Hi, I’m working on cycle development for terminal sterilization. I thought to sterilize at 115C during 40 min to obtain F0=12 at the end of the sterilization phase or 115C during 25 min to obtain F0=8 at the end of the sterilization cycle.
My question is:
- Can I use the overkill method in validation if I obtain F0 between 8 and 12 at the end of the sterilization phase regardless the sterilization temperature (ie here 115C) ? Or to use overkill method we have to sterilize at 121C and have F0=12 at the end of the sterilization phase ?