AB 201-320

GLP (Good Laboratory Practice) requirements include the periodic checking of analytical instruments for reproducibility and accuracy using standard operating procedures (SOP).

The user is advised to validate the Metrohm titrators as a complete, integrated titration system, i.e. to perform a series of titrations using standard titrimetric substances (primary standards) and critically assess the results using statistical methods.

Checking the electronic and mechanical components of measuring instruments can and should be undertaken by qualified personnel of the manufacturing company as part of regular servicing. All Metrohm instruments are provided with start-up test routines which check that the relevant assemblies are working perfectly when the instrument is switched on. If no error message is displayed, it can be assumed that the instrument is functioning faultlessly. Metrohm instruments are also 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. Diagnostic programs may also be integrated in a validation procedure.

As a guideline for the preparation of Standard Operating Procedures to check a titration system comprising a titrator, dispensing unit, measuring chain and possibly a sample changer, Metrohm suggests the procedure described in this Bulletin. The limiting values specified must be considered as recommendations. Specific limiting values must be defined in the particular Standard Operating Procedure regarding in-house requirements concerning the demanded accuracy of the measurement system.

 AB_255_3_d.pdf (78 KB)

 AB_255_3_e.pdf (67 KB)