1 回答
就干热灭菌而言，计算FH时的参考温度没有强制的规定，目前主要是以160℃作为参考温度。其他参考温度也可以考虑
参考：
1.ISO 20857:2010 Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
2.PDA TR03 (2013) Validation of Dry Heat Processes Used
for Depyrogenation and Sterilization
3.PDA TR03 (1981) Validation of Dry Heat Processes Used
for Sterilization and Depyrogenation
4.2010版药品GMP指南-无菌药品
