Play it Safe with Secure Packaging

Inspired package design requires considering the “worst case” for any technologies selected.

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RFID is here, whether we like it
or not. FDA guidelines mandate
deployment of RFID at the pallet
level this year. Photo courtesy of
Symbol Technologies.

By Angelo De Palma, Ph.D., Contributing Editor

Implementing product security at the package level is a lot like ordering food at a restaurant with a nine-page menu. There are so many choices that, as soon as you order, you wonder whether what the folks at the next table are having isn’t better.

In fact, packaging security technologies should be sampled buffet-style, since no single entrée, even radio frequency identification, is enough to satisfy. Despite RFID’s near-mythic status as an all-purpose security measure for everything from people to pills, technical and business uncertainties abound.

And there are plenty of tried-and-true technologies that won’t raise adrenaline levels but get the job done all the same. Counterfeiters are crafty and adapt quickly, and thus a good packaging security program requires a shifting mix of high and low technologies, and a clear view of what can go wrong with each one.

RFID not yet robust

When asked what could go wrong with RFID, Amar Singh, VP of Global RFID at SAP (Newtown Square, Pa.), jokes, “There are never any problems with RFID.”

All jest aside, those who aspire to RFID’s promise find themselves stuck between an irresistible trend and the intransigent laws of physics. Tag reading distances vary widely, from a few feet to a few meters, and there are multiple forms of interference. “Radio frequencies are affected by humidity, nearby metals – including packaging and foils – the direction of the receiving antenna, and the presence of liquids,” adds Singh. “What you read in a magazine or technical specification is not necessarily what you get in the field.”

Even geometry plays a role in RFID’s practicality, as a tag on the wrong side of a pallet might not be properly read. Singh cites one SAP customer who implanted tag readers on two shipping doors. One worked perfectly while the other stopped transmitting because a water pipe installed near the second door damped the signal. Another SAP client implanted RFID tags on detergent bottles but shrink-wrapped the pallet with a metallic wrapper, foiling not just its product but attempts to read the tags inside.

“Clearly, RFID is not yet robust enough for every environment,” Singh concludes. “Since RFID physics change with the environment, testers must simulate actual conditions, including different locations. There is no substitute for real-world testing.”

RFID’s economics have also come under fire. Companies must understand and model business processes and supply chains to identify points where RFID is most appropriate. Unless a major purchaser (e.g., Wal-Mart) forces a packager’s hand by demanding radio tags, an incremental approach is best. “Start at a higher level such as pallet and case to realize the technology’s potential and understand its challenges before moving to cases and bottles,” advises Singh.

A third constraint on getting the most out of RFID is what Singh calls “limitations on the exploitation of data.” That is, unless all back-end RFID information is available in real-time, it may as well not exist – and may actually get in the way. There are also situations where RFID’s rich data capabilities are simply overkill. A pharmaceutical manufacturer need not know every product’s movement in real-time when daily sales numbers are adequate. The objective should be utility, practicality, and usability – not technology per se.

“In many cases RFID doesn’t do much more than barcodes, but what it almost always does is reinvigorate and facilitate capabilities that were theoretically available with bar codes but may not have been practically feasible,” observes Singh. “The advantage might not be seen at the point of sale, but where RFID is used it can lower data collection costs and allow handling of much more accurate information than printed codes.”

Security myth and mysticism

FDA guidelines mandate phased-in, industry-wide RFID deployment by 2007. By 2005, companies should have implemented the technology at the pallet level, and by 2006, for cases. From there, the agency will likely consider individual product security needs for smaller units.

But is this timetable realistic? Hurdles are not restricted to technology and data.

“RFID is going through the same growing pains as grocery-store scanning did 15 years ago,” says Don McMillan, VP of marketing at West Pharmaceutical Services (Lionville, Pa.).

Pharmaceutical manufacturers and packagers eager to implement new security measures face an uphill battle, not just from regulators but from within. High-speed packaging lines are designed to carry out specific operations. “Adding a bar-coded label or incorporating an RFID tag takes time and additional validation,” says McMillan. “And despite volumes and volumes of validation protocols things still can go wrong.” Significant RFID defect rates spell double trouble, since if a chip fails the vial and its high-value contents are trashed along with the tag.

There are three types of RFID implementation, according to Kevin Prouty, senior director of the Manufacturing Industry Solutions Group at Symbol Technologies (Holtsville, N.Y.): “Those that work, those that work with development, and those that will never work.”

Harsh words, but true in an industry where 99% accuracy is not enough. “Non-regulated manufacturing can perhaps live with 80% read accuracy,” Prouty says, “but in pharm’s validation climate you have to think in terms of 99.999% accuracy. RFID has shown such a lack of reliability that manufacturers are falling back on 2-D bar codes.”

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