臭氧浓度要求，求指示

Ryan15

ISPE水和蒸汽指南提到：
Many pharmaceutical water users have found that storing and distributing water at ambient
temperatures with periodic sanitization, (utilizing either clean steam or heating to 80℃ for
microbial control) to be safe and cost effective. The ambient system can also be effectively operated
with an ozonated storage and a periodically ozonated loop, in lieu of hot water sanitization (see
Figure 8-7). Levels of 0.02ppm to 0.2ppm of ozone protect the water from microbial
recontamination. Ozone needs to be completely removed from process water prior to usage, using
UV radiation. Consideration therefore must be given to verifying/assuring that ozone has been
eliminated, such as the use of In-Line monitors.
许多使用制药用水的用户已经发现在环境温度下存储和分配水并进行定期消毒（用干净的蒸
汽或加热到80℃进行微生物防治）是安全且成本有效的。用一个臭氧存储器及一个定期生成
臭氧的回路也能代替热水消毒（见图8-7），有效地操作环境温度系统。0.02ppm 到0.2ppm
的臭氧水平即能防止水受到微生物的再污染。使用前，应当使用UV 辐射将臭氧从过程用水
中完全去除。因此必须考虑验证/确保臭氧已经去除，比如使用在线监测。

Ryan15

0.02ppm 到0.2ppm的臭氧水平即能防止水受到微生物的再污染。

这句话，貌似在2010版GMP指南里也有