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1、洁净室系统详解洁净室各主要系统图文讲解-KLCFILTER资料整理:洁净室工程_KLChttp://www.klcfilter.comwww.klcfilter.com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3www.klcfilter.com工程业务模式www.klcfilter.com主营业务:Mainlybusiness:HVAC&洁净室系统Cleanroomsystem洁净管道系统Sanitarypipingsystem自动化系统AutomationSystem项目管理&EPCC
2、onstructionManagement验证Validation概念设计ConceptualDesign详细设计DetailedDesign植物提取工艺优化Optimizationofherbsextraction水机设备Hydraulicengineequipment工程总承包www.klcfilter.com洁净系统服务架构www.klcfilter.com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Toprovideaproperindoorenvironmentfor
3、productionandstaff.降低污染和交叉污染的危险Tolowertheriskofcontaminationandcrosscontamination.保护员工,保护周边环境Toprotectthestaffandtoprotecttheoutdoorenvironment.www.klcfilter.com洁净系统控制---要素www.klcfilter.com洁净系统控制---洁净度Cleanness-Particlenumber/洁净度-尘埃粒子数atrestinoperatio
4、nGrademaximumpermittednumberofparticles/m3equaltoorabove0.5μm5μm0.5μm5μmA3,500203,5001*B3,50029350,0002,000C350,0002,0003,500,00020,000D3,500,00020,000notdefinednotdefinedwww.klcfilter.com洁净系统控制---洁净度Cleanness/洁净度-欧盟同ISO标准对照CleannessAtrestInoperationR
5、emarkGradeAISO5ISO5Thelocalzoneforhighriskoperations.GradeBISO5ISO7Forasepticpreparationandfilling.GradeCISO7ISO8Cleanareasforcarryingoutlesscriticalstagesinthemanufactureofsterileproducts.GradeDISO8NotdefinedAsperEUGMP:PIC/SJuly2004www.klcfilter.com洁
6、净系统控制---温湿度TemperatureandRelativeHumidity/温度和相对湿度CleannessTemperatureRelativehumidityGradeBS:22℃W:20℃55%GradeC,GradDS:24℃W:20℃55%Thesedataarefordesigning.Thesedatacanbeadjustedifneeded.此数值用于设计,参数可根据需要进行调整www.klcfilter.com洁净系统控制---压差Adjacentroomsofdiff
7、erentgradesshouldhaveapressuredifferentialof10-15pascals(guidancevalues).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-------FDAPressureDifferential/压差
8、www.klcfilter.com洁净系统控制---气流组织及自净Itshouldbedemonstratedthatair-flowpatternsdonotpresentacontaminationrisk,e.g.careshouldbetakentoensurethatairflowsdonotdistributeparticlesfromaparticle-generatingperson,operationormachinetoazoneofhigherproductr