ABSTRACT
An increase in medical devices and components made of materials (e.g., plastics) that require low-temperature sterilization necessitated the use of other means of sterilization such as radiation and ethylene oxide gas, which has been used for heat- and moisture-sensitive medical devices, and ingredients. Recently, low-temperature sterilization systems (e.g., hydrogen peroxide gas plasma, peracetic acid immersion, ozone) have been developed and are being used to sterilize medical devices. Sterilization destroys all microorganisms on the surface of an article or in a drug-compounded fluid, or solutions to prevent disease transmission associated with the use of that item or compound. The sterility assurance level of the product is defined as a single viable microorganism occurring on a product after sterilization. Medical products that have contact with sterile tissues or fluids are considered critical. These items should be sterile when used because any microbial contamination could result in disease transmission.
