洁净厂房和HVAC系统

药品生产质量管理规范洁净厂房和加热空调系统洁净厂房和加热空调系统药品(包括药品和疫苗)GMP检查研讨会BAliKhdWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESCHANDIGARH,4CHANDIGARH,4--12AUGUST200312AUGUST2003WHOSEAROBy:AlirezaKhadem目的目的1.讲述洁净厂房2.讲述HVACWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESCHANDIGARH,4CHANDIGARH,4--12AUGUST200312AUGUST2003WHOSEARO洁净厂房洁净厂房WORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESCHANDIGARH,4CHANDIGARH,4--12AUGUST200312AUGUST2003WHOSEAROWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESCHANDIGARH,4CHANDIGARH,4--12AUGUST200312AUGUST2003WHOSEAROWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESCHANDIGARH,4CHANDIGARH,4--12AUGUST200312AUGUST2003WHOSEAROWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESCHANDIGARH,4CHANDIGARH,4--12AUGUST200312AUGUST2003WHOSEAROWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESCHANDIGARH,4CHANDIGARH,4--12AUGUST200312AUGUST2003WHOSEAROWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESCHANDIGARH,4CHANDIGARH,4--12AUGUST200312AUGUST2003WHOSEARO什么是洁净厂房•洁净厂房是一个特殊构建的区域,区域内输入来自HVAC系统的高质量空气并对输入来自HVAC系统的高质量空气,并对环境因素如湿度、温度、尘埃粒子和微生物进行控制区域内的房间表面完整生物进行控制。区域内的房间表面完整光滑易于清洁且无脱落。•环境受控的区域WORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESCHANDIGARH,4CHANDIGARH,4--12AUGUST200312AUGUST2003WHOSEARO洁净室分级系统洁净室分级系统WHOUSAUSAISO/TCEECWHO(GMP)U.S.A(209E)U.S.A(惯用）ISO/TC(209)EEC(GMP)A级M3.5100级ISO5A级B级M3.5100级ISO5B级C级M5.510000级ISO7C级D级M6.5100000级ISO8D级WORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESCHANDIGARH,4CHANDIGARH,4--12AUGUST200312AUGUST2003WHOSEAROWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESCHANDIGARH,4CHANDIGARH,4--12AUGUST200312AUGUST2003WHOSEARO条件确定条件确定静air建造airair静止正在操作WORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESCHANDIGARH,4CHANDIGARH,4--12AUGUST200312AUGUST2003WHOSEARO空气播散粒空气播散颗粒分级级别静态正在操作颗粒最大允许量/3颗粒最大允许量/3颗粒最大允许量/m3颗粒最大允许量/m30.5–5μm5.0μm0.5–5μm5.0μmμμμμA3500035000B350003500002000C3500002000350000020000C3500002000350000020000D350000020000NDNDWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESCHANDIGARH,4CHANDIGARH,4--12AUGUST200312AUGUST2003WHOSEAROWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESCHANDIGARH,4CHANDIGARH,4--12AUGUST200312AUGUST2003WHOSEAROWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESCHANDIGARH,4CHANDIGARH,4--12AUGUST200312AUGUST2003WHOSEARO微生物污染限度级别空气样品沉降碟接触碟手套印压级别空气样品(CFU/m3)沉降碟(直径90mm)(CFU/4hours)接触碟(直径55mm)(CFU/plate)手套印压（5手指)(CFU/手套)(CFU/4hours)(CFU/plate)(手套)A3333B10555B10555C1005025-D20010050-WORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESCHANDIGARH,4CHANDIGARH,4--12AUGUST200312AUGUST2003WHOSEARO空气播散颗粒分级空气播散颗粒分级级别静态正在操作颗粒最大允许量/m3颗粒最大允许量/m3颗粒最大允许量颗粒最大允许量0.5–5μm5.0μm0.5–5μm5.0μmA3500035000B3000300002000B350003500002000C3500002000350000020000D350000020000NDNDWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESCHANDIGARH,4CHANDIGARH,4--12AUGUST200312AUGUST2003WHOSEARO环境控制分级•颗粒物生物载量•生物载量•温度温度•湿度力•压力•换气次数换气次数•风速WORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESCHANDIGARH,4CHANDIGARH,4--12AUGUST200312AUGUST2003WHOSEARO生物载量生物载量•空气样品–CFU/m3•沉降碟–90mm直径碟–CFU/4小时•接触碟–55mm直径–CFU/碟•手套压印WORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESCHANDIGARH,4CHANDIGARH,4--12AUGUST200312AUGUST2003WHOSEARO压力压力•10–15帕•100000帕=1大气压•100,000帕=1大气压•正压或负压WORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESCHANDIGARH,4CHANDIGARH,4--12AUGUST200312AUGUST2003WHOSEAROWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESCHANDIGARH,4CHANDIGARH,4--12AUGUST200312AUGUST2003WHOSEAROWORKSHOPONGOODMANUFACTURINGPRACTICES(GMPs)INSPECTIONFORVACCINESWORKSH