Originally Published PMPN January 2005

Secruity Supplement

Safe and Secure

Pharmaceutical packaging companies are doing more than ever to protect their products.

Ben Van Houten
Senior Editor

Some manufacturers are increasingly turning to RFID technology to help protect their packaging.

Stepping Up Security Efforts

RFID inlets from Omron include a data carrier chip and antenna, both of which form the basis of an RFID tag.

As a result of these developments, pharmaceutical and medical packaging companies are taking more steps than ever before to protect their products. Through the use of RFID tags on bottles, tamper-evident and compliance packaging, or covert and overt security solutions, manufacturers are making security an integral part of their packaging.

“Drug companies have traditionally invested their money in developing the best drugs, and developing packaging that was convenient and helped them comply with regulatory mandates,” says Traub, whose company has recently started creating new technologies specifically designed for the pharmaceutical industry. “Now they’re turning their attention to security, because of all the risks that are out there. Protecting the bottom line is now literally about protecting products and keeping them out of the hands of the wrong people. ”

“More than ever, we’re looking at security in a holistic way,” adds Scott Denley, marketing manager for Alcan Packaging (Shelbyville, KY). “Whether it’s a bar code, tamper-evident packaging, compliance packaging, or RFID, there are many ways to help secure the supply chain, and we look at all of them.”

Overt and Covert Solutions

Weber's RFID smart label applicator system makes it possible for manufacturers to encode and apply RFID smart labels to packages.

Many companies are employing overt security technologies, such as optical variable devices (OVDs), holograms, line embossing, and microtext in the fight against counterfeiters. In addition, covert technologies such as taggants and security inks, typically read with an optical reader, are being used more and more. Hueck Foils, for example, currently offers a variety of holograms that can be applied to substrates. A recent example is the company’s Medica Protec identical holographic. This feature is designed for application to the blister foil and can also be used as a hot-stamping strip on cartons and leaflets.

Similarly, American Bank Note has created Hollow-Seal, a new line of tamper-evident security holograph labels. The line also includes Hollow-Cap, a holographic induction capsule, and Hollow-Sleeve, a holographic shrink-sleeve designed for pharmaceutical bottles.

Topflight (Glen Rock, PA) is another company employing overt and covert features in packaging. For example, its new tamper-evident, self-destructing hologram label is “the most promising thing we’ve developed,” according to marketing director Dave Becker. “If the hologram is removed, it destroys itself,” he adds. “You have a broken hologram with pieces missing, so the tampering is more than obvious.” Topflight is also using gold labels on some of its customers’ packaging. “If the label gets peeled off, a clear disk is left behind,” he says. “Again, the tampering is obvious.” Topflight also uses microtext, nanotext, and concealed imagery with other security features built in.

Authentix (Addison, TX) is also increasing its use of overt technologies. “We’re really focused on authentication technologies right now,” says Jim Rittenberg, the company’s vice president, pharmaceuticals. “We feature a range of polychromatic inks (color-shifting inks) combined with covert solutions such as trace-chemical detection. In addition, we’ve started to use spectral materials that allow fingerprints to be detected on the packaging. We can do that on all parts of a package, including labels, cartons, induction seals on a bottle closure, and blister foils.”

Authentix also offers a program called Mark, Monitor, & Measure. The program is designed to manage the risks associated with counterfeits and diversion throughout the global supply chain. The company uses the Internet to search for suspect and illegal activity. Also within this program, Authentix puts markers into pharmaceutical dosage forms. “By marking the actual dosage form, pills can be definitively authenticated in the field within minutes,” says Rittenberg. The company also has a partnership with Cardinal Health (Dublin, OH) , through which the two organizations offer security inks for folding cartons, inserts/outserts, and labels.

Nosco Inc. (Chicago) has similarly delved into security packaging. In addition to overt security features such as optically variable devices (OVDs) and color-shifting inks, the company offers a variety of covert features such as taggants, reactive inks, and forensic marking solutions. “We offer both high-tech and low-tech features,” says Gregg Metcalf, Nosco’s industry market manager for Nosco Security Protection. “Our microtext and UV solutions, for example, are low tech, but we also offer high-tech features including optical watermarks, OVDs, and color-shifting inks.”

