February 28, 2019

ASTM D4169 DC13: To Include or Not to Include? That is the Question

ASTM D4169 is perhaps industry’s most well-known standard, with good reason. The standard provides a uniform basis by which we can evaluate how well shipping units hold up during product distribution. To perform ASTM D4169 lab simulations, samples packed in their shipping configuration undergo a sequence of simulated hazard elements. We can simulate many conditions within the lab as your package might encounter them on the product journey. Do you need to perform every test within the standard? Maybe, maybe not. Identifying which hazard elements are applicable to your specific samples will tell. Since Packaging Compliance Labs works with medical and pharmaceutical products, we will focus on Distribution Cycle (DC) 13 specifically for the medical device industry.

There are seven schedules included in the DC 13 test plan:

Schedule A – Manual Handling (ASTM D5276)

Schedule C – Vehicle Stacking (ASTM D642)

Schedule F – Loose-Load Vibration (ASTM D999)

Schedule I – Low Pressure

Schedule E – Vehicle Vibration

Schedule J – Concentrated Impact

Schedule A – Manual Handling (another series of drop tests simulating conditions of the final carrier-to-end-user delivery leg). Of these, some portions within the schedules (or entire schedules) may be omitted based on packaging construction and materials and distribution conditions.

What D 13 Tests Can You Omit?

It needs little explanation that Schedule A – Manual Handling, is universally required. Every package in the world is handled by human hands. But fewer packages require running the Bridge Impact Test within Schedule A; the Bridge test applies only to elongated packaging that may encounter midpoint impact damage while the ends of the package are supported. The standard states, “Conduct bridge impacts on long, narrow shipping units which have a length of at least 36 in. (915 mm) and each of the other two dimensions are 20% or less of the longest dimension.” If your product has standard dimensions or does not meet these parameters, you can safely skip Bridge Impact Testing.

Another schedule that may be omitted for certain packaging is Schedule I – Low Pressure. This schedule simulates different modes of transport such as feeder aircraft or ground transport across high altitude passes where low pressure conditions will be encountered. Applicable products and packages for Schedule I are those that could be sensitive to a low-pressure environment such as non-porous packages, liquid containers, etc. The schedule subjects samples to a pressure equivalent to 14,000 ft (4267 m) for a period of 60 minutes. The test may be omitted if shipping units contain a porous material, such as Tyvek, as the primary package.

The last schedule that may be omitted is Schedule J – Concentrated Impact. Schedule J simulates packages during sorting operations and in transit by subjecting samples to low level concentrated impacts to the package. The impact energy used in the laboratory of 4.0 ft-lbf (5.4 J) is imposed by a cylindrical mass dropped from a vertical distance of 32 in (0.8 m). This test may be omitted to corrugated shipping containers that are double-wall or single wall corrugated containers that are or above 275 Burst or 44 ECT.

There are many factors to weigh when designing your test plan for either feasibility or design validation studies. If you aren’t sure about a particular test, ask a PCL expert. We can easily guide you on ASTM D4169 D13 testing to ensure you are not overexposing (or underexposing) your packaging through the distribution environment simulation. Sometimes a simple consultation can save you money—and headaches.

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