Fact or Fiction: Automated Dissolution Testing Reduces Operator Error and Increases Overall Efficiency

Overview:

While the automation of dissolution testing is primarily touted as a means to reduce operator bench time, the reduction in operator error is often overlooked. In fact, many pessimists argue that the calibration and service hours associated with automation negate the overall reduction in operator bench hours. The proper way to view the overall picture is to include a measure of the quality of the data obtained by the manual and automated methodologies along with the difference in bench hours. Operator-induced error occurs at two points during a UV-Vis based dissolution test: (1) when sampling from the dissolution vessel and (2) during the spectroscopic analysis. Both sources of error are due to variations in the technique of the bench chemist. Although the testing performed for these simple studies was relatively small, it has indicated whether induced variance has an effect on a seemingly sensitive pharmaceutical product, the USP 10-mg Prednisone dissolution calibrator tablet. The studies discussed in this white paper showed that whereas automated dissolution testing did not improve the accuracy or precision of the results, it did boost overall efficiency (in that it reduced the time required for analysis).