主题：【原创】EP6.3纯化水中英对照

呵呵，楼主把PDF的复制都给禁了，不过不是什么问题，我看看吧。

先贴第一段我的翻译:

WATER, PURIFIED
Aqua purificata

Purified water in bulk 散装纯化水

Microbiological monitoring: During production and subsequent storage, appropriate measures are taken to ensure that the microbial count is adequately controlled and monitored. Appropriate alert and action levels are set so as to detect adverse trends. Under normal conditions, an appropriate action level is a microbial count of 100 CFU/ml, determined by filtration through a membrane with a nominal pore size not greater than 0.45 μm, using R2A agar and incubating at 30-35 °C for not less than 5 days. The size of the sample is to be chosen in relation to the expected result. 

微生物监测：在生产和贮存过程中，应采取适当的措施来确保有效控制或监测水中的微生物总数。设置适当的警戒阈值与行动阈值可用于发现不利的趋势。正常条件下，可用标称值不大于0.45 μm的微孔滤膜过滤，然后使用R2A琼脂在30-35℃培养至少5天后计数微生物总数，其合适的行动阈值是100CFU/ml，。检测所用样品量的选择与期望结果有关。

PS：最后一句是否应为：The size of the sample to be chosen is in relation to the expected result.  不是太明白。

原文由 hyheying 发表:
EP6.3中纯化水的标准有了一些改变，为了确保COS产品的生产用水符合EP标准，抽空从头至尾翻译了一遍，里面有很多不够专业的地方，希望大家看后批评指正。


纯化水中英对照

为什么附件被删除了那

原文由 fromaer 发表:
呵呵，楼主把PDF的复制都给禁了，不过不是什么问题，我看看吧。

我这里是可以复制的
可能跟你保存的路经有关

原文由 fromaer 发表:
先贴第一段我的翻译:

微生物监测：在生产和贮存过程中，应采取适当的措施来确保有效控制或监测水中的微生物总数。设置适当的警戒阈值与行动阈值可用于发现不利的趋势。正常条件下，可用标称值不大于0.45 μm的微孔滤膜过滤，然后使用R2A琼脂在30-35℃培养至少5天后计数微生物总数，其合适的行动阈值是100CFU/ml，。检测所用样品量的选择与期望结果有关。

感觉你翻译得比我好多了

原文由 fromaer 发表:
先贴第一段我的翻译:

WATER, PURIFIED
Aqua purificata

Purified water in bulk 散装纯化水

Microbiological monitoring: During production and subsequent storage, appropriate measures are taken to ensure that the microbial count is adequately controlled and monitored. Appropriate alert and action levels are set so as to detect adverse trends. Under normal conditions, an appropriate action level is a microbial count of 100 CFU/ml, determined by filtration through a membrane with a nominal pore size not greater than 0.45 μm, using R2A agar and incubating at 30-35 °C for not less than 5 days. The size of the sample is to be chosen in relation to the expected result. 

微生物监测：在生产和贮存过程中，应采取适当的措施来确保有效控制或监测水中的微生物总数。设置适当的警戒阈值与行动阈值可用于发现不利的趋势。正常条件下，可用标称值不大于0.45 μm的微孔滤膜过滤，然后使用R2A琼脂在30-35℃培养至少5天后计数微生物总数，其合适的行动阈值是100CFU/ml，。检测所用样品量的选择与期望结果有关。

PS：最后一句是否应为：The size of the sample to be chosen is in relation to the expected result.  不是太明白。

这个意见我赞同

Adjust the pH so that after sterilisation it is 7.2 ± 0.2. Sterilise by heating in an autoclave at 121°C for 15 min.
适当调整以使R2A琼脂灭菌之后的pH值为7.2 ± 0.2。通过在121°C高压锅中加热15分钟进行灭菌。

通过 不需要了吧

Growth promotion of R2A agar
— Preparation of test strains. Use standardised stable suspensions of test strains or prepare them as stated in Table 0008.-1. Seed lot culture maintenance techniques (seed-lot systems) are used so that the viable micro-organisms used for inoculation are not more than 5 passages removed from the original master seed-lot.
Grow each of the bacterial strains separately as described in Table 0008.-1. Use buffered sodium chloride-peptone solution pH 7.0 or phosphate buffer solution pH 7.2 to make test suspensions. Use the suspensions within 2 h, or within 24 h if stored at 2-8 °C. As an alternative to preparing and then diluting a fresh suspension of vegetative cells of Bacillus subtilis, a stable spore suspension is prepared and then an appropriate volume of the spore suspension is used for test inoculation. The stable spore suspension may be maintained at 2-8 °C for a validated period of time.
R2A琼脂促生长试验
—测试菌珠的准备：使用标准菌悬液或按表0008.-1中指定的方法制备。菌珠传代次数不得超过5代，并采用适当的菌种保藏技术以保证所使用菌珠的生物学特性。每种菌珠的生长分别按表0008.-1中描述的程序进行。使用pH7.0的氯化钠蛋白胨缓冲液或pH7.2的磷酸盐缓冲液制备测试菌悬液。制
备好的菌悬液应在2小时内使用，当贮存在2-8 °C时在24小时内使用。也可以通过制备并稀释枯草芽胞杆菌营养细胞的新鲜悬液进行替代，制备稳定的胞子悬液，在接种测试中使用适当体积的胞子菌悬液，稳定的胞子悬液在2-8 °C保存，保存期是经过验证的。

楼主的本文
Seed lot culture maintenance techniques (seed-lot systems) are used so that the viable micro-organisms used for inoculation are not more than 5 passages removed from the original master seed-lot.
菌珠传代次数不得超过5代，并采用适当的菌种保藏技术以保证所使用菌珠的生物学特性。这句话有待商讨

关于微生物监测的翻译是我最没有信心的一部分，请多提宝贵意见

As an alternative to preparing and then diluting a fresh suspension of vegetative cells of Bacillus subtilis, a stable spore suspension is prepared and then an appropriate volume of the spore suspension is used for test inoculation. The stable spore suspension may be maintained at 2-8 °C for a validated period of time.
也可以通过制备并稀释枯草芽胞杆菌营养细胞的新鲜悬液进行替代，制备稳定的胞子悬液，在接种测试中使用适当体积的胞子菌悬液，稳定的胞子悬液在2-8 °C保存，保存期是经过验证的。
新鲜悬液  新制备悬浮液
也可用另外一种方法：制备并稀释新制备的枯草芽胞杆菌营养细胞的悬浮液，得到一个稳定的孢子悬液，然后使用适当体积的此胞子菌悬液进行接种测试。此稳定的胞子悬液可以在2-8 °C保存一定的时间而不失效。