Validation Of Dry Heat Sterilization Processes

By Zach Sparks, Manager of Validation Services, Mesa 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.
Source: Pharmaceutical Online News - Category: Pharmaceuticals Source Type: news