ASTM F1929

ASTM F1929 is a standardized integrity test used to evaluate and identify potential leaks in porous medical packaging. The standard includes a series of test methods that use dye to find leaks generated by channels or other imperfections following the sealing process. The standard can be used for both pouches and trays with a  transparent layer and sealed with a porous substrate.

Purpose of ASTM F1929

ASTM F1929 is a standard test designed to identify and locate leaks in porous medical packaging. Any leak will compromise the Sterile Barrier System (SBS) and may allow the ingress of microorganisms causing contamination of the medical device. This type of testing is especially important to illustrate the integrity of the SBS has been maintained following a distribution test.

ASTM F1929 uses a specific dye penetrant to conduct the dye leak testing which can identify leaks in a SBS using one of the following methods:

• Injection
• Edge Dip Method
• Eye Dropper Method

Each of these test methods functions differently and is better suited for some products than others. Below, we’ll take a look at the differences between these methods in greater detail.

There are many types of dye leak testing, but the ASTM F1929 standard describes materials and a technique that will identify and locate a leak equal to or greater than a channel formed by a 50μm (0.002 in.) wire.

What are the various test methods for a dye penetration test?

ASTM F1929 testing is performed by applying dye to a SBS using one of the following methods:

• Test Method A (Injection): Inject dye solution into the sealed package and look for leaks originating from the inside edge of the package seal through the outside edge. In a worst case dye would drip out of the package. 
• Test Method B (Edge Dip Method): Dip the outer edge of the package seal equally in the dye solution and look for leaks that originate from the outside edge of the package seal and travel through to the interior edge. This uses capillary action to wick the dye up into the defect. 

• Test Method C (Eye Dropper Method): The eye dropper method can only be used for pouches that have an unsealed area that extends beyond the outer edge of the seal. To administer dye, the test personnel will start by separating the transparent material from the porous material. Once the substrates are separated, they can use a pipette or eye dropper to apply dye between the two substrates allowing the dye to run along the sealed edge. The package is then examined for leaks that originate from the outside edge of the SBS and travel through the interior edge.

What are the requirements for ASTM F1929 testing?

• ASTM F1929 testing is only compatible with porous materials. Porous packaging is prone to wicking, therefore, the entire inspection of the seals should be conducted in less than 20 seconds.
• Packaging must not have any condensation or other source of liquid water. Pre-existing water found in the seal may compromise the test, making leaks undetectable with a dye penetrant.
• The test method ASTM F1929, requires that the color of the dye penetrant has good contrast to the opaque packaging material.Is ASTM F1929 testing intended for specific types of packages?

Is ASTM F1929 testing intended for specific types of packages?

Yes, ASTM F1929 is designed to detect and locate leaks found in a medical device SBS formed with transparent substrate and a porous substrate.