Despite a downturn in FDA investigations into counterfeiting, concerns within the industry have actually increased, fueled by higher threat levels, the value of the products, and their sheer numbers. “Globally, the problem is getting worse,” according to Dave Sayers, market development supervisor for 3M Security Solutions (www.3m.com).
“Counterfeiters aren’t lone wolves in garages,” he says. “They’re getting more organized and better at it.” To emphasize that point, Ben Miyares, industry relations, Packaging Machinery Manufacturers Institute (PMMI; www.pmmi.org), tells of a company devoting 18 months to developing a blister pack with a hologram, only to find it duplicated within six months. Other companies—notably Microsoft—have found knockoffs with proper security packaging on the street within a month of release.
The often-overlooked point is that counterfeiters don’t have to make the exact thing. “Look-alikes” often pass, Sayers, says. “It’s rare that you see the real security feature next to the counterfeit feature.”
To stay one step ahead, pharmaceutical and packaging experts recommend a multi-layered “belts and braces” approach that layers overt and covert deterrents with forensic features as well. A package, therefore, may have an adhesive flap over cartons, coupled with a hologram, a hidden code, and a microdot in the ink or adhesive. The objective is to make your product and packaging so difficult to duplicate that the counterfeiters move on to easier targets.
Next spring, 3M is releasing 3M CONFIRM™, which features a floating image that moves above, below, or through the designated path. It is delivered on the label. “This isn’t a hologram,” Sayers says. “It’s a virtual, one-color line image.”
One of the benefits, Sayers, says, is that this is an overt technology and doesn’t require special tools to authenticate it, yet it’s much harder to duplicate than a hologram. And, he adds, it’s been used successfully in the passport and document security arenas.
Inks also are garnering attention. Ella Drummond, director of pharmaceutical sales at All Packaging (www.allpack.com), is seeing metal reactive inks that change color when metal—a coin, for example—is rubbed across it. Other inks react to various frequencies.
NanoInk (www.nanoink.net) focuses on Nanoencryption™ technology for the pharmaceutical industry. Cedric Loiret-Bernal, M.D., explains that the technology deposits “virtually any molecule on virtually any substrate at the nanolevel.” Due out in 2007, the technology was codeveloped with Seiko to deposit various inks to repair photomasks, it is also used to repair flat-panel displays.
If counterfeiters can see a label, they will defeat it. Nanoencryption incorporates semi-overt, covert, and nanoscale forensic features at the unit-dose level, which also can be linked to the package level for a multilayered protective shield. “The technology is applied at the customer’s site, encrypting tablets or capsules, for example, to identify each product, site, batch, and production date. In our system, only the manufacturers would have access to the code.” The advantage, he says, is “deep, covert traceability at the unit level,” as well as unique links between the package and the tablets.
Nanoscanning is another new technology. Miyares explains that “every package has a unique topography that can be recorded.” The notion is to scan the label or closure of individual packages, which registers as a unique topography, making it “difficult to counterfeit the package. It’s an intriguing possibility.”
“A number of technologies have been proposed, but the problem is cost,” according to Ed Bauer, a member of PMMI’s packaging management council. “Machine manufacturers are good about putting together the machines,” but until there is sufficient demand to lower the costs of solutions like microtaggants, thermo-sensitive inks, etc, most manufacturers will balk.”
Since West Pharmaceutical Services (www.westpharma.com) introduced its flip-off seal a few years ago, it has refined it to allow the customer to choose the color of the seal, the button, and the printing on either. The aluminum shell, and the plastic button, can be embossed, too, or printed with UV ink that fluoresces at either a standard or customer-specified wavelength.
One effective technology is decidedly low-tech. Bauer notes that serial codes with sequential numbers, recorded so that a certain sequence is shipped to a particular customer at a given time, can be effective.
Track and Trace
“There is a pass-the-buck mentality,” Sayers says, “that says a product’s authenticity is based upon who you buy it from.” RFID responds to that mentality by documenting chain of command throughout a product’s life. Consequently, some question the commitment throughout the supply chain to put the equipment in place to read the tags and the manpower to match the tags to the online database to help ensure authenticity. Whether it will make a huge difference in the ability to divert and counterfeit goods or is merely good inventory control depends upon whom you ask.
RFID, whatever its merits, is a step toward the much-touted e-Pedigrees and is symbolic of the increasing connectedness of the entire supply chain.
