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Doppelfunktion von Glas als Primärpackmittel und Injektionssystem

Jochen Alberstetter und Dr. Claudia Roth

Vetter Injekt System GmbH & Co. KG, Ravensburg

Glass Used as Primary Packaging Material as well as Injection System

The author of this article examines the importance of glass that is used in the framework of pharmaceutical production as primary packaging material and component of injection systems. Particular attention is given to the requirements of the pharmaceutical manufacturer (filling of drug substances) with regard to the glass quality, the processing of glass and various processes of surface treatment. Furthermore, the design, i.e. the shapes and types of syringe and cartridge systems, is explained and illustrated by considering various standards, process requirements, customer requirements and specifications. Various application systems are dealt with by describing the requirements concerning the glass quality and system components. In this respect, closure parts are the focus of attention. Closure parts have to ensure the tightness of application systems and, through this, the sterility of the drug substances filled. In the framework of cleanliness and microbiological safety, the materials used for the production of closure parts have to meet the same requirements as glass components. Therefore it is absolutely necessary to subject packaging material systems, i.e. glass barrels and system components, to a leak test.

Key words Behandlungsmethoden · Kanülen · Oberflächenbehandlung · Spritzensysteme · Verschlußsysteme · Verschlußteilauslegung