SGD Pharma speeds up time to market for moulded glass vials
The 20ml EasyLyo molded glass Type I vials made by SGD Pharma are now available Ready-to-Use (RTU) in SG EZ-fill Nest & Tub, an industry-recognized state-of-the-art secondary packaging format.
SGD Pharma was the first moulded glass manufacturer to offer RTU vials at an industrial scale for injectable drugs in 2019, and its partnership with Stevanato Group has enabled the company to be the first to market with 20ml EasyLyo moulded glass Type I vials in EZ-fill Nest & Tub.
RTU Type I moulded glass vials are delivered pre-sterilized in Nest & Tubs ready for automated fill and finish, skipping up-front washing and depyrogenation steps in an aseptic environment and allowing pharma companies to focus on core business activities to expedite product launches.
Nest & Tub is a secondary packaging solution required for combi-lines used for fill and finish. It is largely adopted by contract manufacturing organizations and contract development manufacturing organizations for processing a variety of primary packaging containers including vials, syringes, and cartridges for optimal manufacturing flexibility. The Nest & Tub solution avoids glass-to-glass contact, protecting the sterility and the integrity of each vial.
SGD Pharma identified 20ml EasyLyo moulded glass Type I vials, part of the Sterinity platform, as a priority for development in Nest & Tub packaging due to the specific needs of biopharmaceutical companies to protect the safety of lyophilized drugs. EasyLyo’s optimized heel radius reduces the risk of costly breakages in the freeze-drier and by removing the vials’ base mould marks, manufacturers can achieve uniform cakes through maximized heat transfer.
The uniform wall thickness of EasyLyo vials improves their cosmetic appearance and are easier to inspect than standard moulded glass.
Moulded glass represents approximately 40% of the injectable vials market: its higher mechanical resistance reduces the risk of breakages during fill/finish and harsh processing conditions such as lyophilization, safeguarding valuable drug products and sensitive molecules, such as oncology therapies. Improved chemical performance minimizes extractables and particle contamination to meet United States Pharmacopoeia (USP) <660> and USP <1660> guidelines.
