WKP Validation Air System 空调系统验证.doc

1. Summary 摘要 2. Validation purpose 验证目的 3. Validation scope 验证范围 4. Members of validation group and their responsibility 验证小组成员及其职责 5. Validation content 验证内容 5.1 Pre-qualification 前期条件 According to the design of the workshops, we obtained AF-internal air condition engine. This air purification system collects internal air from a low-speed tubing system. The tubes transporting the air are of large diameter and feed used air at a low speed into the recycle system. Fresh air is added to the recycled air and the mixture is returned to clean rooms after being treated through pre-filter, mid-filter, heater, blower, humidifier and HEPA filter. 根据车间的设计，我们有AF-内部空调机。该空气净化系统通过低速的管道系统收集内部空气。运输空气的管道的直径很大并且空气以缓慢的速度流入再循环系统。新鲜的空气补充进再循环的空气中，混合气体在经过初效过滤器、中效过滤器、加热器、送风机、湿度调节器和高效过滤器后进入洁净区。 5.2 IQ 5.2.1 Verification of instruments and the air conditioning system for validation: to ensure accuracy and dependability of the measuring data, we must carry out verification of the instruments and the complete system, which is installed in the air-conditioning/air purification room in the factory. Instruments and equipment used for assessing the air-conditioning/air purification system have to be qualified and calibrated. Calibration/qualification of the devices and the equipment is shown in Attachment 1. 仪器查证和空调系统验证：保证测量数据的精确性和可靠性，我们必须进行仪器和整个系统的查证，他们是指安装在车间内的空调系统/空气净化系统内的仪器和系统。评价空调系统/空气净化系统的仪器和设备必须合格并且通过校验。设备和仪器的校验/合格见附件1。 5.2.2 Documents, required for IQ are shown in Table 1. Ensure the following documents are available, complete and are up to the GMP requirements. IQ需要的文件见表1。保证提供完整的如下文件，并符合GMP要求。 Table 1: Documents required for validation 表1： 验证所需的文件 Documents 文件 Obtained 包含 Storage 保存 Design explanation of HVAC system HVAC系统的设计说明 Archives档案室 Plan of the workshops 车间的平面图 Archives Plan for movement of people and material in the workshops 车间的人流物流平面图 Archives Plan of purification classes of