Industrielle Herstellung von Glasspritzen Von der Glasröhre zur anwendungsfertigen Spritze Dr. Stefan Kettelhoit Gerresheimer Bünde GmbH, Bünde Korrespondenz: Dr. Stefan Kettelhoit, Gerresheimer Bünde GmbH, Erich-Martens-Str. 26–32, 32257 Bünde (Germany), Fax +49 (0) 5223 164 316, e-mail: s.kettelhoit@gerresheimer.com Industrial Production of Glass Syringes Glass syringes – especially ready-to-use ones – have shown tremendous growth during recent years not only in market size but also in interest and importance. This is due to their favourable properties as pharmaceutical packaging material and at the same time as a safe and convenient application system for the end user. The production of glass syringes is a multi-step industrial-scale manufacturing process starting with the silica melting process, with glass tubes as intermediate goods, and ending with different types of glass syringes in terms of shape, size and presentation (e.g. Luer cone, Luer lock or needle syringes in bulk or ready-to-use form) or even value-added processing. Quality management of glass syringe production is performed by the industry according to cGMP standards and international guidelines. Pharmacopoeial monographs and international standards (e.g. ISO norms, defect evaluation lists) are used as relevant specifications for quality control. The siliconisation of syringes through spraying or baking on to the surface is still a very important value-added process with sometimes still unresolved challenges for “difficult products”. Besides this, surface treatment with ammonium sulphate and tungsten-free forming are currently hot topics in the exciting and challenging field of pre-filled syringes. Key words Bulkspritze • Ready-to-Use-Spritze • Silikonisierung • Oberflächenbehandlung • Spritzentypen • Wolfram |
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pharmind 2008, Nr. 10, Seite 1261