通风系统|实验室设计装修|创泽实验室|净化实验室施工|GMP洁净厂房
020-29034568   樊经理18664877353  燕经理18589255521
规划设计_GMP车间规划 (下)
发表时间:2018-11-14 09:51

规划设计_GMP车间规划 (下)

The room with clean level should be arranged according to the following requirements  under the condition of meeting the process conditions:

在满足工艺条件的前提下,有洁净级别要求的房间按下列要求布置:


1.clean rooms (areas) with high cleanliness should be located at the least accessible places, and should be close to the air conditioning room;

洁净级别高的洁净室(区)宜布置在人员最少达到的地方,并宜靠近空调房


2.clean rooms (zones) with different cleanliness grades should be arranged in accordance with cleanliness level;

不同洁净度等级的洁净室(区)宜按照洁净度的等级高低油里及外布置;


3.clean rooms (areas) with the same air cleanliness should be relatively concentrated;空气洁净度相同的洁净室(区)宜相对集中;


4.different cleanliness class room between personnel and material access should be to prevent pollution measures, such as setting up locker room, buffer room, transfer window, etc.;不同洁净度等级房间之间人员及物料的出入应有防止污染的措施,如设置更衣间,缓冲间,传递窗等;


5.clean room (area) of the clean air to recycling, effective measures should be taken to avoid contamination and cross contamination;洁净室(区)的净化空气如何循环使用,应采取有效措施避免污染和交叉污染;

6.clean room (area) of the installation of the pool, floor drain shall not cause pollution to the medicines, class 100 clean room (area) shall be set up floor drain, the operator should not bare hand operation, compromise is inevitable, the hand should be eliminated in time; class 10000 clean room (area) the use of transmission equipment may not cross the lower level more than 100000 regional areas; clean work clothes should clean room (area) in the washing, drying, finishing, when necessary, according to the requirements of sterilization.洁净室(区)的安装的水池,地漏不得对药品产生污染,100级洁净室(区)内不得设置地漏,操作人员不应裸手操作,妥不可避免时,手部应及时消除;10000级洁净室(区)使用的传输设备不得穿越较低级别区域;100000级以上区域的洁净工作服应有洁净室(区)内洗涤,干燥,整理,必要时应按要求灭菌。





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