Medical Device Link.

Originally Published PMPN April 2005

BAR CODING SUPPLEMENT

The standardization of bar codes could help form the backbone of track-and-trace documentation.

Ben Van Houten, Managing Editor

Now that more and more pharmaceutical companies are working to meet FDA's 2004 bar code ruling, the nuances of bar coding itself are taking center stage. Specifically, companies are looking at the various standard data structures surrounding the printing of bar codes more carefully than ever, with the knowledge that bar codes will increasingly be used for the tracking and tracing of products through the supply chain.

Photo courtesy of Microscan.

And, because some experts view bar coding as the bridge to future radio-frequency identification (RFID) implementation, the development of a solid bar code infrastructure is becoming more important than ever.

THE IMPORTANCE OF STANDARDS

"Today's bar codes need to meet minimum ANSI/ISO/IEC quality criteria," says George Wright, vice president of Product Identification & Processing Systems Inc. (PIPS; New York City). "Unfortunately, a large number of codes aren't meeting those standards. For supply chains to be running in the best possible manner, that needs to change. In addition, standardized bar code print-quality verification is important." He adds that healthcare bar code application guidelines from EAN and the Uniform Code Council (UCC) and The Health Industry Business Communications Council (HIBCC) currently require a minimum overall symbol print quality grade of C.

Elsewhere, the Health Industry Bar Code (HIBC) Supplier Labeling Standard (SLS) was recently revised. Changes to this standard include the incorporation of a specification for small-package labeling using 2-D symbologies. The SLS includes the HIBC-LIC data format, which is a variable-length alphanumeric format for primary identification of medical goods, as well as secondary information that is critical to healthcare processes such as lot, batch, and serial numbers and expiration dates.

"We want to be getting to the point of one product and one number," says Wright. "We already have the established, standardized item identification tools we need to bring the healthcare supply chain into the next century. We know the standards work, but we need to implement these standards. FDA is insisting on it, as is the marketplace. So should we."

To get to that place, Wright suggests that companies use established application standards, data structures, and symbologies. "More companies are using bar codes on unit-dose packaging now, per FDA," he says. He adds that ISO/IEC 15416 and ISO/IEC 15426-1 are the most important industry standards that measure bar code quality.

Wright also notes that Reduced-Space Symbology (RSS) with a 2-D bar code (RSS/Composite) has become the standard for bar coding in the pharmaceutical industry over the past several years. Developed by UCC to be a compact linear-scannable symbology compatible with its EAN/UCC 14-digit Global Trade Item Number (GTIN) coding structure, RSS/Composite uses the NDC (or a Universal Product Code [UPC] for nondrug products), a one-digit packaging-level indicator, a one-digit check-level digit, and flag or pad digits as specified by the standard.

"RSS is extremely effective because it encodes the EAN/UCC 14-digit GTIN on unit-dose packages that don't have much space," says Wright. He adds that the Composite code can be used for encoding lot codes and expiration dates.

UTILIZING TECHNOLOGY

Laser bar code scanners from Microscan verify codes on pharmaceutical bottles. (click to enlarge)

Some companies are utilizing technology to grade bar codes on-line. "There's no doubt that verifying bar codes to ANSI/ISO, and all other standards, is key to bar code success," says Tim Lydell, president of Label Vision Systems Inc. (Peachtree City, GA).

To that end, the company's Integra 9500 bar code verification system recently earned UCC certification to the EAN/UCC general specifications standards. "EAN/UCC is a worldwide recognized organization that has, and continues to, establish the standards that unify the use of bar codes in the retail, distribution, and pharmaceutical industries," says Lydell. "The Integra 9500 not only verifies to the ISO standards as required for any verifier, but it also points out the exact spot in the bar code where the problem is, so corrective action can be taken. It makes verification simple and mostly eliminates the analysis of determining what is wrong." The Integra provides 100% inspection of all bar codes, RSS, RSS/Composite, and DataMatrix codes.

RSS in particular could potentially be front-and-center for bar code standards in the future, according to Wright. "This is the most robust bar code language, and it's designed to replace UPC and EAN over the next few decades," he says. However, he mentions limitations in this technology. "It's very short and pretty narrow, and usually only used for vials, blisters, and syringes," he says.

Systech (Cranbury, NJ) also offers RSS readers with ISO-standard on-line grading capability, according to David DeJean, director of sales, North America. "It's part of our overall serialized product tracing from unit to carton to case to pallet," he says. "We also use machine vision and line-monitoring technology with bar codes to manage the entire production line. We can actually verify bar codes to all standards through this vision technology, using RSS, 2-D, or DataMatrix."

