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Research ArticleRESEARCH ARTICLE

Pharmaceutical Container/Closure Integrity II: The Relationship Between Microbial Ingress and Helium Leak Rates in Rubber-Stoppered Glass Vials

Lee E. Kirsch, Lida Nguyen, Craig S. Moeckly and Ronald Gerth
PDA Journal of Pharmaceutical Science and Technology September 1997, 51 (5) 195-202;
Lee E. Kirsch
Division of Pharmaceutics, College of Pharmacy and the State Hygienic Laboratory The University of Iowa, Iowa City, Iowa
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Lida Nguyen
Division of Pharmaceutics, College of Pharmacy and the State Hygienic Laboratory The University of Iowa, Iowa City, Iowa
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Craig S. Moeckly
Division of Pharmaceutics, College of Pharmacy and the State Hygienic Laboratory The University of Iowa, Iowa City, Iowa
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Ronald Gerth
Division of Pharmaceutics, College of Pharmacy and the State Hygienic Laboratory The University of Iowa, Iowa City, Iowa
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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 II: The Relationship Between Microbial Ingress and Helium Leak Rates in Rubber-Stoppered Glass Vials
Lee E. Kirsch, Lida Nguyen, Craig S. Moeckly, Ronald Gerth
PDA Journal of Pharmaceutical Science and Technology Sep 1997, 51 (5) 195-202;

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Pharmaceutical Container/Closure Integrity II: The Relationship Between Microbial Ingress and Helium Leak Rates in Rubber-Stoppered Glass Vials
Lee E. Kirsch, Lida Nguyen, Craig S. Moeckly, Ronald Gerth
PDA Journal of Pharmaceutical Science and Technology Sep 1997, 51 (5) 195-202;
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Cited By...

  • Comparing Container Closure Integrity Test Methods--Performance of Headspace Carbon Dioxide Analysis versus Helium Leakage Using Positive Controls
  • A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis
  • Container Closure Integrity of Vial Primary Packaging Systems under Frozen Storage Conditions: A Case Study
  • A Multicompany Survey Study for Helium Leak Container Closure Integrity Test
  • Validating Container Closure Integrity with Statistically Based Tests
  • A New Integrated Modeling Approach with Case Studies for Gas Transmission of Container Closure Headspace
  • Single-Use System Integrity II: Characterization of Liquid Leakage Mechanisms
  • Long-Term Study of Container Closure Integrity of Rubber-Glass Vial Systems by Multiple Methods
  • Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System
  • 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
  • Residual Seal Force Testing: A Suitable Method for Seal Quality Determination of (High Potent) Parenterals
  • 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
  • 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
  • Vacuum Decay Container/Closure Integrity Testing Technology. Part 1. ASTM F2338-09 Precision and Bias Studies
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More in this TOC Section

  • Monitoring of Mannitol Phase Behavior during Freeze-Drying Using Non-Invasive Raman Spectroscopy
  • Long-Term Stabilization of a New Freeze-Dried and Albumin-Free Formulation of Recombinant Human Interferon Alpha 2b
  • Pharmaceutical Development of an Intravenous Dosage Form of Diacetylmorphine Hydrochloride
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