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 ?
Yes, you can; however, you’ll have to meet the 12min requirement for F0 (as per USP and PDA). You can reduce the temperature at the cost of extended cycles in order comply with an F0 of at least 12 min.
You’ll be compelled to state a rationale for the use of a low sterilization temperature though (e.g. product degradation, container-closure integrity, etc.), that supports the quality of the product.