空调洁净室系统详解.pptx

洁净室系统详解洁净室各主要系统图文讲解工程业务模式工程总承包主营业务：Mainly business:洁净管道系统Sanitary piping systemHVAC&洁净室系统Clean room system 自动化系统Automation System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 验证Validation 项目管理&EPCConstruction Management洁净系统服务架构洁净系统控制---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.洁净系统控制---要素洁净系统控制---洁净度Cleanness - Particle number/洁净度－尘埃粒子数洁净系统控制---洁净度Cleanness/洁净度－欧盟同ISO标准对照As per EU GMP: PIC/S July 2004 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洁净系统控制---压差Pressure Differential/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。目录1洁净室系统简介2洁净室维护结构3暖通空调及自控洁净室围护结构洁净室围护结构---墙板硫氧镁彩钢板墙体板材/Melamine skin panel : 面层不会生锈/Anti-rusting surface.抗冲击性能优越/Excellent impact resistant 。加工性能好,可任意切割开孔、切割、锯/Good machinable characteristic.表面平整度好/Excellent surface flatness.彩钢板面层的墙体板材/Steel skin panel与特有龙骨系统相匹配/To match with special extrusion and acce