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History
- Published online April 10, 2017.
Article Versions
- previous version (October 27, 2016 - 16:53).
- You are viewing the most recent version of this article.
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© PDA, Inc. 2017
Author Information
- Helen Brown1,
- Hanns-Christian Mahler2,
- James Mellman3,
- Alejandra Nieto1,
- Daniel Wagner4,
- Matthias Schaar5,
- Roman Mathaes2,
- Juergen Kossinna3,
- Franz Schmitting6,
- Sascha Dreher7,
- Holger Roehl1,
- Markus Hemminger7 and
- Klaus Wuchner8,*
- 1Late-Stage Pharmaceutical and Processing Development, Roche;
- 2Drug Product Services, Lonza;
- 3Biologics Technical Development and Manufacturing, Novartis;
- 4Pharmaceutical Sciences Operations, Sanofi;
- 5Biological and Microbiological Services, Novartis;
- 6Development Sciences, Abbvie;
- 7Device Development, Roche; and
- 8Drug Product and Device Methods, Janssen R&D
- ↵* Corresponding Author: Janssen, Pharmaceutical Development and Manufacturing Sciences, Hochstrasse 201, CH-8205 Schaffhausen, Switzerland. E-mail: kwuchne1{at}its.jnj.com.
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- Article
- Abstract
- Introduction
- Methods for CCIT
- Introduction of Artificial Leaks
- Considerations of Microbial Challenge Container Closure Integrity Testing (mCCIT) To Establish Acceptance Criteria for Physical Container Closure Integrity Testing (pCCIT)
- General Considerations for the Applicability of CCIT
- CCIT in the Product Life Cycle
- Conclusion
- Conflict of Interest Declaration
- Acknowledgments
- References
- Figures & Data
- Info & Metrics
- References
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