Medical Device Link.

Originally Published PMPN November 2003

Coding and Marking

Daphne Allen

Bell-Mark’s new InteliJet uses thermal  ink-jet technology from Hewlett-Packard.

In July 1994, PMP News ran a feature story entitled “What Hospitals Want from Bar Codes.” Author Melissa Larson, then features editor, observed the following: “Today, more and more healthcare center administrators are realizing that bar codes can help in everything from product inventory to avoiding patient drug mixups.” And later on in the article, she wrote: “Until there is a data matrix coding breakthrough in the healthcare industry, effort is centering on better printing of bar codes.”

Larson also refers to one of today’s leading bar coding advocates, which was leading the pack then, too: St. Alexius Medical Center, which began bedside scanning in 1993. Frank Kilzer, St. Alexius’s director of material resources, would speak about the benefits of such bar code scanning 10 years later at WestPack in February 2003.

But bar coding advances have been adopted slowly. Three years before PMP News’s inception, in 1990, the Pharmaceutical Manufacturers Association (now PhRMA) began work in its Bar Code Technical Committee & Interest Group to identify a bar code that could be used for unit-dose blisters. An ad hoc group included representatives from Merck, McNeil, Glaxo, Bristol-Myers Squibb, Griffin-Rutgers, Gottscho, Pharma Systems, Reynolds Metals, Quint, DuPont, Sharp, and Packaging Coordinators. This group determined that Code 128 Subset C with a minimum 10-mil narrow bar could successfully be used to bar code blisters. PMP News would later report in December 1995 that Merck had standardized many of its hospital unit-dose drugs to blisters in 2 ¥ 5 layouts, each unit with its own Code 128. To do so, it used two flexographic platen printers from Adolph Gottscho Inc. (Union, NJ), one mounted on a thermoformer and the other on a cold-form blister machine, both from Uhlmann Packaging Systems (Towaco, NJ).

Now, well over a decade after PMA’s findings, hospital unit-dose bar coding is still not widely employed by drug manufacturers. The healthcare packaging industry is in much the same place as it was in the early 1990s. Leaders like Merck as well as Pfizer, which introduced Reduced Space Symbology (RSS) early this year to encode Dilantin’s National Drug Code, lot number, and expiration date, are the exceptions rather than the rule. As are repackagers like UDL Laboratories, which had picked up where other manufacturers had left off in the 1990s, providing bar coded hospital unit doses using Code 128. 

This year, interest in unit-dose bar coding is finally picking up, given FDA’s bar coding rule proposed in March 2003. Drug manufacturers are now busily evaluating symbologies, printing methods, and verification methods for creating the reliable, space-friendly codes needed for hospital unit doses. As they do, one concern is the same as Larson described in 1994: “better printing of bar codes.” 

BETTER PRINTING

Better printing often means high-resolution printing. When PMP News ran its February 1997 update on coding, titled “The Future of Coders,” resolutions of 150–300 dpi were common. Now, resolutions up to 600 dpi are possible, often at typical line speeds. Such improvement is good news. Crisp, clear printing of the narrow bars that make up a bar code or the tiny squares and rectangles that make up the composite portion of RSS or Data Matrix is essential. 

Flexography was the first method to bring RSS/composite codes to the market, with Pfizer’s Dilantin. “Gottscho did in-house testing and then went to Puerto Rico to Pfizer to assist in the production run,” says Jack Moyle, Gottscho’s OEM sales manager, of Pfizer’s use of Gottscho’s platen printer. In PMP News’s March 2003 feature, “Preparing for Unit-Dose Bar Coding,” we quoted Jim Umbdenstock of Griffin-Rutgers (Ronkonkoma, NY) as saying that “applying ink to a plate that applies it to a substrate is still the best way to print—it gives you the best quality.”

Steve DiAngelis, division manager, print and security, for Romaco Inc. (Pompton Plains, NJ), says that flexographic printing is still favored by many. He points out, however, that some drug manufacturers are finding that it is expensive to replace flexo’s print mats to accommodate changes typical to unit-dose printing. To mitigate this concern, he says that Romaco is offering its Hapa 530 laser engraver for in-house platemaking. A major drug manufacturer and a major contract packager have picked up engravers so far. The system can use variable-data-entry software to transfer artwork to plates in minutes.

At this year’s Pack Expo Las Vegas (PELV), Greydon unveiled its new platemaking system for flexography. According to the firm, the system includes an image setter that converts artwork created on a Macintosh computer into a positive, which then acts as a mask against UV light that burns off a layer of photopolymer material. After exposure to the UV light, residue is washed away using tap water, and the plate is dried and ready to use. 

