Please guide me in the following-
1) What is the frequency of Heat penetration study by Bowie dick test method? What is the rationale behind it & regulatory specifications? Ours is steam sterilizer.
2) On what basis we are deciding the number of temperature sensors while validating steam sterilizer & Tunnel (Dry heat sterilizer)? Is there any guidance for the same?
3) In tunnel we are going for both sterilization & Depyrogenation. But in Autoclave we are doing only sterilization.Can we remove endotoxins in steam sterilization? If not what will be the fate of the items sterilized? How can it be explained? What is the minimum temperature required to remove endotoxins?