The current test method is ASTM F dye penetration. . ASTM F – 98 ( Reapproved ) Standard Test Method for Detecting Seal. Leaks in Porous. 1 This test method is under the jurisdiction of ASTM Committee F02 on Flexible Last previous edition approved in as F – ASTM F testing defines materials and a procedure that will detect and locate a leak equal or greater than a channel formed by a 50 μm ( in.) wire in.
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Overview of ASTM F Dye Penetration Integrity Test
Please contact f192998 with any questions you may have about ASTM F, or if we can help you with any other testing questions or projects. Packaging must be free of condensation or any other source of liquid water.
Most commonly, an eyedropper or pipette is used to apply the dye penetration solution between the transparent and porous materials of the unsealed area. 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.
Observe each seal for a recommended duration of 5 to 20 seconds. ASTM F procedure requires that the dye penetrant have good contrast to the opaque packaging material.
There is no general consensus regarding the level of leakage that is likely to be detrimental to a particular package.
ASTM-F – Medical Package Testing
This pressure creates the force needed to rupture the seal. For more information visit www. These leaks are frequently discovered at seals between package components of the same or dissimilar materials. 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. However, since ASTM F testing is designed solely to detect leakage, components that illustrate any indication of leakage are usually rejected. The dye will have discolored the surface of the material.
If ASTM F testing is used as the quality control method, the test specimen must consist of a complete packaged device.
The Eyedropper method requires the packages to have an unsealed area that extends beyond the outer edge of the seal. Here is a quick overview of the changes: Place a bead of solution between the two materials along the outer edge of the package seal, ensuring the c1929-98 outer edge of the seal is wetted with the dye solution.
The dye solution used in penetration testing will wick through any porous material over time, but normally not within the suggested maximum time. A dye penetrant solution is 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. 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.
Observe the package for any leaks originating from the inside edge of the package seal towards the outside edge of the package seal.
Please keep this in mind when developing your studies and validations. Water already in the seal defects may render asttm undetectable with a dye penetrant.
Leaks may also result from a microscopic pinhole in the packaging material that is invisible to the human eye. The porosity or lack thereof of the package material determines the inflation rate for the burst test.
Harmful biological or particulate contaminants may enter the device through leaks. Along the extended unsealed area beyond outer seal edgethe transparent material is separated from the porous material with use of a finger, paperclip, etc.
If wicking does transpire, it may be verified by observing the porous side of the subject seal area. The package will be visually inspected for dye penetration after contact with the dye penetrant for a specified time. The Creep Test provides a test for slow shear of the adhesive bond similar to a dead weight hanging on the seal.
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