Article CommentaryCommentary
Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry
Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger and Klaus Wuchner
PDA Journal of Pharmaceutical Science and Technology March 2017, 71 (2) 147-162; DOI: https://doi.org/10.5731/pdajpst.2016.006999
Helen Brown
1Late-Stage Pharmaceutical and Processing Development, Roche;
Hanns-Christian Mahler
2Drug Product Services, Lonza;
James Mellman
3Biologics Technical Development and Manufacturing, Novartis;
Alejandra Nieto
1Late-Stage Pharmaceutical and Processing Development, Roche;
Daniel Wagner
4Pharmaceutical Sciences Operations, Sanofi;
Matthias Schaar
5Biological and Microbiological Services, Novartis;
Roman Mathaes
2Drug Product Services, Lonza;
Juergen Kossinna
3Biologics Technical Development and Manufacturing, Novartis;
Franz Schmitting
6Development Sciences, Abbvie;
Sascha Dreher
7Device Development, Roche; and
Holger Roehl
1Late-Stage Pharmaceutical and Processing Development, Roche;
Markus Hemminger
7Device Development, Roche; and
Klaus Wuchner
8Drug Product and Device Methods, Janssen R&D

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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 2
March/April 2017
Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry
Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger, Klaus Wuchner
PDA Journal of Pharmaceutical Science and Technology Mar 2017, 71 (2) 147-162; DOI: 10.5731/pdajpst.2016.006999
Container Closure Integrity Testing—Practical Aspects and Approaches in the Pharmaceutical Industry
Helen Brown, Hanns-Christian Mahler, James Mellman, Alejandra Nieto, Daniel Wagner, Matthias Schaar, Roman Mathaes, Juergen Kossinna, Franz Schmitting, Sascha Dreher, Holger Roehl, Markus Hemminger, Klaus Wuchner
PDA Journal of Pharmaceutical Science and Technology Mar 2017, 71 (2) 147-162; DOI: 10.5731/pdajpst.2016.006999
Jump to section
- 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
- References
- Info & Metrics
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