Your source for news, trends and analysis of pharmaceuticals, biologics, medical devices, and nutraceuticals.

Mounting financial pressures top a list of issues driving the pharmaceutical, biologic, and medical device sectors. In an exclusive interview, Freedonia senior healthcare consultant Bill Martineau discusses where packaging fits into these issues. Even before the recent global financial turmoil, pharmaceutical, biologic, and medical device manufacturers faced considerable economic pressures. Corporate efforts to control costs continue to trickle down to the packaging function, with packaging line efficiencies more closely scrutinized, and material decisions made based on performance and economics.

In this exclusive podcast from Pack Expo 2008, Anne Marie Mohan, senior editor of Packaging World, speaks with Bruce A. Harder, Systech International’s director of business development. Harder provides an overview on what constitutes a complete serialization solution and advises packagers on how to equip their new packaging lines with serialization in mind. Whether it’s for track-and-trace purposes or for brand protection, serialization is becoming an important packaging process, particularly in the pharmaceutical market. But what does serialization comprise? Is it a single unique code on a package? Or can it go beyond authentication to integrate with a brand owner’s business systems?

A pervasive air of secrecy makes trends in brand protection tough to track. But the following two pharmaceutical-based authentication efforts by DPT Laboratories and Med-Health Pharma shed light on some of the solutions being explored to combat counterfeiters, diverters, and gray marketers who appear to be broadening their horizons, reports Pat Reynolds, Editor, Packaging World magazine. Alan Green, logistics director for DPT Laboratories, will discuss how the contract developer, manufacturer, and packager is implementing brand-protection strategies at the Brand-Protection Packaging Forum May 5, 2009 in Chicago.

The relationship between packaging machinery and materials matters in the package design equation, where global brand owners face the challenge of making their product stand out on the shelf. In this question-and-answer article, Kevin Mulligan explores how this relationship effects the package design equation. Mulligan is senior director, Global Packaging, Covidien, a Mansfield, MA-based global provider of healthcare products, formerly known as Tyco Healthcare. Covidien spun off from Tyco International in mid-2007. A 30-year industry professional, Mulligan is also a member of the Packaging Management Council (PMC), an association of senior packaging managers from consumer and industrial goods manufacturing companies, facilitated by PMMI, the Packaging Machinery Manufacturers Institute.

Alcan Packaging Pharma Center in Shelbyville, KY, held an open house Friday, September 19 2008. The 70,000-sq-ft plant, which produces rollstock, more than doubled in size, adding an additional 80,000-sq-ft. The facility houses printing presses and laminators to produce push-through blister lidding, thermoformable blister films, high-barrier, cold-formable laminate structures, as well as N'CRYPT anti-counterfeit packaging technology. The facility also features full support services for concept-to-prototype thermoformable and cold-form blister packs.

Surrounded by Rockland County, NY government officials and business leaders, Roland Schreiner, president of Schreiner MediPharm Global, cut the ribbon for the U.S. facility opening September 12, 2008. On the left is Gene Dul, U.S. president. The pharmaceutical label printer’s expansion in the U.S. “is to serve our customers better by being closer,” said Schreiner, who pointed out that Rockland County officials, with the help of an Empire State tax-incentive package, were eager to aid the startup of the plant, projected to hire as many as 80 people. The company said that several German employees have relocated to the U.S., with local talent brought in by an executive recruiter.

Purdue Pharma LP has one of the most visible RFID programs in pharmaceutical manufacturing. “In trying to get an RFID program off the ground, you’re working with an emerging technology, so you want to go in step-wise fashion, with buy-ins from many cross-functional project teams in your company,” said Mike Celentano, associate director of supply chain systems and RFID for Stamford, CT-based Purdue Pharma. “There’s also off-site testing and considerable concept work.” Celentano credited this steering-by-committee approach for the initial success of the company’ RFID program, when he spoke in a presentation at the recent Brand-Protection Packaging Forum . Celentano and Aaron Graham, Purdue Pharma’s chief security officer, delivered a co-presentation, “The Case for RFID: Is it an Authentication Solution or a Track-And-Trace Tool?”

