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Pharmaceutical Labeling



As the FDA continues to crack down on label requirements, converters find new and innovative ways to provide their customers with extra label space in a cost-effective manner.



Published July 8, 2005
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Pharmaceutical Labeling

As the FDA continues to crack down on label requirements, converters find new and innovative ways to provide their customers with extra label space in a cost- effective manner.

The market for pharmaceuticals is booming. The increased amount of advanced medication available for various diseases has provided new hope for the future. The generation of baby boomers has reached mid-life, and the senior citizen population, which consumes a significant amount of prescription and over-the-counter (OTC) drugs, is rapidly growing as people begin to live longer and healthier lives. In yet another realm, herbal and dietary supplements, nutritional beverages, vitamins, functional foods and even nutraceuticals are powering their way into the hands of many health-conscious individuals.

Packaged in plastic bottles and containers or glass vials and ampules, the only aspect of a product to distinguish itself from its thousands of competitors and relay proper product information to customers is a label. “The label is as important to the product as the ingredients. The number one reason for recalls is labeling issues,” says Jeffrey Levine, VP, The Control Group, Norwood, N.J.

Not just any converter is able to produce these heavily regulated and inspected products. It takes a printer with an education in various federal association rules on labeling, a high-security facility, state-of-the-art equipment, and most of all, a mindset to develop new and innovative ways to provide customers with added label space in a cost-effective manner.

Flexo and letterpress
In a market which calls for exquisite detail and fine print, where a simple smudge of ink can mean the difference between life and death, quality plays a major role. In order to provide the best quality, flexo, UV flexo and letterpress are the printing processes of choice by many converters.

Des Laffan, general manager, Rxperts Printing Alliance, Greensboro, N.C., a combined service of Beck Carton, Pharmalabel and Flottman Company, says flexo appears to be the fastest growing process for pharmaceutical labeling, while letterpress seems to be “a dying species.” UV flexo, he continues, is excellent for printing on clear film and providing finer print.

Tom Ventrudo, regional sales VP for pharmaceutical, CCL Label, Rosemont, Ill., says the dominant printing processes, such as flexo, UV flexo, UV letterpress, and UV screen, all vary with customer demands. UV flexo, however, is the most popular request, he adds.

William Cheringal, VP, The Control Group, says letterpress, which was dominant in its heyday, still has a presence in pharmaceutical printing. The quality and ease of use that flexo offers has driven its use to the top. Roll labels cannot be printed via offset, he explains, because the technology is not there to achieve the proper repeats. The Control Group currently has three flexo presses from Propheteer for use with water based and UV inks, as well as web and perfecting sheet fed offset presses for insert/outsert printing. The company recently purchased a 20” Mark Andy press for its new venture into the flexible packaging market, offering a full package of printed matter to pharmaceutical companies.

Dan Stolfi, executive VP sales and marketing for Innovative Folding Carton, South Plainfield, N.J., says although flexo has made great technical strides, letterpress still holds the advantages of cleaner screens, better vignettes, clearer and sharper images, smaller type, and more consistency from run to run, especially regarding print quality and color.

At Arlington Press, Brooklyn, N.Y., UV rotary letterpress leads the list for quality printing. Flexo and UV flexo are used for many specialty items, while offset heads the printing of inserts. Robin Henfling, general manager, says that although maintaining a press is much easier with flexo and is less costly, letterpress is a much better alternative for quality. “With flexo you need a good pressman because the printing can be inconsistent,” he says, adding that flexo also uses softer plates than letterpress. With harder plates, he says, there is less of a chance of blurred type after numerous impressions. With $40 million in sales, Arlington Press currently owns one Webtron flexo press, four letterpresses, including a Gallus R160B UV rotary letterpress, five web-fed and one sheet-fed offset press.

Paper or film
For an industry filled with various bottles and containers from plastic to glass vials and ampules, using the proper substrate is key. “Two of the overriding requested elements from our customers are consistency and quality. They want the product to work, and to not cause any problems,” says Jeff Robinson, market development leader, packaging, FLEXcon, Spencer, Mass. However, due to health care reform, the prices of pharmaceutical products have been lowered, forcing companies to compromise slightly in their substrate decisions. “For example, in the past polyester was a popular choice for labels, as opposed to now where polypropylene facestock — a lower-cost alternative — is growing,” says Robinson.

Although most companies request paper, the gap has begun to narrow as the costs for film decreases and paper fluctuates. Film also has advantages over paper, such as durability, says Robinson.

The Control Group, which uses about 99 percent paper, finds film useful for smaller labels, such as those used for vials or ampules, says Cheringal. “Film has less memory. It will wrap around the bottle tightly and not lift up,” he says. Paper, however, is more cost-effective, he adds.

In the realm of release liners, says Robinson, the growing trend is toward film and away from paper liner. “Film liners have less of a chance of web breaks than paper, which can allow for an increase in line speeds,” he says. “Paper liners may be less expensive, but the costs have come so close together that customers can pay the extra material cost and make up for it on the application side,” he adds.

