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PDA Journal of Pharmaceutical Science and Technology

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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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Article Information

vol. 66 no. 5 403-419
DOI 
https://doi.org/10.5731/pdajpst.2012.00878
PubMed 
23035025

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 3, 2012.

Copyright & Usage 
© PDA, Inc. 2012

Author Information

  1. Seung-Yil Yoon1,*,
  2. Hemi Sagi2,
  3. Craig Goldhammer3 and
  4. Lei Li4
  1. 1Global Packaging Technology and Development, Eli Lilly and Company, Indianapolis, IN, 46285;
  2. 2ATC, Inc, Indianapolis, IN, 46268;
  3. 3Global Packaging Technology and Development, Eli Lilly and Company, Indianapolis, IN, 46285; and
  4. 4Global Packaging Technology and Development, Eli Lilly and Company, Indianapolis, IN, 46285
  1. ↵* Correspondence author: Seung-yil Yoon, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, 317-361-6433, yoonse@lilly.com
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In This Issue

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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  • Article
    • Abstract
    • Introduction
    • Mass Extraction Measurement Technologies
    • Materials and Equipment
    • Defect Simulation & Fluid Theories
    • Experimental Designs
    • Results and Discussion
    • Conclusion
    • Conflict of Interest Declaration
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    • References
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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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  • A proof-of-concept study on a universal standard kit to evaluate the risks of inspectors for their foundational ability of visual inspection of injectable drug products
  • Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry Surveys
  • Definition of Particle Visibility Threshold in Parenteral Drug Products—Towards Standardization of Visual Inspection Operator Qualification
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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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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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