Medical Device Link.

Originally Published PMPN November 2004

Coding & Marking

Christina Elston
Contributing Editor

The Songbird print head from Nutec Systems prints high-resolution bar codes necessary for unit-dose packages.

Since FDA finalized its rule requiring bar coding of hospital-intended unit-of-use pharmaceutical products, much has been accomplished to help manufacturers comply. More-compact bar codes have come into broader use, printing equipment has improved, and suppliers have been educating manufacturers about print quality.

Many companies whose products were approved after April 26, 2004, have solutions in place, as these products required bar codes within 60 days of the rule’s effective date. And though previously approved products that will be packaged after April 26, 2006, must include bar codes, manufacturers will be allowed to use up existing inventory packaged prior to the compliance date. “We’re not going to make folks go scour the market and take back products that are not bar coded,” says Philip L. Chao, FDA Office of Policy, Planning and Legislation.

Meanwhile, as the compliance date nears, some industry experts have predicted that as many as 30–50% of companies will not have their existing products in compliance by the deadline. “There are too many companies out there that have not even begun to address the issue,” says George Wright IV, vice president of Product Identification & Processing Systems Inc. (PIPS; New York City). Companies that didn’t act early have limited time and a limited pool of expert resources to draw on for help, Wright warns.

IN THE PLANNING

“The challenges are manyfold,” says Paul Mills, software and platform product line manager at Markem Corp. (Keene, NH). “Setting up new systems in any pharmaceutical plant is always going to be a challenge with the need to revalidate before full and proper use can be made of the system. This is both time-consuming and expensive. Perhaps a further aspect is that some manufacturers may have their eye on extra benefits that could be derived from coded unit-dose packs, and this may also delay the decision to purchase equipment and systems.”

The key recommendation for companies is don’t wait, advises bar coding consultant Karen Longe, president of Karen Longe & Associates (Lake Bluff, IL). “There are a lot of things that have to be worked out before you get to the bar coding part,” she explains. “The strategic planning for it is one of the longest parts of the process.”

Companies have to choose which products to tackle first and design pilot projects, Longe says. Some companies may also need to establish databases or clean up existing databases and make sure their numbering schemes make sense.

Manufacturers that previously bar coded only at the case and carton level will need to make sure that Global Trade Item Numbers (GTIN) are different on each packaging level so that a case of product does not scan the same as a single dose. This type of error could wreak havoc with hospital inventory or raise overdose alerts. To avoid this pitfall, Wright advises companies to conduct a thorough bar code audit in which all relevant company databases and every drug label and package is physically examined to determine exactly what standardized Universal Product Number is used on each package. “If a company doesn’t know what numbers it has already used on higher levels of packaging, it cannot know what number to use on the unit of use,” he warns.

In addition, good advance planning will allow manufacturers to go beyond the minimal requirements and add information such as lot number and expiration date to the codes, says Diane Hund, Global AP/IB marketing director of Videojet Technologies Inc. (Wood Dale, IL). “I think that many manufacturers will be able to accommodate the bare minimum requirements of the regulation in time,” Hund says. “However, I think that many should consider using this opportunity to incorporate the right equipment and capabilities to include variable information into their bar coding activities.”

Planning will be more efficient if approached from the proper perspective, advises Longe. “It’s not a bar code project, it’s a labeling project, and the whole thing is about developing and communicating accurate information,” she says.

THE SPACE CRUNCH

It’s also about space. “The biggest challenge is putting a linear bar code on the smaller drug packages,” says Ann Marie Phaneuf, director of marketing at Weber Marking Systems Inc. (Arlington Heights, IL). “There is no problem in printing it. The problem is in making it small enough to fit on the package.”

Real estate is a big issue for many manufacturers, agrees Jim Umbdenstock, president of Griffin-Rutgers Company, Inc. (Ronkonkoma, NY). To fit bar codes along with required human-readable copy, companies are getting creative. “They’re rearranging,” says Umbdenstock. Some are playing with type sizes, while others are using more of the existing label space. “It just means printing out to the edges more,” says Umbdenstock.

Meanwhile, whatever solution a manufacturer turns to, the label or packaging must still be recognizable as their brand, and it must be readable, says Glenn Breslauer, director of marketing and Internet at Bell-Mark Sales Co. (Pine Brook, NJ).

RSS CODE

Bell-Mark’s EasyPrint i is a high-speed, fully programmable thermal-transfer printer for intermittent packaging lines.

UCC/EAN Reduced Space Symbology (RSS) has solved many space problems. Bell-Mark, one supplier of thermal-transfer printers that print RSS codes, has seen increased demand for RSS from customers. When FDA’s rule was first proposed, “people were more interested in how they could use RSS, because it really requires very little space,” says Breslauer.

In addition to being smaller, RSS is a more durable, redundant, and easy-to-print symbology than UPC or UCC/EAN-128. It allows the use of a larger X-dimension (the width of the narrow bar), making it easier to print and easier to achieve good print quality.

“It’s a phenomenal bar code,” says Rich Davis, president of Quint Co. (Philadelphia). Using the 2D component, manufacturers can include not only the GTIN, encoding the National Drug Code (NDC) number required by FDA, but also the lot and expiration date—which is not FDA required but still desirable. “The marketplace is asking for the lot and expiry if it will fit,” says Davis. “We are encouraging everybody to do that.”

