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Research ArticleResearch

Mass Extraction Container Closure Integrity Physical Testing Method Development for Parenteral Container Closure Systems

Seung-Yil Yoon, Hemi Sagi, Craig Goldhammer and Lei Li
PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 403-419; DOI: https://doi.org/10.5731/pdajpst.2012.00878
Seung-Yil Yoon
1Global Packaging Technology and Development, Eli Lilly and Company, Indianapolis, IN, 46285;
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  • For correspondence: yoonse@lilly.com
Hemi Sagi
2ATC, Inc, Indianapolis, IN, 46268;
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Craig Goldhammer
3Global Packaging Technology and Development, Eli Lilly and Company, Indianapolis, IN, 46285; and
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Lei Li
4Global Packaging Technology and Development, Eli Lilly and Company, Indianapolis, IN, 46285
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References

  1. 1.↵
    FDA guidance. Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products. November 1994.
  2. 2.↵
    FDA guidance. Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice. September 2004.
  3. 3.↵
    FDA guidance. Container and Closure Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products. February 2008.
  4. 4.↵
    U.S. Pharmacopeia–NF, 2011, USP 34 〈1207〉 Sterile Product Packaging—Integrity Evaluation, p 759.
  5. 5.↵
    PDA technical report. Pharmaceutical Package Integrity. April 1998.
  6. 6.↵
    1. Brenner D. J.,
    2. Krieg N. R.,
    3. Staley J. T.,
    4. Garrity G. M.
    Bergey's Manual of Systematic Bacteriology, 2nd ed.; Brenner D. J., Krieg N. R., Staley J. T., Garrity G. M. Eds. Williams & Wilkins: Baltimore, MD, 2005; Vol. 2, pp 323, 607 (Part B), and 308 (Part C).
    OpenUrl
  7. 7.↵
    1. Kirsch L. E.,
    2. Nguyen L.,
    3. Moeckly C. S.,
    4. Gerth R
    . Pharmaceutical container/closure integrity. II: The relationship between microbial ingress and helium leak rates in rubber-stoppered glass vials. PDA J. Pharm. Sci. Technol. 1997, 51 (5), 195–202.
    OpenUrlAbstract/FREE Full Text
  8. 8.↵
    1. Burrell L. S.,
    2. Carver M. W.,
    3. DeMuth G. E.,
    4. Lambert W. J
    . Development of a dye ingress method to assess container-closure integrity: correlation to micobial ingress. PDA J. Pharm. Sci. Technol. 2000, 54 (6), 449–455.
    OpenUrlAbstract/FREE Full Text
  9. 9.↵
    1. Morrical B. D.,
    2. Goverde M.,
    3. Grausse J.,
    4. Gerwig T.,
    5. Vorgrimler L.,
    6. Morgen R.,
    7. Büttiker J. P.
    . Leak testing in parenteral packaging: establishment of direct correlation between helium leak rate measurements and microbial ingress for two different leak types. PDA J. Pharm. Sci. Technol. 2007, 61 (4), 226–236.
    OpenUrlAbstract/FREE Full Text
  10. 10.↵
    1. Gorti V.,
    2. Sagi H
    . Simplifying the approach to specify and measure product seal integrity and leak tightness. SAE International, 2006, Paper Number 2006-01-0379.
  11. 11.↵
    1. Sagi H.,
    2. Zhao Y.,
    3. Wereley S. T
    . Wide range flow sensor—vacuum through viscous flow conditions. J. Vacuum Sci. Technol., A 2004, 22 (5), 1992–1999.
    OpenUrl
  12. 12.↵
    1. Sagi N. H.,
    2. Zhang G. R.,
    3. Ghosh R. R.,
    4. Wang X
    . Method and Apparatus of Nondestructive Testing a Sealed Product for Leaks. U.S. Patent 6,584,828 B2, July 1, 2003.
  13. 13.↵
    1. Kirsch L. E.,
    2. Nguyen L.,
    3. Moeckly C. S.
    . Pharmaceutical container/closure integrity. I: mass spectrometry–based helium leak rate detection for rubber-stoppered glass vials. PDA J. Pharm. Sci. Technol. 1997, 51 (5), 187–194.
    OpenUrlAbstract/FREE Full Text
  14. 14.↵
    1. Wolf H.,
    2. Stauffer T.,
    3. Chen S. Y.,
    4. Lee Y.,
    5. Forster R.,
    6. Ludzinski M.,
    7. Kamat M.,
    8. Godorov P.,
    9. Guazzo D. M
    . Vacuum decay container/closure integrity testing technology. Part 1. ASTM F2338-09 precision and bias studies. PDA J. Pharm. Sci. Technol. 2009, 63 (5), 472–488.
    OpenUrlAbstract/FREE Full Text
  15. 15.↵
    1. Fox R. W.,
    2. Pritchard P. J.,
    3. Mcdonald A. T
    . Introduction to Fluid Mechanics, 7th ed.; John Wiley & Sons, Inc.: Hoboken, NJ, 2009; Appendix A.
  16. 16.↵
    1. Karniadakis G. E.,
    2. Beskok A
    . Micro Flows: Fundamentals and Simulation; Springer: New York, 2002.
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PDA Journal of Pharmaceutical Science and Technology: 66 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 5
September/October 2012
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Mass Extraction Container Closure Integrity Physical Testing Method Development for Parenteral Container Closure Systems
Seung-Yil Yoon, Hemi Sagi, Craig Goldhammer, Lei Li
PDA Journal of Pharmaceutical Science and Technology Sep 2012, 66 (5) 403-419; DOI: 10.5731/pdajpst.2012.00878

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Mass Extraction Container Closure Integrity Physical Testing Method Development for Parenteral Container Closure Systems
Seung-Yil Yoon, Hemi Sagi, Craig Goldhammer, Lei Li
PDA Journal of Pharmaceutical Science and Technology Sep 2012, 66 (5) 403-419; DOI: 10.5731/pdajpst.2012.00878
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  • Article
    • Abstract
    • Introduction
    • Mass Extraction Measurement Technologies
    • Materials and Equipment
    • Defect Simulation & Fluid Theories
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  • A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis
  • Container Closure Integrity Test Using Frequency Modulation Spectroscopy Headspace Analysis with Carbon Dioxide as a Tracer Gas
  • 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
  • Method Development for Container Closure Integrity Evaluation via Headspace Gas Ingress by Using Frequency Modulation Spectroscopy
  • Container Closure Integrity Testing--Practical Aspects and Approaches in the Pharmaceutical Industry
  • Artificial Leaks in Container Closure Integrity Testing: Nonlinear Finite Element Simulation of Aperture Size Originated by a Copper Wire Sandwiched between the Stopper and the Glass Vial
  • Integration of Regulatory Guidelines into Protein Drug Product Development
  • Feasibility of Using Fluorescence Spectrophotometry to Develop a Sensitive Dye Immersion Method for Container Closure Integrity Testing of Prefilled Syringes
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Keywords

  • Cartridge
  • Container closure integrity
  • Container closure system
  • Defect
  • Fluid theory
  • Glass
  • Leak
  • Mass extraction
  • Microorganism
  • packaging
  • Parenteral
  • Pharmaceutical
  • Protein
  • sterility
  • Syringe
  • Vacuum, Vial

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