Schott’s German Plant Begins Pharmaceutical-Packaging Production

Schott announced at the Pharma Symposium in Mainz, Germany that it has started mass production of its TopLyo pharmaceutical packaging for lyophilized (freezedried) drugs at its Muellheim, Germany facility.

The TopLyo solution features a special geometry and an ultrathin hydrophobic coating so as freeze dried drugs cannot adhere to the inside walls of the container. As a result, the so-called lyophilisation cake shows a better appearance and enables less disruption of dry material, as well as reduced breakage during the lyophilisation process. Initial capacity of the plant is six million packaging units a year.

Claudia Dietrich, product manager of vials & coating at Schott forma vitrum, said: “The coating is applied by the proprietary Schott PICVD technology –The Schott TopLyo containers currently come in two sizes, 2 and 10ml. We are also planning a 6 ml container shortly. Plasma Impulse Chemical Vapor Deposition.” in a validated and constantly inspected process.

The entire layer is only 40 nanometers thick and therefore has no effect on the dimensions of the pharmaceutical container. It is stable to pharmaceutical processes such as washing, sterilization and depyrogenization (heat treatment of 300°C).

In the pharmaceutical area, lyophilization is used to extend the shelf life of highly sensitive ingredients, such as proteins, that are produced biotechnologically. Dr Dietrich added: “This is an important development for the future. After all, biomolecules are already being used today in over 50 percent of all product developments in pharmaceutical therapy.”

The TopLyo vials have been designed with a special geometry to maximize strength and minimize breakage, and also to improve heat transfer during the lyophilization process.

“The interests of both the pharmaceutical industry and patients alike are rather obvious. They want to provide their valuable and costly medications with the highest possible protection and ensure that they remain effective for as long as possible,” concluded Dr Dietrich.