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;
Uwe Werner
1Bavarian Nordic GmbH, Robert Roessle Strasse 10, D-13125 Berlin, Germany;
Alexander Kort
2IDT Biologika GmbH, Am Pharmapark, D-06861 Dessau-Rosslau, Germany; and
Rene Glowienka
2IDT Biologika GmbH, Am Pharmapark, D-06861 Dessau-Rosslau, Germany; and
Engelbert Wehnes
1Bavarian Nordic GmbH, Robert Roessle Strasse 10, D-13125 Berlin, Germany;
Derek Duncan
3Lighthouse Instruments, Science Park 406, NL-1098 XH Amsterdam, The Netherlands

References
- 1.↵
- Asselta R.,
- Smith E.,
- Sunderland W.,
- Trappler E
- 2.↵
- Templeton A. C.,
- Han Y.-H. R.,
- Mahajan R.,
- Chern R. T.,
- Reed R. A
- 3.↵
- Lin T. P.,
- Hsu C. C.,
- Kabakoff D. B.,
- Patapoff T. W.
- 4.↵
- Mahajan R.,
- Templeton A. C.,
- Reed R. A.,
- Chern R. T.
- 5.↵
- Cook I.,
- Ward K.
- 6.↵
- Lysfjord J.
- Veale James R
- 7.↵
USP 〈1207〉 Sterile Product Packaging—Integrity Evaluation.
- 8.↵
USP 〈381〉 Elastomeric Closures for Injections.
- 9.↵
Ph. Eur. 3.2.9. Rubber Closures for Aqueous Parenteral Preparations, for Powders and for Freeze-Dried Powders.
- 10.↵
PDA Technical Report No. 27. Pharmaceutical Package Integrity. PDA: Bethesda, MD, 1998.
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 66, Issue 5
September/October 2012
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
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
Jump to section
Related Articles
- No related articles found.
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