Stevanato Group S.p.A., a global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries, and Gerresheimer AG, a leading global provider of healthcare & beauty and drug delivery systems for pharma, biotech and cosmetics, announced today at CPhl Worldwide the official launch of a new and innovative ready-to-use (RTU) vial platform, EZ-fill SmartTM, a solution designed to improve drug packaging quality, reduce total cost of ownership (TCO), and shorten lead times for customers. The new EZ-fill Smart™ is an evolution of Stevanato Group’s groundbreaking EZ-fill® platform, and it brings new advancements that can create significant enhancements to customer product offerings amid growing demand for RTU vials.
The companies have implemented process and product changes that can offer substantial improvements for customers. The EZ-fill Smart™ platform leverages increased 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 improves quality and integrity of the vials throughout the product life cycle. The companies have redesigned the secondary packaging, which can yield a significant reduction of particle risks during customers’ operations, delivering improved quality.
The new EZ-fill Smart™ now offers the market a sterilization method that is more environmentally friendly compared to traditional Ethylene Oxide (EtO) sterilization, and that is an alternative sterilization method that can result in improved safety. Intended to be suited for primary packaging solutions in use with highly sensitive drugs, it also incorporates guidelines given by regulatory bodies supporting the current direction to replace EtO sterilization. Together, Stevanato Group and Gerresheimer AG have obtained positive results to date and are in the validation process with this sustainable sterilization method.
EZ-fill Smart™ is intended to improve sustainability in multiple areas, increasing the packaging efficiency, implementing a new eco-friendly sterilization method, and using biopolymers and recycled plastic.
Developed in close cooperation with major machine vendors, EZ-fill SmartTM can provide a proven seamless integration with standard fill & finish operations. The platform also accommodates both small and large batch production. The companies have implemented advancements that can help ensure the processability on filling lines with the primary aim to facilitate the complete automation of the in-feeding process. Along with the Nest & Tub configuration, EZ-fill SmartTM will also be available in tray configuration to support and accelerate the conversion from bulk to RTU vials that is already underway in the market. Customers choosing this option can benefit from the improvements gained with the newly designed Nest & Tub configuration.
EZ-fill SmartTM with Nest & Tub configuration, including process and product optimization, is expected to be available for the commercial phase during the first half of 2024. By mid-2023 the new solution is expected to be available to customers for initial validation. EZ-fill SmartTM with tray configuration for high volume, is expected to be available on the market during the first half of 2024.
“Our EZ-fill® technology is a well-established standard in the industrial process for RTU primary containment solutions, and the new and innovative EZ-fill SmartTM platform responds to increasing demand from customers for RTU products”, said Mauro Stocchi, Chief Business Officer at Stevanato Group. “We believe EZ-fill SmartTM will help pharma companies, CMOs, and CDMOs easily adopt the market-leading technology by optimizing quality, costs, and machinability while keeping our environmental impact in mind”.
“As an innovative and leading solution provider for the pharma and biotech industry, Gerresheimer responds to customer demand with a best-in-class solution. We are convinced that the new EZ-fill SmartTM platform is the next industry standard for RTU vials and in the future also for cartridges”, said Lukas Burkhardt, Member of the Executive Board of Gerresheimer AG. “The new platform will enable customers to optimize their processes, improve their quality and their CO2 footprint. In addition, our customers can benefit from a significant reduction in the total cost of ownership.”
EZ-fill SmartTM will be officially presented at CPhI Worldwide.
https://www.stevanatogroup.com