Package design for pharmaceutical and nutraceutical products is becoming more complex and challenging for companies striving to reach a balance between becoming more sustainable while adhering to regulations and patient safety initiatives. "Furthermore, each change to packaging materials requires new validation trials, which are time-consuming and costly.” That’s according to the “Pharmaceutical/Nutraceuticals Packaging Machinery, Industry Segment Market Research Study,” a Packaging Intelligence Brief issued by the Packaging Machinery Manufacturers Institute.

Purdue’s packaging line process
At Purdue Pharma’s manufacturing and distribution facility in Wilson, NC, RFID is employed on one packaging line for bottles of the company’s OxyContin (oxycodone HCl controlled release) tablets. Used for the management of moderate to severe pain, OxyContin is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine.

Pharmaceutical packaging sales demand in the U.S., including Puerto Rico, is forecast to rise 5.5% annually to $16 billion by 2012, according to a new study from The Freedonia Group. Leading the gains will be regulations and standards addressing issues including barrier protection, infection control, patient drug compliance, drug dispensing errors, and drug counterfeiting.

The Food and Drug Administration is under fire as never before. Environmental law developments around the globe continue to expand and become more complex. Properly coded packages are helping federal, state, and local governmental organizations get to the root of food recalls. And don’t look now, but nanotechnology is beginning to make a positive impact in the packaging world. These were among the key findings at the June 17 Packaging Law Forum produced by Packaging World magazine.

Greed is a mighty and powerful driver that fuels the dark world of counterfeit and diverted drugs. At the recent Pharmaceutical Packaging Forum (www.packworld.com/ppf), presenter/investigative reporter/author Katherine Eban shined the light on criminal activities while conducting research for her book “Dangerous Doses: A True Story of Cops, Counterfeiters and the Contamination of America’s Drug Supply.”

The task of securing the supply chain and the need to adopt a layered approach using overt and covert security features often seems overwhelming; companies don’t know where to start or what technologies to invest in. That was a key message taken from anti-counterfeiting sessions at the 2008 Americas Technology Summit, an event focusing on brand protection and sustainability held in San Juan, Puerto Rico April 16-17. Americas Technology Summit was sponsored by National Label Co. and MWV .

Could illicit trade—involving everything from handbags to humans to counterfeit pharmaceuticals to weapons-grade uranium—be an even greater threat to our way of life than terrorism? Dr. Moisés Naím, editor of Foreign Policy magazine, believes that could be the case. A new National Geographic Special, Illicit: The Dark Trade, which aired April 16 on PBS television stations, estimated the global value of this trade to be as high as $3 trillion, with some assessments believing it represents 10 percent of the world’s trade. As the accompanying photo of counterfeit drugs seized in Bogota, Columbia, shows, counterfeit packaging is part of this illicit trade. (Photo by Richard Numeroff/©2008 National Geographic Television.)

According to a recent report by in-PharmaTechnologist.com, The European Commission (EC) sought a mandate from European Union member states to negotiate the new Anti-Counterfeiting Trade Agreement (ACTA) with major trading partners including the U.S., Japan, Korea, Mexico, and New Zealand.

Packaging technologies help secure America’s drug supply, but the war rages on, says investigative reporter/author Katherine Eban at the Pharmaceutical Packaging Forum. Eban admits she’s not a technical expert on packaging. “But I know a lot about why you need secure packaging,” she says. “It is critically important. You [packaging professionals] save lives with your packaging.” Eban’s appreciation of pharmaceutical packaging comes in part from the investigative research she completed to write her book “Dangerous Doses: A True Story of Cops, Counterfeiters and the Contamination of America’s Drug Supply.”

David Howard (shown), director product protection global brand integrity at Johnson & Johnson, spoke about how to implement a brand-protection program. “The first step in any organization is to know thyself,” Howard advised. “Where are your products made? How do you distribute? Where do you market? Are you local? Regional? Global? Who touches your products?” Without detailed answers to such questions, solutions being considered or the ones already being implemented may be misguided, Howard told the audience at the first Brand-Protection Packaging Forum.

