Is process validation require for addition of terminal sterilizer for terminal sterilization of filled vials with same make and working principle as existing one?
I am asuming you are replacing your current autoclave. An autoclave is a critical piece of equipment that you cannot replace on a like-for-like basis.
You need to qualify all loads to be processed in the autoclave. If multiple final products are to be autoclaved, perform a risk assessment to determine worst case products/loads. Or use bracketing/family approach to limit amount of process validation.
Thank you for your explanation,
But I am not replacing the autoclave , along with existing one one I am adding one for manufacturing flexibility.
Okay, I understand. Still, as a critical piece of equipment, perform risk assessment to determine (and document!) if and how you need to perform validation studies.
Never just assume any piece of critical equipment to perform identical to another, even if same make and model.
Use like-for-like principle only in case of non-impact equipment