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Master Thesis

Stérilisation à basse température par diffusion de peroxyde d’hydrogѐne : principes de fonctionnement, de validation et de libération des charges

Abstract : Hydrogen peroxide (H2O2) is a chemical compound employed for low temperature sterilization (LTS) of heat-sensitive medical devices (MD). Used in gaseous form, it is sensitive to several interactions which determine its effectiveness. Therefore, MD compatibility with LTS process must be demonstrated. Currently in France, 4 manufacturers distribute H2O2 vapor sterilizer using different processes. There is no specific standard H2O2 vapor LTS, processes are developed and validated following general requirements of international standard ISO 14937. Each manufacturer is free to define critical process variables and a validation procedure for its process, so they are difficult to compare. Likewise, product release from sterilization must follow each manufacturer recommendations. Parametric realease may be combined with biological indicators. These sterilization processes are less robust than steam sterilization. Their results depend for instance on correct cleaning and drying steps, MD composition and load configuration. In addition, specific standards deficiency is their most important weakness, a process variable harmonization and a sterilizing agent direct sensor are needed if manufacturers want their processes to compete with steam sterilization. Some issues about these processes must be answered for their development not to speed down.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-02446262
Contributor : Jean-Hugues Morneau <>
Submitted on : Tuesday, January 21, 2020 - 2:24:49 PM
Last modification on : Friday, October 23, 2020 - 5:03:47 PM
Long-term archiving on: : Wednesday, April 22, 2020 - 12:38:29 PM

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Julien Vallée. Stérilisation à basse température par diffusion de peroxyde d’hydrogѐne : principes de fonctionnement, de validation et de libération des charges. Sciences pharmaceutiques. 2020. ⟨dumas-02446262⟩

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