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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleTechnology/Application

Statistical Method for Trending of Excursions in Clean Room Microbiological Monitoring Data

K. Rao Gurijala and Andrew Barnett
PDA Journal of Pharmaceutical Science and Technology September 2021, 75 (5) 407-424; DOI: https://doi.org/10.5731/pdajpst.2020.011791
K. Rao Gurijala
NSF Health Sciences, Washington, DC
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  • For correspondence: rao.gurijala@asepsisinternational.com
Andrew Barnett
NSF Health Sciences, Washington, DC
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  • Article
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References

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    European Medicines Agency, EU GMP Guide Annex 1: Manufacture of Sterile Medicinal Products. EMA: London, 2009.
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    U.S. Food and Drug Administration, Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice. Centers for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 2004.
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    1. Gordon O.,
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    3. Pazdan J.,
    4. Staerk A.,
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    Comparison of Different Calculation Approaches for Defining Microbiological Control Levels Based on Historical Data. PDA J. Pharm. Sci. Technol. 2015, 69 (3), 383–398.
    OpenUrlAbstract/FREE Full Text
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    1. Levinson W. A.
    Statistical Process Control for Real-World Applications; CRC Press-Taylor and Francis, Boca Raton, FL, 2010.
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    Parenteral Drug Association Inc. Technical Report 13 (Revised): Fundamentals of an Environmental Monitoring Program; PDA: Bethesda, MD, 2014.
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    1. Wilson J. D.
    Setting Alert/Action Limits for Environmental Monitoring Programs. PDA J. Pharm. Sci. Technol. 1997, 51 (4), 161–162.
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    World Health Organization. Environmental Monitoring of Clean Rooms in Vaccine Manufacturing Facilities, 2012,. WHO Web site. www.who.int/immunization_standards/vaccine_quality/env_monitoring_cleanrooms_final.pdf. (accessed August 10, 2021).
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    1. Bethea R. M.,
    2. Duran B. S.,
    3. Boullion T. L.
    Statistical Methods for Engineers and Scientists, Marcel Decker, Inc, 1985.
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    U.S. Pharmacopeial Convention, General Chapter <1116> Microbiological Control and Monitoring of Aseptic Processing Environments. In USP 43—NF 38, USP: Rockville, MD, 2020.
  10. 10.↵
    1. Caputo R. A.,
    2. Huffman A.
    Environmental Monitoring: Data Trending Using a Frequency Model. PDA J. Pharm. Sci. Technol. 2004, 58 (5), 254–260.
    OpenUrlAbstract/FREE Full Text
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    1. Yang H.,
    2. Zhao W.,
    3. O'day T.,
    4. Fleming W.
    Environmental Monitoring: Setting Alert and Action Limits Based on Zero-Inflated Model. PDA J. Pharm. Sci. Technol. 2013, 67 (1), 2–8.
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    American National Standards Institute; American Society for Quality. ANSI/ASQ Z1.4–2003: Sampling Procedures and Tables for Inspection by Attributes; ASQ: Milwaukee, WI, 2003.
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    1. Montgomery D. C.
    Introduction to Statistical Quality Control, 3rd ed.; John Wiley & Sons, Inc: New York, 1997.
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    Construction of Operating Characteristics Curve for Acceptance Sampling Plan by Using MATLAB Software. Int J. Eng. Sci. 2012, 1 (1), 44–48.
    OpenUrl
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 75 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 5
September/October 2021
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Statistical Method for Trending of Excursions in Clean Room Microbiological Monitoring Data
K. Rao Gurijala, Andrew Barnett
PDA Journal of Pharmaceutical Science and Technology Sep 2021, 75 (5) 407-424; DOI: 10.5731/pdajpst.2020.011791

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Statistical Method for Trending of Excursions in Clean Room Microbiological Monitoring Data
K. Rao Gurijala, Andrew Barnett
PDA Journal of Pharmaceutical Science and Technology Sep 2021, 75 (5) 407-424; DOI: 10.5731/pdajpst.2020.011791
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  • Article
    • Abstract
    • Introduction
    • Determination of Action and Alert Levels Based on Historical Data
    • Rationale for Using Percentile Method to Determine Action and Alert Levels
    • Definition of Adverse Trends
    • Determination of Adverse Trends in Quarterly and Annual Trend Analyses
    • Determination of Adverse Trends at the Onset of an Excursion Result
    • Type I and Type II Errors
    • Trend Rules Based on Binomial Probability
    • Ongoing Processes
    • Mature Processes
    • Intermediate Processes
    • New Processes
    • Handling of Adverse Trends
    • Case Study
    • Recommendations for Implementation
    • Sample Trend Charts
    • Discussion
    • Conclusion
    • Conflict of Interest Declaration
    • References
  • Figures & Data
  • Info & Metrics
  • References
  • PDF

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More in this TOC Section

  • An Improved Impact Ratio for Identifying Critical Process Parameters in Pharmaceutical Manufacturing Processes
  • Is Retention Time and/or Structure Matching a Solution to the Challenge of Providing Quantitative Data When Screening for Extractables and Leachables by GC/MS?
  • Interventions Risk Evaluation and Management in Aseptic Manufacturing - A Case Study
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Keywords

  • Adverse trends
  • Alert levels
  • Action levels
  • Alert level excursion rates
  • Microbial recovery rates
  • Operational characteristics curves
  • Environmental monitoring
  • Bioburden tests
  • Nonparametric methods
  • Average run length
  • false positives
  • false negatives

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