Muzaffer sarfuddin Tunnel Validation

GOOD VALIDATION PRACTICE (cGVP) LABORATORY, METHOD AND ANALYTICAL VALIDATION
1

Dear all,

Myself Muzaffer sarfuddin, i am having experience in solid oral dosage form and i am new to sterile dosage form and related validation. I want to know about the tunnel validation specially " fh " value how to calculate what is the formula to calculate “fh” value. Plz help me

2

Dear Muzaffer
you can calculated the Fh value for Tunnel As Below

Fh =∆t X 10^((T-250)/Z)

Where
∆t = Time interval between two reading

T = Observed Temp.
Z = 46.4 ° C

you can simple put this formula in Excel Sheet and getting the Fh Value