System Validation
System validation can be passed in two ways:
- Data System and ADC module can be verified using standard
signal source GTS-1. Validation of entire measuring channel
takes place. This style of validation does not relate
chromatographic system at all. The result of validation
is the absolute characteristics of measuring channel (either
voltage and current) and integration algorithm.
- Data System with ADC or using the ADC built in chromatograph
is connected to detection system. Validation procedure
consists of sampling known quantity of substance specific
to each type of detector. UniChrom system detects the
substance peaks, and then using validation package the
following characterisics are determined: detection limit,
mean squared error of retention time, mean squared error
of peak area and height determination.
Which one validation way choose? It is determined by local
metrology laws and recommendations of local metrology departments.
If the system UniChrom is used for other applications than
chromatography then the first way can be chosen. In chromatography
applications the second way is correct one.
The validation process of Chromatographic Complex equipped
with UniChromsystem is consist of following steps:
- Testing. The only purpose - to get the working system. The peak should be distinguishable and reproducible in subsequent injections. If it is not so - this is instrument problem (instrument should be tuned or repaired).
- Baseline registration in isothermal mode. Intended for baseline drift and noise level determination.
- 10 injections are taken repeatedly for area and retention time MSR determination.
- After 8 hours another 10 injections are taken for area and retention time MSR determination and also reproducibilty determination.
- The file with 20 injections plus two testing chromatograms plus two baseline chromatograms contain all information. Then the MS Excel Validation Template should be invoked from UniChrom system. All results are calculated and displayed in spreadsheet.
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