ASTM D4169

ASTM D4169 is a standard packaging test that evaluates how a shipping container or packaging system performs when subjected to hazards found within a typical distribution environment. If you plan to distribute your product, this type of testing is an invaluable tool that can assess package performance while mitigating potentially costly points of failure.

 

What is ASTM D4169?

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

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.

Should I perform other tests on my package?

As distribution testing simulates the transit environment, it is generally considered best practice to pair with environmental conditioning. Adding temperature and humidity test inputs will give a more thorough view of how the packaged products are affected by distribution hazards.

Specifically to medical devices products, package integrity testing in order to challenge if the primary packaging has been compromised is considered best practice following distribution testing.


Accreditations:

Testing at Westpak has been accredited by A2LA to comply with ISO 17025.

Westpak testing labs are ISTA certified to perform a variety of tests.

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