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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Place a bead of solution astn 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 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 the package for any leaks originating from the inside edge of the package seal towards the outside edge of the package 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.
If wicking does transpire, it may be verified by observing the porous side of the subject seal area. The Creep Test provides a test for slow shear of the adhesive bond similar to a dead weight hanging on the seal. These leaks are frequently discovered at seals between package components of the same or dissimilar materials.
Most commonly, an eyedropper or pipette is used to apply the dye penetration solution between the transparent and porous materials of the unsealed area. Leaks may also result from a microscopic pinhole in the packaging material that is invisible to the human eye.
This pressure creates the force needed to rupture the seal. 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 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. 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. Here is a quick overview of the changes: In the Burst Testair is introduced into the package at a predetermined pressure and flow rate. For more information visit www.
ASTM-F – Medical Package Testing
The Eyedropper f1992-98 requires the packages to have an unsealed area that extends beyond the outer edge of the seal.
Observe each seal for a recommended duration of 5 to 20 seconds. Learn more about the different testing services provided at each location. However, since ASTM F testing is designed solely to detect leakage, components that illustrate any indication of leakage are usually rejected.
ASTM F procedure requires that the dye penetrant have good contrast to the opaque packaging material. Water already in the seal defects may render them undetectable with a dye penetrant.
The porosity or lack thereof of the package material determines the inflation rate for the burst test.
Overview of ASTM F Dye Penetration Integrity Test
As a guide, each Test Method f11929-98 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. If ASTM F testing is used as the quality control method, the test specimen must consist of a complete packaged device.
Please keep this in mind when developing your studies and validations. 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.
The package will be visually inspected for dye penetration after contact with the dye penetrant for a specified time.