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Pharmaceutical & Medical Packaging News, November/December 2014

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Page 33 of 43 • Pharmaceutical & Medical Packaging News November/December 2014 34 Coding and Marking antiseptic swaps. Cook typically packages these sets in large, sterile procedure trays that are designed to present each compo- nent in the order in which it would typi- cally be needed during the procedure. Each of these sets receives its own Device Identifier. Components from within these sets that are also sold individually, such as the wire guides, needles, and cath- eters, are sold under their own Device Identifiers. As another example, Cook also markets a number of devices where multiple units are sold in a box or carton configuration. These devices, which are sterile and all from the same lot number, are individually packaged and labeled and then combined into a predefined box configuration, such as a box of ten or twelve catheters, all of the same model or version. For these products, both the pri- mary packaging (the individual pouches) and the secondary packaging (the box) are labeled with a unique Device Identifi- er, which uses GS1's rules for diferentiat- ing levels within the packaging hierarchy. PMP: A case history about Cook discusses that using standards is the right thing to do for patients. But were there business benefits, too? Reed: When we started this process more than 10 years ago, we were finding instances of a single product having seven diferent product numbers, because our global systems were not aligned. That much repetitive data made it difcult to manage inventory, predict demand, and control regulatory filings. It also meant that we needed to have seven diferent labels, seven diferent versions of all the marketing materials, and seven diferent sets of instructions for use. There were a ton of efciencies gained in the reduction of all this repetitive data. PMP: Can you explain bar code formats and labeling? Reed: We print our labels using an in- house print system and use a linear GTIN- 14 bar code (formerly known as EAN-128). Over the next 1 to 2 years, we plan to also add a GS1-compliant 2-D Data Matrix to all finished product labels, and have already done so for Class III devices. PMP: How much package and/or label redesign has been needed? Reed: The label redesign for UDI has focused on including the full date (year, month, day) of manufacture and expiration dates, whereas our labels previously showed only year and month. These dates appear in text form beside the harmonized symbols for manufacture date and expiration date. PMP: What has been the biggest challenge in implementing UDI, and how have standards helped? Reed: In implementing the GS1 stan- dards, it was a major efort to get all of the manufacturing entities at Cook to understand and use the standard. We needed global education and training to correctly implement GS1 standards, which took a significant investment of time and energy. Also, UDI is a U.S. regulation, and we need to meet other international regulations that are similar, but not the same. This means that we needed to build a system that allows for some flexibility. As painful as that sounds, the standards are helping simplify the process of sharing and acquiring product information in a timely manner. PMP: Any advice for other manu- facturers when implementing UDI? Reed: Start! Making the commitment to begin the process is one of the hardest parts, because it's so daunting. Reach out to other organizations that are working on this and learn from their successes. We're finding as we work with a variety of customers as they transition to GS1 that they often have diferent pieces of the puzzle figured out, and could cut down on the overall work that needs to be done by sharing their learnings with one another. Be patient, flexible, and persistent. Some decisions can be very complicated and difcult, but make the decision and keep moving. 0 Videojet showcased the 7810 UV Laser Marking System for marking Data Matrix codes and text for serialization, Tim Kearns, strategic account manager, life sciences for Videojet, told PMP News at the show. Laser marking is a higher-resolution alternative to continuous ink-jet printing, Kearns explained, and the high-contrast laser marking system has been used successfully to directly mark white HDPE bottles with no product damage. For ultimate control, Siegele of Omega Design advocates "physical aggregation before data aggregation. We believe that you have to wait until everything is in the case for data integrity." Omega Design has partnered with Brazil-based packaging equipment pro- vider Grupo Tecnor to introduce the jointly developed semi-automatic ECX-001 Case Packer. The machine supports unit-level serialization in an attempt to both increase production and eliminate hand packing costs. Omega Design integrates software, cameras, and printers to meet future track and trace requirements mandated by the Drug Quality and Security Act, the company reports. MGS Machine Corp.'s new CT200 hori- zontal continuous-motion cartoner prede- signed to handle blisters, bottles, and tubes is serialization ready, with "cartons always in a controlled position for tracking," reported Richard Bahr, MGS's president. An HMI touch screen can control printing and vision systems, and at Pharma Expo MGS operated the line with a Domino printer and Cognex smart sensor. The small-footprint cartoner features predesigned infeeds to reduce cost and lead time. Bosch's CUT 1405 cartoning system, which made its U.S. debut at Pharma Expo, employs full servo technology for fexibil- ity. The system can handle bottles, vials, syringes, ampoules, tubes, blisters, trays, bags, stick packs, and sachets. Optional modules for serialization, aggregation, and tamper-evidence processes can be added. Mettler Toledo PCE exhibited a system for applying and confrming the presence of serialization and traceability codes throughout the aggregation process, from individual cartons all the way through ship- ping cases. Continued from page 33

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