Fo Value
Fo Value
Fo Value
Firstly introduced by the National Canners Association in 1968 (a), F0 has to become a
topic in pharmaceutical production since the FDA used it extensively in the "Proposed
rules" of June 1st, 1976 (b), with the following meaning (section 212.3): "F0 means the
equivalent amount of time, in minutes at 121°C or 250°F, which has been delivered to a
product by the sterilization process".
For the calculation of it, "a z-value of 10°C or 18°F is assumed; the term z-value means
the slope of the thermal death time curve and may be expressed as the number of
degrees.... required to bring about a tenfold change in the death rate".
In practice, the knowledge of the temperature values as the continuous function of
elapsing time is not available, and F0 is calculated as follows:
where:
DELTA t = time interval between to following measurements of T
T = temperature of the sterilized product at time t
z = temperature coefficient, assumed to be equal to 10°C
If we assume a sterilization lasting 15 minutes, constantly at 121°C, we obtain: