Rudolf Schierl1, Carla Masini2, Svenja Groeneveld3, Elke Fischer3, Antje Böhlandt3, Valeria Rosini4, Demis Paolucci4. 1. Institute and Outpatient Clinic for Occupational, Social and Environmental Medicine, Ludwig Maximilians University of Munich, Germany Rudolf.Schierl@med.uni-muenchen.de. 2. Scientific Institute of Romagna for the Investigation and Treatment of Tumors (IRST), Meldola (FC), Italy. 3. Institute and Outpatient Clinic for Occupational, Social and Environmental Medicine, Ludwig Maximilians University of Munich, Germany. 4. Loccioni Humancare, Moie di Maiolati (AN), Italy.
Abstract
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/cm(2) at most locations, but significant on gloves (0.0004-0.0967 ng/cm(2)) and the majority (70%) of infusion bags (<0.0004-2.89 ng/cm(2)). During robotic preparation by APOTECAchemo, gloves (1 of 8: 0.0007 ng/cm(2)) and infusion bags (3 of 20: 0.0005, 0.0019, 0.0094 ng/cm(2)) were considerably less contaminated. Residual contamination was found on the surfaces under the dosing device in the compounding area (0.0293-0.1603 ng/cm(2)) inside the robotic system. CONCLUSIONS: Compared to outcomes of other studies, our results underline good manufacturing procedures in this pharmacy with low contamination for both techniques (BSC and APOTECAchemo). Comparison of both preparation procedures validated that contamination of infusion bags was much lower by using the robotic system.
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/cm(2) at most locations, but significant on gloves (0.0004-0.0967 ng/cm(2)) and the majority (70%) of infusion bags (<0.0004-2.89 ng/cm(2)). During robotic preparation by APOTECAchemo, gloves (1 of 8: 0.0007 ng/cm(2)) and infusion bags (3 of 20: 0.0005, 0.0019, 0.0094 ng/cm(2)) were considerably less contaminated. Residual contamination was found on the surfaces under the dosing device in the compounding area (0.0293-0.1603 ng/cm(2)) inside the robotic system. CONCLUSIONS: Compared to outcomes of other studies, our results underline good manufacturing procedures in this pharmacy with low contamination for both techniques (BSC and APOTECAchemo). Comparison of both preparation procedures validated that contamination of infusion bags was much lower by using the robotic system.
Authors: Sarah Batson; Stephen A Mitchell; Davina Lau; Michela Canobbio; Anna de Goede; Inderjit Singh; Ulrich Loesch Journal: Eur J Hosp Pharm Date: 2019-08-21