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EFPIA wraps up its 2009 test; a new pilot in the UK with Reckett-Benckiser
At both the CBI Bio/Pharmaceutical Anticounterfeiting and E-Pedigree Summit (Philadelphia, March 10-11) and the Reconnaissance International Anti-Counterfeiting Conference a couple weeks before, Jean-Marc Bobée, chair of the EFPIA Coding Project (and a Sanofi-Aventis executive) summarized the pilot project’s initial findings following its four-month run in the fourth quarter of 2009. The project involved 14 biopharma companies, two wholesalers, and 25 pharmacies in the Stockholm, Sweden area. Of the 110,000 product packages that were coded (with EAN 128 linear barcode as well as ECC200 2D data matrix codes), 95,000 were actually dispensed at the pharmacy counters. Prior to completing the transaction, each package was authenticated by scanning the barcode and communicating it to a central database. (IT vendors included HP, Siemens, SAP and Melior Solutions.) The system completed over 99% of the confirmations, usually in less than one second.
Of the uncompleted transactions, some interesting examples of exception handling had to analyzed. In some cases, a package that had been dispensed but never picked up, was returned to stock without a corresponding update; when it was re-dispensed, the system questioned its authenticity. Some erroneous reads occurred when the scanning system read the linear barcode instead of the 2D barcode.
Pharmacists liked the system, especially for being able to confirm non-expired and non-recalled product in a machine-readable format, EFPIA found.
The European Federation of Pharmaceutical Industries Assns (EFPIA) is positioning this pilot as a successful demonstration of an authentication system that meets the requirements of a proposed EU standard. It also serves to throw a significant hurdle at parallel-trade wholesalers, who purchase low-cost product in one EU country and export it to a high-cost EU member. Such parallel traders (who repackage product to meet national language requirements) can still operate as long as they retain “equivalent” safety features. Bobée says that EFPIA expects Europe to adopt this type of mass serialization in the next 4-5 years.
Security inks and optics and RFID too
Meanwhile, a somewhat under-the-radar pilot, SecureTrace, was recently concluded successfully in the UK, involving manufacturer Reckitt Benckiser at its Hull, England plant. A commercial-scale packaging line for blister-packed tablets was equipped so that it could apply a serialized code to each package with a security-enhanced ink, along with an optical “fingerprint” of a selected surface. Next, bundled product was aggregated and coded with barcodes and RFID tags.
The project was planned as a complement to the EFPIA one; EFPIA concentrates on the connectivity of trading partners, while SecureTrace focused on providing anticounterfeiting measures directly to packages, and validating these technologies on commercial packaging lines. “The combined use of four sophisticated technologies, laser surface authentication and forensic signature inks that enable authentication and use of 2D barcodes and RFID, make SecureTrace more comprehensive than any other programs being used to protect pharmaceuticals,” says Ian Eastwood, chief technology officer at Authentix, which was the lead partner in the project.
SecureTrace, with partial funding from the UK government’s Technology Strategy Board, was also meant to showcase UK technology vendors. Participants included:
Authentix for forensic signature inks and field authentication
AND Automation for systems integration
CamData for barcode and RFID scanners
Domino for printing systems
GIS for RFID tags
Imsol for vision systems
Ingenia Technology for laser surface authentication
PERA for information systems.
Once product was encoded, it could be sent into the field where the CamData scanners could be used for validating the barcodes, and Authentix technology for sensing the security-tagged ink.
For their part, the EFPIA project leaders note that their system does not authenticate each package individually, but rather depends on the database confirming the disposition of each package—in effect, invalidating a second package that might have the same barcode as the first, presumably authentic, one. The multiple technologies used in the SecureTrace project potentially can authenticate each package individually.