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Pharmaceutical & Medical Packaging News, May/June 2015

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38 pmpnews.com • Pharmaceutical & Medical Packaging News May/June 2015 Show Coverage Packaging Resource Center Packaging Resource Center PharmaPaCk North ameriCa 2015 The Pen-Prep EVO by Duoject Medi- cal Systems will be on display at Phar- mapack North America's Innovation Gallery from June 9 to June 10 in New York City. Company representatives will be located at Booth #4015. Duoject offers a range of unique medical devices developed to safely and precisely reconstitute all dry-form drugs prior to injection, and it has been work- ing with clients since 1985. The Pen- Prep EVO is used with traditional pen injectors used worldwide by patients seeking a portable device for scheduled multiple self-injections. The Pen-Prep EVO meets a very specific requirement of drug delivery, being a unique application addressing and building on reliability, Williams said. Not only are cartridges reconstitut- ed for use in a pen injector for multiple injections, but it also provides a dual- chamber cartridge without the filling difculties, as well as having no exposed needle. It currently comes in 3-milliliter cartridges. "Its simple elegance sets it apart," he said. "It was a rather challenging recon- stitution system, so we came to build on reliability – to be a simpler and reliable product over time." Duoject just began shipping the Pen- Prep EVO, and the 3-millititer drug cartridge is being launched by "a major pharmaceutical company," Williams tells PMP News. He could not yet name the company. It is the first time Duoject has navigated shipping a commercial product. "We've worked with their market- ing team in Europe and study team in the United States," he said. "A col- laboration that's taken some time, but we're finally getting this one going on the market." Duoject is also talking about its engi- neering services group working with the product's design with engineering phar- maceutical clients. "So we not only design and manufac- ture our own products," Williams said, "but we [also] have a strong engineering group that does their own products as well." The Pen-Prep EVO has been proto- typed for other user studies with 1-mil- liliter cartridges, and, using the easy link adaptor, Williams said, it can also have the 13-millimeter and 22-millime- ter finish commercially available with the 3-milliliter cartridge. An "intelligent vial adaptor" called the E-Z-Link will also be discussed at Pharmapack North America, as well as a cartridge-based injection solution called the VaccJect. Duoject's Pen-Prep eVo readied for market; to be Featured at Pharmapack North america that Novelia doesn't use any filter is a key advantage to the product; indeed filtered devices cannot be controlled at 100 per- cent whereas our silicone-based venting system allows us to control each device on the assembly line to prove its efcacy and safety." Benjamin Quaglia, senior design engi- neer, said that since there are no preser- vatives in the formulation, the system itself needs to ensure that no contamina- tion can enter the product and the con- tent of the bottle remains sterile during treatment duration. "In order to make sure Novelia works as a preservative-free system, Nemera has designed and conducted numerous microbiology challenge tests, in normal patient use as well as in patient misuse, up to 90 days," he said. Quaglia noted that 4800 products have been tested from November 2009 to assess Novelia's steril- ity performance. During Novelia's production, the Innovation Center and Nemera's La Verpillière plant worked in a close collab- oration to industrialize the device, Sellier said. It began with a pilot experiment to assess the design robustness and reduce risks to the industrial process. Drop sizes are also addressed with the Novelia system, aiming to produce consistent drops for better patient compliance. "The calibration is created by the valve's design and, more precisely, the diameter of the valve's head," Sellier said. The current drop size is 40 microliters (+/- 15 percent) with water. Drops can vary due to its viscosities and surface ten- sions, and Nemera notes it is developing new drop sizes in order to accommodate more formulations. The Duoject Pen-Prep EVO.

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