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fbtwitterlinkedinvimeoflicker grey 14rssslideshare1
Whyte, W.; Eaton, T. (2004)
Publisher: Euromed Communications Ltd.
Languages: English
Types: Article
Subjects:
This paper describes the fundamental mechanisms of microbial contamination during manufacture\ud of pharmaceutical products. Models are derived that describe air and surface contact contamination.\ud These models can be used to develop and improve methods of microbial risk assessment. The use of\ud the FMEA (FMECA) method of risk assessment is discussed and, when used with the correct risk\ud factors, its use endorsed.
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    • 4. IEC 61025-1990, Fault Tree Analysis (FTA). Geneva, Switzerland, International Electrotechnical Commission, 1990.
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    • 17. Whyte W and Eaton T. Microbial risk assessment in pharmaceutical cleanrooms. European Journal of Parenteral and Pharmaceutical Sciences 2004; 9(1): 17-24.
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