Vanrx has announced 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.
Vanrx marketing vice president Greg Speakman 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."
Stevanato Group pharmaceutical systems division marketing director Andrea Zambon said: "The commercialization of this Product Set reaffirms Stevanato Group's approach to offer an integrated solution, glass components and closures, to Pharmaceutical companies.
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.