Qualification of a volumetric automated compounding device to optimize the production of parenteral nutrition bags.

14 October 2019

Bour F1 & Colom M1, Juliat D1,Cerf P1, Vetele F1, Quessada T1
1 : Pharmacy, East group Hospital, Hospices Civils de Lyon, Bron, France

Each year, the East group Hospital Pharmacy of Hospices Civils de Lyon produces more than 22,500 parenteral nutrition admixtures for home patients. To guarantee the efficiency of such a production, a continuous optimization of manufacturing processes is necessary. To date, about two thirds of these bags are prepared using a volumetric automated compounding device (BAXA EM2400®). Electrolytes solutions are delivered using Baxter micro-volume tubing. In this context, we propose to evaluate the impact of increasing the tubing diameters on the accuracy of the analytical controls and secondarily, on the manufacturing time of parenteral nutrition bags.

Materials and Methods
Four "micro-volume" tubing connecting the electrolytes solutions (NaCl 20%, KCl 10%, sodium lactate 11.2% and magnesium sulfate 10%) were replaced by "high-volume" tubing.
An operational qualification was first carried out in two stages

  • Determination of each electrolytes flow factors in the new configuration;
  • Validation of the analytical controls on three series of six bags.
    The compounder’s performance qualification was then conducted on seven bags with “high volume” electrolytes and seven bags with “low volume” electrolytes. The "micro-volume" configuration has been used as a reference method for these qualifications.

All electrolytes and osmolality assays validate both qualifications and are as accurate as with our reference configuration. In addition, the configuration change allows a significant time saving in real conditions of use: 18 seconds for “low volume” bags (p<0.05) and 64 seconds for “high volume” bags (p<0.0001).

This work validates a new, more efficient configuration and is in favor of its implementation in our manufacturing process. In the absence of regulations or specific recommendations regarding the qualification of volumetric automated compounding devices, this study constitutes a basis for future optimization studies.

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