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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It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. In the Burst Testair is introduced into the package at a predetermined pressure and flow rate. A dye penetrant solution is applied locally to the seal edge to be tested for leaks.
Observe each seal for a recommended duration of 5 to 20 seconds. A dye penetrant solution is applied locally to the seal edge to be tested for leaks. Leaks may also result from a pinhole in the packaging material.
If ASTM F testing is used as the quality control method, the test specimen must consist of a complete packaged device. This pressure creates the force needed to rupture the seal. If wicking does occur, it may be verified by observing dyw porous side of the subject seal area. Harmful biological or particulate contaminants may enter the device through leaks. 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.
The Creep Test provides a test for slow shear of the adhesive penetratikn similar to a dead weight hanging on the seal.
Overview of ASTM F Dye Penetration Integrity Test
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. Link to Active This link will always route to the current Active version of the standard.
Historical Version s – view previous versions of standard. These leaks are frequently discovered at seals between package components of the same or dissimilar materials.
For more information visit www. These leaks are frequently found at seals between package components of the same or dissimilar materials.
The dye will have discolored the surface of the material. Because air escapes through the walls of a porous package during inflation, the flow rate must be increased to compensate for the lost air through the walls and create the back pressure in the porous package.
Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. The dye solution used in penetration testing will wick through any porous material over time, but normally not within the suggested maximum time.
Packaging must be free of condensation or any other source of liquid water. If wicking does transpire, it may be verified by observing the porous side of the subject seal area.
ASTM-F – Medical Package Testing
Observe the package for any penteration originating from the inside edge of the package seal towards the outside edge of the package seal. Along the extended unsealed area beyond outer seal edgethe transparent material is separated from dje porous material with use of a finger, paperclip, etc.
There is no general consensus regarding the level of leakage that is likely to be detrimental to a particular package. The dye will have discolored the surface of the material. The porosity or lack thereof of the package material determines the inflation rate for the burst test. No indication of leak size can be inferred from these tests.
Uncoated papers are especially susceptible to leakage and penerration be evaluated carefully for use with each test method. 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.
Leaks may also result from a microscopic pinhole in the packaging material that is invisible to the human eye. Most commonly, an eyedropper or pipette is used to apply hest dye penetration solution between the transparent and porous materials of the unsealed area.
Water already in the seal defects may render them undetectable with a dye penetrant.
The package will be visually inspected for dye penetration after contact with the dye penetrant for a specified time. 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.
ASTM F procedure requires that the dye penetrant have good contrast to the opaque packaging material. Please contact us with any questions you may have about ASTM F, or if we can help you penetraiton any other testing questions or projects.
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. However, since these tests are designed to detect leaks, components that exhibit any eye of leakage are normally rejected. Here is a quick overview of the changes: After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration. However, since ASTM F testing is designed solely to detect leakage, components that illustrate any indication of leakage are usually rejected.
Refer to Appendix X1 for details on wicking and guidance on the observance of false positives. Either is to be regarded as standard. They are not quantitative. Please keep this in mind when developing your studies and validations.