight hanging on the seal.
Place a bead of solution between the two materials along the outer edge of the package seal, ensuring the entire outer edge of the seal is wetted with the dye solution. Link to Active This link will always route to the current Active version of the standard. They are not quantitative. If ASTM F testing is used as the quality control method, the test specimen must consist of a complete packaged device.
Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.
Please contact us with any questions you may have about ASTM F, or if we can help you with any other testing questions or projects. However, since ASTM F testing is designed solely to detect leakage, components that illustrate any indication of leakage are usually rejected. Observe each seal for a recommended duration of 5 to 20 seconds. Requirements ASTM F testing is limited to porous materials which can retain the dye penetrant solution and prevent it from discoloring the entire seal for a minimum of 20 seconds.
There is no general consensus regarding the level of leakage that is likely to be detrimental to a particular package. A dye penetrant solution is applied locally to the seal edge to be tested for leaks.
ASTM F procedure requires that the penetratoin penetrant have good contrast to the opaque packaging material. This pressure creates the force needed to rupture the seal. Packaging must be free of condensation or any other source of liquid water.
The dye will have discolored the surface of the material. For more information visit www.
Uncoated papers are especially susceptible to leakage and must be evaluated carefully for use with each test method. The presence of a number of small leaks, as found in porous packaging material, which could be detected by other techniques, will not be indicated.
Because air escapes through the walls of a porous package during inflation, the flow rate must be increased to de for the lost air through the walls and create the back pressure in the porous package. If wicking does occur, it may be verified by observing the porous side of the subject seal area.
The Eyedropper method requires the packages to have an unsealed area that extends beyond the outer edge of the seal.