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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.

contents 1. essentials of moist heat sterilization kinetics 5 1.1. d-value or decimal decay time 7 1.2. sterility as "probable effect" of exposure time 7 1.3. z-value or temperature coefficient 9 1.4. f 0 or equivalent exposure time at 121°c 11 1.5. lethal rates 14 1.6. example of post-calculation of f 0 17 1.7. symbols and definitions used in sterilization technology 18

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