Performance qualification of a dual-channel compounding system Medimix Vigo^® & +One^®

Introduction
To reduce the risk of musculoskeletal disorders (MSDs) during the filling of 5-fluorouracil (5-FU) elastomeric infusion pumps, to secure the preparation process, and to optimize production, our preparation unit acquired a Medimix Vigo^® & +One^® automated system, consisting of a peristaltic pump connected to the diluent (5% glucose), a syringe pump connected to the 5FU, and an integrated balance. A qualification study was conducted to evaluate the performance of the system and its integration into the unit’s compounding process.

Materials and methods
5-FU was simulated using 0.9% NaCl for the tests. Precision (repeatability/reproducibility) and trueness measurements were performed for filling using the peristaltic pump alone (5% glucose: six volumes ranging from 5 to 240 mL) and the syringe pump alone (NaCl: six volumes ranging from 5 to 200 mL). Fillings were repeated three times over three days. Final volumes were determined by gravimetry using an independent qualified balance. Priming volumes were evaluated by gravimetry and colorimetry. The conformity of the dual-channel filling process was evaluated by gravimetry (using four 5-FU concentrations ranging from 1 to 45 mg/mL over three days) and by colorimetry. Reference weights were used for the metrological qualification of the integrated balance. The acceptance limit for Coefficients of Variation (CVs) and trueness deviations was set at 2%. A Media Fill Test (MFT) was performed.

Results
CVs were <2% for reproducibility and repeatability for all fillings performed with both the peristaltic pump and the syringe pump. All trueness deviations were <2% with the syringe pump. With the peristaltic pump, no deviation was <2% for the 5 mL reference volume [2.26–6.20], while 13/18 deviations were >2% for the 10 mL reference volume [0.30–3.25]. Only volumes >20 mL showed all deviations <2%. Priming volumes were determined as 30 mL of 5% glucose and 5 mL of 5-FU. Deviations and CVs for the four 5-FU concentrations were <2%. Colorimetric analysis confirmed the conformity of priming and dual-channel filling. The internal balance showed precise and accurate results, with no eccentric loading error. MFT showed no microbial growth.

Discussion/Conclusion
The automated system was qualified only for diluent volumes >20 mL. Filling with the peristaltic pump is actually based on gravimetric measurement, with the pump drawing diluent until the desired final weight is reached. The integrated balance was not designed as a control device but contributes to the filling process, resulting in inaccuracies for low volumes (<20 mL). In contrast, filling using the syringe pump is not dependent on the balance, allowing qualification for all tested volumes. Consequently, while the dual-channel automated system can be used for filling infusion devices, it is unsuitable for low volumes, raising future concerns regarding preparations outside the elastomeric infusion pump context.

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