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.