Rich Davis, president of Quint Co. (Philadelphia), says that flexo print plates must be produced with the utmost attention to quality. “The platemaker must ensure that the bar code image in every step of the process will result in a plate that will produce a high-quality printed bar code,” he writes in his primer disseminated this year, An Introduction to Bar Code Platemaking Quality and Verification Procedures. “The platemaker should have process control and documentation procedures in place for every step.”

DiAngelis suggests digital printing as an alternative to flexographic printing. “Upfront costs are 40% higher, but the payback is quick. It is excellent for firms with several print changeovers per day, as with unit-dose bar code printing.” He adds that Romaco offers digital printing with inks that are dried with UV light instead of solvent evaporation. “UV ink gives you print quality in terms of density and edge quality. It also competes with solvent’s ability to yield high resolution with small type,” he says. On display at PELV was Romaco’s Hapa 730 UV Digital system, which uses a master foil system and prints at 600 dpi at 19.2 m/min.

CSAT America’s (Longmont, CO) digital printing system offers the same resolution, with no master foil system. According to the firm, by not using print mats or master foils, users print without interruption. Instead of UV ink, it uses food-certified dry toner. At PELV, out of Uhlmann’s booth, sales manager Joseph Buono was showing CSAT’s capability by printing RSS-14 Limited Composite, RSS-14 Stacked, and Data Matrix at 600 ¥ 600 dpi resolution on paper-backed foil.

Adolph Gottscho’s GottJet Wing uses several HP thermal ink-jet heads for wide webs.

Thermal ink-jet printing is also emerging as a contender in unit-dose bar coding. Adolph Gottscho worked with Hewlett-Packard in 2002 to develop its GottJet coder. It can produce Data Matrix, RSS, Code 128, HIBC, and others on foil, paper, and other substrates at 600 ¥ 600 dpi at 25 in./sec., at 600 ¥ 300 dpi at 50 in./sec, and at 600 ¥ 150 at 100 in./sec.

Jack Moyle, Gottscho’s OEM sales manager and a member of the PMA bar coding committee in 1990, says that programmable coding systems like GottJet give him new hope that unit-dose bar coding will finally take off. Gottscho is also offering the GottJet Wing, which is named after the manner in which several printheads are arranged to cover 42-in. print webs.

Also at PELV, Nutec Systems Inc. (Lawrenceville, NJ) was distributing samples of print produced by the Wolke m600. The system also uses HP thermal ink-jet technology. Data Matrix was printed on plain and paperback foils from Hueck Foils and on Tyvek. Nutec says the m600 can produce codes and text with resolutions up to 600 dpi at 160 in./sec.

Also powered by HP technology is the just-introduced InteliJet SCR from Bell-Mark Corp. (Pine Brook, NJ), a small-character thermal ink-jet printer for in-line printing. According to Glenn Breslauer, director of IT marketing, the system can print 600 ¥ 300 dpi at 50 in./sec. “There are tremendous advances in variable data and real-time printing taking place now. Huge benefits that are now being realized are the elimination of all the costly preprinted materials, and printing variable codes directly onto packaging substrates,” says Breslauer.

Scott Liniger of Videojet (Wood Dale, IL) says that steered-beam lasers have evolved, too. “Ten years ago lasers used to be just ‘cool’ technology. Now they are replacing ink jet and going places ink jet cannot. Lasers provide better print quality and permanent, fully formed codes. And costs for entry systems have dropped to the high teens, low 20s, which is knocking on ink jet’s door.” At PELV, Videojet showed its latest Focus-series laser coder.

BETTER OPTIONS

George Wright IV says that the Uniform Code Council Inc. (UCC; Lawrenceville, NJ) should be recognized for working with Ted Williams to develop a bar code symbol that could solve space constraint problems. Wright is vice president of Product Identification & Processing Systems Inc. (PIPS; New York City). Calling Williams a “preeminent symbologist,” Wright says that RSS, announced in 1999, “will drive deployment of bar codes where they haven’t been before.”

According to UCC’s Web site, the RSS “family of linear symbols includes RSS-14, RSS Limited, and RSS Expanded. RSS-14 and RSS Limited encode GTINs [global trade identification numbers] in the EAN.UCC-14 data structure. RSS Expanded will encode any of the EAN.UCC system keys as well as any of the system’s application identifiers.”

