Dry Heat Sterilization is a sterilization process that can be used to terminally sterilize health care products, medical devices, equipment, components or bulk active pharmaceutical ingredients by exposing the items to a temperature of ≥ 160°C for a defined time. For heat stable items, such as glassware or stainless steel equipment, a dry heat sterilization cycle can be run at 250°C to remove bacterial endotoxins from the items. This process is also referred to as Depyrogenation. Bacterial endotoxins are fever inducing compounds, or pyrogens, that are released when the cell walls of gram negative bacteria such as Escherichia coli are destroyed. Validation of dry heat sterilization cycle(s) is required by ANSI, AAMI, ISO, USP and the FDA to ensure that all items that are required to be sterile or pyrogen free are able to consistently and reliably be sterilized to reduce the chance of introducing or spreading an infectious microorganism or pyrogen. Installation Qualification (IQ) V