当前对药用水系统和臭氧的思考

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Current Considerations on Pharmaceutical Water Systems and Ozone

当前对药用水系统和臭氧的思考

When ozone is used to sanitize storage and distribution systems, its effectiveness must be proven. On the one hand, this is done indirectly by determining the CFU values and, on the other hand, by proving that the ozone concentration is being measured correspondingly in the water system.

当使用臭氧对存贮和分配 系统进行消毒时，必须要证明其有效性。一方面，这是通过测定CFU值来间接证明的，另一方面，通过证明水系统中测量出的对应的臭氧浓度来支持。

For instance, the ISPE Baseline list at least three measuring points for this reason:

例如，ISPE基准根据上述理由列出了至少3个测量点：

• Before the UV system (discharge of the storage tank)
• 在紫外系统（贮罐排放）之前
• After the UV system
• 在紫外系统之后
• In the return flow
• 在回路上
  

The ozone value before UV indicates that during permanent ozonisation, the concentration in the storage tank is sufficient and that the ozone generator is working correctly. After the UV system, permanent measurements are performed during operation to indicate that the ozone is removed. In the return flow of the piping system, measurements are taken to prove that the ozone concentration is sufficient during sanitization of the pipes after the UV lamp.

紫外前面的臭氧值表示在永久臭氧生成过程，贮罐浓度足够高，臭氧发生器工作正常。紫外系统后面的永久措施是在运行过程中实施的，显示臭氧已被清除。在管道回路中，进行测量是为了证明在紫外灯后的管道在消毒过程中具有足够高的臭氧浓度。

Experts recommend comparing the values before UV and in the return flow in order to calculate the system's specific half-life period of the ozone. This typically amounts to 15 minutes for polluted systems and can amount to over 60 minutes for very clean systems. For technical reasons, it is necessary to know the half-life period, as the UV system cannot completely break down the ozone and the current ozone measurement technique has a lower detection limit of 5-10 ppb. For critical applications where the water has direct contact with the product, it is mandatory to know the system-specific half-life period of the ozone for a solid risk assessment. In future, this topic will certainly gain importance when cold WFI will be produced and stored in the course of the European Pharmacopoeia Revision. In case that an upgrade to WFI is planned after April 2017, current HPW systems should be reviewed accordingly even today.

专家建议比较紫外前和回路中的臭氧值，以计算系统的臭氧半衰期。对于受污染的系统该值一般为15分钟，对非常清洁的系统可以长达超过60分钟。鉴于技术方面的原因，有必要知道半衰期，正如紫外系统不能完全阻隔臭氧，当前臭氧测量技术检测限可达到5-10ppb。对于关键的应用系统，如果水直接与药品接触，则必须知道系统中臭氧的半衰期，以进行可靠的风险评估。将来，在EP修订过程中，使用低温制备和存贮WFI时，此主题必将变得很重要。如果在2017年4月之后计划升级WFI，则现在就应该对HPW系统进行相应的审核。

一片红云

谢谢分享

xutongxiang01

可以用巴氏消毒代替抽样啊，那样不是就可以解决后顾之忧了吗？

syhorchid

中英对照，顶一下。

西文

现在数据完整性要求较高  坚决不支持使用臭氧

xqliu

学习一下啦，谢谢提供分享。我们是使用巴氏法。

syp蒲公英

我们使用巴氏消毒

落逸

学习了，谢谢分享

wood295

比较常规为巴氏消毒

oО星辰﹏

辛苦了，谢谢分享。