Sterilization (microbiology) equal to the probability of a non-sterile unit. For high-risk applications, such as medical devices and injections, a sterility assurance level of at least 10 is required by the United States Food and Drug Administration (FDA). A widely used method for heat sterilization is the autoclave, sometimes called a converter or steam sterilizer. Autoclaves use steam heated to under pressure. To achieve sterility, the article is placed in a chamber and heated by injected steam until the article reaches a temperature and time setpoint. Almost all the air is removed from the chamber, because air is undesired in the moist
Sterilization (microbiology) heat sterilization process (this is one trait that differs from a typical pressure cooker used for food cooking). The article is held at the temperature setpoint for a period of time which varies depending on what bioburden is present on the article being sterilized and its resistance (D-value) to steam sterilization. A general cycle would be anywhere between 3 and 15 minutes, (depending on the generated heat) at at , which is sufficient to provide a sterility assurance level of 10 for a product with a bioburden of 10 and a D-value of 2.0 minutes. Following sterilization, liquids in a