Maintaining electronic pedigrees of your pharmaceutical products through the distribution chain is a challenge for most manufacturers. Now imagine tracking products for and with about 250 pharmaceutical companies. That’s the task that will face Somerset, NJ-based Catalent Pharma Solutions, Inc. when e-pedigree regulations are in place. Formerly Cardinal Health’s Pharmaceutical Technologies and Services Div., Catalent provides development, manufacturing, and packaging services for pharmaceutical, biotechnology, and consumer health companies in nearly 100 countries. In this article, Catalent’s Akan Oton (shown) provides a contract manufacturer/packager’s perspective on serialization, authentication and track-and-trace technologies in pharmaceutical distribution, based on his recent presentation at the Brand-Protection Packaging Forum in Schaumburg, IL.

Last September, Summit VetPharm, a subsidiary of Sumitomo founded in 2006 and based in Ft. Lee, NJ, went commercial with a track-and-trace bar-code technology called Bloodhound that’s designed primarily as a means of detecting when Summit’s Vectra 3D flea-and-tick prevention products are being sold outside of authorized channels. These products are contractually designated as being for sale exclusively by vets directly to their clients. Nutec Systems provided turnkey responsibility for the project, including all Information Technology, software, and hardware.

The holographic industry is working hard to destroy the myth that sophisticated holograms cannot be counterfeited; anything can be counterfeited. The question is how well, and this is where the real value of holograms can be appreciated. The evolving anti-counterfeiting role of holograms lies in their ability to combine authentication with detection--and this is why enlightened pharmaceuticals companies and enforcement agencies continue to make them an integral part of their anti-counterfeiting strategies.

• floating image technology provides an extra layer of security in labels

• authentication is achieved by moving the label to an angle relevant to the eye

• images can be verified in most lighting conditions

3M
(www.3m.com)

• can include any information or graphics, including company logos or lot dates for increased traceability

• nearly impossible to replicate or reverse-engineer

• can be hidden within multiple levels of product construction and easily authenticated with digital micro-imaging hardware

Topflight Corp.
(www.topflight.com)

• overt and covert security features are embedded in one insert molded in the base of the container

• can be combined with RFID tagging for additional authentication or tracking

• seamless integration with existing process/packaging equipment

Rexam
(www.rexam.com)

• CPI Security Foil allows for fine-line graphics, text, logos, and micro-features to be applied directly to aluminum surfaces during the rolling process

• can be used in any aluminum-based applications, including blister foil, cold-form foil, pouches, and induction seals for bottles

• images are embedded in the foil and cannot be removed

Constantia Hueck Foils
(www.constantia-hueck.com)

• PocketSure is a next-generation reader weighing 2.5 oz and mea-suring 5.5 in. long

• features include single-code memory, audio and visual indicators, and the ability to operate on AAA batteries

• custom codes and zero false accepts

InkSure Technologies Inc.
(www.inksure.com)

• LS 2000 is a compact TEA CO2 laser designed for simple data matrix, production, and logo security marking on packaging materials or products

• most commonly marked materials are inked paper and DataLase (www.datalase.com) coating, although some plastics and other materials can be marked

• emits 10.6-micron laser light, with a print speed for the basic system starting at 20 marks/sec

Lasec Systems
(www.lasecsystems.com)

• anti-counterfeiting solution based on the unique natural microstructures found in the substrate of an individual package

• camera-based technology captures the information embedded in the package structure and transforms it into a digital signature using software

• requires no changes or additions to the product or package and is applicable to all types of packaging substrates

Cortegra Group Inc.
(www.cortegra.com)

Through the years, there has been little change in the appearance of packaging materials and components in delivery systems for injectable drugs. The material science and manufacturing technologies that go into the creation of these systems, on the other hand, have undergone significant advancement. In this article, guest author Fran DeGrazio of West reports on the drivers behind the manufacturing systems for injectable drugs, and what can be expected in the future.

