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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleTechnology/Application

Charting and Evaluation of Environmental Microbial Monitoring Data

Raphael Bar
PDA Journal of Pharmaceutical Science and Technology November 2015, 69 (6) 743-761; DOI: https://doi.org/10.5731/pdajpst.2015.01079
Raphael Bar
BR Consulting, Rehovot, Israel 76247; email:
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  • For correspondence: rbar@netvision.net.il
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References

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    USP General Chapter <1116> Microbiological Control and Monitoring of Aseptic Processing Environments, USP 38/NF 33.
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    PDA Technical Report No. 13 (Revised): Fundamentals of an Environmental Monitoring Program. Parenteral Drug Association, 2014.
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    Understanding Statistical Process Control, 4th ed.; SPC Press: Knoxville, TN, 2010.
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    1. Wheeler D. J.
    Individual charts done right and wrong: how does your software rate? Quality Digest [Online] 2010 http://www.qualitydigest.com/inside/quality-insider-column/individual-charts-done-right-and-wrong.html (accessed December 31, 2014).
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    1. Wheeler D. J.
    Are you sure we don't need normally distributed data? Quality Digest [Online] 2010 http://www.qualitydigest.com/inside/twitter-ed/are-you-sure-we-don-t-need-normally-distributed-data.html (accessed December 31, 2014).
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    1. Wheeler D. J.
    Myths about process behavior charts: how to avoid some common obstacles to good practice. Quality Digest [Online] 2011 http://www.qualitydigest.com/inside/quality-insider-article/myths-about-process-behavior-charts.html (accessed December 31, 2014).
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    1. Wheeler D. J.
    What makes the XmR chart work? Quality Digest [Online] 2012 http://www.qualitydigest.com/inside/quality-insider-article/what-makes-xmr-chart-work.html (accessed December 31, 2014).
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    1. Wheeler D. J.
    Statistics and SPC: two things sharing a common name can still be different. Quality Digest [Online] 2014 http://www.qualitydigest.com/inside/quality-insider-column/statistics-and-spc.html (accessed December 31, 2014).
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    1. Wheeler D. J.
    What is chunky data?: What happens when the measurement increment gets too large? Quality Digest [Online] 2011 http://www.qualitydigest.com/inside/quality-insider-article/what-chunky-data.html (accessed December 31, 2014).
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    Working with rare events: what happens when the average count gets very small? Quality Digest [Online] 2011 http://www.qualitydigest.com/inside/quality-insider-article/working-rare-events.html (accessed December 31, 2014).
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    Improved control charts for attributes. Quality Engineering 2002, 14(4), 531–537.
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In This Issue

PDA Journal of Pharmaceutical Science and Technology: 69 (6)
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 6
November/December 2015
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Charting and Evaluation of Environmental Microbial Monitoring Data
Raphael Bar
PDA Journal of Pharmaceutical Science and Technology Nov 2015, 69 (6) 743-761; DOI: 10.5731/pdajpst.2015.01079

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Charting and Evaluation of Environmental Microbial Monitoring Data
Raphael Bar
PDA Journal of Pharmaceutical Science and Technology Nov 2015, 69 (6) 743-761; DOI: 10.5731/pdajpst.2015.01079
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  • Article
    • Abstract
    • Introduction
    • Common Bioburden Levels of EM Samples
    • XmR Charts of Microbial Counts
    • Rationale for Using XmR Process Behavior Charts
    • Examples of XmR Control Charts of EM Microbial Counts
    • Evaluation of Contamination Rates of EM Samples for Cases of Rare Contaminations
    • Examples of Charting of EM Contamination Rates
    • Conclusions
    • References
  • Figures & Data
  • References
  • Info & Metrics
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Keywords

  • Statistical process control (SPC)
  • Control charts of individual values
  • Control limits
  • Poisson distribution
  • Normal distribution
  • Controlled rooms
  • Contamination recovery rates
  • Instantaneous contamination rates
  • USP <1116>

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