ASTM-F describes the standard test method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration. 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. While the traditional ASTM F Dye. Penetration standard is Triton-X used in dye penetration testing is a non-ionic surfactant with both a hydrophilic.

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For more information visit www. However, since ASTM F testing is designed solely to detect leakage, components that illustrate any indication of leakage are usually rejected. There is no general consensus regarding the level of leakage that is likely to be detrimental to a particular package.

Packaging must be free of condensation or any other source of liquid water.

ASTM-F – Medical Package Testing

Learn more about the different testing services provided at each location. The Eyedropper method requires the packages to have an unsealed area that extends beyond the outer edge of the seal.

It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. 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.

In the Burst Testair is introduced into the package at a predetermined pressure and flow rate. After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration. The dye will have discolored the surface of the material. ASTM F procedure requires that the dye penetrant have good contrast to the opaque packaging material. The porosity or lack thereof of the package material determines the inflation rate for the burst test.


Refer to Appendix X1 for details on wicking and guidance on the observance of false positives. Leaks may also result from a pinhole in the packaging material. These leaks are frequently found at seals between package components of the same or dissimilar materials. If wicking does transpire, it may be verified by observing the porous side of the subject seal area.

Uncoated penetratoin are especially susceptible to leakage and must be evaluated carefully for use with each test method. Either is to be regarded as standard.

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. If ASTM F testing is used as the quality control method, the test specimen must consist of a complete packaged device. If wicking does occur, it may be verified by observing the porous side of the subject seal area.

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

The dye solution used in penetration testing will wick through any porous material over time, but normally not within the suggested maximum time. The package will be visually inspected for dye penetration after contact with the dye penetrant for a specified time.

The test methods are limited to porous materials which can retain the dye penetrant solution and atm it from discoloring the seal area for a minimum of 5 seconds. A dye penetrant solution is applied locally to the seal edge to be tested for leaks. 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. These leaks are frequently discovered at seals between package components of the same or dissimilar materials.


Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. Along the extended unsealed area beyond outer seal edgethe transparent material is separated from the porous dey with use of a finger, paperclip, etc.

The Creep Test provides a test for slow shear of the adhesive bond similar to a dead weight hanging on the seal.

Leaks may also penetratiom from a microscopic pinhole in the packaging material that is invisible to the tsst eye. No indication of leak size can be inferred from these tests. Please keep this in mind when developing your studies and validations. They are not quantitative. Observe each seal for a tes duration of 5 to 20 seconds. The dye will have discolored the surface of the material. 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.

This pressure creates the force needed to rupture the seal. However, since these tests are designed to detect leaks, components that exhibit any indication of leakage are normally rejected. Historical Version s – view previous versions of standard.

Overview of ASTM F1929 Dye Penetration Integrity Test

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. 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.

Link to Active This link will always route to the current Active version of the standard.

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