What is ASTM D4169 testing?
ASTM International developed the standard ASTM D4169, “Standard Practice for Performance Testing of Shipping Containers and Systems,” to test a shipping systems’ ability to withstand typical distribution hazards that occur in a supply chain. The standard uses a series of schedules that are based on real-world transportation and historical data.
What is ASTM D4169 testing used for?
This ASTM standard is often used as the testing method to provide documented evidence to regulatory agencies that a shipping system can be used for shipping products. Depending on the schedules selected for testing, conducting ASTM D4169 testing could prove that a shipping system can withstand the following simulated distribution hazards:
- Manual and Mechanical handling
- Warehouse/Vehicle Stacking
- Stacked/Vehicle Vibration
- Loose-load Vibration
- Rail Switching
- Concentrated Impact
- High Altitude (Low Pressure)
- Environmental Hazard (Ambient temperature changes and moisture)
Why is there an ASTM D4169-22 and an ASTM D4169-23e1?
ASTM D4169-22 was the previous version of the D4169 test standard which was published in 2022. ASTM International decided to update the standard in 2023 to ASTM D4169-23e1. The “e” indicates that there was an editorial change (in March 2024) made since the most recent revision in 2023.
What is the difference between ASTM D4169-22 and ASTM D4169-23e1?
While most of the testing standard remained the same, the following technical changes were made:
- Define small and lightweight packages (less than 10 pounds and smaller than 2.0ft3)
- Add another standard for climactic conditioning ASTM F2825
- Remove the option to calculate the F factor for Schedule B – Warehouse Stacking and Schedule C – Vehicle Stacking if the product or container supports a portion of the load
- Provide rationale how shipping density factor has been increased to 12 lb/ft3 for unknown distribution systems for Schedule C – Vehicle Stacking
- Increase the stack height of a small subset of small parcel packages with unknown maximum stack height in transit vehicle during Schedule C – Vehicle Stacking
The changes have clarified what signifies a small and lightweight package and what other considerations for warehouse and vehicle stacking schedules. Overall, the changes have increased the rigor of testing during vehicle stacking, additionally for small parcel packages between 10 and 30 pounds and under 2.0ft3.
What does this mean for FDA filings?
The FDA currently still recognizes ASTM D4169-22, as the changes made between ASTM D4169-22 and ASTM D4169-23e1 are minor. Lean Biologix recommends testing against the latest ASTM standard recognized by the appropriate regulatory body.
What can Lean Biologix do to help?
The LBX team has extensive experience with ASTM D4169 testing. LBX can develop, evaluate, execute, and summarize ASTM D4169 testing for a customer’s review while being compliant with the current industry and regulatory standards. LBX can help successfully demonstrate a shipping system’s ability to protect product from physical damage and maintain thermal shipping requirements during distribution. See the Design Qualification (DQ) and Operational Qualification (OQ) Testing Services tab on the LBX website for more information.
References
ASTM D4169-22, Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM D4169-23e1, Standard Practice for Performance Testing of Shipping Containers and Systems
FDA: Recognized Consensus Standards: Medical Devices https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm
Westpak “ASTM D4169-23e1 Was Released March 27, 2024 – See What Changed” (https://westpak.com/astm-d4169-23e1-was-released-see-what-changed/)