Résumé
The regulatory and technological change have led us to our current practices in the sterilization of medical devices in the pharmaceutical industry. The objective is the elimination of living microorganisms to obtain drugs whose parameters of quality, safety and efficacy are controlled. This is a critical process in the drug manufacturing process. So, we are going to do a global inventory of this process. A retrospective analysis will allow us to point the historical events at the origin of modern practices and all the processes available today. Then, we will select the reference method from a comparative analysis. This method turns out to be moist heat sterilization. To understand all the elements for its operation, an Ishikawa diagram will be developed with five points, method, environnement, machinery, material, and manpower. Finally, to ensure the robustness and reproducibility, we will develop optimization and performance aspects of this process.