What Happened?
The American Society for Testing and Materials (ASTM) recently released ASTM F1929-23, Standard Test Method for Detecting Seal Leaks in Porus Medical Packaging by Dye Penetration, replacing F1929-15. To keep you updated, we have prepared a summary of the change and the potential impact.
Who’s Responsible for the Changes?
The committee responsible for F1929 is the ASTM Committee F02 on Flexible Barrier Materials; the Subcommittee working group is F02.60 on Medical Packaging.
Changes to ASTM F1929-23 Compared to F1929-15
ASTM has removed the Wetting agent TRITON X-100 from section 5.7.
Purpose of the Change:
The update allows the use of other wetting agents and surfactants for this test. Note that TRITON X-100 is still allowed because it meets the requirements of -23.
Impact of the Change:
It’s important to note that if you use this standard, you will need to do a gap analysis to show that the change does not affect any of the previous testing done before this revision — and if there is an effect, instructions for the mitigation process must be clearly outlined.
Want to Learn More about Dye Penetration or Leak Testing?
WESTPAK is accredited to perform Dye Penetration testing of flexible medical device packaging systems per ASTM F1929. Please visit the Dye Penetration Test page on our website to learn more.
Stay Up to Date with WESTPAK
As a leading, third-party independent testing laboratory, we believe that accreditation is the highest level of competence a laboratory can exemplify — and it’s why we are proud to be recognized as an ISTA-certified and ISO 17025-accredited laboratory. WESTPAK is always up to date on the latest regulatory updates and changes, as some key team members have been honored to serve on ASTM committees and actively participate in shaping many facets of the industry. Stay updated on the latest industry changes when you follow us on LinkedIn.