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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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 have discolored the surface of the material. Here is a quick overview of the changes: If ASTM F testing is used as the quality control method, the test specimen must consist of a complete packaged device.
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 procedure requires that the dye penetrant have good contrast to the opaque packaging material. 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.
Learn more about the different testing services provided at each location. Leaks may also result from a microscopic pinhole in the packaging material that is invisible to the human eye. Packaging must be free of condensation or any other source of liquid water. However, since ASTM F testing is designed solely to detect leakage, components that illustrate any indication of leakage are usually rejected.
The porosity or lack thereof of the package material determines the inflation rate for the burst test. 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. Harmful biological or particulate contaminants may enter the device through leaks. Because air escapes through the walls of a porous package during inflation, the flow asym must be increased to compensate for the lost air through the walls and create the back pressure in the porous package.
The Eyedropper method requires the packages to have an unsealed area that extends beyond the outer edge of the seal. This pressure creates the force needed to rupture the seal.
Observe the package for any leaks originating from the inside edge of the package seal towards the outside edge of the package seal.
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Observe each seal for a recommended duration of 5 to 20 seconds. In the Burst Testair is introduced into the package at a predetermined pressure and flow rate.
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 contact us with any questions you may have about ASTM F, or r1929-98 we can help you with any other testing questions or projects.
Water already in the seal defects 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. Requirements ASTM F testing is limited to porous materials which can retain the dye penetrant solution and prevent f192998 from discoloring the entire seal for a minimum of 20 seconds.
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. Please keep this in mind when developing your studies and validations. Along the extended unsealed area beyond outer seal edgethe transparent material is separated from the porous material with use of a finger, paperclip, etc.