I have a question about FH value of sterilizing dry heat.
According to Chapters: <1229.8> DRY HEAT STERILIZATION in USP
For the specific reference temperature of 170 and a z-value of 20, the FH (reality) calculation can be determined by the following equation:
FH = ΔT x Σ10^[(T − 170) / 20]
I want to ask: What is the acceptance criteria for FH?
The biological indicator (BI) that I used to have the population N = 2.1x10^6 and d-value of 1.3 at 170.
I hope you can help me to resolve this problem.