Testing and Standards Knowledge Essential For Device Package Designers

Medical device package engineers should be aware of the most current materials, testing, distribution, and standards information in order to design the most successful packages, according to an industry expert.

Speaking at the recent WestPack conference in Anaheim, CA, Jan Gates, senior packaging engineer for Guidant Corp. (Indianapolis), told attendees that such knowledge makes it easier for device developers to do their jobs. “Developing a package to fit and protect a product is the main goal, but designers should also maintain ease of use for manufacturers, customers, incoming inspection, shipping, and ergonomics,” she said.

Some of the subjects Gates urged engineers to learn more about are paperboard, printing, labels, laminates, and plastics, distribution, warehousing, shipping, and transit. Distribution testing is especially important, explained Gates, who added 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 variations, 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 that 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; ISTA Series 1 and Series 2; FDA consensus standards; and ISO 11607.

In addition, Gates pointed out important differences between U.S. regulators 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 standards are TIR19, 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 Packaging School, United Parcel Service, and FedEx are some of the organizations that are involved in shipping-environment tests, though their tests are proprietary.

Gates also noted that there are many studies being conducted on how medical devices and products are used. However, few studies show how medical packaging is used. She said opportunities exist for such studies and urged conference attendees to explore them.

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