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反渗透膜作为各类杂质的主要屏障在纯化水和冷却注射用水的生产过程中发挥重要的作用。在制药行业，这个模块要能被加热消毒。消毒的频率要在确认中设定并且要在PQ中确定。问题是它应该以何种频率开始？答案是按照要求的频率，不要过多，因为消毒意味着对设备有热压力。 反渗透膜不是水纯化的唯一因素。RO常和EDI系统以及超滤系统结合在一起。消毒消毒操作并不是对每一个组件单独进行而是对整个纯化链一起进行。这里，EDI系统构成了对温度最敏感的部件。为了避免比每隔五年更多的更换，每三个月热消毒一次证明效果不错。这样耐用性可以达到100-120个周期。至少欧洲和Scandinavian地区如此。在原水质量更差的地区，可能需要提高频率。如已经提到的，无论如何在PQ的3阶段都要确定其功效。 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. 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. | 
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发表于 2017-4-24 22:16:12
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