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

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.

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.

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.

When packaging operations for Abilify, a drug to treat schizophrenia, and Coumadin, a blood thinner, were transferred to a different plant, Bristol-Myers Squibb decided to install a new bottle containment filling line. The goal was to improve fill accuracy and protect workers from the products’ dust. New Brunswick, NJ-based Bristol-Myers Squibb researched different fillers on the market and chose the Model 815 15-wheel bottle filler from Aylward Enterprises. This story describes Bristol-Myers Squibb’s Mt. Vernon, IN, facility's employment of a restricted access barrier system to protect workers from high-potency drugs.

Pharmaceutical company packaging OEE's (Overall Equipment Effectiveness) are reported to be among the lowest in the industry. Experience teaches that those feeling the greatest amount of pain are the ones most likely to successfully drive change. Perhaps that is why three giant pharmaceutical companies reported on their efforts in this area at ARC's Forum on Winning Strategies and Best Practices for Global Manufacturers.

Watch for pharmaceutical manufacturers to employ robotics more frequently to boost efficiencies throughout their processing and packaging operations. “We may be ‘OnTheEdge’ of a major growth spurt for robotics on North American packaging lines,” notes Keith Campbell, consultant and OnTheEdgeBlog.com blogger. “Mechatronics and robotics are two ‘disruptive technologies’ that have the potential to transform the development of packaging equipment,” adds Ben Miyares, vice president of industry relations for the Packaging Machinery Manufacturers Institute.

A cloud of uncertainty hangs over the pharmaceutical industry in Puerto Rico following the expiration of tax incentives from Section 936 of the U.S. Internal Revenue Code. Could emerging combinations of biopharmaceuticals and medical devices provide a silver lining? A report from Interphex Puerto Rico.

We may be OnTheEdge of a major growth spurt for robotics on North American packaging lines. That is what some, including Ben Miyares of Packaging Machinery Manufacturers Institute (PMMI), reported at a robotics conference held over the weekend leading up to Pack Expo in Las Vegas last autumn. I think that this is great news for packagers! Robots can provide highly flexible automation options and mitigate capital risk on new lines that may be installed to support the launch of finicky new products. I'm not as confident that the news is as good for the robot manufacturers. While I would expect them to experience a portion of this growth, packaging machinery manufacturers have several options for bringing robotic functionality to end-users.

Packaging a blockbuster prescription drug such as AstraZeneca’s Nexium blister- and wallet-packs (shown in photo) demands efficiency. At AstraZeneca’s plant in Södertälje, Sweden, nine robotic cells, featuring a mix of 16 robots from ABB Robotics and other suppliers, is providing that efficiency during case packing and palletizing on multiple packaging lines.

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.

Are restricted access barrier systems (RABS) and isolators replacing traditional cleanrooms? All have the same aseptic requirements, but some argue that isolators and RABS increase asepsis. Many companies, especially large pharmaceuticals, are making the switch from cleanrooms to RABS or isolators. But others remain leery of these relatively new technologies. The first isolators of the early 90s fell short of expectations, leading to the development of RABS as an alternative.

Validating heat sealers, dye penetration and burst tests, the consequences of designing packaging late in the product design process, and sterilization issues are among the topics that Jacob Kearns has answered in the past year on his "Medical Device Blog." Kearns is an engineer for a medical device company. Differing points of view may be shared on this blog.

Pharmaceutical firms seek packaging line improvements to cut costs, biologics present packaging challenges, and medical device growth is driven by aging baby boomers. These treatment advances bode well for the healthcare/life sciences packaging community. Packaging materials need to offer protection from point of manufacture to the “last mile” where healthcare products reach a patient. Packaging materials must provide barriers for moisture, oxygen, light and heat, and they may include overt and/or covert security measures to combat counterfeiting and diversion. Equipment will need to package products more efficiently, be validatable and versatile.

