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Research ArticleTECHNOLOGY/APPLICATION

Vacuum Decay Container/Closure Integrity Testing Technology. Part 1. ASTM F2338-09 Precision and Bias Studies

Heinz Wolf, Tony Stauffer, Shu-Chen Y. Chen, Yoojin Lee, Ronald Forster, Miron Ludzinski, Madhav Kamat, Phillip Godorov and Dana Morton Guazzo
PDA Journal of Pharmaceutical Science and Technology September 2009, 63 (5) 472-488;
Heinz Wolf
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Tony Stauffer
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Shu-Chen Y. Chen
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Yoojin Lee
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Ronald Forster
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Miron Ludzinski
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Madhav Kamat
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Phillip Godorov
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Dana Morton Guazzo
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  • For correspondence: dguazzo@rxpax.com
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References

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    〈1207〉 Sterile Product Packaging—Integrity Evaluation; United States Pharmacopeia 31; United States Pharmacopeial Convention, Inc.: Rockville, MD, 2007.
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    U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Veterinary Medicine. Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products, Guidance for Industry, 2008.
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    Pharmaceutical container/closure integrity. IV: Development of an indirect correlation between vacuum decay leak measurement and microbial ingress. PDA J. Pharm. Sci. Technol. 1999, 53 (4),211–216.
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    Pharmaceutical container/closure integrity. V. An evaluation of the WILCO 'LFC' method for leak testing pharmaceutical glass stoppered vials. PDA J. Pharm. Sci. Technol. 1999, 53 (3),235–239.
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    1. McMaster R. C.
    Nondestructive Testing Handbook, 2nd edition; American Society of Nondestructive Testing: Columbus, OH, 1982; Vol. 1, pp214–215.
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    1. Schramm G.
    New Leak Detection Method for the Pharmaceutical Industry. PDA annual meeting, 1998.
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    ASTM F2338-09 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method; ASTM International: West Conshohocken, PA, 2009.
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    United States Federal Register Notice, FR Notice (list #014), Docket No. 2004N-0226, 3 31, 2006, Volume 71, No. 62.
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PDA Journal of Pharmaceutical Science and Technology: 63 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 63, Issue 5
September/October 2009
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Vacuum Decay Container/Closure Integrity Testing Technology. Part 1. ASTM F2338-09 Precision and Bias Studies
Heinz Wolf, Tony Stauffer, Shu-Chen Y. Chen, Yoojin Lee, Ronald Forster, Miron Ludzinski, Madhav Kamat, Phillip Godorov, Dana Morton Guazzo
PDA Journal of Pharmaceutical Science and Technology Sep 2009, 63 (5) 472-488;

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Vacuum Decay Container/Closure Integrity Testing Technology. Part 1. ASTM F2338-09 Precision and Bias Studies
Heinz Wolf, Tony Stauffer, Shu-Chen Y. Chen, Yoojin Lee, Ronald Forster, Miron Ludzinski, Madhav Kamat, Phillip Godorov, Dana Morton Guazzo
PDA Journal of Pharmaceutical Science and Technology Sep 2009, 63 (5) 472-488;
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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
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