Abstract
Objectives: 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.
Material and methods: Two dosing pumps have been qualified regarding their use: a processor-controlled dosing pump MediMixmini® 4010 with a single piston and processor-controlled dosing pump MediMixmulti® R with twelve pistons. Solutions used during pumps performance qualifications were pharmaceutical products conventionally employed to make mixtures for parenteral nutrition (electrolytes, micro and macro nutrients). A simple experimental protocol based on recommendations for validation of assay methods was used to determine the precision, the accuracy and the intermediate precision of pumping operations. Performances were then checked with the production of test batches.
Results: 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).
Conclusion: The single pump controller MediMixmini® and the multi-pump controller MediMixmulti® R can deliver with precision, accuracy, repeatability and reproducibility volumes between 5 and 9,999 mL and 0.5 and 9,999 mL respectively.
Comments (0)