Transportation Packaging Test Methods Should Aim for Flexibility
One of the last things some device manufacturers think about when releasing a new product is the potential for damage during shipping. Addressing this issue, Dennis Young, senior consultant at Dennis Young & Associates Inc. (Grand Rapids, MI), observed that "the medical device manufacturer has the responsibility to know how its product is shipped....and what steps it goes through in order to get from the point of manufacture to the point of use."
In a session titled Transportation Testing for Medical Devices, presented during the Medical Design & Manufacturing (MD&M) West Conference and Exposition January 1720 in Anaheim, CA, Young outlined the steps manufacturers need to take to ensure the effectiveness of their packaging. ISO 11607 outlines the manufacturer's responsibility to evaluate package performance by defining the limiting conditions, then by selecting appropriate testing methods. A company's "testing needs to be flexible enough to match what actually happens during shipping," he pointed out.
The use of a transportation simulator is one step that manufacturers can take to ensure the effectiveness of their packaging.
The logistical hazards that can affect the safe delivery of medical devices include dropping, vibration, and compression of the packaging container. The need to efficiently use storage facilities introduces a second set of hazards: stacking packages to efficiently use space and maintain an inventory, and the absence of atmospheric controls within the building can contribute to a loss of package integrity. Excessive atmospheric pressure and daily temperature and humidity cycling can also cause damage. The way a package is handled is yet another factor that must be considered. Packages are both intentionally (when they are palletized, loaded, or sorted) and accidentally dropped.
Three types of preshipment performance tests can be used to limit potential damage, according to Young. The first type is integrity testing, which challenges product and package strength. One such test is ISTA procedure 1A, the most commonly used package performance test in the world, according to Young. "People have found that if they have a package that passes this test, they'll rarely have problems."
The test is intended for small packages and is made up of a vibration test and a drop test. The vibration test uses a selected fixed frequency to bounce the package 14,200 times. The drop test involves dropping a package once on its corner, three times on an edge, and once on all six faces.
ISTA procedures 1G and 1H are designed for small and large packages and are identical to 1A, except that they use a random vibration test.
The second type of procedure is a general simulation test for small parcels that "simulates what goes on across fairly wide scopes of distribution events," said Young. ISTA test project 3C starts by drop-testing the package onto an object, followed by a compression test, a vibration test, and a second drop test without a hazard.
Focused simulation tests "link lab tests to specific measurements of environmental hazards," noted Young. Devices are used to record temperature, humidity, vibration, and pressure drop in the distribution environment. The data are then analyzed and applied to the drafting of appropriate tests.
Young announced at the meeting that a medical device distribution test procedure is currently under development by ISTA that will combine a screening test and a simulation test. David Bowen
PVC PHOTO COURTESY OF HYDRO POLYMERS LTD.