Microbiologic monitoring setting limits

Appropriate alert and action limits should be set for the results of particulate and microbiological monitoring. If these limits are exceeded operating procedures should prescribe corrective action. 

The monograph Water, purified of the Ph. Eur. set limits for total organic carbon (TOC) or oxidisable substances, endotoxins (if intended for dialysis solutions), conductivity and the following ions nitrates, aluminium (if intended for dialysis solutions) and heavy metals. In addition it is necessary to perform microbiological monitoring during production and storage. For purified water in containers, the Ph.Eur. 

Where a water cooling cycle is incorporated in the autoclave design, the water should be treated to minimise microbiological contamination and should be monitored for microbiological residual, with action limits set... 

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