Validation, AutoQ, and System Wellness
Operational and Performance Qualification for HPLC Systems

Chromeleon provides a datasource with a master template in the Template directory on the Chromeleon software CD. This template is designed for Performance (Operational) Qualification in a standard HPLC configuration. In addition to various sequences, the template contains a Report Definition File (RDF) for OQ and PQ, providing the following pages:

SPECIFICATION: On the SPECIFICATION page, enter the system specifications (instruments, fluidics, and limits).

COLUMN OVEN: The COLUMN OVEN page indicates whether the column oven temperature corresponds to the selected temperature (within the specified limits).

INJ_REPRO_AND_RET_REPRO and ASI_100_REPRO_AND_RET_REPRO, respectively: On the INJ_REPRO_AND_RET_REPRO page, serves for checking the reproducibility of the injector and the retention time. If the result is within the specified limits, the Result column indicates OK.

INJ_CARRY_OVER: The INJ_CARRY_OVER page supplies a measure for the carry over in your system. If the result is within the specified limits, the Result column indicates OK.

INJ_LINEARITY: The INJ_LINEARITY page supplies a measure for the linearity of injection volume and peak area.

PUMP_GRADIENT: On the PUMP_GRADIENT page serves for checking the gradient precision. The limits of the Specification page are included. If the values are within the specified limits, the last column (Result) indicates OK. The Result of all tests column indicates Test passed.

PUMP_GRADIENT_REPRO: The PUMP_GRADIENT_REPRO page serves for checking the gradient reproducibility (with 3 repetitions in this example). The limits of the Specification page are included. If the values are within the specified limits, the last column (Result) indicates OK. The Result of all tests column indicates Test passed.

RI_NOISE_AND_DRIFT and RI_LINEARITY: These pages serve for evaluating the noise, drift, and linearity of the Shodex Refractive Index Detector.

DET_NOISE_AND_DRIFT: The DET_NOISE_AND_DRIFT page serves for checking whether noise and drift in your system correspond to the limits on the SPECIFICATION page. If the values are within the specified limits, the Result column indicates OK.

DET_WAVELENGTH: The DET_WAVELENGTH page supplies a measure for the wavelength precision of the corresponding detector.

DET_LINEARITY: The DET_LINEARITY page serves for checking the detector linearity. From five different injections at different concentrations, the correlation coefficient (supplied in %) between the peak height and the concentration is determined. If the value is above the specified limit, Test passed is returned as the result.

RF_DET_NOISE and RF_DET_WAVE: These pages evaluate the noise and the wavelength precision of the fluorescence detector.

Audit Trail: The Audit Trail page displays the Audit Trail for the analyzed sample.

 Caution:

Do not edit the report pages (except the Specification page), even if editing is possible. Chromeleon automatically reads the corresponding values and often references individual data sheets in the report. If you insert or delete lines and columns, these references will be lost. Thus, the calculations will be wrong.

The report must be printed as Batch Report from the browser. This ensures that Chromeleon reads and processes the data correctly in the report. Select the sequence for which you want to print the report. Make sure that no sample is selected. Select Batch Report on the File menu and click OK to start printing.

 Tip:

Enter the actual concentrations of the used standards in the Amount columns of the QNT File for evaluating the detector linearity.

For more information about Operational and Performance Qualification, refer to the Operational Qualification/Performance Qualification Operating Manual that is available from Dionex Service.