空调净化系统的验证和研究+HVAC/ 空调净化系统的验证过程
关键词: 洁净度；高效过滤器检漏；悬浮粒子数；GMP,4351
Verification and research system of purifying air conditioning
Abstract：Daily operation of air conditioning purification system and pharmaceutical water in pharmaceutical enterprises occupy a play a decisive role in the position. This paper is about the air purification system in the systems analysis and research. The main air purification system includes the following: the clean room terminal HEPA filter leak detection, the balance of the indoor air output and determination of the average wind speed, the determination of indoor air supply volume and discharge volume determination, ventilation frequency, the balance of the clean room static pressure difference and determination, testing of indoor temperature and relative humidity detection, the determination of the clean room level of maximum allowable number of suspended particles. The validation process in strict accordance with the GMP standard and enterprise standard combined, make indoor air clean production environment to meet the process requirements, to ensure that the drug production environment safety.
Key word: clean ; HEPA filter leak detection ;number of suspended particles ;GMP
目录
1 研究背景 1
2 空调净化系统 2
2.1 空调净化系统处理对象2
2.2 空调净化系统的空气处理简介及其主要措施2
2.2.1 空气过滤器 3
2.2.2 气流组织 3
2.2.3 提高空气静压 3
2.2.4 采取综合净化措施 4
2.3 空气净化处理4
3 空气净化系统的验证 5
3.1 空调净化系统的组成5
3.1.1 洁净室的控制参数 5
3.1.2 空气净化系统测试仪器的校准 5
3.1.3 空气净化系统安装确认的主要内容 7
3.1.4 空气净化系统的运行确认 7
3.2 空调净化系统验证的各项程序与指标8
3.2.1 高效过滤器的确认 8
3.2.2 房间送风量与换气次数确认 8
3.2.3 房间静压差的确认 8
3.2.4 房间温度与相对湿度的确认 9
3.2.5 房间静态洁净度测试 9
3.2.6 房间微生物的确认 10
3.3 空气净化系统验证的文件10
4 HVAC/ 空调净化系统的验证过程 12
4.1 验证前的准备工作12
4.1.1 成立验证小组 12
4.1.2 验证方案确定 12
4.2 HVAC 验证 12
4.2.1 HVAC 系统测试仪器校准12
4.2.2 HVAC 系统验证安装确认13
4.2.3 HVAC 系统验证运行确认13
4.3 HVAC 系统验证性能确认 14
4.4 验证报告14
5 测试报告 15
5.1 验证仪器校准的确认15
5.2 现场图纸的确认15
5.3 高效过滤器确认16
5.4 房间送风量与换气次数确认23
5.5 房间静压差的确认27
5.6 房间温度和相对湿度29
5.7 房间洁净度的测试（静态) 30
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