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Research ArticleResearch

Validating Container Closure Integrity with Statistically Based Tests

Daniel Coleman, Tony Pourmohamad, Yenny Webb Vargas and Maury Mossman
PDA Journal of Pharmaceutical Science and Technology November 2021, 75 (6) 465-473; DOI: https://doi.org/10.5731/pdajpst.2020.012622
Daniel Coleman
1Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA 94080, USA; and
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Tony Pourmohamad
1Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA 94080, USA; and
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  • For correspondence: pourmoht@gene.com
Yenny Webb Vargas
1Nonclinical Biostatistics, Genentech, Inc., South San Francisco, CA 94080, USA; and
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Maury Mossman
2Pharmaceutical Development, Genentech, Inc., South San Francisco, CA 94080, USA
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References

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    1. Kirsch L. E.,
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    3. Moeckly C. S.,
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    Pharmaceutical Container/Container Closure Integrity II: The Relationship between Microbial Ingress and Helium Leak Rates in Rubber-Stoppered Glass Vials. PDA J. Pharm. Sci. Technol. 1997, 51, 195–202.
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    Leak Testing in Parenteral Packaging: Establishment of Direct Correlation between Helium Leak Rate Measurements and Microbial Ingress for Two Different Leak Types. PDA J. Pharm. Sci. Technol. 2007, 61 (4), 226–236.
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    1. Jovanovic B.,
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    A Look at the Rule of Three. The American Statistician 1997, 51 (2), 137–139.
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    1. Harrell F. E. Jr..
    Regression Modeling Strategies. Springer Series in Statistics, Springer International Publishing: Cham, Switzerland, 2015.
  5. 5.↵
    1. Pettitt A.
    Cramér-Von Mises Statistics for Testing Normality with Censored Samples. Biometrika 1976, 63 (3), 475–481.
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  6. 6.↵
    1. Hashimoto T.
    Cramér-Von Mises-Watson Type Statistics for Testing Normality with Censored Data. Hokkaido Math. J. 1996, 25 (1), 183–214.
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    1. Waller L. A.,
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    Probability Plotting with Censored Data. The American Statistician 1992, 46 (1), 5–12.
    OpenUrl
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PDA Journal of Pharmaceutical Science and Technology: 75 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 6
November/December 2021
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Validating Container Closure Integrity with Statistically Based Tests
Daniel Coleman, Tony Pourmohamad, Yenny Webb Vargas, Maury Mossman
PDA Journal of Pharmaceutical Science and Technology Nov 2021, 75 (6) 465-473; DOI: 10.5731/pdajpst.2020.012622

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Validating Container Closure Integrity with Statistically Based Tests
Daniel Coleman, Tony Pourmohamad, Yenny Webb Vargas, Maury Mossman
PDA Journal of Pharmaceutical Science and Technology Nov 2021, 75 (6) 465-473; DOI: 10.5731/pdajpst.2020.012622
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Keywords

  • Rule of 3
  • one-sided confidence interval
  • lower limit of validation (LLOV)
  • left-censored data
  • significance level
  • type 1 error
  • zero-failure test
  • one-failure test

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