主题:【原创】EP6.3纯化水中英对照

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lingzhong
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原文由 redanqi 发表:
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
其实这句话就是强调采用的菌种保藏技术不能过度损伤传代菌株的生物活性,即仍然可生长繁殖,同时传代不得过5代。因为保藏技术其实跟传代代数无关,还是怪这话又臭又长。
其实意思都是一样的。
PS:菌株
lingzhong
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原文由 redanqi 发表:
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。


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。
这个还不如原来的,这句话强调这个保存期要验证。
该帖子作者被版主 redanqi8积分, 2经验,加分理由:一起奖励了吧
何当奇
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原文由 lingzhong 发表:
原文由 redanqi 发表:
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。


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。
这个还不如原来的,这句话强调这个保存期要验证。

保存期如何验证?
何当奇
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原文由 lingzhong 发表:
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。


警戒阈值可为警戒限、行动限。最后一句应该是说检验量可以增大。

不明白
何当奇
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原文由 lingzhong 发表:
原文由 redanqi 发表:
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


通过在121°C高压锅中加热15分钟进行灭菌。可为使用高压锅121°C下高压灭菌15分。

简单的说,高压锅121°C下高压灭菌15分。
lingzhong
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原文由 redanqi 发表:
— Growth promotion. Test each batch of ready-prepared medium and each batch of medium, prepared either from dehydrated medium or from the ingredients described.
Inoculate plates of R2A agar separately with a small number (not more than 100 CFU) of the micro-organisms indicated in Table 0008.-1. Incubate under the conditions described in the table. Growth obtained must not differ by a factor greater than 2 from the calculated value for a standardised inoculum. For a freshly prepared inoculum, growth of the micro-organisms must be comparable to that obtained with a previously tested and approved batch of medium.
—促生长试验:测试每批已制备好的培养基以及采用脱水培养基制备或按指定的成分制备的培养基。
分别将表0008.-1中指定的不超过100CFU的菌悬液(或孢子悬液)接种在R2A琼脂上,按表中指定的条件进行培养。对于新鲜制备的细菌培养液,微生物的生长必须与先前测试过或者已经认可的培养基具有可比性。

这是楼主的原文

这个感觉差不多


对于新鲜制备的细菌培养液,微生物的生长必须与先前测试过或者已经认可的培养基具有可比性。
细菌培养液应该是培养基,对于第一句中每批的理解,或许应该理解为每高压一批。
lingzhong
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原文由 redanqi 发表:
Total organic carbon or oxidisable substances. Carry out the test for total organic carbon (2.2.44) with a limit of 0.5 mg/l or alternatively the following test for oxidisable substances: to 100 ml add 10 ml of dilute sulphuric acid R and 0.1 ml of 0.02 M potassium permanganate and boil for 5 min; the solution remains faintly pink.
总有机碳或易氧化物质:按2.2.44所描述的方法测试总有机碳,限度为0.5 mg/l;或按下述方法测试易氧化物质:取本品100ml,加稀硝酸10ml及0.02M高锰酸钾滴定液0.1ml,煮沸5分钟,溶液仍然显粉红色。

我怎么觉得这个英文的问题很大啊,是缺少内容了吗?
限度时检测限吗? the solution remainds faintly pink,这句什么意思?是煮沸前就是粉色,还是煮沸后呈粉色?


前后都应该是粉红色吧,remain嘛
lingzhong
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原文由 redanqi 发表:
Conductivity. Determine the conductivity off-line or in-line under the following conditions.
EQUIPMENT
Conductivity cell:
— electrodes of a suitable material such as stainless steel;
— cell constant: the cell constant is generally certified by the supplier and is subsequently verified at suitable intervals using a certified reference solution with a conductivity less than 1500 μS·cm−1 or by comparison with a cell having a certified cell constant; the cell constant is confirmed if the value found is within 2 per cent of the certified value, otherwise re-calibration must be performed.
电导率:按下列条件进行在线或离线电导率测试。
设备:电导池。
一个适当材料(如不锈钢)的电极;
电池常数:电池常数通常被供应商校正,并且以适当的周期使用已经过鉴定的电导率低于1500 μS·cm−1的参照溶液进行确认,或者用一个已经过鉴定的电池常数进行测试比较(标准电极?),如果测得值在给定值的2%以内则此电池常数符合规定,否则应重新校正
这个英文本身比较别扭,翻译出来的中文就有点不顺口。
很可能是因为隔行如隔山,我对这行不懂


已经过鉴定的可以为有资质证明的,该处1500有待商榷,可参考制药用水章节里的内容。
lingzhong
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原文由 redanqi 发表:
Conductometer: accuracy of 0.1 μS·cm−1 or better at the lowest range.
System calibration (conductivity cell and conductometer):
— against one or more suitable certified reference solutions;
— accuracy: within 3 per cent of the measured conductivity plus 0.1 μS·cm−1.

电导率仪:准确度为0.1 μS·cm−1或更低的范围;
系统校正(电导池和电导率仪):
一个或一个以上的已经过鉴定的参照溶液;
准确度:在被测电导率加0.1 μS·cm−1的3%以内;
better at the lowest range 最低范围更好
against这里是什么意思


可以理解为使用、依据一类的吧
lingzhong
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原文由 redanqi 发表:
Temperature measurement : tolerance ± 2 °C.
PROCEDURE
Measure the conductivity without temperature compensation, recording simultaneously the temperature. Temperature-compensated measurement may be performed after suitable validation. The water to be examined meets the requirements if the measured conductivity at the recorded temperature is not greater than the value in Table 0008.-2.

温度测量:误差± 2 °C
操作程序:在没有温度补偿下测试电导率,同时记录测试温度。在适当的确认之后温度-补偿测量可能被执行。在所记录的温度下测得的电导率不超过表0008.-2中的值则被检测水的电导率符合要求

Temperature-compensated measurement may be performed after suitable validation. 在适当的确认之后温度-补偿测量可能被执行。
这句翻译有点异议  在适当的验证之后可执行温度-补偿测量  主要是这个被动语态在中文感觉不是很常见  然后那个validation是什么操作呢?


其实validation可理解为确认、也可为验证,这里其实就是要验证温度补偿功能是否适用,一般而言,不建议使用这个功能。好像USP就是不让使用温度补偿功能。
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