Monitoring of surface chemical contamination in a robotized chemotherapy preparation process
1- CHU Lille, Institut de pharmacie, F-59000 Lille, France
2- Univ. Lille, EA 7365 – GRITA – Groupe de Recherches sur les formes Injectables et les Technologies Associées, F-59000 Lille, France
For several years, many hospitals have decided to invest in a robotized system for the preparation of chemotherapy. These motivations are multiple, such as productivity, security, accuracy or autonomy and also control of human resources. For the manual chemotherapy manufacturing process, the control of chemical contamination is well known and is the subject of guidelines. But what about chemical contamination in a robotized process? The purpose of this work is to carry out a follow-up of the surface chemical contamination after the set-up of the RIVA robot (ARxIUM).
An analysis of the chemical risk linked to the robotized process was realized by taking into account the loading, the preparation and the unloading steps in order to define the sampling points. This study was carried out from 02/08/2021 to 30/03/2022. The monitoring of contamination was performed monthly by surface sampling, before the cleaning the robotic area. Samples are taken by swabbing the surface with a swab and 0.1 mL of sterile water. One blank is made per campaign. Among the molecules prepared by the robot, 10 were searched by LC-MS/MS. In case of a positive sample and according to the trend analysis, a corrective action plan is define.
The risk analysis highlighted 10 locations at risk inside the robot and 7 outside. During this study, 6 campaigns of 170 samples, that’s means 1020 samples in total, were carried out. The contamination rate (CR) was 3.0%; 7 molecules were found, with gemcitabine (32%) and cyclophosphamide (29%) especially. The average quantity of cytotoxic drugs found was 1764ng (min 2ng, max 26000ng). This contamination was mainly found in the sampling, needle removal and waste areas. Corrective measures were implemented such as daily cleaning with Sodium Dodecyl Sulfate/Isopropyl Alcohol, which reduced the positivity rate from 4.12% to 2.35%.
Discussion - Conclusion
This first assessment at 6 months shows encouraging results, especially compared to a previous study performed in our unit using a manual process under isolator. A CR of 26.4% was retrieved and the most frequent molecule was also gemcitabine with a CR of 13.2%. The analysis of the robotic process revealed higher average quantities related to incidents (splashing when rejecting syringes after preparation). The implementation of corrective actions has effectively reduced contamination, but this study will be maintained with post-decontamination sampling to validate the efficiency of daily cleaning.