PRINT QUALITY

But just fitting a readable bar code onto the packaging isn’t enough. FDA also specifies that bar codes must meet ISO 15416 standards for print quality verification with a grade of C (1.5) or better. So pharmaceutical companies that have also had to become packagers are now learning about print quality, says John Roberts, director of healthcare at Uniform Code Council Inc. (UCC; Lawrenceville, NJ).

“A grade of C is what our (UCC/EAN) standard requires, but most pharmaceutical companies are looking for a B or better,” says Roberts. The challenge is being able to print verifiable bar codes at such a small size. “That requires more due diligence than they had to do with a Universal Product Code,” he says.

One company that UCC worked with was initially able to print only C- or D-grade codes, but had never used the gauge bar provided by the manufacturer of their printing equipment to check the distance between the print plate and the substrate. Their engineer had adjusted the print press by feel, and this had been adequate for human-readable print. After UCC suggested that they use the gauge bar and adjust the distance, they began printing A and B grade codes. “You need good SOPs so that the bar codes are printed reliably, accurately, and repeatably,” Roberts says.

Print quality is essential because many hospitals may be scanning bar codes with wands, “the worst of all reading devices,” says Charles Geraldi, director of sales and marketing at Adolph Gottscho (Union, NJ). Manufacturers will run into problems if nurses have to waste time entering information by hand because codes don’t scan. Healthcare facilities will contact their suppliers, who will contact manufacturers and demand improvement. “I think that you may see that course of action being taken more than people reporting to FDA,” says Umbdenstock.

Wright points out that a number of VA hospitals are investing in ANSI/ISO bar code print quality verifiers for RSS/Composite and traditional linear symbols and will therefore be in a position to assess bar code quality as never before.

MORE THAN PRINTING

When looking for a printing supplier to meet bar coding challenges, “the number-one thing is versatility,” says Breslauer. The supplier should be able to supply equipment that can print to multiple surfaces and be able to match the best equipment to the application. Ink-jet printers, for instance, are not ready for nonporous materials, he says.

And sometimes suppliers must work together to come up with solutions, says Geraldi. “People have got to stop thinking that if it doesn’t print well, it’s the printer’s fault.” Good high-resolution printing requires cooperation between suppliers of ink, substrate, and printing equipment. Adolph Gottscho has been working with companies such as Hueck Foils, Alcoa, and DuPont to create systems that will work well. “It’s a coordinated effort,” Geraldi says, that is yielding “nice new solutions” involving ink- delivery systems, inks, substrates, and curing systems.

In the case of digital printing solutions, material handling can become the challenge. Nutec (Lawrenceville, NJ) printers using HP ink-jet technology can print 600 dpi, with dot accuracy to 1¼100 of a millimeter, but it is difficult for material-handling technology to keep up.

“The challenge is, can my customer provide the substrate with those same tolerances?” says Mike Shaw, vice president of sales. Can the label or packaging web move as accurately as the print head? “The challenge becomes the movement of the materials,” Shaw says. Despite this challenge, new digital printing solutions offer “quantum leaps forward in print resolution,” he says.

VERIFICATION

Verifying the print quality of bar codes is another area proving challenging for manufacturers. “This is what’s really causing pharmaceutical a lot of trouble,” says Davis. “For all these years, we weren’t as worried about print quality as we should have been.” Davis says Quint Co. has “taken on a mission of education,” and is working to teach customers about print quality. “We’re talking to them about print quality verification, and it’s really catching a lot of people by surprise,” Davis says.

One huge obstacle is the lack of in-line automated bar code–verification equipment for the new RSS/Composite symbology. However, Webscan (Brentwood, NY) has beta units in development, and should have equipment in the marketplace early next year, according to Wright. Meanwhile, the problem is that off-line verification is time-consuming. “There is no spare manpower in a HUD blister line,” Wright says. One of the most significant potential costs of the FDA rule is the extra manpower needed to verify codes.

THINK-AHEAD COMPANIES

In the race to bar coding compliance, some companies have clearly jumped ahead. For example, Abbott Hospital products (now Hospira) completed compliance soon after FDA published its proposed rule, according to Wright. The company reviewed some 1200 products comprising 5000 different packages in their hospital division. “A week after FDA first published the proposed rule, Abbott announced 100% compliance,” says Wright.

Pfizer also made an early effort, working closely with their printer supplier, Adolph Gottscho; their printing plate supplier, Quint Co.; and their verification consultant, PIPS, to bring unit-dose blister packaging into compliance. “Pfizer had a very unique HUD application that we had to print very small stack bar codes on,” says Geraldi.

Though complying was costly, it has been worthwhile for company reputations. “They’re gaining market share because they have this to offer,” Umbdenstock says.

THE FUTURE IN 2D

The April 24, 2006, compliance deadline will not be the end of bar coding developments. The rule is scheduled to be reopened in April 2006 for further discussion and comments, according to Roberts.

One of the main topics to be tackled will be whether FDA will eventually allow 2D Data Matrix codes under the rule. These codes are easier to print and can be read even if they are missing 30% of the code, says Shaw, but most hospitals don’t have the area imaging scanners needed to read them.

However, Shaw believes that within two years or so, even cameras in cell phones will likely be sophisticated enough to read Data Matrix. Until then, manufacturers will have to continue to work with existing linear codes, and overcome the challenges that entails.

Copyright ©2004 Pharmaceutical & Medical Packaging News