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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. Prior to ASTM F testing, all test specimens must be conditioned. ASTM F "Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration" is a dye penetration integrity test used by package engineers that is designed to detect and locate leaks caused by channels formed between a transparent film and a porous material.
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Dye Penetration Testing - ASTM F Dye Penetration Testing is an effective and widely used method of locating defects in pouch and tray seals. The test process places enough dye penetration solution into a package to create a 5mm deep well of dye along the seal's inner edge. • 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 tested with a precision & bias statement with a defined sensitivity, which are helpful for test method validation. • Recognized as a consensus standard by the FDA.
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The dye penetration test involves injecting a sealed package with dye solution and then observing for any capillary movement of the dye through the sealed area. Dye Penetration Testing is a methodology that utilizes visual inspection. ASTM-F is the standard test method for detecting seal leaks in porous medical packaging by dye penetration. ASTM-F is the standard test method for detecting seal leaks in porous medical packaging by dye penetration.
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•What is dye penetrant? An aqueous solution of a dye and a surfactant designed to penetrate and indicate a defect location in the time prior to the onset of wicking which could mask its presence Dye Penetration-Terminology.
A dye penetrant solution is applied locally to the seal edge to be tested for leaks. After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration. This test method is intended for use on packages with edge seals formed between a transparent film and a porous sheet material.
ASTM F Designation: F - 98 (Reapproved ) Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration1 This standard is issued under the ﬁxed designation F ; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision.
A dye penetrant solution is applied locally to the seal edge to be tested for leaks. The package will be visually inspected for dye penetration after contact with the dye penetrant for a specified time. Harmful biological or particulate contaminants may enter the device through leaks.
injection of the dye penetrant solution. tioning atmosphere of 23 6 2°C ( 6 °F) and 50 6 2 % Microscope or optical loop with magnification of 53 to relative humidity is recommended, for a minimum of 24 h prior to testing. Fresh aqueous dye penetrant solution consisting of, by.
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