【ECA新闻】WHO发布新指南草案：通过蒸馏以外的方法生产注射用水

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New WHO Guideline on "Cold Production of WFI"

According to the European Pharmacopoeia, it has been possible to produce water for injection (WFI) using non-distillation methods since March 2017. The WHO has now published a new guideline on this subject for comment. The draft document entitled "PRODUCTION OF WATER FOR INJECTION BY MEANS OTHER THAN DISTILLATION" doesn't contain any significant innovations compared to the WFI Monograph (0169) itself or the Q&A document of the EMA.

根据欧洲药典，自2017年3月起，可以使用非蒸馏方法生产注射用水(WFI)。世界卫生组织现在就这一主题发表了一项新的指南，现征求意见。与WFI各论(0169)或EMA问答相比，这份题为“通过蒸馏以外的方法生产注射用水”的草案没有任何重大创新。

The text contains few technical details, but it is said that the combination of reverse osmosis (double-pass) with ultrafiltration, softening, pre-filtration and degasification can be useful. All parts of the system should be suitable for routine sanitization, including reverse osmosis membranes. The text refers to thermal, chemical methods or a combination of both methods. WFI should be produced from drinking water or purified water (PW). It shall be demonstrated that the purification process of distillation is comparable or better. The integrity of the membranes should be checked regularly. In addition, in-line monitoring should be provided, without specifying which parameters are to be considered here (conductivity, TOC, microbiology?).

指南中技术细节不多，但据说将反渗透(双通)与超滤、软化、预滤和脱气相结合是有用的。系统各部分应适合常规消毒，包括反渗透膜。指南所参照的方法是热法、化学法或两种方法的结合。WFI需基于饮用水或纯化水（PW）产生。应证明蒸馏的净化工艺是相当的或更好的。定期检查膜的完整性。此外，应提供在线监测，但未指定此处应考虑哪些参数(电导率、TOC、微生物？)。

The document mentions the term "no risk" several times, i.e. that non-distillation production does not pose a risk of contamination of the WFI (5.4, 6.1, and 7.7). However, a "no risk" or "0 risk" requirement is not practicable. In paragraph 6.2, however, this is somewhat mitigated. It states that the risk must be reduced to an acceptable level.

该文件多次提到“无风险”一词，即非蒸馏生产不引起WFI污染的风险(5.4、6.1和7.7)。然而，“无风险”或“零风险”要求是不切实际的。但是，在指南的第6.2段中，这种情况有所缓和。它规定必须将风险降低到可接受的水平。

The draft can be commented on until 15 April 2019.

该草案可以在2019年4月15日前可供评论。

For further details please see the WHO Guideline "PRODUCTION OF WATER FOR INJECTION BY MEANS OTHER THAN DISTILLATION" - also to be found on the WHO website under Current Projects.

更多细节见WHO指南：通过蒸馏以外的方法生产注射用水，也可在WHO网站上找到。

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