Assessment of degree of risk from sources of microbial contamination in cleanrooms; 3: Overall application
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چکیده
The European Commission and the Food and Drug Administration in the USA suggest that risk management and assessment methods should be used to identify and control sources of microbial contamination1,2. A risk management method has been described by Whyte3,4 that is based on the Hazard Analysis and Critical Control Point (HACCP) system but reinterpreted for use in cleanrooms, and called Risk Management of Contamination (RMC). This method is also described in the PHSS Technical Monograph No 145 and has the following steps.
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Assessment of degree of risk from sources of microbial contamination in cleanrooms; 3: Overall application
The European Commission and the Food and Drug Administration in the USA suggest that risk management and assessment methods should be used to identify and control sources of microbial contamination1,2. A risk management method has been described by Whyte3,4 that is based on the Hazard Analysis and Critical Control Point (HACCP) system but reinterpreted for use in cleanrooms, and called Risk Man...
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