Medical Device Link.

Pharmaceutical and Medical Packaging News Magazine
PMPN Article Index

Originally Published January 1999

SPOTLIGHT

Labeling: More Than Just a Pretty Picture

by Erik Swain, Senior Editor

It seems as though drug and device labelers are being asked to do the impossible. To meet regulatory and market demands, companies are being asked to include even more information on their labeling, whether it is multiple languages to meet European requirements, standardized over-the-counter (OTC) drug information to meet FDA rules, warnings to protect latex allergy sufferers, or eye-catching graphics to attract consumers. The labeling information must be produced accurately, and every label must be inspected, either by two operators or by one machine. And they're being asked to accomplish all this by keeping costs down, even reducing them.

All label production, including that involving a roll press, must comply with GMP standards and rigorous in-house SOPs. Photo courtesy Altwood Roll Label.

Suppliers are expected to help labelers meet all of these demands. "Customers are tending to look toward suppliers for more services than they used to," says Walt Kirchofer, president of Altwood Roll Label Company, Inc. (Elmwood Park, NJ). "One reason is to reduce the amount of quality assurance they have to do internally. Another is to get more value from their suppliers." The goal is to produce a label that is graphically appealing, 100% accurate, traceable, and inexpensive. Contrary to first impressions, it's not so impossible after all.

JAZZING UP GRAPHICS

The OTC drug industry has been using bright colors and sophisticated designs on their labeling for several years. But now some medical device and prescription drug manufacturers want their labeling to look just as sophisticated. While prescription drugs may not need to win over consumers with their appearance, they do need good graphics to allow the pharmacist to differentiate them. "Folding cartons have been eliminated on about 80% of prescription drug trade packages, so we are seeing a much greater emphasis on graphics in the label," says H. D. Auerbach, president of Plymouth Printing Co. (Cranford, NJ).

With medical devices used in hospitals, he says, "sometimes it's all specified by the surgeon, or the hospital formulary committee has eliminated duplicate inventories. But not always. A nurse will have to select between brands A and B in the supply room." Those brands compete against one another, so they each need their own shelf appeal, even in a hospital.

BURGEONING TEXT

As splashy as the graphics may have to be, they can't overwhelm the information on the label. This is especially a concern for OTC drug labelers, who will need to follow FDA's proposal that the wording on the labels adhere to a certain format and be in at least 6-point Helvetica type. This means companies need to include more standardized information on labels along with any marketing information.

Equipment must be constantly upgraded to ensure that clients benefit from the latest technology. Photo courtesy Altwood Roll LabelImtec's.

Space, or a lack of it, is also a concern. Take, for example, the challenge of labeling and coding a contact lens vial with only a 0.75 x 2.5-in. space to work in, a task that the firm TLF Graphics (Rochester, NY) faces every day. "You have to go to a high resolution printer," says Rich Cromwell, TLF's machine division manager. Cromwell opted for the Labeljet from Willett America Inc. (Fort Worth, TX). "They were able to provide premium dot resolution for the printing of a small bar code, and they could print the label in the right area." TLF now distributes the labelers in addition to producing labels.

Using inserts and outserts enables companies to include information that cannot fit on an outside label, but some of them have had to incorporate so much information that they've become physically unwieldy. "They can get so fat that if they bundle up too much, they want to open up," says James Agney, president of Argent Tape & Label Inc. (Troy, MI). "So we got a new outserter with a gluing station. Once the last piece is folded, it is being held by a spot of glue or adhesive."

An alternative to an insert is an expanded content label, which can be attached to a bottle and can fold out to display extra information. "That cuts down on labor because you don't have to glue it to the bottle during a separate operation," says Tom Moore, president of California Litho Co. (Chatsworth, CA).

Challenge Printing Co. (Wallington, NJ) came up with another solution when faced with a space crunch. "Because of the size of the bottle in one case, we determined it would be best if the label could be affixed to the bottle cap," says Margaret Polt, Challenge's marketing manager. "By modifying our RemovaTab label to fit the size requirements, we were able to provide a solution. Attached to the label are two removable mini labels, which the pharmacist can remove and place directly on the prescription given to the patient."

To overcome space constraints, CCL Label (Rosemont, IL) has developed Spinformation, a double-layer film label that has a clear window in the top layer that lets users view text printed on the bottom layer. The interactive label provides 75% more space on the bottle. One of CCL's clients will be marketing its products in a bottle with the label early this year.

