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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;
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Hanns-Christian Mahler
2Drug Product Services, Lonza;
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James Mellman
3Biologics Technical Development and Manufacturing, Novartis;
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Alejandra Nieto
1Late-Stage Pharmaceutical and Processing Development, Roche;
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Daniel Wagner
4Pharmaceutical Sciences Operations, Sanofi;
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Matthias Schaar
5Biological and Microbiological Services, Novartis;
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Roman Mathaes
2Drug Product Services, Lonza;
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Juergen Kossinna
3Biologics Technical Development and Manufacturing, Novartis;
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Franz Schmitting
6Development Sciences, Abbvie;
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Sascha Dreher
7Device Development, Roche; and
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Holger Roehl
1Late-Stage Pharmaceutical and Processing Development, Roche;
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Markus Hemminger
7Device Development, Roche; and
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Klaus Wuchner
8Drug Product and Device Methods, Janssen R&D
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  • For correspondence: kwuchne1@its.jnj.com
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PDA Journal of Pharmaceutical Science and Technology: 71 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 71, Issue 2
March/April 2017
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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

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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
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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
  • References
  • Info & Metrics
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Cited By...

  • Comparing Container Closure Integrity Test Methods--Performance of Headspace Carbon Dioxide Analysis versus Helium Leakage Using Positive Controls
  • Container closure integrity testing and process validation of closed system transfer devices for aseptic reconstitution of drug vials connected to fluid bags
  • A Multicompany Survey Study for Helium Leak Container Closure Integrity Test
  • Container Closure Integrity Test Using Frequency Modulation Spectroscopy Headspace Analysis with Carbon Dioxide as a Tracer Gas
  • Determining Maximum Allowable Rubber Stopper Displacement for Container Closure Integrity (CCI)
  • Quantifying the Vial-Capping Process: Reexamination Using Micro-Computed Tomography
  • Single-Use System Integrity I: Using a Microbial Ingress Test Method to Determine the Maximum Allowable Leakage Limit (MALL)
  • Comparing Physical Container Closure Integrity Test Methods and Artificial Leak Methodologies
  • Container Closure Integrity Testing--Method Development for Freeze-Dried Products Using Laser-Based Headspace Oxygen Analysis
  • Evaluation of Container Closure System Integrity for Storage of Frozen Drug Products: Impact of Capping Force and Transportation
  • Sealing Behaviour of Container Closure Systems under Frozen Storage Conditions: Nonlinear Finite Element Simulation of Serum Rubber Stoppers
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Keywords

  • Container closure integrity testing
  • Methods for container closure integrity testing
  • Artificial leaks
  • Industry perspective
  • Container closure system
  • Primary packaging
  • USP <1207>

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