As the packaging industry continues to evolve, staying current with ASTM standards updates is critical for compliance, product integrity, and patient safety. Recent revisions to ASTM F1886/F1886M and ASTM D4991 introduce important changes that impact visual inspection and vacuum leak testing protocols. Here’s what you need to know—and how WESTPAK can help you navigate these updates.
ASTM F1886/F1886M-25 Update: Visual Inspection Gets an Upgrade
The latest revision of ASTM F1886/F1886M—the standard for determining the integrity of primary packaging by visual inspection—introduces a significant structural change:
● Part 1: Seal Inspection
This section remains unchanged. It continues to focus on detecting channels and defects in package seals, ensuring that sterile barriers remain intact.
● Part 2: Material Surface Inspection (New)
The big update is the addition of Part 2, which addresses visual inspection of packaging material surfaces for defects that could compromise integrity. This applies to both transparent and opaque materials, expanding the scope of visual inspection beyond seals alone.
ASTM D4991-25 Update: Minor Refinements in Vacuum Leak Testing
ASTM D4991—the standard for leakage testing of empty rigid containers using the vacuum method—has also been updated. While the changes are minor, they reinforce best practices for testing containers under differential pressure conditions, such as those encountered during air transport. In section 6.4 of the standard it changed from no more than one inch under the surface to no less than one inch below the surface
This method remains essential for industries where container closure integrity is critical, including pharmaceuticals, chemicals, and food packaging. WESTPAK’s ISO 17025-accredited labs are equipped to perform these tests with precision and reliability.
ASTM Updates: Key Takeaways
● Part 2 of ASTM F1886 introduces new requirements for material surface inspection.
● TMV is mandatory before implementing Part 2 inspections.
● ASTM D4991 updates are minor but underscore the importance of vacuum leak testing for rigid containers.
● Revised standards are published but not yet fully available for use—plan ahead for compliance.
How WESTPAK’s ASTM Lab Experts Can Help
As an ISTA-certified and ISO 17025-accredited laboratory, WESTPAK stays at the forefront of ASTM revisions. Our team actively participates in standards committees and offers comprehensive testing services, including:
● Visual inspection per ASTM F1886 (Parts 1 & 2)
● Vacuum leak testing per ASTM D4991
Update your packaging validation strategy with WESTPAK
Stop worrying about constant ASTM updates and their impacts. Contact WESTPAK today to schedule a consultation with our packaging experts.