Addressing the aggregation problem in pharma traceability

One of the nagging problems with implementing the Drug Supply Chain Security Act (DSCSA), which mandates putting a unique serial number on each bottle or container of pharmaceuticals in commercial distribution—is accurately determining which bottles went into which cases. Based on a news release issued jointly by Antares Vision, a packaging automation vendor, and Xyntek, a Newton Square, PA systems integration house that is the US distributor of Antares equipment, the problem has been addressed with a coding and robotic system that checks bundles of bottles as they are packed into cases. The system was recently installed at unnamed pharma company for DSCSA compliance.

In practice, bottles are serialized (with a barcode on the bottle label) on a packaging line—a fairly conventional labeling step in pharma packaging. The bottles have a “helper” barcode placed on their bottoms, with that barcode tied to the barcode on the label. Bottles are then arranged in a bundle, picked up by a Fanuc robotic arm (pictured above), and presented to an Antares camera that quickly reads and verifies each of the bottles in the bundle (pictured below); then the arm stacks multiple bundles in a case. A unique case label is generated for the case, and the codes of the bottles within the case are aggregated to that label. Machine vision technology from Cognex, barcode printing from Domino, packaging machines from Omega Design and ESS Technologies, and labeling systems from Weiler Labeling. All these steps, along with the data collection of which bottles went into which cases, are managed by the Antares Tracking System software.

A screen display of the 'helper' code verification

“The solution implemented by Xyntek and Antares further simplifies the downstream product tracking and tracing as the product enters and navigates through the pharmaceutical supply chain; enabling verification steps to happen at the case or pallet level versus having to open every case to confirm the contents" observes Mac Hashemian, CEO of Xyntek.

Such helper codes are not a mandated part of DSCSA, but the aggregation problem needs to be addressed one way or another, because the major US drug wholesalers do not want to be obligated with verifying the contents of each case they receive—which would be an enormous time- and effort-consuming step in pharma distribution--but to depend on the case label and data collected during the packaging process. The general term for this is “inference,” and inference and aggregation have been argued over for years within the industry as part of GS1 data standards and FDA traceability guidance. The aggregation problem also highlights the prior state of pharma packaging, with cases having too many or too few packages within them. DSCSA essentially compels 100% accuracy.