Industrialization of a cleaning process for textile prostheses intended for hernia repair

This work has been done during an intership with Medtronic Trévoux, specialists in the repair of hernias. This was an opportunity to participate in the industrialization phase of a new project. This comes to the placing on the market of a textile prosthesis for ventral hernia, intended to be inserted thanks to an innovative method of surgery. That is a mini-invasive approach by laparoscopic surgery via robotic. The manufacturing step that has been studied here is the cleaning of the textile prostheses, also called de-oiling. Indeed, the interest of the cleaning step is to remove the spin-finish oil on yarns, this last being necessary for the first stages of manufacturing but undesired in patient’s body. The first objective of the thesis was to qualify the installation (IQ) of the new equipment for this cleaning, and thus verify that the machine complies with the manufacturer’s recommendations, the safety standards and that it can operate as expected. This is an important step common in medical industries to conform to high level of quality and safety requirements. Secondly, the study of the Proven Acceptance Range (PAR) was carried out to evaluate the robustness of the proposed cleaning process. It signifies to check whether, even in the worst cleaning conditions, products are conformed or not, and the process is capable or not. This study is conducted as a preparatory step to evaluate the robustness of the process before moving into the formal validation phase. Its purpose is to anticipate and address any potential issues in the cleaning process to prevent unexpected failures during validation. By identifying possible weaknesses in advance, this phase aims to improve the likelihood of successful process validation. The process involves two main steps: a water-based cleaning phase followed by a spinning phase. The installation qualification tests were planned using various references, including technical manuals, site utilities, and room configuration details. Concerning the PAR study, a cleaning program was developed to simulate extreme conditions, allowing analysis of their impact on the cleaning and spinning process for textile prostheses. Cleaning efficiency was measured according to defined TOC limits, and drying efficiency by a quantification of water content, with Medtronic’s process capability targets in mind. The study finally demonstrated encouraging results for the next validation phase.