Serialization implementations are making progress

News announcements and presentations at the this year’s HDMA Track and Trace Seminar (National Harbor, MD; Nov. 8-10) attest to a slow but steady accretion in projects and technology development for serialization of pharma packages—the goal of the California e-pedigree initiative that was postponed in 2008 in the US, but a capability that more countries around the world are imposing (Pharmaceutical Commerce, Sept/Oct, p. 28).

In the latest round of announcements, IT vendor Axway (Phoenix) and AstraZeneca have announced that 10 sites and a total of 33 production lines will be feeding serial numbers into a corporate system by the end of the year, with more sites to be added in 2011. A couple years ago, Systech International (Cranbury, NJ) announced that it had won the contract to install packaging-line serialization systems at AZ plants around the world; now, those packaging lines are feeding data and “events” (the term for a change in status of a package as it undergoes assembly, inventorying and storage) so that AZ customers can verify product authenticity.

Similar capabilities were announced at the HDMA meeting by Teva Pharmaceutical, which is notable for being one of the first generic manufacturers to install serialization capability, using 2D barcodes on packages. Throughout much of the debate over serialization in the past several years, the belief has been that generic manufacturers would have near-insurmountable cost pressures to serialization because of the lower pricing and margins common in generic manufacture.

Finally, in an action very reminiscent of a variety of consortia that formed up in the 2005-2008 period, four companies have formed a group to ensure that manufacturers can obtain a unified serialization solution, from the packaging machinery through to serialized labels, and data management of the process. The consortium, called 4 Serialization, combines Acsis Inc. (Marlton, NJ), an IT solutions provider; Cognex Corp. (Natick, MA), a machine-vision systems vendor, Nosco (Waukegan, IL) a contract provider of labels and folding cartons; and Omega Design Corp. (Exton, PA) a packaging machinery vendor. By forming their alliance, the companies promise to offer a turnkey serialization solution that would minimize the need for custom interfaces between the various parts of a serialization system. The alliance plans to provide a solution compliant with GS1 serialization standards.

“We’re on our third generation of our Track and Trace solution,” says Dave Bennett, chief technology officer at Axway, “successfully handling millions of records and terabytes of data. We’re really proud of our relationship with AstraZeneca.”

To those who would say that national or international standards are not yet mature enough to make confident decisions on what technology requirements to meet, Bennett says that existing GS1 standards are “solid enough to move forward.” Generally speaking, the basic requirement of a serialization system—to record an ID number and associate it with a particular package—is a difficult but manageable process-control task. The process becomes substantially more complicated when a manufacturer or contractor needs to update that record with subsequent events, such as moving the product into inventory, or out to customers. “We have a robust event-processing engine in our Track and Trace solution,” says Bennett.