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Drawing showing all equipment in the system from the water feed to points of use and all sampling points and their designations Microbial limits Sterile water is a requirement Less than 10 CFU/100ml is an acceptable action limit as per FDA All limits are action limits 100 - 300 mL is preferred sample size when sampling Water for Injection systems Monitoring of WFI systems for or both endotoxins and microorganisms is important because it can pass the LAL endotoxin test while failing in the above microbial limits Stills Heat exchangers To ensure that the higher pressure is on the clean fluid side, provide gauges for constantly monitor pressure differentials Utilize the double-tubesheet type of heat exchanger Perform periodic visual inspections to detect early signs of leaks in your tubesheet or gaskets Visual inspections also can help you detect early signs of fouling

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