ASTM D4169 is a consensus standard practice that provides a basis for simulating, in a laboratory, the ability of medical device packages to withstand worse-case dynamic forces within a distribution environment. The standard is widely used in the medical device industry as it is one of the standards that is recognized by the FDA and meets the requirements of ISO 11607.  Our team of packaging experts actively engages in thorough discussions and assessments of this standard, contributing to the safeguarding of consumer safety worldwide. Matt TerBush, Director of Packaging Innovations, and a member of the D10 and F02 ASTM committees, along with participation in the D4169 Working Group, emphasizes, “My responsibilities involve ensuring the laboratory adheres to these updated standards, providing our clients with confidence that their packages meet FDA testing requirements.”

What Changed in the ASTM D4169 Revision:

The new 2023 revision includes some major changes from the previous 2022 revision. These changes include:

• Section 3 Terminology – A new definition for Small and Lightweight Package was introduced in order to provide further clarity for the identification of a package that was previously confusing to packaging professionals when determining the maximum stack height (H) factor.
• Section 6 Conditioning – F2825 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery was added to the applicable conditioning standards for DC13.
• Section 11 Schedule B – Warehouse Stacking and Schedule C – Vehicle Stacking
  1. Type 4 for Shipping Unit Construction was eliminated for redundancy.
  2. A Shipping Density Factor (M_f) range was included, and the default value increased. This directly increases the theoretical target load force applied to packages during compression.
  3. A Maximum Stack Height (H) Decision Matrix was added.

What does this mean for medical device manufacturers?

While we are not regulatory consultants at PCL, we can confirm that the changes in the new revision to ASTM D4169 may affect previous validations as the target load force applied to packages during compression will increase in severity compared to the 2022 revision. With that said legacy packaging system validations are often exempt from required re-testing due to standard revision changes but will need to be reviewed on an individual basis while considering potential risks to end users.

How does PCL adapt to standard revisions?

In addition to participation in ASTM D10 and F02 committees, PCL has an internal team that meets bi-weekly to discuss consensus standard updates. In the case of ASTM D4169 revision, we complete the following activities to ensure that our lab can accommodate the newest revisions:

• Revise work instructions and equipment operating instructions.
• Review equipment capabilities.
• Re-train the team on the revision.
• Re-validation of PCL’s validated compression calculator.

Reach out to one of PCL’s packaging professionals today with any questions you might have about your existing transit validation, and we’d be happy to assist you.

ASTM has granted PCL the ability to publish about this standard revision.