Evaluation of a filling system for binary pediatric solutions.

Abstract

The aim of this study was to assess the use of an automatic filling system (Siframix™ M31 and M32 system) to prepare pediatric parenteral nutrition. Volumetric accuracy was measured for each siframix™ system loads cells (< 5% for 5 ml with the Siframix™ M32 and < 5% for 9 ml with the Siframix™ M31) with sterile water for injection. The minimal 20 ml of flushing sterile water of the common tubulure of the Siframix™ M32 (p=0.211 for 20 ml and p=0.75 for 500 ml), the use of viscous solutions (70 % dextrose) on the Siframix™ M31 (p=0.28 for 20 ml and p=0.12 for 500 ml) and the use of a special tubulure for using E.V.A. Luer‐lock bags (p=0.89 for 20 ml and p=0.103 for 500 ml) do not modify the accuracy. Changing bags or bottles during the filling operation modify the accuracy (p=0.004 for 20 ml and p=0.009 for 500 ml). A flushing operation is necessary to lower the risk of electrolytic pollution for the filling of little bags. The filling speed for each module was also measured (the maximal filling speed was five liters per minute). The Siframix™ system allows one to prepare pediatric parenteral nutrition bags when volumes are above 4 ml and with adapted source solutions in terms of concentration and conditioning volumes.