Identification and risk analysis of a robotized chemotherapy manufacturing 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
Within the framework of the acquisition of the RIVA® (ARxIUM) chemotherapy preparation robot in our unit, an analysis of the robotic process was carried out. The goal was to determine and analyze the risky steps in order to qualify the equipment and guarantee the quality of the preparations and the safety of the patients while maintaining the personnel safety.
A risk identification in the form of an Ishikawa diagram was carried out on the environment and the robotized production of chemotherapy preparations in order to list all the risks and critical points of this process. Then, a comparison was made with the literature data on the qualification protocols of three preparation automats (Kiro® (Kiro Grifols), Pharmahelp® (Fresenius Kabi) and Apoteca® (Loccioni).
The Ishikawa diagram identified 38 major causes that could lead to a non-conforming preparation.
In the « Material » tab, the main causes listed are technical and computer failures or poor component recognition.
For « Manpower», the main hazards identified are lack of training, communication, non-compliance with procedures or lack of manpower.
« Raw materials » can be a source of hazards such as poor preservation of vials, a parameterization error, a traceability, or supply problem.
Concerning the risks related to the « Environment », we find the aeraulic problems, microbiological, chemical and particulate contamination or the non-control of the aseptic process.
For the « Method », the risks are mainly a wrong dosage, a lack of optimization of the occupation time of the robot.
In addition, the literature review highlights a similar qualification protocol for the three automatons, especially for the risks linked to the « Environment » (microbiological and chemical contamination as well as validation of the aseptic process). The « Method » was evaluated by an analysis of the accuracy and precision of the preparations, but also the impact of the excipient composition. The risks of the « Materials, Labor and Raw Materials » tabs are poorly described.
The implementation of this robotized production is a new issue for our establishment. The control of the process requires an identification followed by an analysis of the risks (severity, detectability and probability) and a detailed qualification protocol integrating the design, installation, operational and performance qualification. The implementation of monitoring indicators is essential to evaluate the proper functioning of this process and the impact on patient care.