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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There is no general consensus regarding the level of leakage that is likely to be detrimental to a particular package. 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 penetratjon 5 seconds.
Here is a quick overview of the changes: The Eyedropper method requires the packages to have an unsealed area that extends beyond the outer edge of the seal. These leaks are frequently found at seals between package components of the same or dissimilar materials. Leaks may also result from a microscopic pinhole in the packaging penegration that is invisible to the human eye.
This pressure creates the force needed to rupture the seal. 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.
The porosity or lack thereof of the package material determines the inflation rate for the burst test. 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.
Most commonly, an eyedropper or pipette is used to apply the dye penetration solution between the transparent and porous materials of the unsealed area.
ASTM-F – Medical Package Testing
Along the extended unsealed area beyond outer seal edgethe transparent material is separated from the porous material with use of a finger, paperclip, etc. 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. Harmful biological or particulate contaminants may enter the device through leaks.
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. Because air escapes through the f129 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.
However, since these tests are designed to detect leaks, components that exhibit any indication of leakage are normally rejected. After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration. 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. If ASTM F testing is used as the quality control method, the test specimen must consist of a complete packaged device.
Uncoated papers are especially susceptible to leakage and must peneyration evaluated carefully for use with each test method. Either is to be regarded as standard.
If wicking does occur, it may be verified by observing the porous side of the subject seal area. A dye penetrant solution teat applied locally to the seal edge to be tested for leaks. In the Burst Testair is introduced into the package at a predetermined pressure and flow rate.
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Overview of ASTM F Dye Penetration Integrity Test
These leaks are frequently discovered at seals between package components of the same or dissimilar materials. The Creep Test provides a test for slow shear of the adhesive bond similar to a dead weight hanging on the seal.
No indication of leak size can be inferred from these tests. Penetrattion already in the seal defects may render them undetectable with a dye penetrant. ASTM F procedure requires that the dye penetrant have good contrast to the opaque packaging material.
Overview of ASTM F1929 Dye Penetration Integrity Test
The package will be visually inspected for dye penetration after contact with the dye penetrant for a specified time. If wicking does transpire, it may be verified by observing the porous side of the subject seal area. The dye will dyye discolored the surface of the material. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.