F0 a technical note - Fedegari

F0 a technical note What it means How to calculate it How to use it for adjustment, control and validation of moist-heat sterilization processes F0 A technical note What it means How to calculate it How to use it for adjustment, control and validation of moist-heat sterilization processes Written by: D. Pistolesi, V. Mascherpa First published: 1988 Revised: June 27th, 2014 Issued by: R&D Fedegari TN 170977-v3 / VIM - DM 352178 Pages: 33 This document is available for download at Fedegari web site: The F0algorithm was first introduced in 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.

Let us now consider what happens within a batch of units (vials, bottles or others) with an initial constant unit contamination of 100 microorganisms = 102. If the D-value at 121°C is assumed = 1, after one minute at 121°C, the reduction = to 101 = 10 microorganisms is achieved; after another minute, only 100 = 1 microorganism is still surviving.

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