Specifically, the company's TIPS Sentri LX, an automated inspection system, is designed to verify RSS or DataMatrix codes in-line. The product gathers data from laser scanners and can scan bar codes at speeds of up to 500 scans per second. It also has the ability to separately read and match bar code scanner outputs to allow a better interface to machine controllers.

And with this increasing number of bar code applications comes the need for printing, which companies like Bell-Mark Corp. (Pine Brook, NJ) are hoping to meet with new technology. For example, Bell-Mark's Intellijet R is a small-character ink-jet printer that is designed to be very economical, according to the company, and can meet different requirements for in-line printing.

MASS SERIALIZATION

Today's bar code scanners, such as this product from Microscan, are able to handle the increasing number of bar code applications. (click to enlarge)

The standardized nature of bar coding lends itself well to mass serialization, according to many industry experts, which in turn means more-effective tracking and tracing of products. "Mass serialization uses unique, randomly-generated alphanumeric codes, typically made of 12 digits. That makes it very tough for counterfeiters to guess the numbers," says Kevin Erdman, president of Verify Brand (Minneapolis).

Verify provides customized product authentication solutions designed to detect and deter counterfeiting and diversion and to ensure strict chain of custody, according to Erdman. Verify's authentication solutions enable manufacturers to keep their production or distribution processes, he adds. Once his company finds a place to put a bar code on a package's label, "very little disruption is caused, with few added costs or equipment needs for the label manufacturer."

Gregg Metcalf, industry market manager for Nosco Security Protection, Nosco Inc. (Chicago), agrees that mass serialization can be used effectively with bar codes. "Bar codes are an intricate part of a track-and-trace solution when using mass serialization," he says. "2-D and RSS are specifically well suited, because their ability to store larger formats of information makes them ideal for mass-serialized products. They allow a brand owner to start data capture and data storage for the development of an electronic pedigree." Metcalf also says that, because many customers are already using bar codes and scanning bar codes within the framework of their operation, they can be one step ahead of the process. "The way in which a bar code becomes an anticounterfeiting device is the fact that a mass-serialized number becomes attached to the code," he says. "These numbers can be both serialized and random serialized and implemented into the bar code."

Sarah Schabacker, business development manager for Datamax Corp. (Orlando), agrees. "The main advantage of bar coding as a track-and-trace tool is that it takes human error almost completely out of the equation," she says. "Studies have shown that in human-managed data-entry systems, errors are unavoidable. Bar codes allow both automation and secure and accurate data entry so that the system does not become compromised by the quality of data within it."

Datamax makes thermal and thermal-transfer printers and labeling supplies for use in bar code applications. The company recently introduced its die-cast-aluminum chassis concept, which allows users the flexibility to configure a printer however necessary with options that are field-installable and removable. "This makes our printers user-friendly so that bar coding is accepted not only by senior management, but also by the operators running the printers," she says. "Our printers are often used to create necessary product labels indicating information such as lot number and expiration date for pharmaceuticals. With the recent FDA bar code requirements, Datamax printers are also currently assisting pharmaceutical manufacturers, labelers, packagers, and repackagers in ensuring that drug labels are correct and contain the proper information."

MEETING THE MANDATE

Videojet's S60 laser printer for bar codes. (click to enlarge)

"Many companies have been working on compliance with FDA's bar code mandate," says Wright. Because the final bar code rule requires the use of any linear bar code in the EAN.UCC system, he says, some pharmaceutical companies are adopting the use of RSS and RSS/Composite codes for unit-dose packages. One such company, Pfizer (New York City), has implemented an RSS system for its hospital unit-dose (HUD) products package in blister cards. "We ran extensive trials, and by December 2002, we demonstrated we were able to achieve what we set out to do and commenced our implementation and committed to be producing all of our HUD blister packs with the RSS/Composite symbology by the end of 2003. We met this objective," says Rich Hollander, senior director of packaging services for the company. "We acquired Pharmacia in mid-2003 and, with further collaboration and alignment with our new manufacturing sites, we were able to get the majority of its products in production with the RSS/Composite symbology with that same timing as well."

As Wright points out, most companies are using in-line flexographic printing on HUD blisters, thanks to the ample space available for bar codes. However, that is not without its challenges. "Our most significant challenge was not so much a technical one, but more in our own learning of how to treat printing as a science rather than what we had traditionally considered an art," says Pfizer's Hollander. "We needed to recognize printing small machine-readable codes on paper using flexographic platen printing at existing production speeds. That required a level of quality even higher than what we already had in place for our existing human-readable information, and required an increased awareness and specificity of mechanical setup procedures, increased frequencies in cleaning the print mats, and an understanding of not only how to measure print quality via the ANSI grading system, but to utilize the information generated to control our print operation accordingly."

