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See an overview of the simple steps involved with calibrating the QbD1200 laboratory TOC analyzer
Welcome to the second QbD1200 virtual demo where we'll look at the qualification routines.
First, let's take a look at what's involved in calibrating the QbD.
From the Home screen, go to "Qualifications” and “Calibration."
Now you have the option to record the lot IDs and expiration dates for any standards or reagents you're using. This is a really nice feature for audit trails.
When the calibration starts, you can look at the indicator bar telling you what's occurring in the measurement process. We're going to fast-forward here once it gets through the very first few steps.
The calibration procedure looks at 18 data points, six concentrations, with three measurements at each concentration.
A complete calibration takes only 90 minutes.
When complete, the calibration statistics are reported on the screen — the calibration linearity expressed as R2, the calibration slope, and so forth.
You can toggle over to the graph view and compare the calibration you just ran to the last calibration. In the example shown, the curves are right on top of each other suggesting there has been very little drift since the last calibration. You can then have the option to accept the calibration and create a report.
The report wizard guides you through the process to set up the report, choose you’re the format you want to export the report in and whether you want to output the report as an electronic record, or whether you want to send the report to the printer to get a paper copy. You can now view the report on the screen before you export, or print it.
This concludes the virtual demo covering calibration.
Hear Tony Harrison discuss validating a pharmaceutical grade TOC laboratory analyzer to the International Committee on Harmonization procedure ICH Q2. ICH Q2 contains guidance on how to ensure that a TOC analyzer is fit for purpose and for providing batch release data.
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