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Ompi EZ-fill vials and Daikyo Seiko PLASCAP press-fit closures are a confirmed product set for use with Vanrx Pharmasystems' Aseptic Filling Workcells.
Ompi EZ-fill vials and Daikyo Seiko PLASCAP press-fit closures are a confirmed product set for use with Vanrx Pharmasystems’ Aseptic Filling Workcells.
Ompi’s glass primary packaging range includes traditional vials and ampoules, as well as syringes and cartridges for auto-injectors and pen-injectors, all available in sterile and ready-to-fill configuration.
Daikyo Seiko’s press-fit closures use a closure system that integrates elastomer closure in a plastic cap. Conventional filling procedures, including stoppering and capping, can be done simultaneously with the use of nested and sterile vials with nested and sterile company press-fit closures in compatible robotic filling systems, according to Daikyo Seiko, managing director Kunihiro Noto, in a press statement. Noto also states that the press-fit closures offer the advantage of eliminating possibilities of aluminum contamination.
The ready-to-use product set is fully commercially available and certified to work with Vanrx’s Microcell Vial Filler, a fully integrated gloveless robotic isolator for vial filling that can be used to make clinical trial supplies and develop new products, and SA25 Aseptic Filling Workcell, a gloveless robotic isolator that performs all of the material handling, filling, and closing activities within a completely closed isolator. According to Vanrx, the product combination will function as a high-performance primary packaging system for sterile injectables and 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 the company’s robotic aseptic filling systems.
“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,” said Greg Speakman, vice president of marketing at Vanrx, in a company press release. “Combining them with Vanrx’s robotic Aseptic Filling Workcells enables companies to build highly flexible manufacturing operations.”
All described sizes and configurations of vials and press-fit closures are commercially available. Product set combinations are available in International Organization for Standardization standard 6R, 8R and 10R vials, and corresponding 20 mm press-fit closures. Commercial ready-for-human-use stock and closure integrity performance results are available from the suppliers.