ASTM F1929 Dye Penetration Test

The dye penetration test specified in ASTM F1929 can be conducted.

- This test is a method established by ASTM to detect seal leaks in medical packaging using a dye penetration solution. - The dye is applied to the seal area between transparent materials and porous sheet materials, and the presence or absence of defects (leaks) in the channels is visually confirmed. - ISO 11607-1 states that as part of packaging system performance testing, "the integrity of the sterilization barrier system must be demonstrated after sterilization and subsequent performance testing." Annex B of this standard describes ASTM F1929 as the standard test method for evaluating seal integrity in medical packaging. - This test method is recognized by the FDA as a consensus standard. ▼ For more details, please download the PDF document (recommended). ▼ If you need immediate assistance, please contact us using the "Contact Us" option below.

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basic information

[Testing Procedure] ・Method A: Injection Method Make a hole approximately in the center of the film section and pour the dyeing permeation solution so that it reaches a depth of about 5mm relative to the long side. Allow a maximum of 5 seconds per side and visually check for the presence of channels while rotating to ensure the solution spreads to all sides. ・Method B: Edge Dip Method Fill a container with the dyeing permeation solution to a depth of about 3-6mm, dip each edge of the medical packaging, and quickly pull it out. Repeat this for each edge and visually check for the presence of channels. *Remove any unnecessary margins, such as those from chevrons, in advance. ・Method C: Eyedropper Method Open the unsealed margin areas of the transparent material and porous sheet on each edge, and using a dropper or similar tool, pour the dyeing permeation solution between them with the transparent sheet facing you. Repeat this for each edge and visually check for the presence of channels.