Further, “RSS’s composite component is a two-dimensional symbol designed to act as a component of existing and new EAN.UCC-system linear symbols. The composite component is not designed to carry EAN.UCC system keys (these would be carried by the host linear symbol), however, it can carry any of the system’s application identifiers.” UCC says that it is for “confined space.”

The Health Industry Business Communications Council (HIBCC; Phoenix) argues that other symbologies, such as the two-dimensional PDF-417 and Data Matrix, are preferred for items with minimal real estate, like unit-of-use packages. In June 2003, HIBCC wrote to FDA in response to its proposed bar code rule, requesting that FDA “strike all specifications for linear bar coding.”

EAN International and UCC even appreciate Data Matrix’s potential. In October at the EAN.UCC Global Standards Management Process meeting, the Physical Technical Requirements Group agreed “to add Data Matrix (ECC 200) as an approved symbology within EAN.UCC standards for small healthcare products and for direct part marking,” says John Terwilliger, UCC’s vice president of market development. “Final acceptance of Data Matrix will occur pending approval of application guidelines and technical changes to EAN.UCC specifications.”

HIBCC also advises FDA to reconsider radio-frequency identification (RFID). “Given the already significant deployment of nonlinear codes, as well as the rate of technological advancement, linear bar codes are not suited to long-term relevance within healthcare applications,” HIBCC writes. The proposal “will force the creation of a system infrastructure that will be technologically obsolete by the time the regulation is implemented.”

EAN and UCC are also interested in RFID. In September, the two announced their joint venture, EPCglobal Inc. Their goal is “to drive global, multiindustry adoption of the [electronic product code] EPC Network, based on radio-frequency identification (RFID) technology, that will enable companies to have true visibility of their supply chains in real time, in any industry, anywhere in the world,” explains a press release. “EPCglobal will oversee the development of open, global standards for the EPC Network to facilitate worldwide, multisector industry adoption.”

Printer providers are gearing up for RFID demand to support EPC initiatives. At PELV, Markem Corp. (Keene, NH) was exhibiting its new RFID capabilities with its Cimjet applicator. The system can print, apply, and encode RFID tags present in the labels without adding an additional printer stroke. On hand was David Benjamin, who explained that “one year ago, Markem planned to help customers implement RFID without affecting their line throughput.” He added that one of the challenges in using RFID is that frequency interference can often disrupt lines, so the firm is also “working on reducing that interference.”

Zebra Technologies has announced systems that convert and print labels and encode RFID tags. The 110Alchemy engine creates what the firm calls “smart labels” by using existing label stock and attaching conventional RFID transponder inlays.
Robert Karr, vice president and marketing manager for Sato America Inc. (Charlotte, NC), says that RFID will become more widely used, while bar codes will continue to be important.” He says that once companies start to demand that product have compliant labels, implementation rates soar, just as they have in the automotive, electronics, and retail industries. “Overall, the speed and accuracy that bar codes and automatic identification codes provide are no longer just nice to have. They are now a necessity.”

Wal-Mart’s declaration that its suppliers provide pallets and cases tagged with RFID by January 2005 can be seen as such an example. Simon Langford, manager, global RFID strategy, for Wal-Mart, spoke about this mandate during his PELV keynote address.

Wright welcomes another significant change in the last decade: the end of company-specific, proprietary bar codes. He points to global coding standards, like GTIN and HIBC, as replacing proprietary coding on packages accessible to the customer. 

BETTER ACCEPTANCE?

In 1994, we cited St. Alexius as one of the few hospitals scanning bar codes. In 2003, it still leads a relatively small pack. Joe Mase, senior marketing manager for Baxter Healthcare, finds that today only a small percentage of hospitals have the ability to scan products at the bedside. 

Costs may be an issue, but PIPS’s Wright says that scanning infrastructure costs have been reduced to a third of what they once were. “Low-cost Ethernet networks with scanners and systems can be connected throughout a healthcare provider’s campus. A well-conceived and well-implemented point-of-care data-capture system ought to have a 100% return on investment in less than two years,” he says. He adds that if liability insurance providers were convinced of the increased safety benefits of bedside scanning and the likely reduction in liability payouts, those “underwriters could be partnered with to find the money to pay for the bedside scanning infrastructure.”

Hospitals once cited a lack of unit-dose codes to scan at the bedside as the reason for not doing so. But if FDA requires hospital drugs to bear bar codes, they won’t be able to use that excuse anymore. 

Copyright ©2003 Pharmaceutical & Medical Packaging News