Sterilizarea industrială a dispozitivelor medicale din mase plastice cu oxid de etilină [Articol]

Abstract

The paper presents a case study conducted at the UISPAC SRL company, specialized in the production and sterilization of plastic medical devices. The study involves mathematical calculations (fractional method with negative results) for the theoretical determination of the minimum sterilization time; establishes and implements on an industrial scale the conditions of the sterility test (time, temperature, humidity, dose of ethylene oxide). The efficiency of sterilization under the established conditions (SAL 10⁻⁶) was confirmed by the results issued by 2 analysis laboratories, one national (ANSP) and the other international (TUV Sud International Laboratory, Italy). The certificates confirm the sterility of the products and that the applied method and the equipment used comply with the requirements set forth by ISO 13485:2016.