Mass Production of Packaging for Freeze-Dried Drugs

Schott announced at the Pharma Symposium in Mainz, Germany, that it has started mass production of its TopLyo™ pharmaceutical packaging for lyophilised (freeze-dried) drugs at its Muellheim, Germany, facility. The TopLyo solution features a special geometry and an ultrathin hydrophobic coating that is so smooth and homogeneous that 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. The Schott TopLyo™ containers currently come in two sizes, 2 and 10ml. “We are also planning a 6 ml container shortly,“ said Dr Claudia Dietrich, Product Manager Vials Coating at Schott forma vitrum. The coating is applied by the proprietary Schott PICVD technology - 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, sterilisation and depyrogenization (heat treatment of 300°C).

In the pharmaceutical area, lyophilisation is used to extend the shelf life of highly sensitive ingredients, such as proteins, that are produced biotechnologically. “This is an important development for the future. After all, biomolecules are already being used today in over 50% of all product developments in pharmaceutical therapy,” explained Dr Dietrich. The advantage of freeze-drying is its ability to preserve products for a longer period of time, keeping their effectiveness stable and better protecting the highly effective and sensitive ingredients. Such preparations are used, for example, in oncology. The TopLyo vials have been designed with a special geometry to maximise strength and minimise breakage, and also to improve heat transfer during the lyophilisation process.