Amidst the rising demand for ready-to-use (RTU) vials, Stevanato Group has partnered with Gerrisheimer AG to produce EZ-fill Smart, a pre-sterilized RTU vial platform that improves on its predecessor: the EZ-fill platform launched in 2007. The new EZ-fill Smart platform incorporates both pharmaceutical process and packaging enhancements, including an alternative sterilization process, as well as optimized product-handling and sustainable improvements to secondary packaging.
Riccardo Butta, president of Stevanato Group Americas, attributes the growth spurt in RTU vials to patient safety improvement efforts as well as drug companies’ needs to simplify processes and boost productivity. Additionally, RTU vials offer flexibility, with fill-and-finish solutions capable of processing different containers — a benefit that speeds time to market and reduces total cost of ownership.
Sustainability and seamless integration.
The EZ-fill Smart platform leverages automation throughout the manufacturing process to increase productivity and reduce human errors. The optimized platform features no glass-to-glass and no glass-to-metal contact, which helps prevent breakages and improves the quality and integrity of the vials throughout the product lifecycle.
“EZ-fill Smart provides glass containers for direct filling, enabling a consistent reduction of time to market and ensuring the same filling process can be used throughout the development process, from the clinical stage to industrialization,” Butta explains.
Developed in close cooperation with machine vendors, EZ-fill Smart is compatible with standard fill-and-finish lines, resulting in seamless integration and reduced complexity in packaging operations.
Eco-friendly packaging features are an added benefit for customers: EZ-fill Smart uses biopolymers for the secondary packaging and recycled plastic materials for the external box. The company has also focused on packaging efficiency.
Moreover, Stevanato Group offers the market an alternative sterilization method that is more environmentally friendly compared to traditional ethylene oxide (EO) sterilization. The company is unable to disclose additional information about the new sterilization method at this time because it is still in its validation process.
“As an industry, we have a collective responsibility to continually review how we can limit the environmental impact of our products and operations,” says Butta.
Minimizing risks, costs.
With Stevanato Group’s platform for aseptic manufacturing, the company manages vial packaging, washing, and sterilization processes, thereby taking care of all the risks and issues related to these procedures.
“Pharmaceutical companies can rely on an experienced external partner, freeing up operational time and cleanroom space and reducing overall costs,” notes Butta. “In drug manufacture, any compromises to product integrity or production efficiency can be extremely costly. With EZ-fill Smart, we have evolved our RTU vial platform process to further minimize these risks.”
In addition to reducing risks through increased automation, the company has redesigned secondary packaging that yields a greater-than-90% reduction of contamination risks during customers’ operations.
In addition to reducing risks through increased automation, the company has redesigned secondary packaging that yields a greater-than-90% reduction of contamination risks during customers’ operations, as verified by internal testing and an external certified laboratory.
The EZ-fill Smart platform accommodates both small and large batch production. Along with the nest and tub configuration, EZ-fill Smart will be available in tray configuration to support and accelerate the conversion from bulk to RTU vials.
EZ-fill Smart with nest and tub configuration is expected to be available for the commercial phase during the first half of 2024. The tray configuration for high volume is also expected to be available on the market during the first half of 2024.