Dye Leak Test
ASTM F1929 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetrations
The ASTM F1929 is the FDA recognized dye leak test that is used to identify leaks caused by channels between a transparent film and a porous sheet material. The latest version of this standard is the ASTM F1929-12 which has three methods that can be utilized to detect and locate unsealed areas on packages:
- Method A: Injection method
- Method B: Edge drip method
- Method C: Eyedropper method
The dye leak test evaluates seal integrity. It is typically performed during sealer validation or for in-process maintenance. The sensitivity of this test is 50 microns. The test is performed using a specialty dye solution to identify minute defects within a sterile closure seal. NOTE: This test is not intended to be a whole-package integrity test. See Bubble Leak Test.
Frequently Asked Questions
What is dye leak testing?
Dye leak testing per ASTM F1929 is a test method that is used to identify leaks caused by channels between a transparent film and porous sheet material. Dye leak testing per ASTM 3039 is a test method that identifies leaks between transparent film to film packaging.
How sensitive is Dye leak test per ASTM F1929 and ASTM F3039?
Dye leak testing per ASTM F1929 and ASTM F3039 can detect breaches in the sterile barrier down to 50 microns.