Einsatz von Disposables in der Pharma-Parenteralia-Produktion
Originale
Key words Extractables | Leachables | Parenteralia | Pufferherstellung | Single-Use Disposables | Threshold of Toxicological Concern
Abstract
While planning to produce more batches per week a single-use disposable system, Flexel® 3D Bag for LevMixer® from Sartorius Stedim, has been implemented in the Liquid Vial Filling Line for Bulk Production at Roche Diagnostics GmbH in Mannheim since May 2011 for the buffer preparation in the production of parenterals. Therefore extractables and leachables studies were carried out. All substances found in the leachables studies were also found in the extractables profile of the bag. The concentrations of all leachables were far under the threshold of toxicological concern (TTC) 1.5 µg/person/day. Hence, a toxicological study for these leachables was not required. Based on this study outcome these Sartorius Stedim Bags are suitable for use in mixing and storing of the buffer under validated conditions. After the implementation of Sartorius Stedim Bags the production capacity increased up to 60 % in combination with a new shift model in the Production Module.
Korrespondenz:
Dr. André Mang, Roche Diagnostics GmbH Mannheim, Sandhofer Straße 116, 68305 Mannheim, Germany; e-mail: andre.mang@roche.com
Zusammenfassung
Mit dem Ziel, mehr Chargen pro Woche herzustellen, wurde seit Mai 2011 in der Flüssigviallinie der Roche Diagnostics GmbH (RDG) in Mannheim ein Single-Use-Disposable-System für die Pufferherstellung in der Parenteralia-Produktion eingeführt, der Flexel® 3D Bag für LevMixer® von Sartorius Stedim. Dabei wurden Extractables und Leachables des Bags untersucht. Alle in der Leachables-Studie gefundenen
