湿热灭菌柜温度控制要求

我真是你宇哥

请教大家，关于湿热灭菌柜空载和负载的温度分布的法规要求中，是否有见过这样一条“灭菌阶段各点温度的平均值与设定值的差值在±1度范围内”；如果见过，请问在哪个法规中有，十分感谢！

代山涛

没见过这种说法

猫咪特工

未曾听闻

连天巷

没见过，只是这一条：


8.2.1.2.3        Throughout the holding time the temperature measured at the reference measurement point of the sterilizer chamber, any temperature measured within the test pack and the theoretical temperature of the saturated steam determined from the measured sterilizer chamber pressure shall:

a)        be within the sterilization temperature band;
b)        not differ from another by more than 2 K.

star19890531

化学药品注射剂灭菌和无菌工艺研究及验证指导原则(试行)里边有，热分布试验的保温阶段内温度波动应在±1.0℃之内