F value (Dry sterilizer)

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
1

Dear. all
According to the recently revised EU GMP ANNEX1
It says that a study should be done on the F value, does anyone have any experience on how to do this?

8.26 when a thermal process is used as part of the depyrogenation process for any component or prodcut contact equipment/material, validation studies should be performed to demonstrate that the process provides a suitable fh value and results in a minimum 3log reduction in endotoxin concentration.

2

Hello,
The temperature should be monitored by a calibrated data acquisition system with proper accuracy. Data should be collected (we use 1 min as frequency) and FH can be calculated by the system or in Excel. It’s a quite simple formula. Depending on the D value of the endotoxin, the SAL can be calculated. FH should be divided by D value to get the log reduction.