制药行业全面设备管理与GMP相适应的对策

制药行业全面设备管理与GMP相适应的对策TotalEquipmentManagementinPharmaceuticalIndustryandtheCountermeasuresCompatiblewithGMP2011制药工程国际论坛2011InternationalForumonPharmaceuticalEngineering2011年06月22日June22,2011中国上海Shanghai,P.R.ChinaGMP制度内容GMPSystemContentsGMP硬件Hardware厂房Building设备Equipment环境Environment软件Software先进可靠的生产工艺Advancedandreliableproductionprocess严格的管理制度Strictmanagementsystem质量控制QualitycontrolGMP对于制药设备的相关规定GMPregulationsforpharmaceuticalequipment设备的设计、选型、安装应符合GMP生产要求Equipmentdesign,selectionandinstallationshouldmeettherequirementsofGMPproduction易于清洗、消毒和灭菌Easyforcleaning,disinfectionandsterilization便于生产操作和维修、保养Easyforproductionoperation,repairandmaintenance能防止差错和减少污染Topreventerrorsandreducecontamination全面设备管理举例-从设计开始考虑Exampleoftotalequipmentmanagement–startfromdesign设备工艺设计Equipmentprocessdesign保证工艺流程畅通Ensuresmoothprocessprocedure保留合适设备距离Reservessuitableequipmentspace满足土建要求Meettherequirementsofcivilconstruction满足安全卫生和防震要求Meettherequirementsofsafety,healthandearthquake-proof1.保证工艺流程畅Ensuresmoothprocessprocedure通按工艺流程的顺序布置，保证水平方向和垂直方向的连续性，保障生产连续正常运行。Arrangetheequipmentsaccordingtothesequencesofprocessproceduretoensurethecontinuityinhorizontalandverticaldirection,tomakesurethecontinuousproductionoperation.2.保留合适设备间距Reservessuitableequipmentspace设备间距过大，管道拉长，操作管理不方便。Toolargeequipmentspacewillelongatedtubeandcauseinconvenienceinoperationandmanagement;设备间距过小，给操作安装维修带来困难。Toosmallequipmentspacewillcauseprobleminoperation,installationandmaintenance.设备与设备、设备与建筑物之间的安全距离。Safespaceamongequipments,betweenequipmentsandbuildings.化工车间工人操作设备最小距离。Minimumequipmentspaceforworker`soperationinchemicalworkshop.其他Others：a.设备水平运输通道（进出车间）Thehorizontaltransportationpassageofequipment.(inandoutofworkshop)b.设备垂直运输通道（起吊，安装）Theverticaltransportationpassageofequipment.(liftingandinstallation)全面设备管理举例-从设计开始考虑Exampleoftotalequipmentmanagement–startfromdesign5001200~1500800≥700500700~90050020007001000~1200b+400bl+300≤900650800~100010002000l≤900全面设备管理举例-从设计开始考虑Exampleoftotalequipmentmanagement–startfromdesign序号No.项目Item净安全距离netsafespace/m1泵与泵的距离spaceofpumps不小于notlessthan0.72泵离墙的距离spacebetweenpumpandwall至少atleast1.23泵列与泵列间的距离（双排泵间）spaceofpumplines不小于notlessthan2.04计量罐与计量罐间的距离spaceofmeasuringtanks0.4～0.65贮槽与贮槽间的距离（指车间中一般情况）spaceofstorageslots(normalstatusinworkshop)0.4～0.66换热器与换热器间距离spaceofheatexchanger至少atleast1.07塔与塔的间距spaceoftower1.0～2.08离心机周围通道passagessurroundingcentrifuge不小于notlessthan1.59过滤机周围通道passagessurroundingfilter1.0～1.810反应罐盖上传动装置离天花板距离（如搅拌轴拆装有困难时，距离还需加大）spacebetweentransmissiondevicesabovethereactorandceiling(enlargethespaceifthereisproblemindismantleandinstallationofmixershaft不小于notlessthan0.811反应罐底部与人行通道距离spacebetweenthebottomofreactorandstaffpassage不小于notlessthan1.8～2.012反应罐卸料口至离心机的距离spacebetweenthereactordischargeportandcentrifuge不小于notlessthan1.0～1.513起吊物品与设备最高点距离spacebetweenthelifteditemsandthehighestpointofequipment不小于notlessthan0.414往复运动机械的运动部件离墙距离spacebetweentheactingpartsofreciprocatingmachineryandwalls不小于notlessthan1.515回转机械离墙距离spacebetweentherotatingmachineryandwalls不小于notlessthan0.8～1.016回转机相互间距离spaceofrotatingmachineries不小于notlessthan0.8～1.217走廊、操作台通行部分的最小净空高度theminimumnethighofcorridorandpassageofconsole不小于notlessthan2.0～2.518不常通行的地方seldompassarea净高不小于nethighnotlessthan1.919操作台梯子的斜度slopeofconsoleladder一般情况normalcondition不大于notmorethan45º特殊情况specialcondition60º20控制室、开关室与炉子之间距离spaceamongthecontrolroom,switchroomandcampstove1521产生可燃性气体的设备和炉子间距离spacebetweenequipmentgeneratingofflammablegasandcampstove不小于notlessthan8.022工艺设备和通道间距离spacebetweenprocessequipmentsandpassages不小于notlessthan1.0全面设备管理举例-从设计开始考虑Exampleoftotalequipmentmanagement–startfromdesign3.满足土建要求Meettherequirementsofcivilconstruction笨重，运转产生振动较大的设备（如离心机、压缩机、鼓风机、真空泵等）应布置在厂房底层，以减少楼面的荷载和振动。Heavyandlargevibrationequipments(suchascentrifuges,compressors,blowers,vacuumpumpsetc.)shouldbearrangedinthebottomfloorofplanttoreducetheloadandvibration.有强烈的振动或静载荷很大的设备，其操作台和设备基础等不得与建筑物的柱，墙和基础连在一起，以免影响厂房的安全。Theconsoleandfoundationofequipmentswithstrongvibrationorlargestaticload,shallnotbeconnectedwiththecolumns,wallsandfoundationsofbuilding,soasnottoaffecttheplant'ssafety.穿过横面的设备孔、安装孔和吊物孔，一律避开厂房的柱子和主梁，绝不允许穿过主梁。Theequipmentholes,mountingholesandhangingobjectsholeswhichneedcrossthehorizontalsurfaceofthebuilding,shallnotbesetonthecolumnsandmainbeams,forbiddentocrossthemainbeams.全面设备管理举例-从设计开始考虑Exampleoftotalequipmentmanagement–startfromdesign4.满足安全卫生和防震要求Meettherequirementsofsafety,healthandearthquake-proof通风：医药生产中有毒物质的散发是不可避免的，故应考虑车间的通风。Ventilation:Thedisseminationoftoxicsubstancesisunavoidableinpharmaceuticalproductionin,itisveryimportanttoconsidertheventilationofworkshop.防火防爆区Fireandexplosionproofareaa.易燃易爆的生产部门布置在防火防爆区，区内防火爆，防静电等；Theexplosiveandfireproductionsectorshouldbesetinthefireandexplosionproofarea,whichisfireandexplosionproof,anti-staticetc.;b.防爆防火等级高的生产区，宜应独立布置在敞开或半敞开的厂房中，或布置在厂房中单层靠外墙处或多层厂房的最上层靠外墙处，并采取必要的泄压设施。Theproductionsectorwithhighglassrequirementoffireandexplosionproof,shouldbesolelysetintheopenorsemi-openplant,orneartheexternalwallofsinglelayerplantornearthe