Preliminary Evaluation of the Mundus HD Automated Compounding System (Equashield) in terms of Productivity, Accuracy, and Microbiological and Chemical Contamination Control
30 September 2026
M. Vasseur¹˒² , L. Négrier¹˒² , A. Lecoutre¹ , J. Courtin¹ , M. Bouchfaa¹˒² , N. Simon¹˒² , C. Danel¹˒² , P. Odou¹˒²1. University of Lille, CHU Lille, Faculty of Pharmacy, 59000 Lille, France.
2. University of Lille, CHU Lille, ULR 7365 – GRITA – Research Group on Injectable Drug Forms and Associated Technologies, 59000 Lille, France.
Introduction
Automation of chemotherapy compounding is a major challenge for hospital production units. The Equashield Mundus HD system has two main features: the use of Closed System Transfer Devices (CSTDs) and volumetric control provided by a precision motor and verified by visual control cameras.
Objective
To evaluate the productivity, accuracy, and the risk of microbiological and chemical contamination associated with the Equashield Mundus HD automated compounding system.
Materials and Methods
A series of 90 preparations was performed using 100 mL vials of fluorescein 0.2 mg/mL to simulate a 5-fluorouracil (5-FU) production process: 30 elastomeric pumps (Homepump Eclipse, Avanos) and 60 infusion bags (Freeflex, Fresenius). Productivity was assessed by measuring preparation time. Accuracy was evaluated by gravimetric analysis (Sartorius, n = 90) and HPLC-UV assay (10 elastomeric pumps and 20 infusion bags). Residual chemical contamination was investigated by swabbing the CSTD membranes followed by HPLC-UV analysis (LOD = 0.015 ng; LOQ = 0.05 ng). An aseptic process simulation (APS) under worst-case conditions (outside a cleanroom environment) was performed, with incubation for 7 days at 20°C followed by 7 days at 32°C
Results
The mean preparation time was 4 min 53 s for elastomeric pumps (V = 138 mL) and 1 min 47 s for infusion bags (V = 120-150 mL). Gravimetric analysis showed a bias of −2.0% (±0.6%) for elastomeric pumps and −0.8% (±1.1%) for infusion bags. HPLC-UV assay showed a bias of −2.3% (±2.2%) for elastomeric pumps and −2.4% (±1.1%) for infusion bags. No chemical contamination was detected in 46.7% of preparations (14/30). 40.0% of preparations (12/30) showed detectable but non-quantifiable contamination, while 13.3% (4/30) exhibited contamination levels ranging from 0.12 to 0.20 ng. No microbial growth was observed after 14 days of incubation.
Discussion / conclusion
This evaluation demonstrated that the system meets the requirements for productivity, accuracy, and contamination control. The analytical method enables the quantification of the tracer, fluorescein, with high sensitivity and accuracy. This automated system should now be evaluated under real-world conditions using cytotoxic drugs. Beyond these encouraging results, the system is easy to use and requires only minimal setup. Further studies will be necessary to confirm these findings and to assess its ergonomics within a hospital compounding unit.
Keywords: Preparation robot ; Closed-system transfer device ; Chemotherapy