The F0 value of a saturated steam sterilisation process is the lethality expressed in terms of the equivalent time in minutes at a temperature of 121 °C delivered by the process to the load in its container with reference to micro-organisms possessing a theoretical Z-value of 10.
——- Equation 1.0
Lethality rate (L) = 10(T-Tref)/z ——- Equation 2.0
T= Temperature of load article
Tref = Set sterilization temperature 121° C
Z Value = 10 (if not known for challenge organism)
Fphy or/ Fphysical = Time interval (Δt) × Accumulated Lethality (ΣL) ——- Equation 3.0
To demonstrate over kill approach Fphy must be > 12. Lower F0 can be acceptable for product specific approach based on the detailed knowledge of bioburden.
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