STERILIZATION OF HIGH-RISK LEVEL CSPs BY STEAM
The process of thermal sterilization saturated steam under pressure, or autoclaving, is the preferred method to terminally sterilize aqueous preparations that have been verified to maintain their full chemical and physical stability under the conditions employed (see Steam Sterilization and Sterility Assurance of Compendial Articles <1211>). To achieve sterility, all materials are to be exposed to steam at 121C under a pressure of about 1 atmosphere or 15 psi for the duration verified by testing to achieve sterility of the items, which is usually 20 to 60 for CSPs.
Not directly exposing items to pressurized steam may result in survival of microbial organisms and spores. Before their sterilization, plastic, glass, and metal devices are tightly wrapped in low-particle shedding paper or fabrics or sealed in envelopes that prevent poststerilization microbial penetration.Immediately before filling ampuls and vials that will be steam sterilized, solutions are passed through a filter having a nominal pore size not larger than 1.2um for removal of particulate matter. Sealed containers shall be able to generate steam internally; thus, stoppered and crimped empty vials shall contain a small amount of moisture to generate steam.