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100 % Container Closure Integrity Testing of Lyophilized Drug Products by the Oxygen Head Space Analysis Methodology
Determination of minimum Hold Times for Detection of Blue Dye/Microbial Ingress Leak Rates
Originale
1. Introduction
2. Materials and Methods
3. Results
4. Discussion
5. Conclusion
Acknowledgements
2. Materials and Methods
3. Results
4. Discussion
5. Conclusion
Acknowledgements
Key Words: leak detection, lyophilisation, blue dye, helium leak testing, ingress testing methodologies, headspace analysis
Tobias Posset1, Misael Schleger1, Fredric J. Lim2, Marco Mumenthaler3, Sebastian Schneider4, Thomas Kaiser5 · 1 Parenteral Production, Roche Diagnostics GmbH; Mannheim
2 Late Stage Pharmaceutical and Processing Development, Genentech, a member of the Roche Group; California (USA)
3 Biologics Manufacturing Sciences and Technology Drug Product, F. Hoffmann-La Roche Ltd, Basel (Switzerland)
4 Pharmaceutical Development & Supplies , F. Hoffmann-La Roche Ltd, Basel (Switzerland)
5 Biologics Technology Transfers, F. Hoffmann-La Roche Ltd, Basel (Switzerland)
2 Late Stage Pharmaceutical and Processing Development, Genentech, a member of the Roche Group; California (USA)
3 Biologics Manufacturing Sciences and Technology Drug Product, F. Hoffmann-La Roche Ltd, Basel (Switzerland)
4 Pharmaceutical Development & Supplies , F. Hoffmann-La Roche Ltd, Basel (Switzerland)
5 Biologics Technology Transfers, F. Hoffmann-La Roche Ltd, Basel (Switzerland)
Correspondence:
Tobias Posset, Parenteral Production, Roche Diagnostics GmbH Mannheim, Sandhofer Strasse 116, 68305 Mannheim, (...)
