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Evaluation of a filling system for binary pediatric solutions
D Combeau1, J B Rey, J E Fontan
1Hôpital Robert Debré, Service Pharmacie et Laboratoire de Toxico-pharmacologie, Paris, France.
Pharmacy World & Science : PWS
|April 16, 1998
Summary
The Siframix system accurately prepares pediatric parenteral nutrition bags above 4 ml. Flushing is crucial for small volumes to prevent contamination, and system accuracy is unaffected by solution viscosity or bag type.
Area of Science:
- Pharmaceutical Technology
- Pediatric Pharmacy
- Medical Device Engineering
Background:
- Parenteral nutrition (PN) preparation requires high accuracy, especially for pediatric patients.
- Automatic filling systems aim to improve efficiency and reduce errors in PN preparation.
- The Siframix M31 and M32 systems are evaluated for pediatric PN compounding.
Purpose of the Study:
- To assess the volumetric accuracy and filling speed of the Siframix M31 and M32 systems for pediatric parenteral nutrition preparation.
- To determine factors affecting the accuracy of the Siframix system, including flushing volumes, solution viscosity, bag types, and changes during filling.
Main Methods:
- Volumetric accuracy was measured using sterile water for injection with the Siframix M31 and M32 systems.
- Accuracy was tested under various conditions: different flushing volumes, viscous solutions (70% dextrose), special tubulures for E.V.A. Luer-lock bags, and during bag/bottle changes.
- Filling speed was measured for each module.
Main Results:
- Both Siframix M31 and M32 systems demonstrated volumetric accuracy within acceptable limits (<5% error) for volumes as low as 5-9 ml.
- Accuracy was not significantly affected by minimal flushing volumes (20-500 ml), use of viscous solutions, or specialized tubulures.
- Changing bags or bottles during filling significantly impacted accuracy (p < 0.01).
- A flushing operation is necessary to minimize electrolytic pollution risk when filling small bags.
- The maximal filling speed achieved was five liters per minute.
Conclusions:
- The Siframix system is suitable for preparing pediatric parenteral nutrition bags with volumes exceeding 4 ml.
- Adapted source solutions in terms of concentration and conditioning volumes are necessary for optimal performance.
- Implementing a flushing procedure is essential for small-volume pediatric PN preparations to ensure safety and accuracy.