USP39-1231制药用水-药典.pdfVIP

Accessed from 10.6.1.1 by flavin2 on Tue Apr 26 23:50:46 EDT 2016 1690 á1230ñ Water for Hemodialysis Applications / General Information USP 39 and Tests for Specified Microorganisms á62ñ. Quantification of bacterial endotoxins is performed using procedures found in the USP general test chapter Bacterial Endotoxins Test á85ñ. Because of the incubation time required to obtain definitive microbiological results, water systems should be microbiologi- cally monitored to confirm that they continue to produce water of acceptable quality. “Alert” and “Action Levels” are there- fore necessary for the monitoring and control of the system. An Alert Level constitutes a warning and does not require a cor- rective action. An Action Level indicates a drift from normal operating conditions and requires that corrective action be taken to bring the process back into the normal operating range. Exceeding an Alert or Action Level does not imply that water quali- ty has been compromised. The maximum recommended Action Level for a total viable microbial count in the product water should be no greater than 25 cfu/mL, and the maximum recommended Action Level for bacterial endotoxins should be no greater than 0.25 USP Endotoxin Unit/mL. As with all process control values, Action and Alert Levels should be established from normal system monitoring trends and process capabilities in a fashion that allows remedial actions to occur in response to process control level excursions well before specifications are exceeded (also see Microbial Considerations under Water for Pharmaceutical Purposes á1231ñ). á1231ñ WATER FOR PHARMACEUTICAL PURPOSES s INTRODUCTION r e t p Water is widely used as a raw material, ingredient,