【讨论】validation-of-pure-steam

zhulikou431

Pure steam is used in various operations in pharmaceuticals but its use in
sterilization is very common in pharmaceutical sterile manufacturing.
Pure steam system should be qualified. A WHO guide to good manufacturing
practice (GMP) requirements-Part 2: Validation (page-11) clearly says to perform
the performance qualification of pure steam. At the time of performance
qualification of pure steam generation system, sample shall be taken from each
steam user point and analyzed for three consecutive days. Purified water system
must be qualified before starting the qualification of pure steam.
Sampling of Pure Steam: Sampling for Bacterial Endotoxin Test and chemical tests
should be done separately. Depyrogenated tubes or bottles should be used for
taking sample for bacterial endotoxin test. Allow the steam to drain for minimum
one minute. Open the cap of bottle and fill the bottle with steam condensate by
holding the bottle in the holder. Gloves should wear into the hands while
sampling the pure steam. Tighten the cap of the bottle and mark with the
sampling information. It sample is not analyzed within 2 hours of sampling,
store the sample at 2-8 °C.
Analysis of Pure Steam: Pure steam should be analyzed for following tests.
1. Non-condensable Gases: Non condensable gases are air and carbon dioxide
those do not condense with the steam. These are generated due to their presence
in the purified water that continuously circulates in the water distribution
system. Non condensable gases should not be more than 3.5%.
2. Steam Dryness Value: Dry steam has more energy than the wet steam. Wet steam
has water with it and does not have heat energy as dry steam. Dryness of steam
is determined by the latent heat. Dryness of the pure steam should not be less
than 90%. High moisture content can cause the loss in energy of steam and that
may cause the longer sterilization time.3. pH: Steam condensate is analyzed for
pH value at 25 °C . It should be between 5-7.4. Conductivity: Conductivity
should be tested with calibrated conductivity meter at 20 °C. Conductivity
should not be more than 1.3 μS/cm.5. Microorganisms: Steam condensate is tested
for microbial contamination using pore plate method. There should not any
microbial contamination in steam condensate.6. Endotoxin Test: Determine the
endotoxin in the pure steam condensate and it should not be more than 0.25 EU/ml
as in water for injection.

wangjin1023

你不能翻译下啊虽然我看不吃力，别人看可能吃力啊

andysyq

wangjin1023 发表于 2014-4-8 15:00
你不能翻译下啊虽然我看不吃力，别人看可能吃力啊

你也可以翻译一下的吧

VS____L

    纯蒸汽在制药业生产中有着不同的运用，但是在灭菌生产中使用非常广泛。因此纯蒸汽需要做确认。WHO关于GMP的法规要求——第二部分：验证章节中明确指出实施纯蒸汽的性能的确认。在纯蒸汽性能确认的过程时，取样点为每个纯蒸气的使用点且连续取样三天。纯水系统的验证必须在纯蒸汽验证之前完成。
    纯蒸汽取样：细菌内毒素取样和化学检测取样必须分开进行。细菌内毒素取样必须使用脱氢酶的取样管或取样瓶。打开蒸口至少放出1分钟蒸汽，然后打开取样瓶，让瓶子装满蒸汽冷凝水，取样时取样人需要带手套防止烫伤。拧紧瓶盖，贴上取样标签。将样品放置在2~8°C储存，取样两小时内不得检测。
    纯蒸汽的检测：纯蒸汽必须按照以下步骤进行检测。
1、        非冷凝性气体：非冷凝性气体指空气和二氧化碳那些不于蒸汽凝结的气体。产生这些都是由于他们的存在在不断循环的纯净水水分配系统。非冷凝性气体不得超过3.5%
2、        蒸汽干燥值：干蒸汽能量超过湿蒸汽，因为湿蒸汽中有水，所以没有干蒸汽能量高。干燥蒸汽由潜伏热决定。干燥蒸汽的量不得低于90% 。水分含量高会导致蒸汽能量的损失，最终导致灭菌时间延长。
3、        Ph：蒸汽冷凝水在25°C时进行pH检测，检测合格范围5~7。
4、        导电性：导电性应该在20°C时用经过校准的电导率仪进行检测。导电性不应超过1.3μS/cm。
5、        微生物检测：使用孔板进行微生物污染检测蒸汽冷凝液。微生物不得检出。
6、        内毒素检测：检测蒸汽冷凝液的内毒素，不得超过0.25EU/ml。


翻译比较仓促，如果有错误之处，望指正。

ptq518

将样品放置在2~8°C储存，取样两小时内不得检测。

应该是“样品不能在2小时内测试，则应在2-8℃下贮存”吧

郦无悔

这段话的出处是哪里呢？

VS____L

ptq518 发表于 2014-4-9 14:33
应该是“样品不能在2小时内测试，则应在2-8℃下贮存”吧

这个不是一个意思吗？放在2~8度下储存，两小时内不得检测，可能没润色吧，两小时后检测好点。

chia62888

"取样点为每个纯蒸气的使用点且连续取样三天。"
取样点好象应该在纯蒸汽发生器中,而不应该是使用点吧

相约酒吧as

请问楼主，这句话出自哪里？能否再详细一下，实在找不到，谢谢。

天天蓝

你好，关于纯蒸汽验证的这段英文的出处是什么？

小金库

学习一下，谢谢分享