What are the typical parameters for ASTM D4169 testing?

ASTM D4169 is a packaging test standard that outlines specific parameters for how testing procedures should be completed when evaluating shipping containers and packaging systems. ASTM D4169 utilizes different types of tests, such as drop testing, vibration testing, compression testing, and incline impact tests to evaluate a packaging system’s ability to withstand the distribution environment. This type of testing, categorized as transportation and distribution testing, is required for all shipping containers that contain medical devices.  In order to accurately and uniformly understand how a shipping container or packaging system will hold up in a distribution environment, the test standard must indicate parameters that represent realistic scenarios.  To test for anticipated hazards, ASTM D4169 includes a selection of 18 distribution cycles (DC), which are related to the mode of transportation used (i.e., air, train, truck), not the product type. Each DC represents a combination of travel types and the associated risks they pose to the products being transported.  For example, DC 13 simulates a distribution process that involves intercity air freight and local motor freight for a single package up to 150 lb. If there is not a distribution cycle that accurately represents your distribution route, you can select the standard’s DC 2 option, which allows packaging engineers to create a custom combination of distribution hazards. After you've chosen the suitable DC, you'll need to choose an assurance level (AL). The AL is selected based on the likelihood of certain events occurring, such as drop heights, compressive loads, and vibration intensity. When choosing the AL, product cost and patient risk are also taken into account. Assurance levels range from I to III, with AL I being the most severe and AL III being the most conservative option. Generally, AL II is recommended. What are the typical parameters for ASTM D4169 testing?

• Distribution Cycle (DC): 1 to 18
• Assurance Level (AL): I to III
• Number of Samples: 1 or more for critical shipments
• Specimen Dimensions: Same as actual distribution
• Conditioning and Testing Temperature: Ambient unless otherwise specified
• Conditioning and Testing Relative Humidity: Ambient unless otherwise noted

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How do I know which distribution cycle and assurance level to test for with ASTM D4169 testing?

Selecting the appropriate distribution cycle and assurance level is a critical component of ASTM D4169 testing. These considerations help ensure your sample will be tested accurately under circumstances that reflect the real-life distribution process. To identify the distribution cycle, consider the steps your package will take throughout the distribution process. For example, will it be transported by air, rail, sea, or truck? How far will the package travel during each phase of distribution — cross country or locally? The answers to these questions will help you select the right DC for your test sample. As for the assurance level, you’ll need to determine the level of risk involved during the distribution process. To test for severe conditions, use AL I; for minimal risk, use AL III; and, for moderate risk, use AL II. If you’re unsure which DC or AL is best suited for your package, Westpak can help.

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ASTM D4169-22 was released in February 2022. What were the changes?

Updates were made to the vibration profile for the Air Spectrum. Changes were made to its duration, intensity, frequency band, and shape.

• Frequency band was decreased from 300Hz to 200Hz.
• The new power density (PDS) plot is more intense in the sub-10Hz range with higher displacement.
• The overall intensity has been decreased by approximately 5x.
• Test samples subjected to low, medium, and high intensity input for a total of 40 minutes per axis.
• Eliminates the need to choose an Assurance Level for the Air profile.

Note that the lower frequency will require higher displacement; not all vibration test machines will be able to reproduce the new profile. The other test inputs remain unchanged. Our 2-page summary "Performance Testing of Shipping Containers and Systems - Q&A - ASTM D4169-22 Revision" provides more specifics on the changes.

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Should I perform other tests on my package?

Specifically for medical device products and following distribution testing, package integrity testing determines if the primary packaging has been compromised.