AB 201-320

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AB-273 Validation of Metrohm KF Coulometers using Standard Operating Procedures  
Validation of Metrohm KF Coulometers using Standard Operating Procedures

Among other things, GLP (Good Laboratory Practice) requires that the accuracy and precision of analytical instruments are checked at regular intervals using Standard Operating Procedures (SOPs). The user is advised to validate the KF Coulometer as a whole integrated measuring system, i.e. to perform a series of determinations with certified standard solutions and critically assess the results using statistical methods. Checking of the electronic and mechanical components of the measuring instruments can and should be carried out by qualified personnel of the manufacturing company as part of regular servicing. All Metrohm instruments are equipped with start-up test routines that check the correct functioning of the relevant assemblies upon switch-on of the instrument. If no error message is displayed, it can be assumed that the instrument is functioning perfectly. In addition, Metrohm instruments are supplied with built-in diagnostic programs that enable the user to check the functioning of certain components in the event of malfunctions or erratic behavior and to localize the fault. These diagnostic programs can also be included in a validation procedure. The procedure described below is meant as a guideline for setting up a Standard Operating Procedure to check the entire measuring system. The limits specified should be regarded as recommendations. In compliance with particular in-house requirements on the accuracy of the measuring system, these limits may have to be redefined in the Standard Operating Procedure.


German:  AB_273_3_d.pdf (362 KB)
English:  AB_273_3_e.pdf (324 KB)
French:  AB_273_3_f.pdf (358 KB)

Industry
 
Methods
Karl Fischer Titration > Automated coulometric KFT
Karl Fischer Titration > Direct coulometric KFT
Karl Fischer Titration > Karl Fischer Oven Method
   Validation of Metrohm KF Coulometers using Standard Operating Procedures