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Research ArticleRESEARCH ARTICLE

Pharmaceutical Container/Closure Integrity I: Mass Spectrometry-Based Helium Leak Rate Detection for Rubber-Stoppered Glass Vials

Lee E. Kirsch, Lida Nguyen and Craig S. Moeckly
PDA Journal of Pharmaceutical Science and Technology September 1997, 51 (5) 187-194;
Lee E. Kirsch
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Lida Nguyen
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Craig S. Moeckly
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Article Information

vol. 51 no. 5 187-194
PubMed 
9357304

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online September 1, 1997.

Copyright & Usage 
Copyright © Parenteral Drug Association. All rights reserved.

Author Information

  1. Lee E. Kirsch*,
  2. Lida Nguyen and
  3. Craig S. Moeckly
    1. *Author to whom correspondence should be addressed: 118 Pharmacy Building, Iowa City, Iowa 52242-1112.

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    PDA Journal of Pharmaceutical Science and Technology
    Vol. 51, Issue 5
    September-October 1997
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    Pharmaceutical Container/Closure Integrity I: Mass Spectrometry-Based Helium Leak Rate Detection for Rubber-Stoppered Glass Vials
    Lee E. Kirsch, Lida Nguyen, Craig S. Moeckly
    PDA Journal of Pharmaceutical Science and Technology Sep 1997, 51 (5) 187-194;

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    Pharmaceutical Container/Closure Integrity I: Mass Spectrometry-Based Helium Leak Rate Detection for Rubber-Stoppered Glass Vials
    Lee E. Kirsch, Lida Nguyen, Craig S. Moeckly
    PDA Journal of Pharmaceutical Science and Technology Sep 1997, 51 (5) 187-194;
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    Cited By...

    • Single-Use System Integrity IV: A Holistic Approach Based on Compiled Scientific Study Data
    • A Multicompany Survey Study for Helium Leak Container Closure Integrity Test
    • A Vial Container Closure System Performance Optimization Case Study Using Comprehensive Dimensional Stack-Up Analyses
    • Time Temperature Superposition Evaluation and Modeling for Container Closure System's Seal Performance at Low Temperatures
    • 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
    • Time-Dependent Testing Evaluation and Modeling for Rubber Stopper Seal Performance
    • 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
    • Feasibility of Using Fluorescence Spectrophotometry to Develop a Sensitive Dye Immersion Method for Container Closure Integrity Testing of Prefilled Syringes
    • Impact of Vial Capping on Residual Seal Force and Container Closure Integrity
    • Mass Extraction Container Closure Integrity Physical Testing Method Development for Parenteral Container Closure Systems
    • Visualization Techniques for Assessing Design Factors That Affect the Interaction between Pharmaceutical Vials and Stoppers
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    • Long-Term Stabilization of a New Freeze-Dried and Albumin-Free Formulation of Recombinant Human Interferon Alpha 2b
    • A Novel Approach to the Statistical Evaluation of Media Fill Tests by the Difference from No Contamination Data
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