20160203 ECA新闻：常见问题：高/常温存贮注射水系统需要的臭氧浓度是多少？

20160203 ECA新闻：常见问题：高/常温存贮注射水系统需要的臭氧浓度是多少？

GMP News
03/02/2016

Frequent Asked Question: Which Level of Ozone is Required in a Hot- or Cold-Stored WFI System?

常见问题：高/常温存贮注射水系统需要的臭氧浓度是多少？

The usage of ozone is only senseful in cold water systems. But the decisive question is whether ozone is used for a short-term (1-2 hours) or for a long term (> 6 hours) prevention of microbial growth. In the first case, > 50 ppb ozone is generally sufficient whereas in the second case at least 20 ppb are required.

使用臭氧只在冷水系统里才有意义。但决定性的问题在于臭氧是要短时（1-2小时）应用还是长时（>6小时）应用才能防止微生物生长。在第一次情况下，>50ppb的臭氧一般就足够了，而在第二种情况下，则至少需要20ppb的浓度。

One should keep in mind that WFI cold systems have basically a higher risk of microbial contamination. The need for ozone in large ring systems or in areas difficult to access may be higher. The ozone levels mentioned should thus be achieved in the return flow. Setting the correct ozone concentration for the system must be done within the scope of the PQ - i.e. validation of the water system.

生产商应记往，常温注射水一般来说会有更高的微生物污染风险。循环线比较长或难以达到的区域内其臭氧浓度可能需要高一些。应在回水中达到上述臭氧浓度。在PQ（即水系统的验证）里必须为系统设定正确的臭氧浓度。

In contrast, ozonisation of hot-stored WFI systems doesn't make sense. Indeed, the half-life of ozone considerably decreases at temperatures over 40° Celsius. Moreover, the heat in hot WFI system causes sanitisation itself; the usage of additional ozone wouldn't be meaningful. The risk of biofilm formation in hot-stored WFI systems is considerably lower.

相反，高温存贮的注射水系统则没有意义。实际上，臭氧的半衰期在40摄氏度以下会显著降低。另外，高温注射水系统里的热量本身就有消毒作用，额外使用臭氧其实并没有意义。在高温存贮的注射水系统里，生物膜形成的风险要低很多。

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