The January 2009 e-Pedigree deadline set by California may have been pushed back two years, but that didn’t stop Biogen Idec from forging ahead with a solution. The March 25 decision by the California Board of Pharmacy to push back the state’s e-Pedigree deadline to January 1, 2011 (its second two-year delay) gives the overwhelming majority of the pharmaceutical companies in the U.S. new breathing room to meet the anti-counterfeiting measures laid out by the Golden State. But those same foot-draggers are now are at risk for being awarded the Black Hat worn by bad guys. That allows the small handful of companies who have solved the packaging serialization puzzle to claim the competitive and public relations benefits that come to those who wear the White Hats.

More is going on in RFID apart from news of the decision by the California Board of Pharmacy to delay requirement for e-pedigree tracking of drugs until 2011. RFID analysts from ABI Research commented about RFID developments and drivers in pharmaceutical markets. Analyst Peter Poorman (shown here) says the current state of affairs in RFID is typical to that of many technologies. "After a period of excitement and then a period of disappointment, there follows a period of adoption on an upward ramp. I think we’re at the beginning of that ramp with RFID."

MATERIAL

Unit-level traceability

* version 2.0 authentication platform includes unit-level traceability features to automatically detect diversion and improve product protection and security through the distribution channel

* generates, analyzes, and tracks secure, nonsequential, nonrepeating codes applied to packages via labels or printing

* platform can be integrated into a manufacturer's production process for verification and tracing via the Internet, secure Web portals, and mobile phones

YottaMark, Inc.

“It really is about time we got some form of e-pedigree system in place” for drug products, states Bryan Liang, law professor, medical professor, and Vice President of the Partnership for Safe Medicine.
He describes the Partnership for Safe Medicine as “a group of organizations and individuals dedicated to ensuring the safety of the drug supply,” including physician, pharmacist, university, industry, and other professional organizations. The partnership has been heavily involved in advocating for a pedigree system to thwart counterfeiting and diversion, but it wants a workable system.

A two-year-old boy is rushed to a Kwale hospital in Kenya’s Coast Province. The clinical officer at the health facility diagnoses febrile convulsions and quickly rushes to the hospital’s pharmacy for a dose of medicine that will ease the boy’s suffering. But nothing happens, so the boy is given additional doses but still the boy does not respond. Finally, he dies. Only later, upon investigation, is it discovered that the drug had no active ingredients. The drug was a fake. Read how health officials and drug manufacturers are developing ways to battle counterfeiting in an effort to keep this African nation from becoming what some would call “a healthcare catastrophe.”

New Brand Protection Packaging Forum presents strategies for brand owners to protect their products from counterfeiting, diversion, and gray-market distribution, using the latest packaging-related technologies. Summit Publishing Company, publisher of Healthcare Packaging magazine, announces the launch of a new conference for brand owners looking to enhance the security of their products using the latest packaging technologies. Produced by Summit Publishing Company’s flagship magazine, Packaging World, the Brand-Protection Packaging Forum will take place on April 8, 2008 at the Chicago Marriott Schaumburg.

Synchronized lines, rather than individual pieces of equipment, will be a focus of pharmaceutical manufacturers, predicts PMMI’s Ben Miyares. In this exclusive Q&A interview with Healthcare Packaging, Miyares addresses multiple healthcare packaging-related issues, including mechatronics and robotics, which, he says, "have the potential to transform the development of packaging equipment." He also looks at sustainability, packaging equipment purchase considerations, E-machinery, and counterfeiting topics.

In the next decade, counterfeit drugs will double, according to Alistair Dand, marketing manager for LGR Emballages, a supplier of folding cartons in France. Currently, one out of every two drugs bought on the internet is a fake. “Counterfeiters are benefiting in developed countries from our desire for lifestyle drugs," said Dand, "and in developing countries from the need for life-saving drugs." Dand offered these remarks February 7, 2008, at Pharmapack in Paris.