Medical Device Link.

CARTONING AND LABELING

Pharmagraphics makes large-format outserts of up to 120 panels to fit with packagers’ space requirements.

As packagers confront a variety of options in packaging format and aesthetics, requirements for label content are unrelenting. For instance, package insert (PI) sizes swelled after FDA revised the PI format this year, according to printing companies. Thankfully, these carton and label providers are offering drug packagers multiple alternatives for delivering drug information to professionals and consumers.

Companies are focusing on keeping inserts and outserts to manageable sizes.

“We are seeing unprecedented demand for large-format inserts as a result of the new PI design and type-size requirements from customers with new products and new product indications,” says Ernest Chaplin, vice president, marketing and sales, Pharmagraphics (Greensboro, NC).

The PI format applies to new drug applications and drugs approved for new uses submitted after June 30, and it will be phased in for all drugs approved in the last five years. New features include a Table of Contents, a half-page Highlights section, and a Patient Counseling Information section. PIs must be updated each year with a list of any substantive changes.

Adding to the label volume, Medication Guides (Med Guides) for patients are now required for nonsteroidal antiinflammatory drugs (NSAIDs) as well as antidepressants. Many marketers choose to distribute Patient Package Inserts (PPIs) with medications, though they are required for only a handful of drugs.

Since six- and eight-point type sizes are mandated for the PI, flat sizes have ballooned for many companies that were using tiny type. Six-point type is required for PIs meant for professionals. PIs used promotionally, such as for consumer consumption, require eight-point type, Chaplin explains.

“The copy size is increasing 60 to 70% in some cases, so the flat size has to increase. You can accomplish that by sticking with the same-finished-size insert or outsert and increasing the number of panels, or you can increase the finished size,” adds Kregg Albrecht, director, Nosco Solutions Engineering, Nosco (Gurnee, IL).

“There is a tendency to go to more panels, because everyone is trying to avoid packaging changes [that might arise with a larger folded insert], he adds.
Printers have anticipated the upward curve of labeling requirements with investment in folding equipment to reduce often-massive flat sheets into compact folded pieces that fit with existing packaging formats.

FATTER OUTSERTS

Pharmagraphics, for instance, handles a maximum flat size of 17 × 39¼ in., folded to a 120-panel outsert of 5¼ × 1¼ in., using the MV 2005 folding machine from Vijuk Equipment Inc. (Elmhurst, IL). “Pharmagraphics has offered the Vijuk MV 2005 capability for two years as we knew that space needs would increase and people would want to keep pieces to the same size. We have on or-der our next series of Vijuk MV 2005 folders,” says Chaplin.

Folding machines from Vijuk Equipment have advanced to meet the demand for right-turn-angle (RTA)– style outserts to accommodate the growing space requirements. “Over eight years ago, we started designing outsert folding machines as we saw the demand for putting more useful information on leaflets and to accommodate larger type sizes,” says Bill Neubauer, vice president of administration and technical services.

The Vijuk MV 2005 can be configured to produce up to 130 panels with a minimum fold size of 1¼× 1¼ in., or a maximum fold size of 6 in. wide × 3 in. high. Maximum folding thickness is 0.375 in., compared with the Model MV 2001, which produces up to 100 panels at a folded thickness of up to 0.275 in., Neubauer says.

“The MV 2005 offers the opportunity for a lot more copy space, and with the 2001 and 2005, we are addressing productivity and speed issues,” he says. These models produce outserts at 12,000 cycles per hour, compared with Vijuk’s earlier Model MV 97 RTA outsert folder, which accomplishes 7200 cycles per hour, he says.

Perforated paperboard backing that requires peeling provides the child-resistant function in Keller Crescent’s turnkey wallet system.

Neubauer notes that to meet the space needs of one pharma client, Pharmaceutic Litho & Label Co. (Chatsworth, CA) folded a sheet 27 in. wide × 30 in. long. The company used a wider-version model of the MV 2005 to create a 120-panel outsert with a finished fold size of 3¼ × 2¼ in.

“We are in the design phase to expand the MV 2005 to do even larger RTA outserts to meet clients’ needs if FDA regulations change to require more than 130 panels,” he says.

RTA-style outserts are often favored as more user-friendly than ribbon-style configurations. Yet packagers have a variety of options to choose from for delivering professional and consumer materials.

LABEL DELIVERY

“The key is to understand what brand owners want to accomplish at the strategic marketing level, and carry the strategy through to the package,” says Joe Tenhagen, vice president, marketing, Nosco.

Tenhagen points out that objectives might be shelf presence, easier product identification in the operating room, ease of use, or simply reinforcing the brand image. For delivering labels, companies might favor binding two ribbon inserts together instead of going to an RTA. As copy demands increase, professional and patient inserts could be produced as separate pieces, instead of in perforated pieces for tearing off, he says.