Rules and regulations
In the dizzying world of pharmaceutical labels, one of the most challenging aspects of printing is conforming to new and existing regulations — which govern what must be included on the label — and developing new ways to fit all of this added information onto the same size label.

“FDA regulations are requiring the entire evolution of the label so they are more user friendly. The problem is finding enough room for all of this new information and keeping it within a 2” x 5” area,” observes Laffan.

Most recently, Vice President Al Gore and Health and Human Service Secretary Donna E. Shalala announced a final Food & Drug Administration (FDA) regulation to provide new, easy-to-understand labeling on over-the-counter (OTC) drugs. Under the regulation, labels must clearly show the drug’s ingredients, dosage and warnings to provide the consumer with an easier understanding of the benefits, risks and proper use of the drug.

The FDA proposed the OTC labeling regulation in February 1997. After lengthy discussions among numerous industry professionals, consumer groups and health care providers, a final rule was recently published in the Federal Register on March 17, 1999.

According to Cazemiro Martin, chemist for the division of OTC drug products for the FDA, some of the changes include:

• minimum type sizes of six point
• the creation of interchangeable terms
• bullet format rather than text format to provide more white space
• the establishment of deletable terms without changing the information provided to the consumer
• the addition of specific headings and subheadings

A complete version of the final regulation can be viewed on the Internet at www.gpo.gov.

So how much will these changes cost the industry? Under the proposed rule published in February 1997, William W. Bradley, VP technical affairs, Consumer Healthcare Products Association, says that a two-year deadline will carry an approximate $140 million price tag, based on label changes, such as alterations in copy and artwork. An additional $1.3 billion is estimated for physical changes in the packaging itself. Examples in this category include adding a fifth panel to the package if expanded content labeling is required.

With the publication of the final regulations in March, however, Bradley says these estimates can be slightly lower because of the differences between the proposed and final rules. One of the differences, he says, is the change to a more condensed type with a leading of one-half point, instead of 1 point.

But Martin says the new regulations may not take up more space on a label. “We have trimmed the excess verbiage and presented it in a way that the information can sit on a label without taking up more space than previous labels,” he says.

As for the reasoning behind the new regulation, Martin says, “We received a great deal of comments from consumers who complained that the labeling on OTC products was not clear enough, and not easily read.” With the addition of more potent drugs switching from prescription to OTC status, the need for a standardized format has become even more evident, he adds.

According to the FDA, most OTC drugs with the new labeling will be seen on the shelves within the next two years. All OTC drugs will be required to conform to the new regulation within the next six years.

Also in effect is the FDA Modernization Act of 1997, which requires that labels of prescription products contain the symbol “Rx only.” This new symbol replaces the previous “Caution: federal law prohibits dispensing without prescription.”

Diane Fienemann, labeling analyst, Merck & Co. Inc., Whitehouse Station, N.J., says the process of this changeover is lengthy. Merck is currently undergoing compliance with this regulation and is expected to have all labels marked “Rx only” by next year, she adds. Although Merck does print most of its labels in-house, “if our shop cannot meet certain demands, then we will look to an outside supplier,” says Fienemann.

Expanding the possibilities
With the growing amount of information required on pharmaceutical labels, as well as the interest in multi-lingual labels, converters have been busy developing innovative designs to provide their customers with extra label space in a cost-effective manner. Over the past five years or so, expanded content labeling (ECL) has bombarded the pharmaceutical market, with the integration of a traditional label and loose, folded outserts.

Some of the advantages of this label design include fewer packaging components to inventory and manage, reduced packaging line labor cost and increased production rates. One of the most popular ECL constructions from CCL Label is a laminated, printed base label and a fold-out leaflet accessible via a zipper perforation. In addition, CCL offers its patented segmented base ECL, which allows extremely thick booklet constructions to wrap on product containers without buckling.

The Challenge Printing Company, Wallington, N.J., has also introduced its own creation — “ReSealaTab” and “Extended ReSealaTab” labels. Both of these label designs can be peeled back to reveal important product information and then resealed.

In a similar arena, the Control Group offers its “Wrap-Around” label. Utilizing existing bottle sizes, this label creates additional printing space by overlapping — the resealable label is lifted up, allowing the consumer to read the additional copy underneath.

Most recent to hit the market, however, is the “Spinformation” label from CCL. This particular design increases a product’s carrying surface by 75 percent (see sidebar).

Not only must a label be developed to assist the customer in receiving complete product information, but it must simplify the work of a pharmacist as well. Separate warning stickers, such as “Take before bed” or “Take with milk,” must be applied to prescription medication containers. In an effort to avoid the possible error of selecting the wrong sticker, and eliminate the need to purchase additional stickers, The Control Group has developed the “Pharm-Assist” label. With this particular label innovation, the warning message is printed on removable/reusable tabs.

Security in pharmaceutical labels is another trend on the rise. For applications where the threat of theft exists, CCL Label incorporates Electronic Article Surveillance (EAS) detection devices into its labels. Rather than being attached at store level, small radio frequency (RF) circuits are placed behind the label to the underside of the adhesive at the time of manufacture, making then undetectable to the consumer. This process is known as source tagging.

