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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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.

In the Burst Testair is introduced into the package at a predetermined pressure and flow rate. DDL has conducted package integrity testsfor over 20 years and recommends the use of Method A due to its consistency f192 applicability to more package ast. As in method B, channels are detected from the exterior to the interior of the package.

Water already in the seal defects may render them undetectable with a dye penetrant. Refer to Appendix X1 for details on wicking and guidance on the observance of false positives. Method A — Injection: The package will be visually inspected for dye penetration after contact with the dye penetrant for a specified time.

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

The presence of a number of small leaks, as f192 in asstm packaging material, which could be detected by other techniques, will not be indicated.


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

ASTM F1929 – 15

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. With this revision, however, two new test methods have been developed, edge dip Method B and the eyedropper Method C. These leaks are frequently found at seals ast package components of the same or dissimilar materials. Below are descriptions of the methods that can be considered when choosing a method for evaluating a sealed package.

Referenced Documents aastm separately The documents listed below are referenced within the subject standard but are not provided as part of the standard. Method C — Eye Dropper: Learn more about the different testing services provided atsm 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. The Eyedropper method requires the packages to have an unsealed area that extends beyond the outer edge of the seal. However, since these tests are designed to detect leaks, components that exhibit any indication of leakage are normally rejected.


ASTM-F – Medical Package Testing

A dye penetrant solution is applied locally to the seal edge to be tested for leaks. The edge dip method may be preferred because needles or syringes are not used, and is faster to f199. Method B — Edge Dip: Either is to be regarded as standard.

Observe the package for any leaks originating from the inside edge of the package seal towards the outside edge of the package seal. Leaks may also result from a microscopic pinhole in the packaging material that is invisible to the human eye.

Observe each seal for a recommended duration of 5 to 20 seconds. Harmful biological or particulate contaminants may enter the device through leaks. Most commonly, an eyedropper or pipette is used to apply the dye penetration solution between the transparent and porous materials of the unsealed area. The test methods are 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.

Method C requires packages to have excess material along the outside of the seal to contain the dye. They are not quantitative. The package is then removed and inspected for channels. Learn more about the different testing services provided at each location.