Through its security protection line, Nosco incorporates single- or multiple-security features into one or more packaging components. The features are currently integrated into its line of folding cartons, primary and secondary labels, expanded-content labels, and folded literature. In addition, Nosco’s Life Cycle Management system helps manufacturers plan, implement, and manage multigenerational technologies to stay ahead of counterfeiting and diversion methods. “We use mass serialization, microprinting, invisible graphics, reactive inks, and security substrates as part of that,” says Metcalf. “A full layered approach is the best method.”

Robert Sherwood, vice president of sales and marketing for Sekuworks (Cincinnati), concurs. “People are looking for total assurance,” he says. “Overt features are necessary, but you have to have a covert layer, too.” To that end, the company has recently begun to focus on intaglio printing, an in-line flexographic printing method. “If you’re going to use multiple levels of security, the printing should not be overlooked,” he says. He adds that Sekuworks is in the initial stages of developing partnerships with pharmaceutical companies.

Another company actively engaged in security solutions is Kurz Transfer Products (Lexington, NC). “We are definitely getting more requests from pharmaceutical packagers, in terms of security,” says Sam McElree, product manager, graphics. The company offers a wide array of anticounterfeiting solutions featuring OVD technology, in addition to security foils. Kurz is also involved in the manufacturing of Trustseal security devices, which contain synthetic, computer-controlled diffraction graphic elements. “The advantage of this seal is that it can only be made with proprietary equipment and knowledge,” says McElree, “as opposed to a hologram, which is available worldwide and can be created by many people.” He explains that the Trustseal allows a huge amount of versatility in light management with clearly recognizable effects.

Kurz also offers an array of coding foils that are used to stamp various markings onto product packaging. These markings provide the consumer with important information such as the expiration date, production date, weight, or price, according to McElree. As a result, Kurz coding foils are ideal for security packaging. The foils include a wide range of grades and colors.

Product authentication is also the goal of Appleton (Appleton, WI). However, the company is specifically developing products with ease of use in mind. “We’ve recently added some lower-tech, medium-range security products that aren’t machine readable,” says Trevor Willis, the company’s segment manager for brand protection. “But they can still enable a brand owner to authenticate products.” Willis points to the company’s DocuCheck security papers as examples of products that provide protection for high-value documents such as checks, titles, and certificates. “We also have the DocuMark, TechMark, and AssurMark security solutions,” he says, referring to Appleton’s pharmaceutical packaging solutions. In addition, Appleton’s Pen-Tick and Tech Mark Taggant II products use less-complex readers. “These are slightly higher tech, but they’re still easy for companies to check and test,” he says.

UV data matrix codes are another method of product authentication, designed to help facilitate the tracking and tracing of packages. “These codes are invisible to the end-user, but they have tons of important information actually embedded in that code,” says John Pitts, product manager for Domino Amjet (Chicago). “They use mass serialization that can have anything from a lot expiration date to a serial number hidden inside.”

Some companies are also relying on existing materials for their security features. Alcoa Flexible Packaging, for example, manufactures Safety-Pak blister backings, reportedly one of the first flexible-packaging foil backing materials used to pass FDA’s child protocol tests. The Safety-Pak incorporates tear- and puncture-resistant films that improve the overall strength of the packaging, according to the company. Alcoa’s unit-of-use packages that utilize Safety-Pak blister backing are designed to provide child-resistance characteristics while still being senior- friendly. The end result is a package that can potentially thwart tampering as well.

In addition, Alcoa is one of the leading suppliers of high-performance shrink films and tamper-evident films. These FDA-compatible films can be used for product assurance safety banding. The company also offers specialty folding cartons that include high-quality rotogravure printing on foil and holographic film.

RFID Becomes a Reality

Appleton’s Pen-Tick reader is one of the many products companies are using to authenticate their products.

And then there’s RFID. Based on recent developments, one could conclude that the technology appears ready to replace bar coding as a method of tracing products. RFID tags contain a unique identification number known as the electronic product code (EPC). A standards organization called EPCGlobal oversees and develops commercial and technical standards for the EPC.

According to a 2003 study conducted by The Freedonia Group (Cleveland), the U.S. demand for smart labels is expected to grow more than 14% annually through 2007 to reach $460 million. The report specifically singles out the RFID label segment as the biggest gainer.

Coupled with FDA’s recent support of RFID technology, it’s clear to manufacturers that RFID is the wave of the future in terms of tracking and securing their products. “We’re starting to dip our toes into RFID,” says Nosco’s Metcalf.

Likewise, software company Unisys (Boston) is involved with a variety of pharmaceutical companies on RFID pilots. “Both drug and medical device companies are looking into RFID much more seriously,” says Todd Skriner, partner in life sciences for the company. “We’re working on pilots with some of them, using our Guardian framework, which is an infrastructure designed to capture product pedigree reads using RFID.” Skriner adds that this track-and-trace blueprint is coming along at the right time. “Some of the early adopters of RFID, like Pfizer, are shifting from the thinking stage to the doing state,” he says. “That’s an encouraging sign. Industry is getting out front on this.”

Matrics Inc. (Columbia, MD) is one supplier doing its part. The company offers a complete line of passive ultra high-frequency smart inlays and tags, data management software, and multiprotocol advanced readers. All these products are designed and packaged for interface with EPC-compliant Class 0 and Class 1 RFID tags.

Similarly, Omron Electronics LLC (Schaumburg, IL) has formed a new strategic alliance with Weber Marking Systems Inc. (Arlington Heights, IL), a label and label applicator manufacturer. Under the terms of the agreement, the two companies will provide pharmaceutical customers with EPC-compliant RFID smart labels and UHF agile readers. Omron already produces RFID inlets that carry the data carrier chip and antenna that form the basis of an RFID tag.

Combining Omron’s RFID inlets and Weber’s label conversion and automatic label-application expertise will offer companies “high-quality tags that can be applied at production speeds in high volumes,” according to Bill Arnold, partner/business manager with Omron. The partnership involves retrofitting straight label applications using Omron’s V740 RFID reader, according to Arnold.

Another company heavily involved in RFID is Sato America Inc. (Charlotte, NC), which offers a bar code printer that applies tamper-evident seals, RFID printing solutions, and security labels to boxes and other packages. Sato just introduced a complete multiprotocol RFID service for customer pilots and beta tests. The program includes preplanning consultation, on-site survey, pilot planning and implementation, and postpilot consultation and customer service.

Omron’s V740 RFID reader is part of the company’s new strategic alliance with Weber Marking Systems.

In addition, Sato has established an alliance with RFID hardware provider SAMSys Technologies Inc. to manufacture RFID readers for Sato’s RFID printers. Along with SAMSys, Sato will provide users a convenient way to produce RFID labels and tags. Using ultra high-frequency (UHF) chips embedded in the labels, the custom SAMSys module enables Sato RFID printers to print the label and program the chip inside the label simultaneously, according to Scott Liniger, product manager for Sato. “The RFID-enabled smart labels can be read even if the label is not in the line of sight of the reader, which allows reading operations to be done automatically,” he says. “Also, the information encoded onto smart labels can be changed during their lifetime, eliminating the need to remove and re-label items.” He adds that the printers are designed for antitheft, asset tracking, supply-chain logistics, baggage tags, and factory automation applications.

The Challenge Printing Co. (Clifton, NJ) is also looking at RFID for enhancing the security and integrity of the drug information that the patient received through the packaging. To that end, the company has developed a security authentication protocol that governs the use of both overt and covert packaging authentication features. Part of that includes RFID implementation projects with several customers, including the programming and testing of tags, as well as their inclusion in packaging components such as labels and inserts.

Questions Remain

Some of Topflight’s security labels contain RFID tags and other security features.

