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Research ArticleTechnology/Application

Container/Closure Integrity Testing and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at −80 °C

Brigitte Zuleger, Uwe Werner, Alexander Kort, Rene Glowienka, Engelbert Wehnes and Derek Duncan
PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 453-465; DOI: https://doi.org/10.5731/pdajpst.2012.00884
Brigitte Zuleger
1Bavarian Nordic GmbH, Robert Roessle Strasse 10, D-13125 Berlin, Germany;
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Uwe Werner
1Bavarian Nordic GmbH, Robert Roessle Strasse 10, D-13125 Berlin, Germany;
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Alexander Kort
2IDT Biologika GmbH, Am Pharmapark, D-06861 Dessau-Rosslau, Germany; and
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Rene Glowienka
2IDT Biologika GmbH, Am Pharmapark, D-06861 Dessau-Rosslau, Germany; and
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Engelbert Wehnes
1Bavarian Nordic GmbH, Robert Roessle Strasse 10, D-13125 Berlin, Germany;
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Derek Duncan
3Lighthouse Instruments, Science Park 406, NL-1098 XH Amsterdam, The Netherlands
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References

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    1. Asselta R.,
    2. Smith E.,
    3. Sunderland W.,
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    . Effect of Low Temperatures on Parenteral Vial Seal Integrity. Presented at the PDA Annual Meeting, Las Vegas, NV, 2007.
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    1. Templeton A. C.,
    2. Han Y.-H. R.,
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    . Rapid Headspace Oxygen Analysis for Pharmaceutical Packaging Applications, Pharm. Technol. 2002, July, 44–61.
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    1. Lin T. P.,
    2. Hsu C. C.,
    3. Kabakoff D. B.,
    4. Patapoff T. W.
    . Application of frequency-modulated spectroscopy in vacuum seal integrity of lyophilized biological products. PDA J. Pharm. Sci. Technol. 2004, 58 (2), 106–115.
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    1. Mahajan R.,
    2. Templeton A. C.,
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    . Frequency modulation spectroscopy: a novel non-destructive approach for measuring moisture activity in pharmaceutical samples. Pharm. Technol. 2005, 29 (10), 88–104.
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    1. Cook I.,
    2. Ward K.
    . Applications of headspace moisture analysis for investigating the water dynamics within a sealed vial containing freeze-dried material. PDA J. Pharm. Sci. Technol. 2011, 65 (1), 2–11.
    OpenUrlAbstract/FREE Full Text
  6. 6.↵
    1. Lysfjord J.
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    . New Inspection Developments. In Practical Aseptic Processing Fill and Finish; Lysfjord J. Ed., Davis Healthcare International Publishing/PDA: Bethesda, MD, 2009; pp 305–372.
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    USP 〈1207〉 Sterile Product Packaging—Integrity Evaluation.
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    USP 〈381〉 Elastomeric Closures for Injections.
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    Ph. Eur. 3.2.9. Rubber Closures for Aqueous Parenteral Preparations, for Powders and for Freeze-Dried Powders.
  10. 10.↵
    PDA Technical Report No. 27. Pharmaceutical Package Integrity. PDA: Bethesda, MD, 1998.
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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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Container/Closure Integrity Testing and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at −80 °C
Brigitte Zuleger, Uwe Werner, Alexander Kort, Rene Glowienka, Engelbert Wehnes, Derek Duncan
PDA Journal of Pharmaceutical Science and Technology Sep 2012, 66 (5) 453-465; DOI: 10.5731/pdajpst.2012.00884

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Container/Closure Integrity Testing and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at −80 °C
Brigitte Zuleger, Uwe Werner, Alexander Kort, Rene Glowienka, Engelbert Wehnes, Derek Duncan
PDA Journal of Pharmaceutical Science and Technology Sep 2012, 66 (5) 453-465; DOI: 10.5731/pdajpst.2012.00884
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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
  • Assessment of Functional and Physical Performances of Pre-filled Syringes in Deep Cold Storage Conditions
  • Container Closure Integrity of Vial Primary Packaging Systems under Frozen Storage Conditions: A Case Study
  • Container Closure Integrity Test Method Development on Vials Stored at -80{degrees}C Using Headspace Carbon Dioxide Analysis
  • Container Closure Integrity Test Using Frequency Modulation Spectroscopy Headspace Analysis with Carbon Dioxide as a Tracer Gas
  • 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
  • Sealing Behaviour of Container Closure Systems under Frozen Storage Conditions: Nonlinear Finite Element Simulation of Serum Rubber Stoppers
  • Holistic Considerations in Optimizing a Sterile Product Package to Ensure Container Closure Integrity
  • The Application of Noninvasive Headspace Analysis to Media Fill Inspection
  • Evaluation of Container Closure System Integrity for Frozen Storage Drug Products
  • 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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More in this TOC Section

  • Mechanical Container Closure Integrity Test: A Method for Cartridge Systems
  • A Container Closure Integrity Test Method for Vials Stored at Cryogenic Conditions Using Headspace Oxygen Analysis
  • Best Practices for Microbial Challenge In-Use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations
Show more Technology/Application

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Keywords

  • Storage at −80 °C
  • Live viral vaccines
  • Container closure integrity
  • headspace analysis
  • Frequency modulation spectroscopy
  • Glass transition temperature

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