Validation of the 774 Oven Sample Processor in combination with a KF Coulometer by using standard operating procedures
GLP (Good Laboratory Practice) requires, among other things, the regular checking of the accuracy and precision of analytical instruments by using standard operating procedures (= SOPs).
The user is recommended to validate Metrohm instruments as a whole integral measuring system, i.e. to carry out a series of determinations with certified standards and to critically assess the results by statistical means.
Checking the electronic components of measuring instruments can and ought to be carried out in the context of regular service work by technical specialists from the manufacturing company. All Metrohm instruments are provided with start-up test routines that check that the relevant components are functioning properly when the instrument is switched on. If this produces no error message then it can be assumed that the instrument is functioning perfectly. Metrohm also supplies its instruments with built-in diagnosis programs that, if faults or malfunctions should occur, permit the user to check the functioning of particular assemblies and localize the fault. These diagnosis programs can also be included in a validation method.
As a guideline for drawing up a standard operating procedure for checking the complete analytical system, Metrohm recommends the procedure described in this Bulletin. The limiting values mentioned should be regarded as being proposals. Depending on your company-specific requirements for the accuracy of the measuring system these limits may need to be redefined in the standard operating procedures.
German:  AB_281_1_d.pdf (232 KB)
English:  AB_281_1_e.pdf (246 KB)
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Karl Fischer Titration > Karl Fischer Oven Method
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