Ready-to-use vial platform

Stevanato Group, a provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical and biotechnology, and Gerresheimer, a provider of healthcare & beauty and drug delivery systems for pharma, biotech and cosmetics, have recently announced 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 brings new advancements which can create significant enhancements to customer product offerings amid growing demand for RTU vials.

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 offers a sterilization method which is more environmentally friendly compared to traditional Ethylene Oxide (EtO) sterilization, and it is an alternative sterilization method which 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. Stevanato Group and Gerresheimer 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 which 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 which 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.

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