SGD Pharma introduces industry-first glass vials with Stevanato’s SG EZ-fill tech

02 Mar 2022 --- SGD Pharma and Stevanato Group are unveiling ready-to-use (RTU) sterile 100 ml molded glass vials. The vials are designed to package high-value parenteral drugs in large volumes and use Stevanato’s EZ-fill packaging technology to accelerate time-to-market.

The addition of the clear and amber glass vials to the Sterinity platform reportedly makes SGD Pharma the first global molded glass manufacturer to offer this solution size to the RTU market.

“SGD Pharma is the sole player in the market that is currently offering 100 ml molded glass vials in SG EZ-fill trays, and it’s important for us to be at the forefront of this innovation,” says Alexander Bautista, product manager for the Sterinity Platform.

“Currently, 100 ml represents the boundary between small and large parenteral vials and by introducing sterile empty vials in this size, we can offer drug manufacturers and pharmacists an alternative option.”

Mechanically robust solutions
The chemical resistance of molded glass makes the SGD Pharma 100 ml ISO version an optimum solution for organizations using vials for different injectable applications, says the company. The chemical inertness of molded glass protects drug stability, even for cytotoxic oncological drugs.

“The mechanical resistance of molded glass makes this large vial size a first-choice solution for drug manufacturers,” continues Bautista. “The new vials, available immediately and in flexible quantities, are mechanically robust and can be transported globally, with a minimum order of one box for those who only need small quantities.”

Meanwhile, the 100 ml vial in Stevanato Group’s EZ-fill tray has a range of benefits, including no glass-to-glass contact, which reduces particle generation to protect patient safety. This quality also has the advantage of eliminating scratches on the vials, supporting the visual inspection of the filled vial and reducing the possibility of rejection at quality control.

“Innovation is at the heart of SGD Pharma, and this 100 ml vial launch highlights our commitment to supporting our customers and their products as we drive the market in the direction of having additional alternatives for primary packaging solutions,” adds Bautista.The vials use Stevanato’s EZ-fill packaging technology, accelerating time-to-market.

Minimized contamination risk
The tray is covered with two SteriBags, minimizing the risk of contamination to the aseptic area. SGD Pharma says this packaging system guarantees five years of sterility while also protecting the physical integrity of the vial.

Moreover, the company designed the 100 ml standard ISO 20 version to easily integrate into existing manufacturing processes with minimal changes.

SGD Pharma was the first global glass manufacturer to offer RTU molded glass vials for injectable drugs. Its long-serving partnership with Stevanato Group has enabled the company to introduce 100 ml molded glass vials powered by EZ-fill, an industry-recognized secondary packaging platform that supports end-to-end RTU processes.

Upfront washing, depyrogenation, and sterilization steps are taken care of, with RTU Type I molded glass vials arriving in trays or nest & tubs ready for manual, semi-automatic, or automating fill/finish, allowing drug manufacturers to focus on core business activities to expedite product launches.

Sterinity platform
The Sterinity platform includes ISO 20 vials in tray 50 ml and 100 ml and EasyLyo vials in tray 20 ml, 25 ml, 50 ml. EasyLyo 20 ml is available in nest & tub. All vials are available in clear and amber versions.

EasyLyo provides stronger packaging that is more resistant and suitable to extreme conditions encountered during the lyophilization process. EasyLyo is a range of Type I glass vials that combines the strength of molded glass with superior cosmetic quality and weight reduction.

Edited by Joshua Poole

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