ASTM F “Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration” is a dye penetration integrity. ASTM recently announced a significant update to ASTM F The update to the dye leak standard marks the first significant change in the. 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.

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Uncoated papers are especially susceptible to leakage and must be evaluated carefully for use with each test method.

Overview of ASTM F1929 Dye Penetration Integrity Test

Link to Active This link will always route to the current Active version of the standard. 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. Packaging must be free of condensation or any other source of liquid water. For more information visit www.

After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration. Below are descriptions of the methods that can be considered when choosing a method for evaluating a sealed package. Refer to Appendix X1 for details on wicking and guidance on the observance of false positives. However, since ASTM F testing is designed solely to detect leakage, components that illustrate any indication of leakage are usually rejected.

Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. Historical Version s – view previous versions of standard. ASTM F procedure requires that the dye penetrant have good contrast to the opaque packaging material.

Please keep this in mind when developing your studies and validations.

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.


Most commonly, an eyedropper or pipette is used to apply the dye penetration solution between the transparent and porous materials of the unsealed area. DDL actively works with customers to select the best test method for their package and situation as each dye method is subject to change depending on the packaging materials.

Here is a quick overview of the changes: Learn more about the different testing services provided at each location.

The Creep Test provides a test for slow shear of the adhesive bond similar to a dead weight hanging on the seal. If wicking does transpire, it may be verified by observing the porous side of the subject seal area.

With this revision, however, two new test methods have been developed, edge dip Method B and the eyedropper Method C. Method C — Eye Dropper: 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.

Learn more about the different testing services provided at each location. 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 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.

Observe the package for any leaks originating from the inside edge of the package seal towards the outside edge of the package seal. 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.

The dye is allowed to contact the sealed edge for a maximum of five seconds and a channel would be detected within this time, if present. The dye will have discolored the surface of the material. Method A f929 Injection: If wicking does occur, astj may be verified by observing the porous side of the subject asm area.

Overview of ASTM F Dye Penetration Integrity Test

This pressure creates the force needed to rupture the seal. The package will be visually inspected for dye penetration after contact with the dye penetrant for a specified time. The method involves injecting dye into the package covering the longest edge with a depth of approximately 0. Asm dye will have discolored the surface of the material. As in method B, channels are detected from the exterior to the interior of the package. The update results in three different dye application methods. The package is then removed and inspected for channels.


These leaks astk frequently discovered at seals between package components of the same or dissimilar materials. Cited by of ISO as a method to test package integrity, F is a dye penetrate 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. These leaks are frequently found at seals between package components of the same or dissimilar materials.

A dye penetrant solution is applied locally to the seal edge to be tested for leaks. Either is to be regarded as standard. Leaks may also result from a microscopic pinhole in the packaging material that is invisible to the human eye.

This method involves using an eye dropper to apply dye along the edge f192 the package seal between the transparent and porous materials. In the past, the only option was by injection Method A where the dye solution was exposed to the seal from the inside of the package.


Method C requires packages to have excess material along the outside of the seal to contain the dye. Satm, since these tests are designed to detect leaks, components that exhibit any indication of leakage are normally rejected.

Harmful biological or particulate contaminants may enter the device through leaks. Water already in the seal defects may render them undetectable with a dye penetrant.

They are not quantitative.

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