Assessment of chemical contamination by cancer drugs during use of the RIVATM compounding robot: A pilot study

Author:

Bouchfaa Myriam12,Vasseur Michèle12ORCID,Courtin Justin1,Pinturaud Marine12,Beauval Nicolas34,Allorge Delphine34,Odou Pascal12,Simon Nicolas12ORCID

Affiliation:

1. Institut de Pharmacie, CHU Lille, Lille, France

2. Univ. Lille, ULR 7365 – GRITA – Groupe de Recherche sur les formes Injectables et les Technologies Associées, Lille, France

3. Univ. Lille, ULR 4483-IMPECS-IMPact de l’Environnement Chimique sur la Santé humaine, Lille, France

4. CHU Lille, Pôle Biologie-Pathologie-Génétique, Unité Fonctionnelle de Toxicologie, Lille, France

Abstract

Introduction Many hospitals are now investing in robotic compounding system for the preparation of cytotoxic agents. The objective of the present study was to describe contamination by cytotoxics inside and outside the RIVATM robot (ARxIUM, Winnipeg, Canada). Material & Methods We applied a risk analysis to determine which locations inside and outside the compounding robot should be monitored. Samples were collected by swabbing with a wet swab (using 0.1 mL of sterile water) before the robots was cleaned. Ten cytotoxics compounded with the robot were screened for using LC-MS/MS. We determined the percentage contamination rates inside (CRin) and outside (CRout) the robot and the amounts of each contaminant (in ng/cm²). If a sample was found to be positive, a corrective action was implemented. Results Our risk analysis highlighted 10 locations inside the robot and 7 outside. Ten sampling campaigns (10 samples per campaign) were performed. The mean CRin (40%) was significantly higher than the mean CRout (2%; p < 10−4). Gemcitabine and cyclophosphamide were the main contaminants. After the implementation of corrective measures (such as daily cleaning with SDS/isopropyl alcohol), the CRin fell from 60% to 10%. Discussion/conclusion The frequency of contamination was lower for robotic compounding than for manual compounding in an isolator. However, robotic compounding tended to generated larger mean amounts of contaminant; this was related to incidents such as splashing when syringes were disposed of after the compounding. The implementation of corrective actions effectively reduced the CRs. Further longer-term studies are required to confirm these results.

Publisher

SAGE Publications

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