Dear all,

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.