Essentials Of Moist Heat Sterilization Kinetics

The F₀ algorithm was firstly introduced 1968 in the international practice of food industry, and proposed by FDA in 1976 for the pharmaceutical sterilization of Large Volume Parenterals: it is now officially included in most Pharmacopoeias.

Yet, F₀ is still regarded with some suspicion from a conceptual point of view, and frequently misinterpreted. It is always necessary to remember that F0 has been invented in the industrial field of heat sterilization processes of water-containing products.

The purpose of this Fedegari Technical Note, firstly distributed in 1988 and perseveringly revised, is to clarify the nature of F0 and its related parameters (D, z, PNSU/SAL), and to explain their use and limits for the setting, adjustment, control and validation of moist-heat sterilization processes.