In a recent article, we reviewed the broad range of distribution testing standards and methods available.  As a follow up to that article, let’s take a moment to go into detail of one of the most widely used test methods, ASTM D4169 – Standard Practice for Performance Testing of Shipping Containers and Systems.  Since its inception in 1982, ASTM D4169 has been widely utilized to release high performance packaging system designs for pharmaceutical, medical device and consumer product manufacturers.

Laboratory-based distribution simulation via ASTM D4169 provides a standardized, uniform and repeatable basis of evaluating the ability of your packaging system to withstand routine distribution.  This is accomplished by subjecting packaged product to a sequence of representative, anticipated hazards.   The recommended test sequences and intensity levels are based on field research of typical shipping and handling environments and ASTM procedures, such as D4169 (recognized as FDA consensus standards) are democratically approved by a group of packaging experts prior to publication or revision; the most current revision is ASTM D4169-14.

What do you need to know before you start a package performance project using the D4169 test? 

You will need to understand your product and routine shipping environment to select a Distribution Cycle (DC) and determine the test intensity or Assurance Level (AL) that you have to meet.  Each DC addresses a different shipping environment, each with different shipping hazards.  Typical hazards include vibration, impact (shock/drop) and compression.  You can select from DC’s 1 through 18 for a variety of scenarios simulating rail, air and truck transport for any product from a single package shipped FedEx or UPS to a pallet load for import or export.  For each DC there are three intensities of testing:   Assurance Level I provides a high level of test intensity – but has a low probability of occurrence.  Level III is a low level of test intensity – but has a correspondingly high probability of occurrence.  Level II falls between these two extremes.

What does this all mean? 

Let’s take a moment to review one of the most common DC’s used today – Distribution Cycle 13.  DC 13 provides a general representation of the hazards experienced during air (intercity) and motor freight (local) for single packages up to 150 lbs.  Is should be noted that ASTM has released a newer procedure, D7386 which covers general movement of packages through single parcel shipping systems (UPS, FedEx, etc.) but for the purposes of our conversation, let’s review DC 13 as many of the elements are similar to other methods (including ISTA procedures and D7386).  Typical ASTM D4169, DC 13 test schedules include:

Hazard Type ASTM D4169, DC 13 Test Schedule Referenced ASTM Standard
Shock / Drop Schedule A Manual Handling ASTM D5276
Compression Schedule C Vehicle Stacking ASTM D642
Vibration Schedule F Loose Load Vibration ASTM D999
Low Pressure Exposure Schedule I High Altitude ASTM D6653
Vibration Schedule E Vehicle Vibration ASTM D4728
Impact Schedule J Concentrated Impact ASTM D6344
Shock / Drop Schedule A Manual Handling ASTM D5276

Schedule THIS… Distribution Cycle THAT – what does it all mean?

Let’s go over the basics of each line item above:

Shock/Drop testing per Schedule A, Manual Handling is usually performed using a free-fall drop tester; a test sample is subjected to a series of drops on various orientations to determine the ability of a sample to withstand typical hazards of routine handling such as loading, unloading, stacking, sorting or palletization.  A bridge impact test is required to be performed on long, narrow packages as defined by D4169.

Compression testing per Schedule C, Vehicle Stacking is a test method intended to determine the ability of the package system to withstand compressive loads experienced during warehousing or vehicle transport.  A calculated load is applied to the package at a controlled rate and released.

 

Loose Load Vibration or Schedule F is a test method intended to evaluate the ability of the package to withstand repetitive shocks during transport.  Using vertical linear or rotary motion, a package is exposed to repetitive shocks for a period of 30-60 minutes, depending on the Assurance Level utilized.  Dwell time is distributed over multiple shipping orientations.

When packages are shipped by air transport or shipped over certain mountain passes, they can experience a reduction in ambient air pressure during transport.  Schedule I, Low Pressure hazard testing performed in accordance to ASTM D6653 helps you evaluate the effects that this reduction in pressure may create during transport.  This test may be omitted when the primary packaging is comprised of a porous material known to not be affected by low pressure exposure. 

Vehicle Vibration or Schedule E assists you with evaluating the ability of the packaging system to withstand vibration input during transport.  Random vibration profiles for Truck, Air and Rail transport are provided.  A sixty minute truck profile, followed by two hours of air profile exposure is recommended for DC 13 in absence of known inputs; dwell time is distributed over multiple shipping orientations.

Sorting operations or transport in general, inflict low level impacts – Schedule J, Concentrated Impact testing provides a simulation of how these impacts may affect your package.  This schedule will only be utilized if the corrugated shipping container is Lightweight, single wall material and is <275# Burst or <44 ECT (Edge Crush Test).

In conclusion, an independent, contract test lab well versed in ASTM D4169 can help you determine the appropriate distribution cycle and associated test schedules for your product and packaging.  When considering your ASTM D4169, ASTM D7386 or ISTA 3A distribution simulation testing needs, work with your test lab partner to understand the specific test procedure or procedures that you will use to evaluate your shipping configuration.  You’re test lab partner should be able to direct you to the procedure or procedures that will best simulate your distribution environment.

In addition to packaging performance testing through simulated distribution testing, consider your end goal – that is, sterile barrier maintenance for medical device, package or product integrity for pharma or minimizing damage to your product or brand in the case of consumer goods.  Prior to full blown validation, consider performing feasibility testing if your packaging system or product is new or in development; your test lab partner should have the knowledge and expertise to point you in the right direction.

If you have any further questions regarding your package testing or would like help evaluating your next distribution simulation project, please don’t hesitate to contact Whitehouse Labs.

Eric Creveling

Director, Package Testing
ecreveling@whitehouselabs.com