SCOPE AND BACKGROUND

Steam sterilization is perhaps the most common of all sterilization processes. It is used in settings ranging from practitioner offices to large-scale manufacturing facilities. The diversity of practices that use steam sterilization is reflected in the range and sophistication of the equipment used. This general information chapter addresses sterilization in which saturated steam comes into direct contact with the load items (whether wrapped or unwrapped) and provides an overview of the basic concepts of this mode of sterilization, including its validation. The load items in this sterilization process are variously termed parts, components, hard goods, wrapped goods, or porous goods. These items may be metallic, glass, ceramic, elastomeric, or polymeric materials that have little or no sensitivity to thermal degradation at the sterilizing temperatures. For steam sterilization by direct contact, it is customary to sterilize items using an overkill method.