We r validate the terminal Sterilizer (Super Heated Water Shower) at two temperature 106.1 for LDPE vials & 121.1 for PP vials. That is why we are using B.subtillis. I want to know that can I calculate the Fo value or not. is it required or not. i am giving the BI indicator details below…
B.subtillis (at 106 degree)
D value- 11.3 min
then we are going for 91 min at 106.1 for 8 log reduction by using the calculation.
8 Log reduction = D value at 106 x 8
= 11.3 x 8
Fo value is required or only on the basis of hold time & BI indicator sterility assurance we can released our terminal sterilizer for routine purpose.
please suggested me
Executive : QA Validation
Promed Exports Pvt. Ltd.