The film Ace Ventura Pet Detective opens with a package delivery person delivering a standard cardboard box marked fragile. This scene is best described as cringeworthy as the poor package is subjected to multiple layers of abuse at the hands of the delivery person. Watching this scene will help you to understand the importance of performing simulated distribution testing:

What is distribution testing?
Distribution Testing is designed to simulate the distribution environment in a laboratory environment. Laboratory testing provides a setting that can be controlled and where processes (methods) can be repeatable which provides the ability to evaluate shipment packages to withstand the distribution environment they will be subjected to in the real world. Packaging Distribution Testing offers manufacturers a controlled opportunity to anticipate how products and their package systems will perform during shipping. Testing can evaluate whether sustainability changes have jeopardized the protective quality of the packaging and help determine the most ideal means to improve the package system. For example, can breakage of glass bottles be negated by cushioning the package interior with a thicker foam insert.

What are the common Standards used for Package Distribution Testing?
There are two common approaches that are routinely used for Package Distribution testing.

ASTM D4169 “Standard Practice for Performance Testing of Shipping Containers and Systems” tends to be the most commonly used by the FDA regulated industries due to ASTM being a recognized standard. This test method is performed by subjecting shipping units to a test plan consisting of a sequence of hazard elements which would be encountered in various distribution environments. A simple example would be shock testing followed by drop testing, then vibration and finally compression testing. The test plan provides a uniform basis of evaluating in a controlled and repeatable laboratory environment the ability of the shipping units and contents to withstand the distribution environment. The test plan uses established testing services methods at levels representative of those encountered in actual distribution. The Distribution Cycle (DC) most commonly used for medical device and pharmaceutical product packages is DC-13 which is designed for the small parcel and overnight shipping mode. Customized distribution cycles can be designed when the anticipated distribution of the product is well understood and defined.

The second approach that may be taken are based upon ISTA standards. ISTA (International Safe Transit Association) is global alliance of shippers, carriers, suppliers, testing laboratories, and educational and research institutions focused on the specific concerns of transport packaging. ISTA has developed a series of testing protocols and design standards that define how packages should be in order to guarantee the protection of their content during the transportation cycle.

What are the common elements of Package Distribution Testing?
The four critical segments of package distribution testing are vibration, shock (drop), compression and atmospheric. Vibration testing is used to simulate the loose load vibration a package may be subjected to when transported on the back of a truck, a train or even a conveyor belt system. Shock, or drop testing, is an evaluation of the actual impact a package may be subjected to when dropped from various heights. Compression testing evaluated the carton’s ability to withstand compressive forces. For example, of the package is on the lowest level of a filled pallet will the downward forces from the packages on top of it cause damage. Finally, atmospheric evaluation is most commonly used to test the package’s ability to withstand changes in altitude as it may be subjected to when transported via airplane in an uncontrolled holding section of the plane. In addition, there may be a need for some type of environmental evaluation of the package is designed to be shipped at a unique temperature (for example on dry ice at minus 80C).

What information will a standard Package Distribution Test report provide?
Historically, package distribution testing reported damage to the exterior package system. Within the pharmaceutical / medical device market the need for more detailed evaluation are critical and a program that is designed to provide a pre-test and post-test inspection of the actual product should be performed. In a case of 220 pre-filled syringes, how many syringes actual broke or are leaking should be a key point of evaluation that should be reported. For solid oral dosage form tablets, how may, if any, are broken or chipped. Did the capsule tablets break apart during shipment testing. The specific evaluation criteria should be determined prior to testing to ensure that the testing meets the specific needs of that specific product.

What information is needed to determine the most ideal test approach?
With just basic package information, an ideal test program can be designed to meet the specific client need. Key pieces of data needed include package size (length, width, height) and approximate weight o the final shipment container. A detailed description, quantity and configuration of the product that it will hold is critical. Any additional details in package buffer materials – foam liners, cardstock divider plates, foam peanuts, etc. Finally, what is the expected shipment process. For example, airplane, parcel truck delivery (FEDEX, UPS, DHL), over ocean shipment container (ship), long haul trucking and / or railroad.

CS Analytical offers complete ISTA and ASTM D4169 testing programs that are specific to medical device and pharmaceutical products. Our team has experience designing and developing test programs that meets the specific need of the client, the package and the expected distribution environment. In addition, we offer a host of custom approaches that enable a thorough pre and post test evaluation of any type of product. The team can also coordinate unique USP 1207 Container Closure Integrity Test programs that add a package distribution component to a standard CCI leak testing program.