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The F-value for steam sterilization (F0) is a measurement tool used to demonstrate accumulated lethality and must be used in both validation and routine monitoring of cycles to demonstrate that acceptance criteria for F0 has been met.
The F0 algorithm 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.
23 sty 2023 · To calculate the F0 value, average the temperature of each probe during the sterile hold and then average the different temperatures to get one single temperature. Use the formula shown in below to estimate the F0 value: Where, F0 Value = Equivalent Exposure Time. Δt = the time interval between two temperature readings.
22 mar 2022 · This article has procedure for autoclave validation including steam penetration, heat distribution and penetration, bio-challenge study, estimation of F0 value and acceptance criteria of steam sterilizer validation in pharmaceutical industry.
ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
5 mar 2021 · The objective of this protocol is to provide the method to be used for the validation of the sterilizing process using an autoclave meant for sterilization of Media, Glasswares, garments, Pipette tips and Borer etc.
F0 is a means for quantifying steam sterilization effectiveness by determining the equivalent sterilization time in minutes relative to a base temperature of 121 °C and a z-value of 10 °C ...
