Calibrating the QbD1200+ TOC Analyzer
The calibration of a TOC Analyzer is a crucial part of ensuring a quality measurement. A commonly used definition of calibration is:
The demonstration that a particular instrument or device produces results within specified limits by comparison with those produced by a traceable standard over an appropriate range of measurements.
-US FDA Guidance for Industry, Q7A. Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
Calibration is typically conducted by taking multiple measurements at different concentrations of a known primary standard. International Conference on Harmonization (ICH) recommends using a minimum of 5 concentrations to demonstrate linearity across the instrument’s calibrated range. The measurement signal can be plotted against concentration to produce a calibration curve. The figure below shows an example of a calibration curve generated on the QbD1200+ analyzer.
The QbD1200+ analyzer calibration is designed to be convenient and easy to perform.
Notes:
- Only a single 125 mL bottle of 5ppm KHP primary calibration standard is required during calibration.
- 6-point calibration (5, 4, 3, 2, and 1 ppm and blank).
- The analyzer automatically dilutes this down (using One Reagent) to concentrations of 4ppm, 3ppm, 2ppm, and 1ppm TOC.
- One Reagent without any added KHP standard is measured for the blank values.
- In regular measurement mode (not calibration), the QbD1200+ automatically checks unknown samples during an auto-range step. All samples >4ppm TOC are automatically diluted down with the One Reagent.
- Calibration performed up to 5 ppm will cover the full measurement range (0.4 ppb-100ppm) because any samples that are > 5ppm are diluted down to <5ppm
- Calibration Pass criteria:
- If the R2 of the calibration curve is ≥ 0.99, then the calibration passes and can be accepted.
- Record keeping
- Every calibration performed on the QbD1200+ is stored in the encrypted database.
- It is easy to create a report of all calibration records.
- Calibration time
- Total calibration time for the QbD1200+ is approximately 90 minutes.
After a calibration, the results are clearly displayed in two formats: 1) table view; 2) graph view
Table View
Graph View
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