Pharmaceutical Regulatory Affairs: Open Access

Hideharu Shintani

Publications

• Review Article
  Simultaneous Achievement of Sterility Assurance Level (SAL) of 10^-6 and Material and Functional Compatibility in Gas Plasma Sterilization Running Title: Simultaneous SAL and Compatibility
  Author(s): Hideharu ShintaniHideharu Shintani
  
  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 ha.. Read More»
  DOI: 10.4172/2167-7689.1000131

  Abstract PDF