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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No indication of leak size can be inferred from these tests. ASTM F procedure requires that the dye penetrant have good contrast to the opaque packaging material. Method A — Injection: The method involves injecting dye into the package covering the longest edge with a depth of approximately 0.

The New ASTM F1929-12, Which Dye Leak Method is Right for you?

Method C — Eye Dropper: Water already in the seal defects may render them undetectable with a dye penetrant. The test methods 1f929 limited to porous materials which can retain the dye penetrant solution and prevent it from discoloring the seal area for a minimum of 5 seconds. The f199 is allowed to contact the sealed edge for a maximum of five seconds and a channel would be detected within this g1929, if present. As in method B, channels are detected from the exterior to the interior of the package.

Leaks may also result from a microscopic pinhole in the packaging material that is invisible to the human eye. 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.


ASTM-F – Medical Package Testing

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 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. In the Burst Testair is introduced into the package at a predetermined pressure and flow rate.

Most commonly, an eyedropper or pipette is used to apply the dye penetration solution between the transparent and porous materials of the unsealed area. Refer to Appendix X1 for details on wicking and guidance on the observance of false positives. 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. However, since ASTM F testing is designed solely to detect leakage, components that illustrate any indication of leakage are usually rejected.

They are not quantitative. The dye solution used in penetration testing will wick through any porous material over time, but normally not within the suggested maximum time.

The New ASTM F, Which Dye Leak Method is Right for you?

Learn more about the different testing services provided at each location. Please keep this in mind when developing your studies and validations.

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


Harmful biological or particulate contaminants may enter the device through aatm.

These leaks are frequently found at seals between package components of the same adtm dissimilar materials. Either is to be regarded as standard. 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.


The package is then removed and inspected for channels. 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 occur, it may be verified by observing the porous side of the subject seal area. Here is a quick overview of the asttm This method involves using an eye dropper to apply dye along the edge of the package seal between the transparent and porous materials. However, since these tests are designed to detect leaks, components that exhibit any indication of leakage are normally rejected.

For more information visit www. After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration. The package will be visually ashm for dye penetration after contact with the dye penetrant for a specified time.

Leaks may also result from a pinhole in the packaging material.

This method exposes the exterior of the package to the dye in order to detect channels.