Simultaneous Achievement of Sterility Assurance Level (SAL) of 10-6 and Material and Functional Compatibility in Gas Plasma Sterilization

Abstract

In the existing sterilization procedures, it is quite hard or impossible to achieve sterility assurance level (SAL) of 10-6 and material/functional compatibility simultaneously. Simultaneous achievement of both is required in ISO 14161 and sterilization validation. As gas plasma sterilization penetration was quite shallow at around 10-20 nm level from the surface, so it can kill only one layer of bioburden and can maintain material and functional compatibility in success without any difficulties. Bioburden means sort and number of viable microorganisms in/or the products. It is so-called contaminant. Sterilization was finished in success but material was damaged and useless, such a phenomenon must be avoided. In the current sterilizations, gamma-ray irradiation, electron-beam irradiation, autoclaving, dry heating, hydrogen peroxide gas or ethylene oxide gas sterilization has inferiority not to obtain material and functional compatibility. If gas plasma sterilization will be applicable to the real healthcare products, simultaneous achievement of SAL of 10-6 and material/functional compatibility can attain without any difficulties, at that time simultaneous achievement is addressed to the existing sterilization procedures and sterilization validation. In that means gas plasma sterilization is the future promise sterilization procedure because only gas plasma sterilization can achieve both in success.