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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