《洁净室系统详解》PPT课件.ppt

洁净室系统详解
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目录
洁净室系统简介
1
洁净室维护结构
2
暖通空调及自控
3
2
工程业务模式
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主营业务：
Mainly business:
HVAC&洁净室系统
Clean room system
洁净管道系统
Sanitary piping system
自动化系统
Automation System
项目管理&EPC
Construction Management
验证
Validation
概念设计
Conceptual Design
详细设计
Detailed Design
植物提取工艺优化
Optimization of herbs extraction
水机设备
Hydraulic engine equipment
工程总承包
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洁净系统服务架构
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洁净系统控制---目标
为产品生产和操作人员提供一个适宜的内部环境
To provide a proper indoor environment for production and staff.
降低污染和交叉污染的危险
To lower the risk of contamination and cross contamination.
保护员工，保护周边环境
To protect the staff and to protect the outdoor environment.
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洁净系统控制---要素
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洁净系统控制---洁净度
Cleanness - Particle number/洁净度－尘埃粒子数
at rest
in operation
Grade
maximum permitted number of particles /m3 equal to or above

5μm

5μm
A
3,500
20
3,500
1*
B
3,500
29
350,000
2,000
C
350,000
2,000
3,500,000
20,000
D
3,500,000
20,000
not defined
not defined
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洁净系统控制---洁净度
Cleanness/洁净度－欧盟同ISO标准对照
Cleanness
At rest
In operation
Remark
Grade A
ISO 5
ISO 5
The local zone for high risk operations.
Grade B
ISO 5
ISO 7
For aseptic preparation and filling.
Grade C
ISO 7
ISO 8
Clean areas for carrying out less critical stages in the manufacture of sterile products.
Grade D
ISO 8
Not defined
As per EU GMP: PIC/S July 2004
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洁净系统控制---温湿度
Temperature and Relative Humidity/温度和相对湿度
Cleanness
Temperature
Relative humidity
Grade B
S:22℃ W:20℃
55％
Grade C, Grad D
S:24℃ W:20℃
55％
These data are for designing. These data can be adjusted if ，参数可根据需要进行调整
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