A comprehensive sterile system: Ompi EZ-fill® vials and Daikyo Seiko Plascap® press-fit closures, the sterile ready-to-use solution for Vanrx Aseptic Filling Workcells
Stevanato Group announces that Ompi EZ-fill® vials together with Daikyo Seiko PLASCAP press-fit closures are confirmed as Product Set compatible for use with Vanrx Pharmasystems’ Aseptic Filling Workcells.
This Product Set is available in stock, ready for human use and in sterile format. Closure integrity performance results are available from the suppliers.
Using this Product Set, pharmaceutical companies will benefit from a comprehensive solution that function as a high-performance primary packaging system for sterile injectables, since all elements of the set have been proven for compatibility and machinability.
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.”
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.”
The testing leading to this Product Set was completed as part of the Matrix Alliance, a collaboration between leading pharmaceutical packaging companies, of which Ompi, Daikyo and Vanrx are members. The Alliance was constituted to address the need of the next-generation of drugs, which require highly aligned manufacturing processes and packaging solutions.
Product Set combinations are commercially available in ISO standard 6R, 8R and 10R for vials with corresponding 20 mm press-fit closures.