Originally Published MDDI March 2005
There is More to Packaging than Just a Box
Up-to-date knowledge of materials, testing, distribution methods, and standards is essential for today's medical device packaging engineers, said Jan Gates, senior packaging engineer for Guidant Corp. (Indianapolis).
“Developing a package to fit and protect a product is the main goal, but designers should also maintain ease of use for manufacturers and customers, incoming inspection, shipping, and ergonomics,” she told MD&M West conference attendees. “That makes it easier for device developers to do their job.”
As an example, Gates pointed to paperboard packages, which are designed on a smaller scale and require different testing methods than corrugated packaging. “Intricate designs are possible with paperboard,” she said. “Yet one can use bending strength instead of burst tests, for example.”
Package engineers should understand the testing protocols for various materials, as well as tests involving distribution and transit, and warehousing and shipping. Distribution testing is especially important, explained Gates, who also said that controlled-temperature environment, shock, vibration, and pressure testing should be considered when designing packages. “You also have to know about distribution-system conditions,” she said. “Temperature, for example, can vary widely. Similarly, truck and plane shock and vibration can be key factors in a package's success as it travels through the system.”
Gates also said package size should be optimized to allow for ergonomic considerations and hazardous materials in single-parcel posts. “Most importantly, you have to know your distribution system,” she said. “Not just the conditions, but the inner workings of the system itself.”
Gates said the most important testing standards are ASTM D4169, which covers shipping containers and systems; International Safe Transit Association (ISTA) 1 Series and 2 Series, FDA consensus standards; and ISO 11607 standards. In addition, Gates pointed out the important differences between regulators in the United States and those in Europe. “European regulators expect regulations to be adhered to immediately,” she said. “The United States, on the other hand, passes a regulation and allows plenty of time for compliance.”
Other important documents are AAMI TIR 19, which covers material effects from radiation, and ASTM D and F standards for rigid and flexible materials. Gates said various groups have been measuring the distribution environment and closely monitoring changes. ISTA, the Michigan State University School of Packaging, United Parcel Service, and Federal Express
are some of the organizations actively involved in shipping environment tests, though their tests are typically proprietary.
Finally, Gates noted that there are many studies being conducted on how products are used. However, not many studies show how medical packaging is used. She said opportunities exist for such studies—and urged conference attendees to explore them.
Copyright ©2005 Medical Device & Diagnostic Industry