Environmental contamination by cyclophosphamide preparation: Comparison of conventional manual production in biological safety cabinet and robot-assisted production by APOTECAchemo

Objectives The aim of this study was to compare environmental contamination of cyclophosphamide (CP) during 1 week of drug compounding by conventional manual procedure in a biological safety cabinet (BSC) with laminar airflow and a new robotic drug preparation system (APOTECAchemo). Methods During four consecutive days, similar numbers of infusion bags with cyclophosphamide were prepared with both techniques in a cross-over design. Wipe samples (49 for BSC, 50 for APOTECAchemo) were taken at several locations (gloves, infusion bags, trays, BSC-benches, floor) in the pharmacy and analyzed for CP concentrations by GC-MSMS (LOD 0.2 ng/sample). Results The detection rate was 70% in the BSC versus 15% in APOTECAchemo. During manual preparation of admixtures using BSC contamination with CP was below 0.001 ng/cm2 at most locations, but significant on gloves (0.0004–0.0967 ng/cm2) and the majority (70%) of infusion bags (