Medical Device Link.

Originally Published PMPN October 2004

Cartoning & Labeling

Two major trends are guiding labeling and cartoning these days. The first trend has been evolving for the last several years. FDA and patient advocacy groups are encouraging manufacturers of pharmaceuticals and medical devices to include more and more product information on packages. Whether it’s making more type fit onto a label or expanding carton designs to accommodate printed information, manufacturers are finding new ways to get information onto their packages.

A more recent trend that promises to explode in the coming year is the use of radio-frequency identification (RFID) technology on labels. Companies are being asked to embed RFID tags in booklet labels. And while such requests are not yet widespread, some companies are getting ahead of the curve by boosting capacity.

More Words, Larger Outserts

Since available space for printed data is limited, it’s always a challenge for packagers to meet FDA labeling requirements. And in this age of complex labels and multicomponent cartons, companies are required to make these products faster than ever to meet rising production demand.

Several industry players have recently introduced new machines to help fulfill those needs. NJM/CLI Packaging Systems (Lebanon, NH), for example, just redesigned its Model 276 labeling project manager. “More information is being printed on outserts these days, and thicker outserts are required to handle all the information,” says Joe Danyo, labeling product manager. “We redesigned this machine specifically to meet the demand for affixing product-specific literature and outserts to either the container top or side.”

The labeling machine’s feeder now features a 12-pocket carousel. Each pocket holds a 48-in. magazine of outserts. With the expansion of the infeed storage capacity, the 276 eliminates the need to have a dedicated operator on the labeler, “So it reduces labor costs as well,” Danyo says. The machine now handles outserts as small as 0.875 ¥ 1.25 inches and as large as 1.5 ¥ 4 inches. It handles outserts with thicknesses ranging from 0.062 to 0.5 in. “It also allows for much faster line speeds,” he says. With an enhanced stepper motor drive, it now expands the infeed storage capacity of labelers handling up to 300 pieces of literature per minute and more.

Vijuk Equipment’s MV2001 is built to accommodate larger outserts of up to 120 panels of paper.

JH Bertrand (Buffalo, NY) is another company designing products to help label manufacturers capitalize on current trends. It has recently stepped up production of its TwinSerts product. TwinSerts consists of two outserts put together with a special overwrap. “The amount of space available for copy is doubled,” says Jeff Bertrand, the company’s president.

The company also has a new product for booklet label manufacturers simply called “One of a Kind.” The machine allows a customer to make their own customized booklets using their own laser printers and equipment. “It’s designed for short-run medical devices,” says Bertrand.

Another new Bertrand creation is a mega-label encapsulation machine. “It allows customers to put up to three different inserts and a patient card on a package,” he says. “It then heat-seals around edges of the piece.” Bertrand is also seeing more requests for multilingual label content. “When you’re talking about putting different languages in a booklet, again that means a bigger outsert,” he says. “Also, with the population getting older, there are more requests for larger type. In addition, pharmaceutical companies are producing more marketing literature that requires patient information pieces. All of these things are trends we’re seeing.” He also adds that in terms of the OTC market, companies are increasingly producing 3–4 booklets per carton on vitamins and nutraceuticals.

Erin Linville, pharmaceutical product manager for Avery Dennison Corp. (Pasadena, CA), has also seen a recent uptick in requests for labels with more content. “People want extendedcontent labels that display critical information,” she says. Avery Dennison just released the Fasson S4140 acrylic adhesive, designed to address performance and pricing needs for pressure-sensitive labeling. The product is compatible with paper and film facestock, and it adheres well to low-surface-energy substrates providing stability while reducing migratory risk.

Another company that is addressing the need for bigger outserts is Vijuk Equipment (Elmhurst, IL). Roger Matilla, vice president of administration and sales, says customers are starting to ask for jumbo outserts. “They seem to be growing bigger and bigger,” he says. To that end, Vijuk has introduced the MV2001 machine, which can run 120 panels of paper. “It’s an improvement on the MV97, which produced outserts of up to 90 panels of paper,” he says. The servo-driven machine allows customers to produce bigger pieces faster. “So far we’ve gotten a very positive customer response,” he says. “People are saying it gives them 25% more productivity. We’ve even heard from people that it’s up to 50% more productive than the old machine.”

Cartons With Expanded Content

Carton manufacturers are also continuing to focus on content, often using the inside of a carton for information space. In addition, the production of multipanel cartons is on the rise, a trend used by marketers to accommodate Drug Facts and other text.

“Trying to print more information on a carton presents a design dilemma and a production challenge,” says Lisa Malvino, director of marketing for Diamond Packaging (Rochester, NY). “Our customers are increasingly asking us for ways to keep costs down by not making the cartons bigger.”

Malvino reports that the company employs tipping equipment that adheres pamphlets to the inside of a carton at high speed during the gluing process. The pamphlet folds in half, and the drug facts are printed on its inside.

Diamond Packaging also continues to receive many requests for its Design Relief cartons, Malvino says. The cartons have extended-panel and pull-tab designs that offer additional room for drug facts. “They have an expanded surface area without significant changes in cost or carton size,” she says. One version contains a foldout panel that is fastened to a carton exterior. It is easily opened by consumers to reveal compliance information. A second version’s pull-tab panel extends to reveal additional drug information. Both designs leave room for product identity elements and logos.

