Saved by the Delay - Pharmaceutical Technology

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Saved by the Delay
Postponement of California's deadline gives the supply chain time to refine ePedigree solutions.


Pharmaceutical Technology
Volume 32, Issue 8

Challenges

As the industry prepares to meet the deferred California ePedigree deadline, numerous challenges remain, including the lack of federal requirements and the proliferation of different state requirements. "A lack of standardization is trouble," says Paul Baboian, senior RFID business-development manager at Zebra Technologies (Vernon Hills, IL), a supplier of RFID tags, printers, and services. Differing requirements mean exception handling, he explains, which reduces efficiency and increases costs.

To complicate matters for global companies, requirements in Europe are not uniform either. However, the European Federation of Pharmaceutical Industries and Associations (Brussels) recommends a unique serial number presented in the form of a 2D data-matrix code on each secondary packaging unit. The federation expects that the industry will eventually switch to RFID when the technology becomes practical and cost effective (1).

Also, consensus about basic questions has not been established. One of the questions is which type of data carrier should be used. Choices include linear and 2D barcodes, RFID, and manual data entry. RFID and 2D barcodes are the current favorites, and most observers predict that RFID will eventually dominate because it can be read without being in the scanner's line of sight. However, it also seems likely that 2D barcodes will continue to be used as a backup for the RFID tags.

Another unanswered question is whether a product's serialized code should include its National Drug Code (NDC), lot number, and expiration date. Including the product-identifying NDC raises privacy concerns and increases the potential for theft. On the other hand, encoding the NDC provides quick identification, potentially saves network traffic, and eliminates the need to refer to a database.

Whether serialization should be performed by the packaging converter or on the packaging line has yet to be determined. With RFID, tagging is more likely to occur on the packaging line, although a few converters currently offer source tagging. One technology under development applies an RFID antenna to an in-mold label during the injection-molding process (RFID in-mold label, Alcan Global Pharmaceutical Packaging, Kirkland, Canada). Barcodes are easily applied at the converting and packaging-line stages.

One drug plant in Ireland laser codes 300 serialized, 2D barcodes per minute on the bottom of plastic vials. The system consists of an ultraviolet laser, material-handling system, integrated vision system to verify code accuracy and traceability, and software to capture data and maintain ePedigree records (material-handling system, FP Developments, Williamstown, NJ; vision system, Cognex, Natick, MA; "ProTrack" software and systems integrator, Crest Solutions, Little Island, Ireland).

Another 2D barcode system integrates a carton-feeding system with an inkjet printer and vision system to apply and inspect serialized codes. The validated portable unit can be moved from line to line (serialized barcode system, Nutec Systems, Lawrenceville, NJ).

Members of the pharmaceutical supply chain also will need to find networks, servers, and computer systems with the necessary bandwidth to accommodate the huge amounts of data associated with item-level serialization. Trading partners will have to find ways to share data. Three standards established by GS1 EPCglobal (Lawrenceville, NJ) should help, including the programmable 96-bit electronic product code number known as the Global Trade Identification Number, the EPCglobal Information Services (which standardizes XML-based data exchange), and the GS1 EPCglobal Pedigree Messaging Standard.


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