This range extension in amber is the first of several to be announced by SGD Pharma in 2021
SGD Pharma is continuing the expansion of its Ready-to-Use (RTU) Sterinity molded glass vial platform with the introduction of an amber glass 50ml volume option in Tray, now available ex-stock.
The vials, developed at industrial scale, allow global pharmaceutical companies to accelerate the time-to-market of their high-value parenteral drugs with RTU primary packaging.
Alexander Bautista, Product Manager Sterinity Platform, said: “Not only is our Sterinity 50 ml RTU vial now also available in amber glass – which protects sensitive drugs from the harmful effects of light – but we are able to offer customers the immediate lead times that are currently not available elsewhere for Type I vials in large brimful capacities. The Sterinity 50 ml vials in both amber and flint versions are already validated according to Good Manufacturing Practice (GMP) standards and compliant with US and European Pharmacopoeias, and the DMF (drug master files) will be available in May 2021, making this the optimal pharmaceutical packaging container choice for drugs from early development through to commercial phases. Our global customers are reassured that their time-to-market will not be impacted by the stock availability of 50 ml RTU molded glass vials.”
The range extension is aimed to answer the potential need of the pharmaceutical industry to alleviate any supply chain pressures for parenteral primary packaging materials. Having a reliable secondary supplier to provide high-quality alternative packaging options will help mitigate supply chain risk and ensure business continuity in the event of shortages, which is facilitated by the FDA’s March 2021 Guidance for Industry: COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers. This guidance combines the various documentation issued in the past to support SGD Pharma’s customers in any change in vial type.
Molded glass represents approximately 40% of the injectable vials market and is becoming an increasingly popular solution, the company says. Its higher mechanical resistance reduces the risk of breakages during fill/finish and safeguards against harsh processing conditions such as lyophilisation, while improved chemical performance minimizes extractables and particle contamination to meet United States Pharmacopoeia (USP) <660> and USP <1660> guidelines.
The robust mechanical and chemical resistance of molded glass makes the 50 ml ISO version suitable for hazardous liquids like cytotoxic drugs. The 50 ml EasyLyo version is a solution for sensitive drugs manufactured through lyophilisation/freeze drying, including some oncological treatments. The Tray and its secondary packaging design are designed to eliminate glass-to-glass contact, reducing the risk of particles contamination while granting the sterility and physical integrity of each vial.
SGD’s partnership with Stevanato Group has enabled the company to introduce 50 ml amber glass vials powered by SG EZ-fill, a secondary packaging platform that supports end-to-end RTU processes. Upfront washing, depyrogenation, and sterilisation steps are reportedly taken care of, with RTU Type I molded glass vials arriving in Trays or in Nest & Tubs ready for manual, semi-automatic, or automating fill/finish.