MeadWestvaco Healthcare Packaging (Mebane, NC) is another company that is focusing on extended-content cartons. Its extended content carton (ECC) is designed to accommodate FDA labeling requirements while preserving billboard space. The carton uses a fold-out panel on its exterior, sealed to the paperboard carton body during filling, transportation, and display. The panel can be easily opened to reveal compliance information, and then resealed.

The company has also won awards for its Surepak, Dosepak, and Injectapak systems. Surepak offers added billboard space and can include an inner panel for dosing regimens or a large insert. Dosepak has an outer carton for ample billboard space, a fold-over inner blister card, and an attached insert for directions and patient education. The Injectapak system, meanwhile, is designed for products delivered in syringes or vials. It contains space for health education, dosing instructions, and other text and graphics.

MeadWestvaco recently unveiled several new physician blister sample cartons designed to encourage compliance. The sample carton designs contain expanded billboard space for logos, colors, drug facts, and other brand-identity elements.

Alcan Packaging (Baie d’Urfé, QC, Canada) is using a multipanel carton that incorporates a fifth and sixth panel that is glued and folds out. This embellishment allows more room for graphics, copy, and other text.

NJM/CLI’s redesigned Model 276 outsert feeder handles thicker outserts to meet the rising demand for affixing product-specific literature and outserts to the top or the side of the container.

Colbert Packaging (Lake Forest, IL) offers PharmaDial, a unit-dose package that features copy and graphics on the carton reminding patients to take the medication. Instructions on how to remove the drugs from the blisters are also printed directly on the carton. The design implores the user to perform a simple three-step process to access the medication. The user peels a tab, turns the dial 90 degrees, and pushes the tablet out through the back of the package.

Other carton manufacturers are introducing new machines that provide faster cartoning capabilities. “It’s important to offer that since so many people want more cartons produced quicker now,” says Alexander Mayer, sales manager at Uhlmann (Towaco, NJ). The company has launched the C 2155 cartoner, a servo-controlled machine that features intermittent processing with more precision. “It enables much faster carton pick-up and erecting,” he says. The product’s output allows for 25 to 150 cartons per minute. “With the increase in demand, this is a good match for companies.”

RFID Labels

Perhaps one of the more interesting trends companies are monitoring is the use of RFID in pharmaceutical labeling. “That’s where there’s a lot of activity at the moment,” says Jeff Bertrand. “Our company is seeing many more requests for combining a booklet label with RFID. But there are so many questions. Will it replace outserts eventually? How will it be utilized with OTC drugs? Those are some things we want to know more about.”

Bertrand suggests that an RFID reader might enable a pharmacist to find information that couldn’t fit into a booklet. “But again, that technology isn’t here yet, so it’s hard to predict,” he says. “It’s such a promising technology but an unproven one.”

Still, some companies are banking on RFID labels as the wave of the very near future. Argent Group (Troy, MI), for example, just announced it would expand its current capacity

to insert RFID inlays into finished pressure-sensitive or part-printed thermal transfer labels. The company says its capacity will be boosted from the current figure of 100 million to 300 million inlays per year by mid-2005. “More companies are committing to adding RFID labels to cartons and pallets,” says Barry Brown, Argent’s director, RFID business development. “In fact, once the companies that have been asked to supply Wal-Mart with RFID-tagged products complete the trials they are currently engaged in, the current shortage of conversion capacity will be exposed. We expect that by the end of 2004, less than 30% of the overall requirement for 2005 RFID label capacity will be in place.”

Brown sees the recent RFID mandates by Wal-Mart and the Department of Defense as only one part of the trend. “Remember that FDA put out a white paper urging companies to explore RFID as an anticounterfeiting measure,” he says. “That means they will at some point likely mandate it. So the RFID label capacity will have to increase.”

Still, Brown stresses that the demand hasn’t increased dramatically yet. “Nobody’s ordering any of these labels at the moment,” he cautions. “But we still believe there will be a panic in early 2005. It’s only trials and pilots right now, but we don’t think full production is far off.”

Argent is currently utilizing insertion machinery from Europe. Its strategic partner, Advanced Research, is adding upgraded RFID quality/test stations to its machines because high conversion speeds have necessitated a change to ensure faulty inlays are not passed on to customers in finished labels, says Brown.

Avery Dennison is also committing to RFID labels. The company recently announced that it will spend around $20 million on RFID development this year, with much of that devoted to inlaying chips and antennas on adhesive labels. The company already has its own technology for mass-producing adhesive labels embedded with RFID chips, saying that the process can reduce the cost of RFID tags.

What’s Next

Going forward, carton and label manufacturers will likely have to continue finding new ways to meet the demand for more content. In fact, FDA’s potential activity on the matter could increase the demand for high-content labels and cartons.

“We’re waiting on FDA to change the type-size requirement,” says Roger Matilla of Vijuk. “They haven’t moved to the 8-point type requirement yet, but they probably will. In fact, we expect them to make a ruling in October on that regulation. They’re also talking about adding a highlight section and an index along with a new type-size requirement. If all that goes through, companies will just have to find more-creative ways of getting all that content on their packages. It will be a big challenge, no doubt.”

Copyright ©2004 Pharmaceutical & Medical Packaging News