Performance Qualification of Two Processor-controlled Dosing Pumps for the Production of Mixed Infusion Solutions in a Closed System

Abstract

: The aim of this study is to carry out performance qualifications of 2 processor-controlled dosing pumps for the production of mixed infusion solutions in a closed system.: Two dosing pumps have been qualified regarding their use: a processor-controlled dosing pump MediMix: The mean relative biases found with different products used for the qualifications of the two controllers were below the manufacturer’s specifications. When pumping operations were performed outside the manufacturer’s recommended ranges of volumes, relative bias remained below 10 %. Low relative bias (<3 %) and relative standard deviation (<1 %) were also found with routine controls (weight, osmolality, sodium concentration, potassium concentration) performed on test batches produced with the 12-pumps automated compounding device (ACD).: The single pump controller MediMix