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欧盟GMP关于无菌室要求

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al and particulate contamination ofРprotective clothing. They should be flushed effectively with filtered air. The final stage of theРchanging room should, in the at-rest state, be the same grade as the area into which it leads.РThe use of separate changing rooms for entering and leaving clean areas is sometimesРdesirable. In general hand washing facilities should be provided only in the first stage of theРchanging rooms.Р51.更衣室应与气闸室并用,对不同阶段更衣进行物理隔离,以减少服装微生物和尘埃粒子污染。Р更衣室应当用经过过滤的空气有效冲洗。更衣室最后阶段应当与所进入的区域的洁净级别(静态)Р相一致。最好在进入洁净区和离开洁净区时使用不同的更衣室。一般洗手设施应当在更衣的第一阶段。Р52. Both airlock doors should not be opened simultaneously. An interlocking system or a Рvisual and/or audible warning system should be operated to prevent the opening of more thanРone door at a time.Р52.气闸室的两个门应不能同时打开。应当有联锁装置,或视觉或听觉的报警装置,

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