A new course, Packaging Line Performance Workshop, will give packagers the skills, tools, and knowledge they require to improve the efficiency of their packaging lines. Produced by Packaging World, the two-day intensive workshop teaches attendees the fundamentals of packaging line performance improvement. Attendees will learn how to measure OEE (Overall Equipment Effectiveness) on their packaging lines, and will come away with practical experience to put to immediate use.

In this Q&A, Mel O’Leary, Jr., president and CEO of Meredith-Springfield Associates, describes how copolyester resin and supplier cooperation helped make the Artegraft tube. Meredith-Springfield is a plastic molder of technical hollow containers and custom bottles. It uses Eastman Chemical’s Eastar Copolyester MB002 resin to extrusion/blow-mold the Artegraft tubes.

Healthcare Packaging and Packaging World, producers of the Pharmaceutical Packaging Forum, and Ipack-Ima Spa, organizers of Pharmintech, announce a cooperative agreement in which Healthcare Packaging and Packaging World will offer promotional support to Ipack-Ima Spa, increasing the visibility for their Italian trade event, Pharmintech, to the U.S. pharmaceutical market. Pharmintech, held every three years in Italy, will next take place May 12th -14th, 2010 in Bologna, Italy.

Health Resources LLC of Hueytown, AL, was established in 1995 as a manufacturer of natural health supplements available by mail order. Today, the company offers more than 400 different SKUs, with products that promote a range of health solutions, including joint relief, heart health, reduced inflammation, and better digestion, among many others. In March, the company began running six AirPouch™ Express 3 air-pouch void-fill systems from Automated Packaging Systems to protect its bottles of product during shipment. The switch to air-pouch void-fill systems from loose-fill peanuts increases productivity, lessens mess, and reduces costs.

Nowhere in packaging are flexibility and fast changeover more necessary than in the contract-packaging arena, where multiple customers and their many SKUs are a fact of life. That’s why ease of changeover was a key machine characteristic sought by Brecon Pharmaceuticals recently when it came time to install a new line for blister packing and cartoning of tablets. This fast-growing contract packager, acquired last year by Amerisource Bergen, is located in the UK near the town of Brecon, Wales. Both thermoforming and cold-forming of foil are routinely done on this new and highly versatile blister-pack line.

Wyeth’s Charlie Portwood and Teva Global Generic Resource’s Uri Boneh will serve among the keynote speakers at The International Society for Pharmaceutical Engineering’s (ISPE) annual meeting Nov. 4 – 7 at Caesars Palace in Las Vegas. The event will feature more than 40 sessions, with topics including packaging, product quality lifecycle implementation, pandemic flu preparedness, personalized medicine, nanotechnology, disposables, and project management.

In this question-and-answer interview, Andrew Billington (shown), operations manager at Brecon Pharmaceuticals in Wales, addresses recent trends in packaging. What is he looking for in new packaging machinery? Billington says: "Quicker changeover and anything that facilitates GMPs [Good Manufacturing Practices] are at the top of the list. Both are especially important for a contract packager because our runs can be quite short. Added changeover pressure can also come from the multiple languages we deal with here in Europe. That’s something our counterparts in the United States do not have to face."

Süd-Chemie Performance Packaging has opened a new facility in New Milford, CT. Co-located in the same building with one of its strategic partners, MedInstill, the facility will be home to advanced packaging production including injection-molding, injection/blow- molding, printing, and assembly of a variety of polymer-based packaging products. Currently the plant is supplying printed tubes and desiccant stoppers for the effervescent market in the U.S.

By using high-density polyethylene “bladder” bottles redesigned with a flattened base and “feet” that allow them to stand up on the conveyor line, a producer of a topical livestock insect repellant treatment was able to increase filling line efficiency and eliminate the need for pucks to hold the bottles on the filling line. The new 1- and 2.5-L bottles, from Airopak, a subsidiary of Novapak, replace rounded bottles that could not stand upright, so they had to be placed vertically into pucks for filling.

