Installation Qualification for Chromatography SystemsValidation and Qualification
Installation Qualification for Chromatography Systems
Chromeleon provides a datasource with a master template in the IQ/Templates directory on the Chromeleon software CD. This template is designed for Installation Qualification in a standard chromatography configuration (HPLC or GC). The template contains three sequences. Depending on the timebase configuration, the following sequences will be copied if you select the Instrument _IQ command on the Qualification menu in the Browser:
IQ_INJECT_DET: The timebase includes a device with the Inject command.
IQ_Pump: The timebase includes a device with the Pump.Flow property.
IQ_UV_DET: The timebase includes a device with the UV_VIS_1 channel.
The IQ_Pump sequence tests the pump: Three samples are processed, using different flow rates. The procedure evaluates the dependence of the retention time on the set flow rates.
The IQ_Inject_Module_And Detector sequence tests the reproducibility of the detector signal. The ratio between the peak area and the injection volume is evaluated. For autosamplers with variable injection volume, it is also tested whether the different volumes are correctly set on the autosampler. Signal acquisition with any detector you choose is indirectly tested with this sequence as well.
The IQ_UV_Detector sequence sets two wavelengths for two different samples (one wavelength per sample) and evaluates the signal height ratio of the Uracil peak. This sequence is available in case a channel called UV_VIS_1 exists. The sequence is not available by default because it has a function only if you can vary the wavelength on the detector (also manually, if necessary).
In addition, the master template includes an IQ report template with the following pages:
Results: Specify your system on the Results page (instruments, fluidics, and limits). If the values are within the defined limits, the Result column (= last column) reads Test passed. If the values are outside the defined limits, the Result column reads Test failed.
Audit Trail: The Audit Trail page displays the Audit Trail of the analyzed sample.
The created sequences can then be entered manually in the batch list by the user and processed.
Tips:
In the Report, the test result for instruments that have not been tested is n.a.
For more information about Installation Qualification, refer to the Operating Instructions for Instruments Installation Qualification for Chromeleon that are available from Dionex Service.
A qualified Dionex Service Representative must do all Installation Qualification checks for IC systems. For more information, please contact Dionex Service.