洁净室统详解.pptVIP

资料整理:净室工程Klchttp:/ 洁净室系统详解 洁净室各主要系统图文讲解- KLCFILTER 最 ①洁净室系统简介一 2洁净室维护结构 3暖通空调及自控 工程业务模式 程总包EPC 1:;③○营 朗脉技术及管理支持 工程总承包 ●主营业务 ● Mainly business. 洁净管道系统 HAC洁净室系统 Sanitary piping system Clean room system 自动化系统 Automation System 概念设计 Optimization of herbs extraction 验证 水机设备 项目管理EPC Hydraulic engine equipment Construction Management 洁净系统服务架构 实施 GMP审核 洁净围护 培训 二次深化设计 HVAC 机电安装 技术 服务 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 鲁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 洁净系统控制--要素 气流组 压差 温湿度 照度 吉净系 洁净度 自净 统 洁净系统控制--洁净度 Cleanness- Particle number/洁净度-尘埃粒子数 at rest In operation maximum permitted number of particles /m equal to or above 0.5u 3.500 3.500 B 3,500 350.000 2.000 350.000 2.000 3.500.000 0.000 3.500,000 20.000 not defined not defined 洁净系统控制--洁净度 ● Cleanness/洁净度-欧盟同sO标准对照 Cleanness At rest In operation Remark Grade A ISO 5 ISO 5 The local zone for high risk operations For aseptic preparation and Grade b ISO 5 ISO 7 filling Grade C ISO 7 ISo 8 Clean areas for carrying out less critical stages in the Grade d IsO 8 Not defined manufacture of sterile products As per EU GMP: PIC/S July 2004 洁净系统控制--温湿度 mperature and Relative Humidity,温度和相对湿度 Cleanness Temperature Relative humidity Grade B S:22℃W:20℃C 55% Grade C, GradS:24℃W20℃ 55% 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 递行调整