Road to RFID Paved with Bar Codes

Bar codes are the short-term answer, as long as manufacturers strive to understand FDA guidelines at all levels of packaging, says George Wright IV, vice president of Product Identification & Processing Systems, Inc.

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RFID adoption has lagged in pharma and other industries for a number of reasons, including the cost of implementing systems, ongoing changes in global standards and the still-unacceptable-to-many failure rate of RFID tags. Supporting those not rushing to embrace RFID is George Wright IV, vice president of Product Identification & Processing Systems, Inc. He asserts, "The road to RFID is paved with bar codes."

PharmaManufacturing.com spoke with Wright to ascertain the view from his particular mountaintop.



PM: You say the road to RFID is paved with bar codes. What’s the main reason?

GW: There are several reasons. The simplest is that RFID chips still fail at a significant rate and when that happens, you need a backup system, a means of capturing the information that cannot be read from the RFID data carrier. 2D bar codes are the backup system. Even for mass serialization and track and trace applications, bar code technology can do the job.

Another fundamental reason is that the total cost to implement an RFID system in both time and money is significant — much higher than most prospective users realize. As is the case with most productivity-enhancing technologies, RFID systems will be deployed gradually, where the ROI warrants it. As system costs decline over the coming decade, more applications can justify the investment. During this period, bar codes will continue to play their historical item-identification role and will also be called upon to do even more in the way of track and trace.

PM: You’ve also said that 2D matrix bar codes such as Data Matrix will be the technology of choice for the foreseeable future among pharmaceutical packagers. Why?

GW: Well, I don’t think made quite such a sweeping statement. I said if pharmaceutical manufacturers were free to choose, I do believe this would be the case — over the long term — because 2D matrix codes are easier to print (and print well); have the advantage of built-in error correction, which makes them more robust and resistant to a certain amount of physical damage; and byte for byte are much smaller than traditional linear bar codes.

The fact is, however, they are not free to choose, except in certain limited applications, whether because pharmaceuticals move through national supply chains regulated by governments or simply because the choice is constrained by the installed base of scanners, both in their own manufacturing/packaging facilities, at the distribution centers and ultimately at the point of sale and point of care.

In the U.S., where FDA has now mandated that the NDC be encoded in standardized bar code data structures and symbologies and printed on the package or label of 1) all human Rx products and 2) OTC products packaged for institutional use, the use of 2D bar codes was specifically excluded because FDA determined that the added cost to hospitals of 2D scanners/imagers over the less expensive 1D or linear scanners would be prohibitive. In addition, the global marketplace — saturated with 1D scanners everywhere — would still require the traditional linear U.P.C./EAN or other standard 1D symbol.

That said, manufacturers do seem to be migrating toward the use of 2D symbols (and particularly Data Matrix ECC200) for component identification and we see manufacturers evaluating the possible addition of GS1 Data Matrix (also ECC200) bar codes to packaging and labeling as a supplemental symbol (typically, encoding addition secondary data such as expiration date, lot number and possibly even serial number), over and above what the FDA or the current supply chain may minimally require. The idea is that this additional symbol will be “invisible” to traditional linear bar code scanners but would be beneficial to those users who deploy 2D imagers sooner rather than later. To me this is an excellent idea that provides a seamless migration path for the future and it is one that I think you will see formally endorsed in the pharmaceutical supply chain very soon.

PM: The effectiveness of bar codes, while good, can be better. What steps need to happen for  open bar code systems such as the GS1 system to provide everything they are capable of?

GW: There are four main elements of most any bar code scanning system, open or otherwise. With reference to the GS1 system and others, these are: 1) the manufacturer/labeler’s assignment of unique identification numbers at every level of packaging and the communication of that information (and related product attribute data) within the organization and to trading partners; 2) the bar code itself printed on the package or the label; 3) the scanner that reads the bar code; and 4) the application software that handles the scanned data.

To start with, manufacturers need to closely control the assignment of unique item identifiers for all of their products at all levels of packaging. Such assignments must conform to the relevant guidelines, knowledge of which is too often woefully lacking at many manufacturers. Once that is done, this information needs to be published internally to the affected departments such as manufacturing/packaging, distribution, sales, marketing and customer service. The information also needs to be communicated to trading partners.

When it comes to printing bar codes, the correct data needs to be encoded in the right symbology and the symbol must be well printed. ANSI and/or ISO standards have been in place for more than 15 years detailing how bar code print quality is to be assessed reported and most every industry bar code application guideline and vendor compliance guideline specifies a minimum print quality grade. The marketplace offers a wide array of quality bar code print quality verification tools (and unfortunately some others that are not) and the choices are growing in number and in capability. In most retail markets, the cost of verification is more than paid for in savings from avoiding supplier charge-backs for poor quality bar codes. In healthcare, where patient safety is often a big part of the cost/benefit equation, the benefits of quality are even more manifest, particularly when quality is mandated under cGMP, as with the FDA bar code rule.
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