Be spec-tacular

If you write a good spec for your sterilebarrier system (SBS) supplier, you may go a long way toward preventing product recalls. But “good” doesn’t mean overspecifying, explained Alison Tyler, technical director for Beacon Converters Inc. (Saddlebrook, NJ), during HealthPack 2007. Held in New Orleans, the annual medical device packaging event featured speakers who emphasized clarity in manufacturer-supplier relationships.

When preparing specifications, it is important to “characterize both materials and the evaluation of the resultant package,” said Tyler. For instance, “burst testing should be agreed upon by both parties for method and interpretation. Some material combinations have inherent variability in burst data and [that] does not indicate bad packages. It is best used in conjunction with peel testing for in-process testing and package compliance testing.”

Also, she added, “there is an assumption that 1-lb seal strength is the industry standard, when in fact it is an arbitrary specification that may be inappropriate for some material combinations. Forcing an arbitrary specification may cause more harm than good.”

A clear, thorough exchange of requirements between manufacturer and supplier can also ease regulatory filings. “Documentation from your supplier goes into your design history file and can be assembled for regulatorybody review,” said Hal Miller, principal of the packaging consultancy firm Pace Solutions. His talk, “Leveraging Your Suppliers—What’s Available for Critical Design and Development of Material and Package System Information,” outlined what packaging engineers should require of their SBS suppliers.

In addition to documented material qualification and shelf-life data, “You should expect quality dashboards on materials as well as on process validation,” said Miller. For instance, SBS suppliers should provide details on “preheat forming windows, forming depth, in-line stretch, sealing windows, visual attribute windows, heat-seal curves, and printability,” said Miller. “These can be verified off-line at the supplier. These details give you as a user a target for your own processes.”

Clearer specs and better communication may very well lead to better-suited packaging-system designs. And that may reduce recalls caused by packaging problems. After all, packaging failures have created the largest number of product failures, FDA’s Don Marlowe told HealthPack attendees.

Tyler pointed to a recent product recall attributed to a packaging failure. Approximately 2000 disposable biopsy plates were recalled in January. According to a report in FDA’s CDRH database, “the packaging used for the breast biopsy plate may exhibit small holes or tears.”

While Tyler didn’t say she knew what caused the recall, she did offer examples of recalls rooted in packaging problems. “Even printing scuffs can cause recalls,” she said.

Recalls may be an indication that some designers have forgotten FDA’s advice. Reiterates Marlowe: “Quality cannot be tested into a product.” Instead, he says, achieve “quality by design.”

With the proper spec, SBS suppliers can help you design in such quality.