A new generation of pharmaceutical vials from SCHOTT brings the rare phenomenon of glass delamination under control. Photo: SCHOTT AG
A new generation of pharmaceutical vials from SCHOTT brings the rare phenomenon of glass delamination under control
They are small, extremely small. And sometimes even barely visible. It can take weeks, months or even years before they appear: tiny glass flakes that can detach from the inner wall of a pharmaceutical vial while a drug is being stored. This phenomenon is called “delamination.” It rarely ever occurs and then only under very specific circumstances. But it can be dangerous for the patient if the glass flakes are injected into the bloodstream. The technology group SCHOTT has developed unique new pharmaceutical vials that minimize this risk. The innovation called “SCHOTT Vials Delamination Controlled (DC)” is being received very positively and is now more and more being qualified within the pharmaceutical industry in the US and in Europe.
Delamination is the result of an interaction: the glass surface and the drug formulation react under certain circumstances. The glass delaminates over time and tiny glass flakes can then be seen in the solution. In the meantime, the mechanism behind this is very well understood. When the glass tubes are heated up and shaped into vials, inhomogeneous areas form on the surface and weaken the glass in these places. “Knowing this has helped us to improve our existing production process so that the risk for delamination is minimized to the highest extent possible,” says Andreas Reisse, Executive Vice President of SCHOTT’s Pharmaceutical Systems Business Unit. His team continuously conducts tests and trials to prove the quality of the vials. On the one hand, it has developed a quick test that monitors current production. Secondly, SCHOTT Vials DC have demonstrated their properties in long-term studies. The result is that, while standard vials showed delamination or at least early signs of it, the new SCHOTT vials remained stable.
“The concept is of interest to the industry for a number of reasons,” Reisse notes. “SCHOTT Vials DC can also be used for drugs that have already been approved without requiring costly re-registration. They minimize the risk of product recalls and make a major contribution to patient safety,” he adds.
The basic material, FIOLAX® pharmaceutical tubing glass, also plays an important role in the development of this innovation. Company founder Otto Schott developed it more than 100 years ago from which he developed borosilicate glass. The unique thing about this glass is that it is extremely chemically resistant.
SCHOTT manufactures ten billion containers made of FIOLAX® every year. Due to its high quality, this glass has become the de facto standard for the global pharmaceutical industry when it comes to packaging injectable medications – far beyond the boundaries of SCHOTT.