Gabriele Sandri
Analysis of LivaNova’s ETO sterilization process in Mirandola Plant and development of an SPC tool on critical parameters to monitor the Parametric Release.
Rel. Danilo Demarchi. Politecnico di Torino, Corso di laurea magistrale in Ingegneria Biomedica, 2020
Abstract
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
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