Cleaning validation using thermogravimetry

The health authorities require that equipment used in the pharmaceutical industry is clean prior to use. The main raison is to prevent any contamination of the drug products. This article demonstrates that thermogravimetry (TG) can be used for the determination of the residual impurities during the cleaning validation of the equipment of pharmaceutical production plants. The accuracy and the recovery rate of this method are comparable with those of the classical analysis method (determination of the distillation residue using a rotary evaporator). The fully automation of the testing equipment even allows its utilization around the clock by plants operators, leading to a significant reduction of the time necessary for the cleaning validation and to an increase of the plant capacity.