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发表于 2014-1-28 14:49:58
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首先查询走廊的英文单词,分别有如下单词:corridor、passage、lobby、aisle
分别用这些单词,在US FDA《Sterile Drug Products Produced by Aseptic Processing —Current Good Manufacturing Practice》200409版里面检索,
有如下内容:
1-Sample timing, frequency, and location should be carefully selected based upon their relationship to the operation performed. Samples should be taken throughout the classified areas of the aseptic processing facility (e.g., aseptic corridors, gowning rooms) using scientifically sound sampling procedures. Sample sizes should be sufficient to optimize detection of environmental contaminants at levels that might be expected in a given clean area.
仔细阅读这段,描述环境监控内容,没有涉及车间如何布局和设计的内容。
2-passage,在上述指南里面有内容,但是不是作为走廊使用,而是作为通过,主要接受微生物穿透过滤膜,因此不引用原文。
3-lobby,这个单词没有使用。
4-aisle,这个单词也没有使用。 |
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