Hollander adds that meeting verification standards is an essential part of the process. "Before we committed to this initiative, we set the success criteria of ANSI Grade C quality or better at or above a six-sigma level," he says. "We did not want to receive complaints from our customers that these codes were not readable. We challenged ourselves to see if we could meet this high quality level and do it with our existing printing equipment and at existing line speeds."

Another company utilizing bar code technology is McKesson Automated Prescriptions (Pittsburgh), which has been using technology from Microscan (Renton, WA) to automate outpatient medication and supplies-management systems to help hospitals and pharmacies reduce errors. McKesson's new product, the AccuScript Pharmacy Robot, is a compact, scalable robot that can fill up to 130 prescriptions per hour. Bar code verification takes place at the beginning of the dispensing cycle, according to Andrew Zosel, product manager for Microscan. Once the robot pulls the correct cassette for the prescription, the cassette is presented to the Microscan miniature MS-3 laser bar code scanner for verification to ensure the proper drug was selected. It then goes to a dispensing station, where a bar coded label with a customer's prescription information is printed and wrapped around a container.

A BRIDGE TO RFID?

One area many are closely observing is how bar coding's infrastructure might transfer to RFID implementation, an important consideration given FDA's increasing focus on RFID as an anticounterfeiting and track-and-trace technology. "Honestly, electronic pedigree and the tracking and tracing of products are just as viable with bar codes as with RFID," says George Wright. "You cannot have track-and-trace capabilities or pedigree without an infrastructure. That does not exist currently with RFID. But bar coding is ready for this today."

Wright points out that the coordination and processing of data is the main ingredient that RFID is missing. "In my opinion, bar codes will exist side by side with RFID for 10 years, and bar codes will also be the bridge to RFID. However, the hard work comes in building the infrastructure. It's obviously already there with bar codes. And we know how to successfully use that data with bar coding."

Adds Tim Lydell of Label Vision Systems, "The discussion of bar code versus RFID is so much emotional hype. RFID, like bar coding, has a place in the track-and-trace world. However, RFID has an increased level of cost over bar codes that will not be eliminated due to the very type of technology used. To print a bar code on a package that is already being printed costs virtually nothing to print. To apply an RFID tag to a product adds an incremental higher cost. Unless there is a problem with line of sight or high value, there is no need to add the additional cost, as consumers will not want to pay for it."

The Videojet DataFlex, used for thermal transfer package coding. (click to enlarge)

Most importantly, he notes, RFID has much to learn from bar coding. "When RFID solves the disparate standards, multiple frequency issues, data management methods, and environmental issues, it will take off. But bar coding and RFID will both coexist in the future, in their respective niches."

Neil Sellars, director of product development and marketing for National Label Co. (Lafayette Hill, PA), actually thinks bar coding can be more effective specifically based on its standardized nature. "For RFID, there isn't a global infrastructure that can enable companies to take advantage of it for track-and-trace," he says. "You need an infrastructure to be set up to read the technology and then download it. Companies can prepare products and use the information for uplink, but we don't know where it might be uplinked and how that could work on a global scale."

Schabacker from Datamax sees the two technologies as complementary. "Certainly bar coding can be a bridge to RFID implementation at some point in the future. There are already calls from FDA and certain members of the pharmaceutical industry to review RFID technology relative to authentication of the U.S. pharmaceutical supply chain," she says. "But ultimately, bar coding and RFID are complementary technologies, so even those companies that choose to implement RFID will still have some use for bar coding for certain processes. The two technologies each have individual cost-benefit ratios that should be analyzed relative to the user's final objective."

Nosco's Metcalf adds that bar coding as a bridge to RFID will definitely happen, and digital printing will speed the process. "The ease with which bar codes can be produced and the new digital print technologies that we have invested in are going to make this easier for customers to embrace and implement," he says. In addition, he says, "this bridge will allow customers to start developing the electronic pedigree, data capture, and storage of information. Digital printing is going to allow the link between bar code and mass-serialized numbers to happen quickly and virtually on demand."

CSAT America (Louisville, CO), for example, currently offers a complete digital in-line printing system that simplifies in-line requirements. It can print variable data, sequential numbers, and scannable bar codes digitally. "CSAT's printing systems are designed to simplify printing requirements and eliminate the cost and time associated with printing-plate design and development" says Joe Buono, sales manager for the company. "Our systems print variable data, sequential numbers, and reliably scanned bar codes on a variety of commonly-used packaging materials and labels. Real-time date and time function is an option in the event of a product recall."

