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GE Analytical Instruments ©2010
127 of 226
DLM 74001-04 Rev. A
Chapter 6: Calibration and System Protocols
Performing Pharmacopeia Tests
The Sievers 500 RL TOC Analyzer is designed to comply with various Pharmacopeia testing. Additional Method
Specificity and Method Robustness protocols, compliant with ICH Q2(R1), are also available as optional protocols
from GE Analytical Instruments. Contact GE Analytical Instruments 800.255.6964 or 303.444.2009 (North
America or Canada), 44(0) 161866 9337 (UK), or www.GEInstruments.com (to find a local sales partner for other
parts of the world).
The Analyzer firmware performs all functions necessary to meet the following international Pharmacopeia
specifications: China Pharmacopeia, European Pharmacopeia, Indian Pharmacopeia, Japanese Pharmacopeia,
and the United States Pharmacopeia. The response efficiency and response limit are automatically calculated.
For more detailed information regarding compliance with these Pharmacopeias, please refer to “Specifying the
Pharmacopeia” on page 91.
System Suitability Verification
To perform the system suitability verification, follow this procedure:
1. If the Analyzer is taking measurements, press the
Stop Analysis
button.
2. Press the
Menu
button, select the
Maintenance
tab, press the
Cal/Ver/Validate
button, and press the
Suitability
button.
1. If the Analyzer is taking measurements, press the
Stop Analysis
button.
2. If you have a Super
iOS
System, the
Select Rinse
screen appears. Otherwise, go to step 9.
3. Select one of the following rinse options, and then press the
Next
button.
• No Rinse
• Before
• After
• Before and After
4. If you have selected
No Rinse
or
After
, and there are vials in the Super
iOS
, remove them now. Press
Next
to continue. Wait for the Analyzer to drain each of the Super
iOS
vial chambers (about 2 minutes).
5. If you have selected to run a rinse, the Analyzer will prompt you to do one of the following:
• Insert the Super
iOS
Rinse vial set into the Super
iOS
.
• Or, if using individual rinse vials, press
Next
for additional instructions. Insert the individual vials in
the Super
iOS
, and then press
No Set
to proceed.
Содержание Sievers 500 RL
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Страница 177: ...Appendix A GE Analytical Instruments 2010 177 of 186 DLM 74001 04 Rev A Figure 51 Left Side Analyzer Dimensions ...
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Страница 185: ...Notes GE Analytical Instruments 2010 185 of 186 DLM 74001 04 Rev A 186 ...
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