Background and Importance The compounding of injectable anticancer drugs in hospital pharmacies is in constant growth and requires innovation and development of flexible preparation methods while reducing the risk of exposure to hazardous drugs for healthcare workers. To this purpose, a robotic system implemented inside an isolator, Kiro Isolator® (Grifols, Spain), was designed.

Aim and Objectives We report the qualification of the first Kiro Isolator® from a microbiological and preparation robustness point of view.

Material and Methods Dose accuracy and precision were assessed for sampling volumes from 1 to 48 mL for three drugs used in our hospital: paclitaxel (viscous solution), vincristine (aqueous solution) and cyclophosphamide (aqueous solution with reconstitution). For each volume tested (1, 5, 10, 20 and 48 mL), five bags of paclitaxel and cyclophosphamide were produced. A volume of 2 mL was tested with vincristine only (n=10 bags). Tests were repeated over three days. All preparations were checked by gravimetric control using the scales of the robot with a weighing tolerance threshold set at 5%. For paclitaxel and cyclophosphamide preparations, an analytical control was performed to confirm the reliability of the robot’s gravimetric control using an LC-MS. Deviation from the theoretical concentration was expected to be within +/-15%. Microbiological qualification was carried out by performing Media Fill tests (MFT) over three days.

Results Overall, 75 bags of paclitaxel, 75 bags of cyclophosphamide and 30 bags of vincristine were produced. With the exception of the 1 mL volume, accuracy was validated with gravimetric control for all volumes tested. Analytical controls were compliant with the specifications except for three bags (two cyclophosphamide and one paclitaxel). We assume these results are false negatives due to an issue of homogenisation. Excepted the lowest volume of 1 mL, ANOVAs tests showed that for paclitaxel and cyclophosphamide the concentrations were not different from the theoretical concentrations. No growth was observed during a 15-day incubation of the MFT.

Conclusion and Relevance Accuracy was validated for sampling volumes from 2 to 48 mL with a reliable gravimetric control. The robot’s confinement ensures technician safety and environmental protection without affecting its performance. Since its qualification, nearly 20% of our total production is now carried out with this innovative robot.

Conflict of Interest No conflict of interest.