Pharmagraphics is using a specialty device for gluing and adding Med Guides in-line while simultaneously folding the PI at its Puerto Rico facility. This has eliminated the need to consolidate the pieces in a second operation, says Chaplin. In another application, “we acquired a new capability this year for making dynamic-looking 3¼ × 8-in. glued booklets out of one sheet of paper in one pass,” he adds.

Keller Crescent (Evansville, IN) produces collated bundles with two to six or more multiple PI and PPI components married together using a piggyback collation machine with fugitive glue. This addresses clients that want to provide one PI married with multiple patient inserts for sample packaging,” says Mark Smythe, executive vice president, Keller Crescent.

The SmartWallet CUTI30SW wallet machine from Bosch Packaging Pharmaceuticals handles wallets and folding boxes, replacing the need for a wallet packer.

Multiple-panel labels such as expanded-content labeling (ECLs) and multipanel cartons are another solution. “In the case of a multipanel label or carton, the brand owner can choose to print additional patient-compliance and directions-for-use information that is highly user-friendly, beyond that of the compliance-driven Highlights section of the PI,” says Albrecht.

Tursso Companies Inc. (St Paul, MN) has responded to increased label space needs with a new iteration of its X-pandaLabel. Printed on one side, the standard X-PandaLabel wraps twice around a 5-in.-diam bottle. The new version, recently adopted for an OTC product, provides three panels of information with a wraparound label printed on both sides and fixed to a permanently adhering base label. The wraparound portion is printed in one pass on a modified Webtron flexo printer, says David Gray, vice president, sales and marketing.

Security solutions can take many forms, in the devices used and how they are conveyed on labeling and packaging. Carton and label providers are offering programs for sorting through the myriad alternatives and conceiving comprehensive approaches for the use of authentication devices and radio-frequency identification (RFID) tagging.

SORTING OUT SECURITY OPTIONS

MeadWestvaco HealthCare Packaging (New York City) has launched Centuria Brand and Supply Chain Solutions to “bring focus to security solutions with a comprehensive structure and approach,” says Nipon Marwah, product manager for Centuria and cartons, labels, inserts.

Centuria seeks to develop cohesive approaches incorporating tamper-evident features, authentication devices, RFID, and unit-of-use packaging. Marwah says that MeadWestvaco will help clients “ filter through the legions of existing and emerging technologies” and work with authentication device makers to help commercialize technology. Proprietary packaging may incorporate unique graphical, printing, and structural elements.

“Packaging structures can be devised to offer the foundation for the layered approach to security features that FDA favors. We can demonstrate to the marketplace what an end-to-end solution would look like,” says Marwah.

New Jersey Packaging (NJP; Fairfield, NJ) offers its RxTrackNSecure single-source program that helps clients develop custom overt and covert device solutions based on supply-chain characteristics.

NJP this year hosted the RxTrackNSecure Brand Protection Customer Conference in Fairfield, and trends in RFID development and security device options were discussed. Participants included Odin Technology, IBM Business Consulting Services, SysTech International, and Verify Brand.

Narendra Srivatsa, NJP business development manager, said that the acquisition this year by NJP parent Menasha Corp. of Creative Press (Evansville, IN) will support expanded product and service offerings in folding cartons, labels, and inserts. NJP has also expanded to Raleigh, NC, with the opening of a state-of-the-art folding-carton facility serving the pharmaceutical and medical device markets, he said.

With its Brand Shield service, Keller Crescent caters to demand for “quick-and-secure” implementation of security solutions. “The majority of our client base is either actively engaged in this or interested in it,” says Smythe.

Besides a comprehensive set of overt and covert security products, Brand Shield is a process for ensuring security of components, facilities, and the supply chain, says Aaron Weltz, director of quality assurance.

This can involve three-way agreements between brand owners and secure-ink suppliers, for example. The printer has to reconcile ink use based on specified amounts endorsed by the brand company and accommodate background checks and inspections by the ink supplier, Weltz says.

Keller Crescent is a charter member of the North American Security Products Organization (NASPO), which certifies product providers based on security assurance standards and on on-site security audits. NASPO this year announced ANSI approval of the new ANSI standard ANSI/NASPO-Sav3.OP-2005. The standard specifies security-risk-management requirements for protecting security products and securing operations and supply chains. New members announced this year include Authentix Inc., CCL Label, Avery Dennison, and ARmark Authentication Technologies.

Pharmagraphics gained access to new security solutions after the Clondalkin Group (Amsterdam, Netherlands) purchased it this year. In addition, the merger provides the cartoner and labeler with access to European markets and capital resources, says Chaplin.

Pharmagraphics became part of the Clondalkin Specialist Packaging Division, which serves markets in North America and Europe. Clondalkin has rebranded its Guy & Co. Cork, Ireland–based pharmaceutical and medical device packaging business as Pharmagraphics Guy.

“We will take the Pharmagraphics name to Europe in a leadership role with Pharmagraphics Guy for serving multinational healthcare packagers. In the United States, we will become Clondalkin’s platform for further acquisitions in the healthcare printed-component market,” Chaplin says.

