GE Sievers 500 RL, Operation And Maintenance Manual, Page: 92 / 186

GE Analytical Instruments ©2010 92 of 226 DLM 74001-04 Rev. A
Chapter 4: Basic Analyzer Operation
– r
w
) or not more than 0.5 mg/L. The Stage 1 conductivity test is passed if the non-temperature
corrected conductivity is not greater than the table value for WFI at the next lowest temperature
value in the table that is not greater than the measured water temperature.
• JP TOC : The analyzer meets the test requirements of the Japanese Pharmacopeia (JP) monographs;
JP<2.59> Total Organic Carbon for Water for Injection and Purified Water. The test passes if the
measured Water for Injection or Purified Water sample TOC value is not greater than 0.50 mg/L.
• EP PW : The analyzer meets the testing requirements of the following European Pharmacopeia (EP)
monograph for Purified Water (PW); EP<2.2.44 Total Organic Carbon in Water for Pharmaceutical
Use and the Conductivity Requirements of the EP monographs “
Water, Purified ”. The TOC test
passes if the measured TOC of the pharmaceutical water sample is not less than the lower of the
Limit Response or 500 ppbC (per the requirements of the EP PW monograph). The conductivity test
passes if the measured conductivity (not the temperature compensated conductivity) is not greater
that the value in the “Temperature and Conductivity requirements table” (in the EP PW monograph)
at the measured temperature of the water. For temperatures not listed in the table, he maximal
permitted conductivity is calculated by interpolation between the next lower and next higher
temperature data points in the table.
• CP PW : The analyzer meets the testing requirements for the following Chinese Pharmacopeia (CP)
monographs; CP TOC Measurement in Pharmaceutical Water - Appendix VIII R for Water for Injection
and CP Conductivity - Appendix VIII S for Water for Injection. The TOC test passes if the sample of
WFI has a measured TOC value not greater than (r
s
– r
w
) or 0.50 g/L. The conductivity test passes if
the measured conductivity (not the temperature compensated conductivity) is not greater that the
value in the “Temperature and Conductivity requirements table” in the CP Conductivity- Appendix
VIII S (for purified water) monograph at the measured temperature of the water. For temperatures
not listed in the table, he maximal permitted conductivity is calculated by linear interpolation
between the next lower and next higher temperature data points in the table.
• IP PW : The analyzer meets the testing requirements of the India Pharmacopeia (IP) monographs for
Water for Injection: IP<2.4.30> Total Organic Carbon in Water and IP 2.4.9 and Conductivity IP<2.4.9>
for Purified Water. The TOC test is passed if the measured TOC of the sample (r
t
) is not greater than
(r
s
– r
w
) or not more than 0.5 mg/L. The conductivity test passes Step 1, if the measured non-
temperature compensated conductivity is not greater than the conductivity value in the table for
Purified Water at the next lower temperature value in the table, that is not greater than the
measured temperature.
• JP COND : The analyzer meets the testing requirements of the Japanese Pharmacopeia (JP)
Conductivity <2.51>. The test passes if the temperature corrected conductivity is not more than 2.1
uS/cm.
Pass/Fail Reporting
The TOC analyzer will report a Pharmacopeia “Pass” result, if all of the selected pharmacopeial tests pass. The
TOC analyzer will report a Pharmacopeia “Failure” result, if any of the selected tests fail. Conductivity and TOC
tests can be independently tested with the alarms, an alarm can be set for each of TOC Limit, Cond Limit, or