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Master Thesis

Approche globale de la validation de la stérilisation par autoclavage : optimisation et choix stratégiques

Abstract : The production of sterile drugs requires particular attention regarding quality to ensure user’s safety. Indeed, it is essential to minimize the risks of microbial, particulate and pyrogenic contamination that may occur throughout the manufacturing process. For that purpose, quality assurance plays a key role in developing and rigorously validating strict manufacturing methods in order to obtain sterile products with outstanding quality at the end of production. This work is divided into three chapters: the first part reviews conventional and new sterilization methods including sterilization by chemical agents (ethylene oxide, formaldehyde and hydrogen peroxide plasma gas), heat sterilization (steam sterilization and dry heat sterilization), irradiation sterilization (E-beams, gamma rays and X-rays) and finally the latest advances such as pulsed light, high hydrostatic pressures, pulse electric fields and microwaves. A second part recalls the general principles of validation and qualification. Finally, the last part develops the initial qualification of an autoclave after tests optimization thanks to the worst-case product principle. As autoclaves are critical equipments, this study also provides a method for routine validation of this sterilization process.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-01803679
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Submitted on : Wednesday, May 30, 2018 - 4:48:35 PM
Last modification on : Thursday, September 5, 2019 - 2:12:03 PM
Long-term archiving on: : Friday, August 31, 2018 - 5:29:43 PM

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Camille Dupuy. Approche globale de la validation de la stérilisation par autoclavage : optimisation et choix stratégiques. Sciences pharmaceutiques. 2018. ⟨dumas-01803679⟩

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