Background Until April 2016, cytotoxic drugs were prepared in isolators placed in a controlled atmosphere area (ISO 7) in the chemotherapy preparation unit (CPU). Since May 2016, part of the preparations is compounded with the robot Kiro Oncology (Kiro robotics, Spain) in a laminar air flow hood.
Purpose The aim of the study was to identify critical sampling points with high risk of chemical contamination in the CPU and to review cytotoxic contamination before automated compounding becomes operational.
Material and methods Sampling points were determined thanks to a risk analysis method ‘failure modes effect and criticality analysis’ (FMECA). Samples were collected by wiping at the end of a working day before general cleaning. The presence of the following cytotoxic drugs were tested using LC-MS/MS in each sample: 5-fluorouracil, gemcitabin, methotrexate, ifosfamide, cyclophosphamide, etoposide, docetaxel, paclitaxel and total platinum.
Results The working group for the FMECA method was composed of 8 healthcare professionals from the CPU. 19 process steps were analysed with 5 frequency levels, 5 severity levels and 3 protection levels. 3 criticality levels were established. 9 sampling points were selected among those which were revealed to be highly critical: refrigerator door, work surface of isolator, basket rack of isolator, sealing machine, checking area, storage area of finished preparations, storage area of preparation sheets, control laboratory’s computer and spectrometer. Among the 81 results, 48% were below the limit of quantification and 12% were above the European reference value of 0.1 ng/cm2. The work surface of the isolator and the spectrometer were the most contaminated areas (11.4 and 12.3 ng/cm2). All of the others contained <0.2 ng/cm2 of cytotoxic drugs. All samples contained platines. 8 of 9 samples contained gemcitabin and ifosfamide.
Conclusion The FMECA risk analysis method enabled us to select the most critical sampling points. The spectrometer as the most contaminated area was an unexpected result. The robot’s gravimetric analysis may reduce the number of cytotoxic samples analysed by the spectrometer and thus its contamination. A whole package of prevention and protection measures will be required throughout the preparation circuit to reduce the risk of contamination.
No conflict of interest
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