GMP增补培训课程.pptVIP

Purpose of an air handling system  防水百叶风口 消声器 流量控制器 控制风阀 为防止昆虫、树叶、灰尘和雨水进入 降低空气循环/气流产生的噪声 自动控制风量 (昼夜压力控制 ) 固定的风量调节阀 加热单元 冷却单元/除湿器  加湿器 过滤器 风管 加热空气到适当温度 冷却空气到要求的温度或去除空气中的水分 如果空气湿度太低，将空气加到适当的湿度 除去预定尺寸的颗粒和/或微生物 输送空气 流速控制器 控制风阀 加湿器 冷盘管 过滤器  风管 堵塞 调节不良，压差系统不正常 水/汽质量不好/排水不畅 不能去除空气露水/排水不畅  选用不正确/损坏/安装不当 不适当的材料/内部保温处的泄漏  国际洁净级别比较 过滤器分类 加湿器 消音器 加热和冷却单元 空气流量调节阀 带终端过滤器的漩流型散流器 房间压力调整 – 压差概念 注射剂压力梯度的设置 防止微生物和微粒进入  This slide shows additional elements of the air handling units. For humidification purposes, especially in clean areas, high purity water should be used, to avoid contamination. The silencer is not important from a GMP point of view, but from an environmental one, as ventilation units can be very noisy. Be sure that the silencers are manufactured of suitable materials as the linings of standard silencers can contaminate air with particulates. Depending on the local legislation, the installation of silencers can be mandatory. The cooling unit is important during the hot season. Be aware that stagnating water (condensed water) can bring bacterial growth, which can contaminate the filters, pass through them (depending on their retention properties) and end up contaminating production areas. It is essential that there is no stagnating water. Cooling coils can be sanitized as well. Do remember that, if filters are not properly maintained, micro-organisms may grow through the filters and be carried towards the production rooms. Dampers to control pressure differentials are important. They can be automated or fixed. As filters get dirty the system pressure losses increase, and if airflow is not regulated, the flow decreases and pressure differentials change. This could cause flow reversal and cross-contamination. Variable speed drives for fan motors are also commonly used to control airflow. In some c