Global glass primary packaging supplier SGD Pharma has expanded its ready-to-use (RTU) molded glass vial range to introduce a market-first 50ml volume option in tray developed at industrial scale by a molded glass manufacturer.
The Sterinity platform, which includes both ISO and EasyLyo injectable vials, offers high quality sterile Type I molded glass to speed up aseptic filling processes and reduce time to market for high value parenteral drugs.
RTU molded glass vials such as EasyLyo 50ml offer a new choice to pharmaceutical companies for sterile packaging, aligning with the industry need for flexibility within the drug manufacturing line. In RTU systems, packaging is washed, depyrogenated and sterilized by the packaging supplier so that the only step left in the process in-house is to fill and finish the container, eliminating the upfront operational constraints. While RTU solutions for small-volume containers are now widely recognized and adopted by industry and smaller labs, until now the option for larger-volume containers has remained a crucial need in the market that is now met by EasyLyo 50ml vials.
Molded glass represents approximately 40% of the injectable vials market and is becoming an increasingly popular solution: higher mechanical resistance reduces the risk of breakages during fill/finish, while improved chemical performance minimizes extractables and particle contamination to meet United States Pharmacopoeia (USP) <660> and USP <1660> guidelines.
SGD Pharma’s EasyLyo vials are specifically designed to withstand the extreme conditions encountered during the lyophilization process, with a flat bottom to optimize heat transfer, a 30% reduction in vial weight, uniform wall thickness for better mechanical resistance, and a standard 20mm ISO neck compatible with all closures and reconstitution systems on the market.
Alexander Bautista, Product Manager Sterinity Platform, commented: “EasyLyo vials are a proven solution that combine the benefits of molded and tubular glass: superior resilience and robustness with optimal cosmetic quality. As the only molded glass manufacturer offering larger ready-to-use vials, the introduction of our 50ml 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 of 20ml, 25ml, and the launch of new 50ml flint vials, in addition to 50ml amber and 100ml ISO injectable vials launching in 2021, means manufacturers can rely on one primary packaging supplier for all aseptic processes. Available ex-stock, 50ml EasyLyo and ISO20 flint vials can be ordered and shipped within two weeks from December 2020, minimizing delays in filling line changeovers and enabling easy management of procurement supplies. The amber version will be available in 2021.
In partnership with Stevanato Group, the Sterinity range is powered by SG EZ-fill® – an industry-recognized secondary packaging platform that supports end-to-end RTU processes – offering washed, sterilized and depyrogenated molded glass vials ready for filling according to US and European Pharmacopoeias and International Organization for Standardization (ISO) requirements.
