SGD Pharma introduces 50 mL RTU moulded glass vials

Published: 1-Oct-2020

The Sterinity platform, which includes both ISO and EasyLyo injectable vials, offers sterile Type I moulded glass for aseptic filling processes

SGD Pharma has expanded its ready to use (RTU) moulded glass vial range with a 50 mL volume option in tray developed at industrial scale.

RTU moulded glass vials offer choice to pharmaceutical companies for sterile packaging, aligning with the industry need for flexibility within the drug manufacturing line. While RTU solutions for small-volume containers are common, SGD says, until now the option for larger-volume containers has remained unfulfilled.

Moulded glass represents approximately 40% of the injectable vials market. Its high mechanical resistance reduces the risk of breakages during fill/finish, while its chemical performance minimizes extractables and particle contamination to meet United States Pharmacopoeia (USP) <660> and USP <1660> guidelines.

SGD Pharma’s EasyLyo vials are designed to withstand the extreme conditions encountered during the lyophilisation process, with a flat bottom to optimise heat transfer, uniform wall thickness for mechanical resistance, and a standard 20 mm ISO neck compatible with all available closures and reconstitution systems.

Alexander Bautista, Product Manager Sterinity Platform, commented: “EasyLyo vials are a proven solution that combine the benefits of moulded and tubular glass: superior resilience and robustness with optimal cosmetic quality. As the only moulded glass manufacturer offering larger ready-to-use vials, the introduction of our 50 mL vial provides drug manufacturers with more flexibility in their aseptic filling lines, creating the opportunity to expand operations into alternative markets that were not possible with smaller vials.”

The EasyLyo range is also available in sizes of 20 and 25 mL.

In partnership with Stevanato Group, the Sterinity range is powered by SG EZ-fill a secondary packaging platform that supports end-to-end RTU processes, offering washed, sterilised and depyrogenated moulded glass vials ready for filling according to US and European Pharmacopoeias and International Organization for Standardization (ISO) requirements.

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