LABEL ACCURACY

No matter how attractive a label is or how much text it can hold, it is worthless if it is inaccurate. One mistake, whether it is a misprint that leads to an incorrect drug dosage or an out-of-sync labeler that applies the wrong labels to the wrong bottles, can have disastrous consequences.

"It is of huge importance for the printer to have the proper quality assurance program in place and the documentation to show that the product was produced to customer specifications," says Hollis Cobb, special projects manager for J. R. Cole Industries Inc. (Charlotte, NC). "Every precaution must be taken to eliminate the possibility of mixing." His firm, which produces folded coupons and booklet labels as well as cartons for the healthcare industry, uses line purgation procedures to ensure that after each job is complete, all equipment needed for the next order is completely clear of the previous order. No mixing can occur in this environment.

Imtec’s Survivor labels can handle sterilization and other rigorous processes.

Machine vision systems are increasing in popularity, but not all drug and device companies believe they can afford them. So the demand for a less expensive automated inspection system is there. Bill Hingle, marketing services manager of Labeling Systems Inc. (Oakland, NJ), says his company decided to use a system with "sensors that look for light-to-dark contrast of the code to the label. It's a simplified way for lot and date code verification, and it gives the customer the ability to verify within budget constraints. It's built within the design of the machine, which allows for versatility."

TRACEABLE LABELS

Lot traceability is also important in healthcare, and many labelers are choosing to use bar codes. Many hospitals and other healthcare providers now require them on individual items, even within labeling, instead of just on shipping and storage cartons.

Therefore, the ability to integrate bar coding with label printing is crucial, says Joely Fanning, product manager for the packaging group of Markem Corp. (Keene, NH). Her company has developed a software program to ensure that the same codes are printed on all levels of packages and containers, ensuring consistency in tracking. Eventually, the system should be able to handle 2-D codes as well.

Ensuring such consistency is one argument in favor of using print-and-apply labelers, says Eric Pizzuti, product manager for QuickLabel Systems, a division of Astro-Med Inc. (West Warwick, RI). This way, "the companies themselves can control the labeling in-house, and the printers provide for the maximum supervision and control of the process," he says.

REDUCING COSTS

Though crucial to the success of a drug or a device, labeling, like packaging, is an area that drug and device companies almost always look to cut production costs. Labeling suppliers are therefore under pressure to show not only how their products or services are inexpensive, but also how they can make the process more efficient.

"One way to reduce labeling costs is to look for newer and less expensive materials that can function," says John Pacific, vice president of sales at Pharmagraphics LLC (Greensboro, NC). "Another is to come up with products with multiple functions to reduce the total applied cost of packaging."

Companies also look to adhesives as a source of cost reduction. "Customers seek thinner coatings that don't lose their performance," says Ingrid Brase, marketing manager for National Starch & Chemical Co. (Bridgewater, NJ). "There is a lot of pressure for us to continue to bring innovation, to find an adhesive to do more than be an adhesive but also to add value in the system."

End-users are also trying to make the labeling process more efficient. Labeling equipment maker Krones Inc. (Franklin, WI) has found that the healthcare industry wants machines with "redundant heads," says Mark Larson, chief engineer at Krones. "We can put on two rolls of labels, and when one runs out, we can start the other one up without stopping the machine," he says.

Hospital supply purchasers also want a more-efficient process. One way to achieve this is to use the multifunctional label. Says Jeff Wigem, business development manager at TapeMark (St. Paul, MN): "That way, one large label is used as the primary identification, and smaller labels are peeled off and applied for lot traceability in the stock room, on the patient's chart, even all the way back to billing," he says.

And then there are challenges that combine some or all of the above issues. "Our company is troubleshooting how to print on alternative substances like polypropylene and Mylar," says Dennis Kanemori, group leader, packaging technical services, Zeneca Pharmaceuticals (Newark, DE). "There are questions of legibility, print quality, and bar code readability."

CONCLUSION

As with packaging, labeling is considered to be a crucial element in the healthcare industry. But at the same time, as companies are pressured to keep profits high, many turn to the labeling process to cut costs and improve efficiency. Ultimately, it is the suppliers who must reconcile the two trends by finding innovative ways to improve quality without raising price. A wide variety of solutions are being considered, and drug and device packagers are embracing them eagerly.