Two of the big challenges to widespread RFID adoption are the costs and logistics of putting the infrastructure in place, not only to apply the tags but throughout the supply chain to actually read and authenticate the tags. As yet, there’s no single standard for item-level tagging, so manufacturers rightly fear investing in technology that may soon be rendered noncompliant when the actual standard is published. The debate between high-frequency and ultrahigh-frequency wavelengths continues, too.
Another challenge is the issue of who will own the database. With the particularly complex pharmaceutical supply chain, many parties need track-and-trace capabilities, and most could make a good case for database ownership. Ken Reich, marketing director for life sciences at Tagsys (www.tagsys.com), an RFID-tag manufacturer, speculates it ultimately may be guided by a regulatory body like the FDA and managed by the drug manufacturers and/or retail pharmacies.
Purdue Pharma(www.purduepharma.com), Pfizer(www.pfizer.com) and Glaxo-SmithKline (www.gsk.com) all have pilot projects for RFID under way. Purdue is using ultrahigh-frequency while Pfizer and GlaxoSmithKline are using high-frequency tags. The differences are size of inlay, consistent tag reliability, and read performance rates.
Ultrahigh frequency tags are typically used for cases and pallets, which, says Reich, “can be read at longer distances in a warehouse or in conjunction with GPS in an open environment (as in DoD applications). With the advent of the Gen 2 UHF standard and further development of the near-field read capability, UHF has been adapted to item-level tagging.”
The optimal efficiency rate is 99.65% (or 4.2 Sigma), Reich says. There are rumors, however, of even lower efficacy in real-world applications. “But, assuming the best,” Reich adds, “that is a failure rate of about one in every four pharmaceutical totes, equaling 25 percent, and one failure in every six cases, equaling 17 percent.”
Tagsys makes both HF and UHF tags for item level track, trace, and authentication, but tends to recommend HF tags because of their performance around solids and liquids, as well as metallic packaging. They boast efficiency of 99.999% (6 Sigma). “That’s one failure in 3,676 totes,” Reich says, “and one failure (of 48 items) every 6,127 cases.”
Pfizer began using high-frequency 13.56 MHz RFID tags for item, case, and pallet-level identification for Viagra and reports it reads up to 48 tags in a dense-pack case, despite liquids and metal surfaces, with more than 99.9997% accuracy.
Its tags, made by Tagsys, are flexible-form factors applied to the back of the Pfizer Viagra label. A UHF tag, used on the outer case, creates what Reich calls a “parent-child” relationship that correlates each packed product with the case.
West Pharmaceutical Services is using Tagsys’ 8.9-mm rigid high-frequency tags that fit easily on standard 13-mm or 20-mm flip-off seals for vials, according to Carol Mooney, marketing manager for injectable products, pharma/biotech. West chose a rigid tag to withstand the injection molding manufacturing process, component sterilization and years of shelf life, as well as cold chain applications.
For RFID to be widely adapted, “We need a good return-on-investment case study and a clear pedigree road map,” Mooney notes. Pfizer already has implemented a scaleable RFID solution for its Viagra manufacturing facility in France, to provision, commission, associate, and authenticate data within the manufacturing process. EPC and 2-D bar codes are affixed to the flexible RFID tags in the production line, which are then placed on the bottle.
The bottles and tags are then inspected and the case is filled and sealed. UHF labels are then applied to the case with EPC and linear bar codes and the items are read again and either accepted or rejected before the cases are palletized. A bar code and pallet RFID tag are then added.
RFID is generally considered an enabler to ePedigrees. Although the FDA is advocating pedigree adoption by December, it doesn’t have to be electronic. The electronic component simply streamlines the process of tracking and tracing shipments by providing greater supply-chain visibility.
The change to ePedigree should be relatively painless for major distributors, but will likely be different for secondary wholesales because of the greater number of potential entry points, notes Robin Koh, chief strategy officer at SupplyScape(www.supplyscape.com).
To help ensure that implementing pedigrees will be painless, distributor McKesson is partnering with software developer Axway (www.axway.com) to develop a software solution for using and serializing data in a track-and-trace paradigm. Axway Synchrony™ is the starting point. In the future, serialization will provide users with a more granular view of the supply chain, notes Ron Gabrisko, vp, health and life sciences, Axway.
To complicate the situation, states have different requirements. “Florida and the FDA pedigrees requirements are, essentially, from the standpoint of the distributor” so that direct shipments from the manufacturer to the retailer won’t need pedigrees. California, in contrast, wants the pedigree to start with the manufacturer. Koh’s advice is to meet the most stringent requirements and adjust from there.