反渗透（RO）多久消毒一次

胜利者

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Reverse osmosis (RO) as a main barrier to all types of impurities plays an essential role in both the production of Purified Water (PW) and cold WFI production. In the pharmaceutical industry, this module has to be heat sanitisable. The frequency of sanitisation is set in the qualification and has to be confirmed in the course of the Performance Qualification (PQ). Now the question is at which frequency should one initially start? The answer is: as often as required but not more than necessary, as sanitisation means thermic stress for the equipment.

反渗透（RO）作为对所有杂质最重要的屏障在纯化水（PW）和冷注射用水的制备中有着必不可少的作用。在制药行业，这种膜需要被热消毒。消毒的频次在确认时确定，并应该在性能确认期间被确证。现在问题是应该采取什么样的频次？答案是：需要什么频次就什么频次，但是不要过度，因为消毒意味着热的蒸汽给设备。

Reverse osmosis is not the only element for water purification. RO is very often combined with an EDI unity and an ultrafiltration system. Sanitisation doesn't operate for each component separately but for the whole purification chain. Here, the EDI unity constitutes the most temperature-sensitive component. To avoid a replacement more than every five years, sanitisation by heat every three months has proven to be fruitful. A durability of 100-120 cycles can be expected. This applies to at least Europe and the Scandinavian region. Where the quality of the source water is worse, it may be necessary to increase the frequency. As already mentioned, the efficacy has to be confirmed - in any case at stage 3 of the PQ.

RO不是水净化的唯一要素。RO常与一个EDI单元和一个超滤系统联合使用。消毒不会单独对每一个部件进行，而是对整个净化系统。这里，EDI单元包含有温度敏感的组件。为避免每5年就要更换，每三个月热消毒一次被证明是富有成效的。预期能有100~120次的耐用性。这至少在欧洲和斯堪的纳维亚地区有应用。在源水质量较差的地区，有必要增加频次。如上所述，它的有效性应该被确证——总之在PQ的阶段3进行。

albance

根据实际监测结果来吧，莫这么复杂

胜利者

这是EU的问答

静水蓝心

胜利者 发表于 2017-4-20 07:25
这是EU的问答

不错

吐槽2013

盗用他人翻译分享  很好的啦

terbiumcf

非常感谢分享！谢谢！

良心药123

感谢分享，不断学习中