Packaging Hall of Fame inductee Edward J. Bauer, investigative reporter and award-winning author Katherine Eban, and Joint Equipment Transition Team (JETT) Chairman Jim John are among the speakers scheduled to make presentations at the upcoming Pharmaceutical Packaging Forum (PPF) 2008. Produced by Healthcare Packaging and Packaging World magazines, the event will be held on Wednesday, March 12, 2008 at The Rittenhouse Hotel in Philadelphia, the same venue that hosted the initial PPF March 29, 2007.

Providing quality healthcare while holding the line on costs continues to be a priority throughout much of the life sciences industry. Watching expenses is a critical task at Group Health as well, where the company’s Seattle facility handles mail-order prescriptions and serves as a central fill location for its 26 pharmacies located in both Washington and Idaho. Since adding a Maverick Enterprises UPM B/T (Universal Packaging Machine with Bottle and Tote infeed), Group Health has reduced its labor needs, improved efficiency within its confined 7,000 sq’ area, and readied itself to handle growing sales volume. In turn, those benefits help to hold down Group Health member costs.

The Food & Drug Administration’s new current good manufacturing practices (CGMPs) for dietary supplements are rich in requirements related to packaging and labeling. A decade in the making, the CGMP rule, compliance with which will be phased in according to size of company, sets minimum standards for assembly-line contact surfaces, packaging and labeling equipment, inspection of packaging received from suppliers, relations with third-party packagers, personnel hygiene on the packaging line and much more, all within the context of forcing the industry—some of which may already be in compliance—to adopt the kind of CGMPs that the FDA has prescribed for food and drugs.

Much like drivers appreciate the performance, handling, and flexibility of the finest sports cars,
Italian contract manufacturer/packager Fine Foods N.T.M. (New Technology Manufacturing) S.p.A opts for similar characteristics in the packaging machinery it specifies. As manufacturers speed their products to market, it increases the deadline pressures on companies such as Fine Foods. In turn, Fine Foods relies on packaging machinery for the flexibility and output it needs to meet the demands of its manufacturer-customers.

In June, eight U.S. packaging students visited Pharmintech 2007 and toured packaging machinery supplier plants in Bologna and Milan, Italy. The trip was part of the sixth-annual Italian Packaging Technology Awards (IPTA) program. The program included a writing competition in which students from 15 North American universities wrote a paper on technical innovations in the packaging industry. The eight winners were awarded a trip to Italy to visit the Italian packaging suppliers. The accompanying photo shows students during a visit to IMA on June 13.

At a biomedical facility in Ireland, machine automation is coming into play in a validated environment that involves 21 CFR Part 11 electronic signatures, integrated robots and vision systems. The application is a real-world example of good automation standards providing real-world benefits. That’s according to Dr. Ken Ryan, director of the Center for Automation in Motion Control at Alexandria Technical College in Alexandria, MN. Ryan was recently interviewed by Ontheedgeblog.com blogger Keith Campbell. Also interviewed by Campbell was Shane Loughlin, president of SL Controls. Ryan and Loughlin were in Ireland at the time of the interview, investigating the healthcare packaging-related application that leverages automation standards to integrate best-of-breed equipment. The information in this article is excerpted from this recent interview. Listen to the complete podcast.

Michael Becker, director of engineering, Pfizer GmbH, reported on a four-year project, “FAST,” (Fully Automated Supply and Transport), recently completed at the firm’s Freiburg, Germany plant. The plant produces tablets and capsules of Lipitor, Valoron and Neurotin for 80 different countries in a wide variety of package configurations. The highly automated, computer integrated plan helped the plant achieve OEE comparable with other industries, depending on the equipment measured.

Based in Las Vegas, Med-Health is a combination of three independent businesses where Enterprise Resource Planning (ERP) technology from SAP will play a key role. Currently operating is a Med-Health business that sells medical supplies like gowns, gloves, sutures, and other "consumables." Opening this summer was a pharmaceutical drug wholesaler. And some time around January of 2008 will be the opening of a Med-Health pharmaceutical repackaging arm.