PARIS, Feb. 8, 2018 /PRNewswire/ - Pharmapack Europe Expo – Vanrx announces that Ompi EZ-fill® vials and Daikyo Seiko PLASCAP® press-fit closures are confirmed as a Product Set for use with Vanrx Pharmasystems' Aseptic Filling Workcells. This Product Set is fully commercially available and ready-to-use (RTU). Commercial, ready for human use stock and closure integrity performance results are available from the suppliers.
Using this Product Set, pharmaceutical companies have the assurance that the combination will function as a high-performance primary packaging system for sterile injectables. Companies can move drug products to market faster, by establishing flexible manufacturing operations using pre-sterilized, nested ready-to-use vials and press-fit closures with integrated stoppers in combination with Vanrx's robotic aseptic filling systems.
In selecting a Product Set, pharmaceutical companies receive assurance that all elements of the set have been proven for compatibility and machinability with Vanrx aseptic filling systems,
As of this date, all of the described sizes and configurations of vials and press-fit closures are commercially available. Product Set combinations are available in ISO standard 6R, 8R and 10R vials, and corresponding 20 mm press-fit closures. Contacts to request samples and performance specifications are listed below. These products are certified to work with Vanrx's Microcell Vial Filler and SA25 Aseptic Filling Workcell.
Greg Speakman, Vanrx's vice president of marketing, said: "Vanrx has worked tirelessly with Ompi and Daikyo to help pharmaceutical companies bring new drug products to market faster. EZ-fill® vials and PLASCAP® closures are widely recognized for their performance. Combining them with Vanrx's robotic Aseptic Filling Workcells enables companies to build highly flexible manufacturing operations."
Andrea Zambon, Stevanato Group Marketing Director - Pharmaceutical Systems Division, said: "The commercialization of this Product Set reaffirms Stevanato Group's approach to offer an integrated solution, glass components and closures, to Pharmaceutical companies. Over the years, Ompi EZ-fill® has become the market reference platform in terms of sterile process technology able to minimize pharmaceutical and biotech companies' total cost of ownership. Our customers can benefit from an easy, flexible and streamlined process as they can immediately fill the ready to use vials, now also complemented with a sterile and proven closure system."
Kunihiro Noto, Daikyo Seiko Managing Director, said: "With our experience in manufacturing elastomer closures and plastic products, we have succeeded in developing a new closure system that integrates elastomer closure in a plastic cap, branded as PLASCAP®.
PLASCAP® is a revolutionary sterile seal for next-generation filling solutions. With the use of nested and sterile vials with nested and sterile PLASCAP® in compatible robotic filling systems, conventional filling procedures including stoppering and capping can be done simultaneously, providing the benefit of convenience for pharmaceutical companies. Moreover, PLASCAP® offers the advantage to eliminate possibilities of aluminum contamination.
PLASCAP®, manufactured by Daikyo's technology with automation system in a clean manufacturing environment, is one of our key innovations in injectable packaging systems, and we are proud to be contributing to the pharmaceutical fill-finish process unit operations."
The testing leading to this product set was completed as part of the Matrix Alliance, a collaboration between leading pharmaceutical packaging companies, of which Vanrx, Ompi, and Daikyo are members. The Alliance was created because next-generation drugs require highly aligned manufacturing processes and packaging solutions.
About Vanrx Pharmasystems
Vanrx Pharmasystems makes the most technologically advanced sterile filling solutions for the pharmaceutical industry. Vanrx fill-finish machines use isolated robotics and machine vision to automate the packaging of injectable drugs into nested vials, syringes, or cartridges. The company was founded by pharmaceutical industry veterans to create the systems needed to make the next generation of innovative therapies. For more information, visit www.vanrx.com.
Ompi is part of the Pharmaceutical Systems division of Stevanato Group and boasts a unique expertise in providing superior pharmaceutical containers from glass tubing.
With operations in Italy, Slovakia, Mexico, China and Brazil and commercial offices in US and Japan, Ompi offers the widest range of glass primary packaging, from the traditional ones such as vials and ampoules, to the high value ones as syringes and cartridges for auto-injectors and pen-injectors. Vials, cartridges and syringes are also available in sterile and ready-to-fill configuration (Ompi EZ-fill®).
About Daikyo Seiko Ltd.
Daikyo Seiko, Ltd. is a leading manufacturer of high-quality injectable packaging components that include: Daikyo Flurotec® film laminated elastomeric closures, Crystal Zenith® cyclic olefin polymer containment and delivery systems, PLASCAP® seals, and various medical device components. Targeting a "Zero defect" quality, Daikyo products are manufactured in clean rooms and released under 100% vision inspection. Daikyo offers components as sterile and ready to sterilize; and also offers customization. Headquartered in Tochigi, Japan—with manufacturing plants are in Sano, Tochigi Prefecture—Daikyo works closely with pharmaceutical customers to innovate and continuously improve manufacturing processes. Since the late 1970s, Daikyo and West Pharmaceutical Services, Inc. have partnered to provide the pharmaceutical industry with a comprehensive portfolio of products for injectable drugs and healthcare products. For more information, please visit www.daikyoseiko.jp/english/index.html.
EZ-fill® is a registered trademark by Ompi, Stevanato Group
PLASCAP® is a registered trademark of Daikyo Seiko.
SOURCE Vanrx Pharmasystems Inc.