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Pharmaceutical & Medical Packaging News, November/December 2014

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33 November/December 2014 Pharmaceutical & Medical Packaging News • pmpnews.com PreParing for item-LeveL Coding Given the staggered deadlines for Unique Device Identifcation and a lengthy phase-in period for U.S.-market pharma- ceutical item-level serialization, health- care product manufacturers have time to address some of the challenges in imple- mentation. Solutions providers that exhib- ited at Pack Expo International and Pharma Expo 2014 shared their approaches in han- dling data and the packages themselves in an effort to provide the tight control needed for dependable line performance. "We are seeing interest with multiple deployments for multiple lines," observes Glenn Siegele, president of Omega Design Corp. (www.OmegaDesign.com). "Com- panies are being progressive even though not aggressive, because serialization is not yet a requirement. They are developing an understanding of the infrastructure they need and planning for it, such as putting the printing infrastructure in place now so they don't have to revisit it again." Much of the effort involves equipping lines with suffcient printing and inspec- tion. And "most of pharmaceutical compa- nies identify mass serialization with Data Matrix ECC200 codes (2-D) as the best and easiest method that incorporates the main information to be traced in a much smaller space compared to the standard bar codes," reports Monica Cervellati, IMA LIFE Marketing Manager (www.ima- pharma.com), which exhibited its approach to serialization at Pharma Expo and Pack Expo. For instance, "the coding solution provides an efficient and cost-effective method to meet the EC's requirements for pack identifcation put forth in the recently adopted Falsified Medicines Directive," Cervellati says. (IMA North America Inc. is based in Leominster, MA; www.ima-na. com.) To facilitate the track and trace process, Cervellati reports that labeling machines can be equipped with the following components: • Ink-jet, thermal-transfer, laser and hot-foil overprinting units to print bar codes, alphanumeric codes, or 2-D codes such as Data Matrix. • Overprint control systems. • Camera systems to control OCV/OCR. • 1-D/2-D or Data Matrix veriýcation, presence, slope control, pattern matching, etc. Manufacturers may also want to con- sider the possible integration, application, and control of RFID labels, Cervellati says. "Ad-hoc solutions can be tailored to new packaging lines in order to meet with customer's stringent and country specific requirements of the pharma- ceutical industry," Cervellati says. IMA's SENSITIVE AP400 labeler, for instance, can apply labels on one, two, or three faces of the carton (only on top, only on lateral sides, or on all of them). "The pos- sibility to host up to three labelling heads and the high output (up to 450 cpm) gives the machine a high degree of flexibil- ity. The positive transport of cartons by means of toothed belt assures the index- ing of each carton and avoids the pos- sibility of misplaced ones or jams. As well, the correct interdistance between cartons and labeling head is constantly guaranteed." Product manufacturers are also looking at ways to add serialization capabilities to existing lines, observes Fabio Trip- podo, president of MG America (www. mgamerica.com), the U.S. subsidiary of MG2 of Bologna, Italy. The supplier of processing, packaging, and assembly machinery offers the ACE-CT400 carton- ing line for packaging lines already in place. "It can be integrated into any line," says Trippodo. "You just need the two systems to talk to one another with the help of software." MG America provides integration support and can design an infeed belt to the cartoner from the exist- ing packaging line. At Pack Expo, MG America displayed the ACE-BT300 Coding & Veriýcation Unit, an integrated system for bottle serializa- tion down to the unit level. It can process round, square, and rectangular bottles at maximum speeds of 300 per minute. Bottles can be coded either bottom-up or down, and servo-driven side belts provide accurate speed management and position control throughout the process. N u t e c S y s t e m s I n c . ( w w w . nutecsystems.com) introduced a new control system that can employ any print or vision inspection system. Black Box is print engine and vision system "agnostic" and can "serve as the front-end control device for any system," explained Dennis McLaughlin, Nutec's director of engineer- ing/technical sales, at the show. "It can serve as the central location for traffcking all intelligent devices." (If customers do not select particular vendors, Nutec will default to HP thermal-ink-jet printing and Cognex systems.) Black Box can set up, configure, and monitor the status of all print engines and vision systems, and with one single user interface can distribute coding information to all devices, McLaughlin said. Nutec can scale up the amount of capa- bility as needed to suit customer applica- tions, and the highest level of control can monitor up to 12 printing lanes, constantly perform optical character verifcation with an accuracy of 99.99%, and run Nutec's CheQAssure software for batch verifcation, quality control, and solutions for anticoun- terfeiting, antidiversion, track and trace, and returns. Continued on page 34 The Sensitive AP400 labeler from IMA can apply labels to cartons.

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