Henfling of Arlington Press says the company has tried numerous security tactics, such as holograms and special varnishes, but says a problem lies in the visibility of such methods. “The visibility allows people to know these security features are present, increasing the possibility of counterfeiting,” says Henfling. “These methods can also slow down the press,” he adds. Henfling says Arlington plans to use a new covert system within its product within the next two months.

Standing out from the crowd
For a pharmaceutical label converter, finding a new customer is no simple task. With pressure from extensive audits, numerous interviews, and security checks, the entire procedure can take days, sometimes even months. Henfling says the average time for Arlington Press to receive a new customer is about two years. “The audits take up a lot of time,” he says.

Laffan of Rxperts Printing Alliance says some of the points which many customers request are audits of the facility, compliance with the SOP (standard operating procedure) manual, the training levels of employees and documented proof, interviews of personnel, and inspection for proper maintenance of all systems. A close relationship with packaging engineers is also important, he adds.

When Merck & Co. Inc. seeks an outside converter for its products, GMP (good manufacturing practices) compliance, quality and price lead the list of demands, says Jerry Miller, senior planner. The type of process used to print the labels is not a major issue, he says. Among the specific items Merck looks for in a converter are how the company does general business, such as their make-ready, how they receive their paper, and how they discard of defective products. Other factors include security of the facility, where the plates and film are stored, proper destruction of obsolete art or film, the segregation of the plant and proper housekeeping, and the most up-to-date revisions, says Miller.

Quality control, such as bar code scanning and vision inspection systems, is another important aspect of pharmaceutical label printing. “The information printed is the most important factor. If the period from 1.5 mils is missing, it can present a great danger,” says Henfling. For this aspect, vision systems are key. “Within a year you can expect to see many improvements in this area, and within two to three years all systems should have true 100 percent effective inspection that check every label and every color across the web.” Many systems now, he adds, check every fifth label.

Some vision inspection systems available for this market scan the verbiage within a label to detect misprints. Cheringal of The Control Group says these systems are improving, but are expensive. “For the electronics alone, the system could cost about $150,000. Then you have to add in the expense for the host machine,” he says. The Control Group offers 100 percent bar code and 100 percent visual inspection.

Ventrudo says CCL Label is in the process of working with other companies to develop a vision system to read or scan text for defects at finishing speeds. “The unit will be able to detect a misprint or if something is left off of the label, such as the dosage or name of the drug,” says Ventrudo.

Currently CCL utilizes its AVS II Automatic Verification System for inspection of all individual pharmaceutical labels. Introduced in April 1997, this system provides 100 percent inspection of up to three bar codes and verifies each against their code value. A splice inspection feature verifies copy integrity across each splice and an exact count of each label is printed on the reverse of each label.

Strictly for the pharmaceutical market, Focus Automation Systems Inc., Ontario, Canada, has developed PharmaVision — a fully automated system offering pharmaceutical packagers and printers 100 percent label inspection. This system actively inspects the entire label surface at production speeds, and features increased quality, improved productivity and increased security. Potential defects PharmaVision will detect include: scum, ink spots, mis-registration, streaking and missing or partial characters and text.

Security is also important. “All of our labels are kept under lock and key throughout the entire process,” says Laffan, adding that only a limited number of employees have access. This procedure also prevents the mixing of any look-a-like labels, says Laffan. “All of these procedures are GMP and not industry standard. I even know of some companies that do not practice this.”

Another important GMP is line clearance. “It’s extremely important to never have two products in the same area at the same time,” says Henfling. Arlington Press has a solid yellow line separating each station from another to avoid the mixing of labels. Each employee knows that he is not allowed to pass the line with another label if one is currently being worked on in that particular station, says Henfling.

To prevent this same problem, Innovative Folding Carton has a separate room where all labels are inspected and packaged. “This provides less handling, thereby eliminating the possibility of a mix,” says Tim Northrup, label manager.

Stolfi of Innovative Folding Carton says the increase in demand for shorter lead times is another challenge for pharmaceutical label printers. Henfling agrees. “Delivery is extremely important. Two to three hours of lost time can cost a great deal of money to a customer,” says Henfling. “We’ve had labels that were available the same day.”

Stolfi presents his solution in this competitive market — just-in-time (JIT) philosophy. “The entire company is structured to provide just-in-time service through modern processes, which entail order entry, prepress and packaging. Combining these processes along with an intimate understanding of our customers’ needs has truly put us at the forefront of the JIT philosophy,” says Stolfi.

Price is another issue, says Henfling, especially now as customers are looking for bid packages to decrease the number of printers they use. “One of our customers originally had about 137 suppliers, and is now down to 20,” says Henfling.

To add more fuel to the fire, orders are also becoming smaller. “Customers are afraid of having a large inventory due to the changing regulations from the FDA,” he says. “Obsolescence is a big word these days.”

Competition, and the growing number and size of pharmaceutical label converters, especially in New Jersey, is another factor affecting customer demands, says Stolfi. “In the past several years, there has been an increase in the number of mergers, and because of this we (as an industry) have received a backlash from customers. Companies that were once major accounts now find themselves as middle-sized customers as far as importance is concerned, leading to less service and less attention, prior to the merger.”



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