Sterilization

Sterilization refers to a decontamination process that destroys all viable microorganisms on an object or within a medium, including microbial spores. According to EN 556-1 and ANSI/AAMI ST67, a Sterility Assurance Level (SAL) of 10⁻⁶ must be achieved in order to guarantee the sterility of a medical device. This means that, out of one million sterilized products, only a single item may contain a viable microorganism. To ensure this level of safety, biological validation processes require a microbial reduction of at least 6 log₁₀ levels, which must be achieved within half of the exposure time (half-cycle method or overkill method). [1,2]

Sterilization methods can be divided into chemical and physical procedures, depending on whether the sterilization effect is based on thermal or electromagnetic mechanisms or on chemical reactions. The most widely used sterilization method worldwide is saturated steam under pressure, as utilized in autoclaves. [3]

The application of cold atmospheric pressure plasmas for sterilization is the subject of extensive research worldwide. Various studies have demonstrated successful sterilization using different plasma systems. [4,5]