ADAPTIQ^® & VIALS DC

INJECTION

Citation: “Product Update: Schott’s adaptiQ^® and Vials DC”. ONdrugDelivery Magazine, Issue 73 (Feb 2017), pp 45-46.

ADAPTIQ® PORTFOLIO EXPANDED

“The adaptiQ® concept permits pharma firms to fill different container formats on one production line while minimising burdensome changeover times in between…”

SCHOTT has expanded its adaptiQ® portfolio of ready-to-use pharma containers (shown in Figure 1) to meet growing market demand from drug manufacturers. The latest nest format will be able to hold 20R, 25R, or 30R ISO vials when it is released this year, and will add to the existing 2R to 15R formats.

The adaptiQ® concept permits pharma firms to fill different container formats on one production line while minimising burdensome changeover times in between. SCHOTT developed adaptiQ® to be compatible with the industry’s filling and finishing equipment, and collectively, industry leaders such as Bausch & Stroebel, Bosch Packaging Technology, Groninger, Optima and Vanrx have tested and verified adaptiQ® on a large number of machine types.

This ready-to-use packaging solution enables pharma companies to react more quickly to new industry trends without building specific manufacturing capabilities. The vials are nested securely, protecting them from scratches caused by vial-to-vial and vial-to-machine contact, and reducing breakage and contamination. As they are already sterilised, pharma companies can load them directly onto filling lines without expensive and time-consuming washing, sterilising, and depyrogenation.

Figure 1: adaptiQ® concept allows different container formats to be filled on one production line.

“Razor-thin margins and regulatory pressure have forced pharmaceutical manufacturers to make smarter packaging choices,” said Christopher Cassidy, Vice-President of Sales and Marketing for SCHOTT’s Pharmaceutical Systems Business in North America. “When the 20-30R ISO format comes online, SCHOTT will give pharma companies even more flexibility. The entire portfolio of ready-to-use vials allows pharma companies to trim costs while boosting efficiency, leading to higher profits.”

Figure 2: SCHOTT Vials DC bring delamination under control.

SCHOTT VIALS DC NEW SCREENING STUDY

Separately, a new series of studies has once again demonstrated the effectiveness of SCHOTT Vials Delamination Controlled (Vials DC, Figure 2). These pharmaceutical vials have a particularly high chemical durability and are therefore less susceptible to delamination. SCHOTT has had this property confirmed in various storage studies.

First, substances were used that have already caused product recalls due to delamination. In a second series of studies, the question of how effectively buffer systems can be stored in the new bottle was examined more closely. The result: if the respective substances were stored in SCHOTT Vials DC, the vials remained stable and no glass delamination was observed.

“The question of how effectively buffer systems can be stored in the new bottle was examined more closely. The result: if the respective substances were stored in SCHOTT Vials DC, the vials remained stable and no glass delamination was observed…”

The delamination studies were conducted in accordance with USP1660 using two different types of formulations: a KCl 15% solution and a Na₂S₂O₃ 10% solution for both of which recalls due to delamination had been announced. Nevertheless, established buffer or formulations that are often used to develop drugs were also tested, for instance ultra-pure water, citrate buffer, phosphate buffer, sodium bicarbonate buffer and ethylendiamintetraacetic acid (EDTA).

Product Manager Florence Buscke said: “Both series of studies clearly show that switching to SCHOTT Vials DC as primary packaging materials significantly reduces the risk for pharmaceutical manufacturers to experience delamination recalls.”

AVAILABLE IN MANY SIZES

Thanks to SCHOTT Vials DC, pharmaceutical companies now have an interesting alternative course of action against the phenomenon of delamination, the detachment of flakes from the inner glass surface due to interaction of the formulation with the pharmaceutical vials. SCHOTT Vials DC are based on established hot forming principles without any additional post process steps and can therefore replace the packaging that is already being used with approved drugs without causing expensive re-registration. The vials are available in the ISO sizes 2R to 10R.

SCHOTT has also already produced larger sizes to meet individual customer needs, for example, a large-scale 50 ml vial for a biotech company based in the US.

adaptiQ® is a registered trademark of SCHOTT AG

What's this?