Caliari, Valentina (2010) Determinazione di ossido di etilene rilasciato da dispositivi medicali mediante campionamento in spazio di testa e analisi gascromatografica. [Laurea specialistica biennale]
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Ethylene oxide is used in the sterilization of medical devices. It is toxic when its concentration is greater than a specific limit. In this elaborate a new method consisting in a sampling in head space of a water solution and gas-chromatographic analysis has been optimized. The method presents good linearity, sensibility and a very low limit of detection. Many experiments has been made to find optimal conditions, for example the volume of liquid phase (VL) to introduce into the vial for head space, temperature and time of thermostatation of the vial, the amount of salt to introduce into the vial to increased the sensibility of the method, time of sonication of the vial and specific chromatographic conditions. The method has been applied for an exhaustive and simulated-use extraction. Exhaustive extraction is made to recover all of ethylene oxide from medical devices by the use of a solvent or a thermal extraction Simulated-use extraction is made to demonstrate compliance with the requirements of the part of ISO 10993, by the evaluating residue levels available to the patient or user from devices during the routine use of a device with water extraction to simulate product use. New method has been compared with validated method of thermal extraction, but the results obtained with new method (in an exhaustive extraction) are 30% lower than the results calculated with the official method. While with the simulated-use extraction the results are 50 – 60 % lower. The problem is not related either to ethylene oxide decomposition in water or to the difference of the nature of the column use in the two methods. Probably the problem consists in the part of treatment of the samples with new method.
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