Advantages of the merger have quickly materialized. With capital infusion from the merger, Pharmagraphics purchased a new printing and die-cutting press to support its Puerto Rico carton facility.

For a major pharma manufacturer, Pharmagraphics is offering a carton-labeling solution using dimensional inks provided by Clondalkin. “This is a product for which the company wants to maintain a market leadership position. The dimensional ink has almost a holographic depth to it. The manufacturer is presently using sophisticated ink technology on a label, but wanted to incorporate a device onto the carton graphics and avoid the secondary operation of label application. We have a plant in the United Kingdom with product authentication technology that can be employed on folding cartons that is far superior to anything we had,” Chaplin says. “The new application using the specialty ink is under review by the customer, and Pharmagraphics will be assisting in the continued development of the technology to suit their needs.”

ENHANCED MACHINES

Cadmus Healthcare Packaging (Charlotte, NC) addresses the need for short-run efficiency and for providing value-added packaging features with two flexo carton-printing systems from Gallus Inc. (Philadelphia).

The Gallus KM 510 machines feature modular components to add in-line functions such as screen printing, hot-stamping, and film lamination.

Tom McRae, vice president, marketing and technical services, notes that as a North American company competing in a global market, continuing technology investment is of critical importance.

“These systems give us the ability to go from roll to die-cut blank in one in-line pass, producing the kind of value-added features that marketers need to provide perceived value to the package. We can custom-configure the press to particular production specifications, for example, switching out the flexo module with a screen printing unit to accommodate a different graphic style,” says McRae.

Film laminations for package reinforcement, shiny appearance, or creating die-cut windows can also be applied in a single pass.

“We see this as adding value in two ways. One pass to die-cut blank offers efficiency for shorter runs, and we are catering to the move, particularly in North America, for more-exotic substrates such as foil board and plastics. This technology is very friendly for foil and also provides a number of security options such as holographic stamping, thermochromatic and coin reactive inks, screen printing, taggants and microprinting,” he says.

Cadmus has also converted the Gallus units for in-line heat-seal-coated wallet card production. In downstream enhancement to its gluing line, Cadmus has installed a Japack Pro folding carton packager from Heidelberg that shingles, counts, and boxes for automatic packing of cartons off the gluer.

Bosch Packaging Technology Pharmaceuticals (Minneapolis) is introducing the SmartWallet System at Pack Expo International. The SmartWallet CUTI30SW offers an economical alternative to investment in a wallet packer. Preglued wallet outer sleeves, as opposed to flat blanks, are handled like folding boxes. The SmartWallet is erected, and the blister is glued to the outer sleeve by means of lateral holding flaps. An optional paperboard card can be added. Leaflets or booklets can be preconfigured in the outer sleeve and introduced into the wallet during packaging, or be integrated with outer packaging.

The CUTI30SW can be built to produce both wallets and conventional folding boxes. Production speeds are up to 100 wallets per minute, or 300 per minute with a comparable continuous-motion machine mode. By replacing the need for a wallet packer, the system offers 50 to 70% less investment.

“With the SmartWallet, a slightly modified cartoning machine does the job of a wallet packer,” says Jeff Jackson, director of product management and marketing, Bosch Packaging.

“Production investment is similar to conventional folding boxes, which makes wallet packaging a more economically feasible packaging option for more products, and can become an important differentiator in this competitive market,” Jackson adds.

Multivac (St. Louis) has designed and built a 313-model conveyorized labeler for a medical device company that sought to prelabel cartons before they are erected. The labeler keeps flat cartons square on an O-ring-style conveyor for pressure-sensitive-label application.

“They were not going to automate for some time with carton-erecting equipment in the cleanroom. So they wanted them prelabeled for the day’s production for hand-loading off the 313,” says Jay Brewer, product manager for labeling systems.

This year, Multivac debuted the Multivac 6000 Cross Web Labeling System that increases cross-web printing output by 33%. The 6000 sits on an FFS machine for labeling thermoformed packages. Multivac will shortly launch a new series of stand-alone labelers employing the same head design and touch screen controls of the 6000 for in-line carton printing.

“We will have one labeling platform for all of our labeling and traversing (cross-web) applications. With this new function, labelers can be configured for either in-line or cross-web labeling on the fly,” Brewer says.

Nosco’s On Demand Solution digital label-printing system supports efficient printing of multiple package styles and shorter runs for reducing inventory. Clients are offered the On Demand Solutions Calculator to develop a service strategy for specific SKUs.

“Product obsolescence is a big issue. Instead of buying a three- to six-month inventory supply, with digital printing you can run a batch each month at a decent price and require less inventory on hand. Companies often don’t look beyond unit price, but the soft-cost gains of ordering shorter runs are considerable. You are taking cost out of the process, reducing cycle times, and reducing obsolescence,” says Tenhagen.