Analysis of LivaNova’s ETO sterilization process in Mirandola Plant and development of an SPC tool on critical parameters to monitor the Parametric Release.

Sterilization is of prime importance especially in the field of medical devices (MDs), where a lot of products need to be sterilized before being put on the market to prevent patient exposure to infections. Therefore, it is important that the MDs company's sterilization process complies with current guidelines and that a robust quality system ensures that the sterilization cycle meets the prevalidated specifications. ?? My internship in LivaNova consisted in analyzing the ethylene oxide (ETO) sterilization process currently in use at Mirandola Plant. Particularly, during the first months, I familiarized with the regulations of reference, the internal procedures and the three main software programs used for management and monitoring of the sterilization plant. In the following, I managed the implementation of a Statistical Process Control (SPC) tool on critical parameters of the cycle in order to prevent any drift or change in the process by performing a prevention-based quality control. In fact, by monitoring each sensor in real-time, the operators would be able to detect any major changes in the process before they result in a non-compliant product. In this regard, I implemented two Graphical User Interfaces (GUIs) using Matlab® R2019b to lay the groundwork for the development of the SPC tool. And finally, through their use, I analyzed the performances of the sterilization plant over a six-month period to verify the stability of the process and the position of the parameters within the acceptance ranges.