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:

References
- 1.↵EudraLex, The Rules Governing Medicinal Products in the European Union. Vol. 4: EU Guidelines to Good Manufacturing Practice: Medicinal Products for Human and Veterinary Use; Annex 1: Manufacture of Sterile Medicinal Products, 2008.
- 2.↵WHO Technical Report Series 961. Annex 6: WHO Good Manufacturing Practices for Sterile Pharmaceutical Products, World Health Organization, 2011.
- 3.↵Guidance for Industry for Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice, U.S. Food and Drug Administration, 2004.
- 4.↵USP General Chapter <1116> Microbiological Control and Monitoring of Aseptic Processing Environments, USP 38/NF 33.
- 5.↵USP General Chapter <1223 > Validation of Alternative Microbiological Methods, USP 38/NF 33.
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- 7.↵PDA Technical Report No. 13 (Revised): Fundamentals of an Environmental Monitoring Program. Parenteral Drug Association, 2014.
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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 69, Issue 6
November/December 2015
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
Jump to section
- 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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