Still, the promise of RFID as a security solution remains just that at this moment in time—a promise, albeit one with a bright future. It’s also one that experts say needs to be surrounded by other technologies to become most successful. “In order to achieve effective drug pedigree to secure the drug supply chain, unit-of-sale drugs must be tagged at the manufacturing source and have true electronic tracking and tracing across all the partners in the supply chain,” explains ARC’s Blanchard. “Today, this is not possible because of a lack of automation infrastructure and the fact that most drugs are packaged or repackaged by supply-chain partners downstream from the actual manufacturing. This must be changed to effect a layered approach, with RFID included, to anticounterfeiting.” Blanchard adds that RFID may not be officially mandated but will likely be used on most drug products, with limited use of 2-D bar codes as an interim solution for a few drugs.

Nosco Printing’s Metcalf agrees that RFID shouldn’t be the only security solution. “I actually wish FDA would stress other technologies besides RFID,” he says. “There seems to be almost too much emphasis on it, especially considering there are so many other options out there for track-and-trace purposes.”

Many consider the cost to be the biggest hurdle to industrywide acceptance of RFID. “Like most technologies, the cost will go down,” says Bill Arnold from Omron. “But not in the near future. Right now, there’s also still a view that RFID technology isn’t a well-defined technology for the pharmaceutical industry.”

Sato’s Liniger agrees. “RFID definitely has more promise than practical application at this point,” he says. “At what point does the cost surpass the value of return? We’re seeing a pretty slow ramp-up so far.”

Likewise, Appleton’s Willis doesn’t think the cost of RFID will come down anytime soon. “It’s still far off,” he says. “Application is not a reality for most companies right now.”

Robert Sherwood from Sekuworks suggests that the cost “needs to come way down. It’s still so expensive, and I don’t imagine people will be jumping headlong into it and paying several dollars per piece. Also, it’s nowhere near being a silver bullet.”

Sato’s Liniger also thinks RFID needs to be more fully developed. “Will drug tags alone take care of the problem? I’m not so sure,” he says. “Maybe putting tags inside actual packages would be a better solution, and also one that would need more exploration and testing.”

Looking Ahead

New security-enabled labels from Appleton are manufactured with covert authenticating features.

Regardless of where RFID stands today, it is clear that companies are looking at a variety of other promising security solutions. “One thing we’re watching is electronic mass serialization, where consumers can actually authenticate products themselves,” says Nosco’s Metcalf.

Jim Rittenberg of Authentix sees an interest in molecular recognition markers. “These markers can detect trace levels of chemicals on drug products and packages, and they’re very accurate,” he says. His company is currently exploring the use of such markers. He also mentions such covert technologies as phosphorus combination markers and forensic markers that can only be detected under laboratory analysis.

Another promising technology isn’t necessarily new at all—gold labels. “These are tamper-evident labels that can be put on bottles and cannot be easily counterfeited,” says Gadi Honig, president of Tadbik Advanced Technologies (Israel). “Companies can realistically save 30% on material costs with the use of gold-label technology.” He also points to semiactive RFID as the next wave. “I’d say that will be the next step for RFID,” he says. “You need a semiactive battery transponder to get 100% readability with RFID anyway.”

Elsewhere, companies will continue to evaluate RFID while looking at other solutions. “Since Pfizer and GlaxoSmithKline got involved with their RFID pilots, we’ve definitely looked more closely at our own RFID involvement,” says John Pitts from Domino Amjet. “But we’re also looking at other things, such as laser coding of data matrix on vials and ampules.”

Other companies, such as Alcan, remain focused on item-level security. “Our N-Crypt technology is becoming a global project for us,” says Alcan’s Denley of the company’s security packaging technology. “We also think new solutions will be coming out for primary packaging, blister, and bottle applications. And the bar code won’t be going away anytime soon.”

Ultimately, says Denley, the job of protecting products will fall more than ever on manufacturers in the future. “The problem of counterfeiting will continue to escalate in the coming years,” he says. “Our job is to stay ahead of the counterfeiters using the best security solutions that are both practical to implement and difficult to emulate.”

Copyright ©2005 Pharmaceutical & Medical Packaging News