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Pharmaceutical & Medical Packaging News, November/December 2015

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News • Pharmaceutical & Medical Packaging News November/December 2015 12 Nexus Dx Recognizes Robinson Printing as a Certifed Supplier, Plans for Growth While reports for 7-year and 10-year accelerated aging are expect- ed to be complete in 2016, Yost did share some interim test results. And additional new transition proto- col material data can be found on DuPont's Web site, he said. "All the information on the www. site as well as in the regulatory library will be remain available online at a mini- mum through the 5-year real-time aging industry report, which is sched- uled for completion in 2019," added Polkinghorne. Polkinghorne then covered some steps for MDMs to take before switch- ing commercially available medical devices from Legacy Tyvek to Transi- tion Tyvek. DuPont is also extending the avail- ability of Legacy Tyvek. "The U.S. FDA's letter of afrmation . . . was DuPont's requirement to begin selling Transition material commercially in the United States," she said. "How- ever, we do realize that due to some of these other regulatory submis- sion requirements in other parts of the world and because of the current supply constraints, some MDMs may not be ready to transition. So to help MDMs work through these remaining hurdles from a regulatory perspective and as a result of specific customer requests, DuPont is extending the availability of Legacy Tyvek through June 2016." She advised that MDMs contact their direct Tyvek suppli- ers (sterile packaging manufacturers) regarding their own inventory plans. DuPont has not announced a spe- cific date for the full discontinuation of Legacy Tyvek, she added. "It has not yet been determined, and it will depend on many, many factors. As we head into the middle of 2016, the exact timing and information associ- ated with discontinuing that product will become a lot clearer." DuPont will continue to communicate openly and often, she said. MDMs who have developed pro- grams supporting interchangeability among Legacy and Transition Tyvek may find some supply chain bene- fits, Polkinghorne noted, sooner than those who are continuing to need only Legacy products. "So we are encour- aging everyone in the supply chain to work toward the goal of interchange- ability," she said. The MPTP demonstrates DuPont's significant commitment to the indus- try, Pyers noted. "Within DuPont . . . well over a hundred people across multiple functions over many years have worked on this," she said. The team answered several ques- tions during the live Webcast, includ- ing several on submissions to Notified Bodies as well as on the commercial- ization of Transition Tyvek. DuPont emphasized its plans for ongoing support. As Scholla explained at the beginning of the Webcast, "We're not going away, and we've got stuf to do, and we're going to be around to help you through the process." Please view the on-demand ver- sion of the October 6 Webcast as well as past events by visiting the Medi- cal Packaging Community at www. —Daphne Allen Continued from page 9 N exus Dx Inc., a subsidiary of Sam- sung Electronics Co. Ltd., markets lateral-flow blood diagnostic kits for near-patient applications. The com- pany is preparing for growth, with Samsung having forged a partnership last year with Thermo Fisher Scientific for international distribution, reports Spencer Baker, Operations Supervisor. Helping support such growth is Robinson Printing Inc., which was recently awarded certified supplier status from Nexus Dx for providing instruction-for-use (IFU) booklets and cartons. Robinson Printing's solutions along with its consistency in produc- tion have helped increase efciency for Nexus Dx. In order to qualify for Nexus Dx's certified status, a supplier must achieve "100% inspection over six months, or six consecutive lots (which- ever is greater)," reports Baker. "Rob- inson Printing has provided far greater than six conforming lots since the summer of 2012, with zero non-con- formances." Robinson Printing's SOPs, Qual- ity Management System, ISO 9001 certification, and cGMP compliance have all contributed to such a recog- nition. "Robinson Printing is really thorough with its own inspections, and we've found everything to spec," says Baker. "Given its certified supplier status, we don't do any inspections internally. We are very confident in their ability and their history of no nonconformances, and we trust their due diligence." According to Nexus Dx, this helps the company save pro- duction costs, enhance lean manufac- turing practices, and expedite order fulfillment. "We are honored to have received this prestigious ranking and take the trust invested in us very seriously," says Dave Robinson, president of Robinson Printing, in a statement. "Robinson Printing's talented employees are the secret to our commitment to excel- lence and they deserve major kudos for this recognition. Nexus Dx is a val- ued customer that provides important

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