Long-term, Nosco's Metcalf says, RFID implementation will provide one distinct benefit: the ability to read and write information to an RFID chip, as well as the increased amount of information that RFID will allow customers to store in a single chip. "The other obvious advantage is that RFID enables proximity reads, whereas a bar code requires the scanner to be in close contact," he notes. But, like most things, it all comes down to cost. "The advantage to customers is they have fewer expenses involved with bar codes since the hardware in most cases will already be established in the supply chain, versus implementation of an entire RFID protocol," he says.

However, he points to one way in which bar coding can clear a path to RFID implementation for companies. "Many people feel that the mass-serialized bar code can enable them to initially cover several state drug pedigree requirements before having to implement RFID," he says.

In some instances, the use of RFID for track-and-trace purposes could actually be more of a hindrance, according to Pfizer's Hollander. "RFID would be technology overkill for the application for which we are using RSS/Composite," he says. "For prevention of dispensing errors in a hospital bedside setting, the product is already in your hand when you need to identify it, so you inherently have line of sight by which a conventional bar code could be utilized. The RSS symbol has a nice role where line of sight is practical and well-suited to carry the product code along with some variable data such as lot number, expiration date, or even a sequential number via the composite code."

Hollander also considers the use of DataMatrix code the ideal format, in some cases. "Looking back and knowing what we know today, that would have been the optimal route with respect to FDA's rule requiring bar codes on all human drug and biological products from all perspectives," he says. "However, it does come with a cost to the hospital community, as the scanners required to read it are more expensive than what is needed for the RSS/CC. At a minimum, the Data-Matrix code could be utilized as a backup to the RFID tag should the tag fail in the field," he adds. "The electronic product code itself is a long string of characters that does not lend itself well to being considered human-readable and punched into a keyboard without errors. We believe a machine-readable code would be more practical and certainly help reduce the potential for human error."

Whatever the outcome, Hollander believes that all data carriers should be aligned and utilize contemporary technologies. "For now, bar codes will have a role where line-of-sight reading is possible and practical. But as computer systems develop, the information desired will likely not be static, and 2-D codes will be required where real estate is a constraint," he says. "Where line of sight is not practical, we will need a more sophisticated technology like RFID."

Andrew Zosel of Microscan points to verification as the most important aspect of bar coding. "People brag about an 80–85% read accuracy with RFID, but even that should be unacceptable," he says. "Even if you miss one or two reads, it could mean a patient death. It's very important to verify bar codes." Like most other experts on the topic, Zosel envisions a mixed model in the future that uses the best aspects of both. "For example, I feel that companies will probably use an RFID tag and a bar code at the item level," he says. "They can be used in tandem, and probably should."

George Wright from PIPS agrees. "What if the RFID chip doesn't scan? That's a good reason to have a backup bar code," he says. Systech's DeJean points out that many of the pharmaceutical companies currently involved in RFID pilots are using bar codes with RF tags. "People are very worried about the stability of the tags," he says. "Using both allows you to be okay even if the tag isn't readable."

Likewise, Kevin Erdman from Verify Brand sees a link to RFID. "Bar coding is available, it's feasible, and it works. There are few cost or technology problems right now. I'd say it's definitely a potential on-ramp to RFID."

For now, limitations of size and technology, let alone standards, will probably mean bar codes stay at the forefront of pharmaceutical product tracking and tracing. "There are many size limits to RFID tags, for example," says Erdman. "If you're trying to fit a 3/8-inch-square tag onto a vial, and that tag needs a code, that's hard to do. And then there are the readability issues associated with RFID tags on top of that."

Ian Carver, product manager of Videojet Technologies (Wood Dale, IL), concurs. "RFID has quite a few advantages, such as the ability to get more data into a chip, for example," he says. Videojet's product mix, he adds, includes a full array of marking products, such as the company's new P-3400 thermal-transfer printer. The company also offers continuous ink-jet printers that are suitable for high-speed applications.

Most agree that, in addition to having a solid infrastructure in place, the goal with product authentication will always be getting the most information onto a product, whether that means via a bar code, RFID tag, or some other means.

"Ultimately, getting more information on a smaller chip or code is always going to be the industry goal," says Wright from PIPS. "And the challenge will always be trying to get more information into a smaller footprint. We're really at the end of the road in terms of what we can do in smaller footprints. It's all about space constraints."

Copyright ©2005 Pharmaceutical & Medical Packaging News