Baxa MicroMacrocompounder for Parenteral Nutrition Solutions in a Pediatric Hospital

Abstract

The constant increase of parenteral nutrition (PN) manufacturing in our pediatric hospital led us to look for an automatic filling system. The aim of this study was to evaluate the MicroMacrocompounder (MM23) for compounding pediatric PN solutions. MM23 volumetric accuracy was tested with its different inlets (S, D, V) for volumes of sterile water for injection from 0.2 to 2900 mL. The influence of the solution viscosity and the source solution bottle replacements during the filling operation was also investigated. Manufacturing pediatric PN solutions was eventually assessed. Time to set up the system was 30 minutes. Maximum filling speeds with sterile water for injection were 860, 330, 154 mL/min for Vx, V and D inlets, respectively. Inlet S was not tested for MM23 filling speed. Minimal flush volume of 40 mL of sterile water for injection is necessary to clear the tube of residual ions. Average MM23 volumetric accuracy was <5% for volumes ≥0.5 mL for S and D inlets, and for volumes ≥20 mL for V inlet. The volumetric accuracy was equal to 6.25% for 0.2 mL. In all experiments, volumetric accuracy was <5%. The accuracy of electrolyte measurements performed on bag samples was less than 5% for 150 (74%) samples, between 5 and 10% for 27 (13%) samples and greater than 10% for 27 (13%) samples. Microbiological analysis showed no positive culture. The average manufacturing times were 56.8 ± 4.5, 188.2 ± 7.7 and 447.2 ± 13.8 seconds for 130, 660 and 1800 mL bags, respectively. The MM23 compounder is suitable for compounding pediatric admixtures with source solutions volumes ≥0.5 mL. This system has been used daily for five months in our department.