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Research ArticleResearch

A Risk-based Approach to Setting Sterile Filtration Bioburden Limits

Harry Yang, Na Li and Stephen Chang
PDA Journal of Pharmaceutical Science and Technology November 2013, 67 (6) 601-609; DOI: https://doi.org/10.5731/pdajpst.2013.00942
Harry Yang
MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878
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  • For correspondence: YangH@MedImmune.com
Na Li
MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878
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Stephen Chang
MedImmune LLC, One MedImmune Way, Gaithersburg, MD 20878
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References

  1. 1.↵
    1. Schroeder H. G.
    Sterility assurance with filtration: taking bioburden, membrane integrity, and process conditions into account. BioProcess Int. 2006, June, 38–47.
  2. 2.↵
    1. Jornitz M. W.,
    2. Melzer T. H.
    1. Quigley G.
    Pre-Filtration in Pharmaceutical Processes. In Filtration and Purification in the Pharmaceutical Industry, Jornitz M. W., Melzer T. H., Eds.; New York: Informa Healthcare Inc., 2008.
  3. 3.↵
    U.S. FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice, 2004.
  4. 4.↵
    EMA CPMP Notes for Guidance on Manufacture of Finished Dosage Form, 1996.
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    EMA Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials, 2012.
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    1. Jornitz M. W.,
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    3. Agalloco J. P.,
    4. Madsen R. E.,
    5. Melzer T. H.
    Considerations in sterile filtration. Part II: The sterilizing filter and its organism challenge: a critique of regulatory standards. PDA J. Pharm. Sci. Technol. 2003, 57 (2), 88–96.
    OpenUrlFREE Full Text
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    1. Jornitz M. W.,
    2. Melzer T. H.
    1. Akers J.
    Microbiological Considerations in Selection and Validation of Filter Sterilization. In Filtration and Purification in the Pharmaceutical Industry, Jornitz M. W., Melzer T. H., Eds.; New York: Informa Healthcare Inc; 2008.
  8. 8.↵
    USP <61> Microbial Examination of Nonsterile Products: Microbial Enumeration Tests.
  9. 9.↵
    USP <62> Microbiological Examination of Non-Sterile Products: Tests for Specified Microorganisms
  10. 10.↵
    USP <1111> Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use.
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    FDA. Pharmaceutical Current Good Manufacturing Practices (cGMPs) for the Twenty-first Century: A Risk-based Approach: Final report, 2004.
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    ICH Q8(R2). Pharmaceutical Development, 2006.
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    1. Schilling E. G.
    Acceptance Sampling in Quality Control; Marcel Dekker, Inc.: New York, 1982.
  14. 14.↵
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    Handbook of the Poisson Distribution; New York: John Wiley & Sons, 1967.
  15. 15.↵
    1. Hilbe J. M.
    Negative Binomial Regression; Cambridge University Press: Cambridge, UK, 2007
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    http://www.johndcook.com/negativebinomial.pdf.
  17. 17.↵
    1. Clopper C. J.,
    2. Pearson E. S.
    The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika 1934, 26 (4), 404–413.
    OpenUrlFREE Full Text
  18. 18.↵
    1. Agresti A.
    Categorical Data Analysis; New York: John Wiley & Sons, 1990.
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 67 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 67, Issue 6
November/December 2013
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A Risk-based Approach to Setting Sterile Filtration Bioburden Limits
Harry Yang, Na Li, Stephen Chang
PDA Journal of Pharmaceutical Science and Technology Nov 2013, 67 (6) 601-609; DOI: 10.5731/pdajpst.2013.00942

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A Risk-based Approach to Setting Sterile Filtration Bioburden Limits
Harry Yang, Na Li, Stephen Chang
PDA Journal of Pharmaceutical Science and Technology Nov 2013, 67 (6) 601-609; DOI: 10.5731/pdajpst.2013.00942
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  • Article
    • Abstract
    • 1. Introduction
    • 2. Regulatory Guidelines
    • 3. Potential Limitations of the 10 CFU/100 mL Bioburden Limit
    • 4. A Risk-Based Approach
    • 5. Evaluation of Pre-Filtration Test Schemes
    • 6. Discussion
    • Acknowledgements
    • References
  • Figures & Data
  • References
  • Info & Metrics
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Keywords

  • Batch size
  • Negative binomial distribution
  • Poisson distribution
  • Pre-filtration bioburden
  • Risk-based approach
  • Sterilizing grade filter

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