无菌灌装车间的要求.doc

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1、无菌灌装车间的要求ExhibitIV:AsepticFillingRoomRequirements介绍-无菌包装INTRODUCTION-ASEPTICPACKAGING无菌灌装机（TetraBrikAseptic、TetraClassicAseptic、TetraFinoAseptic、TetraWedgeAseptic等)用于在无菌状态下进行商业消毒产品的灌装，应被放置在与其无菌设计和功能相协调的工作环境中。Theasepticfillingmachines(TetraBrikAseptic,TetraClassicAseptic,TetraFinoAseptic

2、,TetraWedgeAsepticetc.)areutilizedforfillingofcommerciallysterileproductsinasepticconditionsandshouldbeplacedinaworkingenvironmentcompatiblewithitsasepticdesignandfunction.无菌包装在食品企业领域内有具体尺寸，并且必须根据下列要求处理。Asepticpackaginghasaspecificdimensioninthesphereoffoodindustryandmustbetreatedaccord

3、ingtothefollowingrequirements.无菌安装车间的要求ASEPTICINSTALLATIONROOMREQUIREMENTS无菌灌装机应安装在单独的灌装车间内。Theasepticfillingmachinesshouldbeinstalledinaseparatefillingroom.只有遵守该条件，空气传播的细菌数量才会下降。增加包装产品带菌可能性的因素应予以避免。如果发生下列情况，车间中的带菌可能性将会增加：Uponcomplyingwiththisconditionthequantityofairbornebacteriadecrea

4、ses.Thefactors,whichincreasethepossibilityofnon-sterilityofthepackedproduct,shallbeavoided.Thepossibilityofnon-sterilityincreasesintheroom:-安装有酸奶产品或奶粉工厂等的加工机。-whereprocessingmachinesforsourmilkproductsormilkpowderplantsareinstalledetc.-安装有洗瓶机和洗箱机。-wherewashingmachinesforbottlesorcratesa

5、reinstalled.-有强气流-withstrongair-currents.-有同其他厂区的往来交通-withtraffictoandfromotherplantareas.-有高湿度，如，装有杀菌器的车间以及在预杀菌和/或生产期间有蒸汽或热水排出的车间。-withhighhumidity,suchastheroomwherethesterilizerisinstalledandwhereyouhavedischargesofsteamorhotwaterduringpre-sterilizationand/orproductionperiods.-正在进行建筑

6、或维修工作，导致扬尘和扬土。-Whereconstructionorrepairworksarebeingcarriedout,whatcausesdustanddirttoappear.灌装车间的要求FILLINGROOMREQUIREMENTS过压Overpressure:整个灌装车间应借助过滤的进气口保持“过压状态”。Thefillingroom,asawhole,shouldbemaintainedinan“overpressurecondition”bymeansoffilteredairintake.地板Floors:地板应铺设防滑、抗酸碱的瓷砖。所有地板

7、/墙角应为圆形，以便清洁。排水沟也应有到出口的斜坡。Floorsshouldbemadeofnon-slipandacid/alkaliresistanttiles.Allfloor/wallcornersshouldberoundedforeasycleaning.Thedraingullyshouldalsohaveafalltooutlet.地板从包装机的后方到前方应有一个1.5%(1:75)的自然的“斜坡”（废水聚集在包装机的前面）。Floorsshouldhaveanatural“fall”of1.5%(1:75)preferablyfro