文本描述
www.klcfilter 洁净室系统详解 洁净室各主要系统图文讲解-KLCFILTER www.klcfilter 目录 洁净室系统简介洁净室维护结构暖通空调及自控www.klcfilter 工程业务模式 www.klcfilter 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 www.klcfilter 洁净系统服务架构 www.klcfilter 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. www.klcfilter 洁净系统控制---要素 www.klcfilter 洁净系统控制---洁净度 Cleanness - Particle number/洁净度-尘埃粒子数
www.klcfilter 洁净系统控制---洁净度 Cleanness/洁净度-欧盟同ISO标准对照 As per EU GMP: PIC/S July 2004 www.klcfilter 洁净系统控制---温湿度 Temperature and Relative Humidity/温度和相对湿度
These data are for designing. These data can be adjusted if needed.此数值用于设计,参数可根据需要进行调整
www.klcfilter 洁净系统控制---压差 Adjacent rooms of different grades should have a pressure differential of 10 - 15 pascals (guidance values).
相邻洁净区房间之间的压差应为10-15帕斯卡(指导值)。
------EUcGMP
洁净区与非洁净区之间、不同等级洁净区之间的压差应不低于10帕斯卡,相同洁净度等级不同功能的操作间之间应保持适当的压差梯度,以防止污染和交叉污染。
-----中国新版GMP
相邻洁净区房间之间的压差应为12.5帕斯卡
-------FDA
Pressure Differential/压差
www.klcfilter 洁净系统控制---气流组织及自净 It should be demonstrated that air-flow patterns do not present a contamination risk, e.g. care should be taken to ensure that air flows do not distribute particles from a particle-generating person, operation or machine to a zone of higher product risk. The particulate conditions given in the table for the “at rest” state should be achieved after a short “clean up” period of 15-20 minutes (guidance value) in an unmanned state after completion of operations.
应证明各种气流方式无导致污染的风险,例如,应采取适当的措施确保气流不会将操作或设备以及操作人员散发的粒子吹向洁净要求高的区域。生产操作全部结束,操作人员撤离生现场并经15~20分钟(指导值)自净后,洁净区的应达到 “静态”标准。