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System Validation

System validation can be passed in two ways:

  1. 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.
  2. 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:

  1. 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).
  2. Baseline registration in isothermal mode. Intended for baseline drift and noise level determination.
  3. 10 injections are taken repeatedly for area and retention time MSR determination.
  4. After 8 hours another 10 injections are taken for area and retention time MSR determination and also reproducibilty determination.
  5. 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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