Zefektivnění procesu uvolnění zboží po sterilizaci
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Vysoká škola báňská - Technická univerzita Ostrava
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Abstract
The diploma thesis describes the practical usage of the Design of experiment method (DOE) in Ethylenoxide sterilization of the company Mölnlycke Health Care ProcedurePak s.r.o. The company is the producer of medical device – single used surgical trays.
The purpose of the thesis is to improve the release process of medical device after sterilization from the perspective of time reducing during the gas – Ethylenoxide (EO) and its hydrogen chloride compound – Ethylene chlohydrine (ECH) aeration from the surgical trays.
In the theoretical part is described the process of Ethylenoxide sterilization and degassing process after the sterilization and also the basic rules of the DOE method. These are then used in the practical part of the work, which includes the proposed plan for the specified factors, the implementation of the plan and its evaluation. Based on the results, the optimum factor parameters are designed, so the resulting Ethylenoxide and Ethylene chlohydrine evacuation time is as short as possible and the goods can be released for shipment to the customer.
The resulting degassing time of both substances from the medical device is shortened after setting the optimal parameters of the factors that influence the resulting degassing time. However, the introduction into routine sterilization requires further approval from stakeholders.
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DOE, Design of experiment, Ethylenoxide sterilization, degassing of Ethylenoxide and Ethylene chlohydrine from medical devices