Attainment of Sterility and Satisfactory Material Functional Compatibility to Devices in the Clean Room

Abstract

Copyright: © 2012 Shintani H. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. A high-level aseptic environment must be maintained in biocleanrooms used for the manufacture of sterile products. Formaldehyde gas exposure was conventionally used to sterilize within biocleanrooms (ISO 14644-1), but Ministry of Health, Labor and Welfare Japan requires quite strict residual limitation of formaldehyde at less than 0.08 ppm because formaldehyde causes one of sick-house disease, so there was a need to seek for a less toxic alternative sterilants. These sterilants are ozone, hydrogen peroxide, peracetic acid and chlorine dioxide gases.