ISO 11607 Changes



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PMP News editors recently toured DDL West (Costa Mesa, CA), taking in its full-service lab for strength and integrity testing as well as aging and distribution simulation. Karen Greene, technical director, told PMP News that the newly revised ISO 11607-1 and 11607-2:2006 more clearly define stability testing (e.g., accelerated aging and real-time aging) and performance testing (e.g., environmental and distribution testing) as separate entities, evaluating different aspects of the sterile barrier package.

This distinction is found in 11607-1’s note section of 6.4.4. This emphasis on the distinction between performance testing and stability testing now facilitates the manufacturers’ rationale to perform accelerated aging studies separately from distribution simulation studies. According to Greene, the previous revision of ISO 11607 was less definitive in the distinction between performance testing and stability testing, and thus manufacturers may have interpreted the standard to require performance testing subsequent to stability testing. “A potential risk with combining or creating a sequential accelerated-aging-and-then-package-performance-testing evaluation is the effects of these extreme stresses on the integrity and performance of the package design and materials. It should be noted, however, that this combined approach is acceptable from a compliance standpoint and/or if the manufacturer has knowledge of their sales, distribution, logistics, and supply chain such that a combined approach accurately reflects their situation. The packager should have some advance knowledge of the behavior and performance of his selected packaging materials through the conditions of his accelerated-aging protocol to anticipate any negative effects of extended high- temperature exposure on materials and seals.”

Another point about separating accelerated-aging studies from distribution-simulation studies made by Dan Rondeau, general manager of DDL West, is that you could get results from distribution studies sooner than you would from accelerated aging, so you could identify a failure sooner than later.

Greene and Mike Foster, packaging engineer, say that some medical device manufacturers still don’t approach package design as FDA intended, meaning they are not deploying risk management strategies for packaging design, development, and manufacturing. “When it comes to packaging, companies really aren’t focused on packaging as an integrated part of the medical device,” says Greene. “They don’t understand that product functionality and package performance during the product’s life cycle are related.” Adds Rondeau: “They wait until just before launch to design packages, and then they get a failure and delay product launch.” Worse yet, Rondeau reported that one customer just had his 30-month-real-time-tested packages fail. This customer did not test at critical intervals during package design and evaluation, so this company does not know the source of the failure and whether to recall any already-marketed product.

The lesson? “You almost need parallel development of product and package,” says Greene. “As a package engineer formerly for a medical device firm, I designed packages for devices that were under constant design revision and that may not have been fully prototyped. We were detectives in ferreting out key features and attributes of the device and its clinical application and used our package development experience to mitigate package, product, and patient risk. Uneducated staff cannot develop the right package.”

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