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pH
TOC
Conductivity
Bacteria
FDA Action Limit
Endotoxin (EU/mL) |
5.0 - 7.0
500 ppb
1.3 uS/cm
100 (cfu/mL)
100 (cfu/mL)
- |
5.0 - 7.0
500 ppb
1.3 uS/cm
10 (cfu/100mL)
10 (cfu/100mL)
0.25 EU/mL |
*Please refer to USP XXVII, article 645, Water
Conductivity for specific stage 1, 2 and 3. |
TOC monitoring can be done on-line or in the lab with a TOC analyzer of better then 50 ppb detection. All analyzers must be periodically challenged with a system suitability solution of 500 ppb USP 1.4 benzoquinone RS. In both cases the analyzers efficiency must be no lower then 85% and not higher then 115%.
System verification is allowed within the USP specified 0.1 uS/cm, using a special NIST traceable resistor that plugs into an end-panel receptacle. Similarly, a pre-packaged, NIST traceable calibration standard confirms / calibrates the cell constant to within the specified 2%. Conductivity is reported as non-temperature compensated, and alarm outputs are based on the Stage 1 parameters established in the USP conductivity method.
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