ABSTRACT
The contact surfaces for injectable drugs usually are of stainless steel, glass, or elastomeric compounds that can be steam sterilized. Ideally, if possible, equipment surfaces that are not in product contact, but in proximity, should be made sterile. A number of surfaces are not amenable to steam sterilization but must be microbe free, or might preferably be sterilized by another means. Sterilization is a process for the destruction of all life-forms, without exception. The life-forms usually taken to be most resistant to kill are bacterial spores. Aseptic practice excludes the introduction of organisms of any type into a system. Most sterilizing gases are either oxidizers or alkylators and, as with sterilization by moist heat, evaluation is with resistant bacterial spores. The primary applications of H2O2 sterilization that are widely applicable in most manufacturing and quality control areas relate to the sterilization of isolators used in sterility testing and the sterilization of the air and surfaces over/around barrier isolator filling lines.
