Stepping—Not Leaping—Toward Electronic Pedigrees
By Daphne Allen
The IMprints Track & Trace Solutions suite from Videojet Technologies (Wood Dale, IL) provides a full, end-to-end package coding system for meeting electronic pedigree and track-and-trace requirements. But with California’s e-pedigree law not taking effect until 2015 and federal rules still taking shape, many pharmaceutical companies haven’t been looking for complete solutions.
|Pharmaceutical companies can verify bar codes as well as closure placement, label quality, and other package attributes with CodeMatch. (click to enlarge)|
So Videojet decided to scale things back a bit with CodeMatch. The solution can be implemented for less than half the investment required for a full e-pedigree packaging line system.
“We saw that many customers weren’t ready for a full e-pedigree system,” says Bob Neagle, business unit manager for Videojet’s brand protection solutions group. “Many pharmaceutical companies are reluctant in today’s economic environment to make a capital outlay for a complete mass serialization system. Instead, they just need a step forward.”
The IMprints CodeMatch incorporating vision inspection allows pharmaceutical companies to begin building an e-pedigree-compliant packaging line system. “Companies can take a step toward e-pedigree by printing 2-D bar codes with the Global Trade Item number (GTIN), without capturing the data, as they would in the complete IMprints system. Companies can then come back in two years for serialization and data collection and transfer to an enterprise resources program (ERP) with the entire IMprints suite.”
In addition to producing fully variable 2-D Data Matrix bar codes, the CodeMatch system also includes tools such as blemish detection, optical character recognition (OCR), and optical character verification (OCV) to ensure code quality. All major bar codes in any positions and combinations on bottles or vials can be inspected in any orientation.
“The first step is getting down the basics to code verification—are the codes present and clear and readable, with no smudges,” says Neagle. “Some pharmaceutical companies are already running automated inspection systems, but others are still using manual spot checks.”
CodeMatch employs a line controller that can compare multiple variable data codes against a database to ensure compatibility, Neagle says. For example, CodeMatch verifies the correct label has been placed on the correct bottle with a valid serial number. It can also be configured to receive inputs from three cameras, which can expand the system’s capability to verify the presence of an onsert, for instance.
The OCV function of the CodeMatch system reads and analyzes codes to ISO 15415/6 specifications and gives the symbol an ANSI grade based on the average of 10 scans.
|Drug manufacturers and packagers can ease into item-level serialization by mastering 2-D Data Matrix printing and inspection first and moving to data capture later.|
CodeMatch can be used with both preprinted materials as well as in-line printing, such as with Videojet’s DataFlex thermal-transfer printer, its continuous and thermal ink-jet systems, and laser marking systems. The system can also interface with third-party marking and coding systems for variable data management. It also integrates with packaging line devices for handling rejection of improperly marked products and associated reporting.
A control system provides visual management for job set up, Neagle says. “Jobs are easily recalled by scanning an existing label or choosing that label from an onscreen menu, reducing time spent on project management,” he says.
Users may find useful business benefits to CodeMatch, says Neagle. “Customers are saying, ‘If we can be thoughtful about implementation, reading every single label can benefit our business.’ These include higher throughput, better quality, and reduced labor.”
As companies ease into code printing and automatic verification and control line performance, they can begin to address some of the more complicated questions. “For instance, you hear about 100% verification—but what does that exactly mean? Every product, or every attribute?” asks Neagle.
In addition, “what are the benefits for patients from automatic product identification in the healthcare setting, and will those potential benefits influence the business decisions you make?” he asks.