20150429 ECA新闻：膜技术生产的注射用水在欧洲会成为替代方法吗？

20150429 ECA新闻：膜技术生产的注射用水在欧洲会成为替代方法吗？  2015-04-29 23:20:56|  分类： ECA新闻

GMP News
29/04/2015

Will WFI from membrane-based technologies now become an alternative for Europe?

膜技术生产的注射用水在欧洲会成为替代方法吗？

In an EDQM paper published in Pharmeuropa in March 2015 the topic production of WFI (water for injections) by means of membrane technologies (reverse osmosis coupled with other suitable techniques) is discussed again and not excluded any more. So far distillation is the only permitted procedure for the production of WFI in Europe. It was already pointed out in the paper on the revision of Annex 1 published in February that alternative procedures for the manufacture of WFI might become possible.

在2015年3月EDQM公布的欧洲药典在线中，关于采用膜技术（反渗透配合其它适当的技术）方法生产注射用水（WFI）的议题又进行了讨论，并且没有被排除其可用性。到目前为止，在欧洲仅允许使用蒸馏方法制备注射用水。在2月公布的对附录1的修订文章中已指出使用替代方法生产WFI可能会成被允许。

The first part of the new document describes the history of the long lasting discussion of the question whether other procedures than distillation should be allowed for the production of WFI. In the end this led to the creation of a new monograph of highly purified water (HPW). This is water with WFI quality produced by means of membrane-based technologies. But its possible applications were very restricted.

新文件的第一部分描述了长期讨论是否除蒸馏以外的其它方法应被允许用于生产注射用水的问题的历史。最后导致了产生了一个新的高纯水（HPW）的各论。这是采用膜技术生产的具备WFI质量的水，但其用途受到限制。

Now it looks as though the Ph. Eur. Water for Pharmaceutical Use (WAT) Working Party has concluded that there is evidence to support a revision of the WFI monograph in the European Pharmacopoeia (0169). As reasons for this change are indicated for example advances in the "non-distillation technology" and improvements in the design of the water-production systems as well as an advanced process control. But it is acknowledged that the design and maintenance of any water-production system plays an important role in ensuring  the security of the produced water. The manufacturer is responsible for compliance with GMP requirements. Presumably, existing guidance documents must be complemented for this by the appropriate stakeholders. Furthermore, quality assurance and monitoring should extend to storage and distribution processes for WFI.

现在看来欧洲药典制药用水工作组已得出结论有证据支持对WFI各论（0169）的修订。这些变化的理由是对非蒸馏技术的先进性，以及制水系统的设计的改善，和先进的工艺控制。但是，大家知道任何制水系统的设计和维护在保证所制得水的安全中起着重要作用。生产商有责任符合GMP的要求。估计现有指南文件必须由适当的干系人进行补充。另外，质量保证和监控应延伸到WFI的存贮和分配过程。

As a result the highly purified water monograph (1927) would be made redundant and be deleted. Furthermore, the inclusion of water for dialysis in the WFI monograph could also be contemplated.

作为修订的结果，高纯水各论（1927）将成为冗余，会被删除。另外可能也会考虑在注射用水各论中包括了透析用水。

The draft monograph is available on the EDQM webpage for free, after registration. The main change reads:

各论草案现在在EDQM的网站上已经公布，可以免费注册后获取。主要变更为：

WFI is produced either by [..destillation, . ].or

by reverse osmosis, which may be single-pass or double-pass, coupled with other suitable techniques such as deionisation and/or ultrafiltration.

Correct operation monitoring and maintenance of the system are essential.

WFI是由蒸馏方式或反渗透方式生产，单次或双重膜，配以适当的技术，例如去离子和/或超滤技术。对系统进行正确的操作监控和维护是必要的。

The EDQM already organised a special webinar on April 22nd where this topic has been discussed.

EDQM已经在4月22日组织了一个专门的研讨会讨论了该主题。

The original document mentioned above discusses the alternative production methods for WFI.

上述讨论所提到的原始文件参见上述网址。