英语沙龙第十期EnglishSalon(NO.10)IntroductionofSterilizingFiltration&IntegrityTesting除菌过滤及完整性测试介绍SterilizingFiltration除菌过滤Sterilizingfiltrationistheprocessofremovingmicroorganismsfromafluidstreamwithoutadverselyaffectingproductquality.除菌过滤是一种从液体中除去微生物且对产品质量无不良影响的工艺。Sterilizingfiltrationisnotintendedtoremoveviruses.除菌过滤不能除去病毒。AstoCPGJ,sterilizingfiltrationisadoptedintheprocessofbulkandfinalsterilefilling.在中信国健,除菌过滤工艺用于原液生产及最终的无菌灌装阶段。IntegrityTesting完整性测试Pre-andpostfiltraionintegritytestsshouldbeperformedwheretheclaimedpurposeofthefilteristosterilize.Ingeneral,theobjectivesofpre-andpostfiltrationintegritytestingaredifferent.当过滤器的目的是除菌时,应在过滤前后进行完整性测试。一般地,使用前和使用后完整性测试的目的是不同的。Theprefiltraionintegritytestmimicsthetestconditionsusedinbacterialretentionstudiesandtheresultanttestvaluesarecorrelatedwiththeintegritytestdatafromthosestudies.Prefiltrationintegritytestsmaybeperformedpriortosterilizationofthefilterandaftersterilization.滤前完整性测试模仿了细菌截留研究中使用的测试条件,测试数值与那些研究中得到的数据相关联。滤前完整性测试可以在灭菌前进行,也可在灭菌后进行。Thepostfiltraionintegritytestdetectsfilterleaksorperforationsthatmayhaveoccurredduringfiltration.Postfiltraionintegritytestvaluescanbeinfluencedbychangesinporositycausedbytheinterceptionofhighlevelsofparticlesduringthefiltrationprocessorchangesintheapparentbubblepointintheeventthelargestporesbecomeblocked.滤后完整性测试用于检测过滤过程中可能出现的泄漏或穿孔,其测试值会受到过滤过程中因拦截大量颗粒导致的孔隙改变或因最大孔径被堵塞而引起的明显起泡点改变的影响。Compatibility-GlossaryofTerms术语配伍看了那么多知识,现在轻松一下,做做题吧!请根据A-J中英文解释完成对应1-10词组配伍A、Theretentionofsolutes,suspendedcolloidalparticlesormicroorganismstofluidcontactsurfaces.液体中的溶剂、悬浮的胶体粒子或微生物被截留在与液体接触的表面上。B、Theprocessbywhichparticlesareremovedfromafluidbypassingthefluidthroughaporousmaterial.通过多孔介质除去颗粒的一种工艺方法。C、Atesttoindicatethemaximumporesizeofafilter.Thedifferentialgaspressureatwhichaliquidispushedoutofthelargestporesandasteadystreamofgasbubblesisdetectedfromapreviouslywettedfilterunderspecifictestconditions.Usedtotestfilterintegritywithspecific,validated,pressurevalues,wettingliquidsandtemperaturesforspecificpore-sizefilters.用以确定一个滤器最大孔径的测试。在特定的测试条件下,液体(通常是水)在一定的压力下被挤出最大膜孔且从已润湿的滤器可检测出稳定的气泡。用于测试在特定的、已验证的压力值和润湿液体、温度下已知孔径的滤器的完整性。D、Thetotalsurfaceareaofthefilteravailabletotheprocessfluid.工艺流体实际可使用的过滤器的总表面积。E、Athin,microporousmediumusedtoremoveparticlesandmicroorganismsfromafluidstreamunderpressure.在加压的情况下可以去除粒子和微生物的一种多孔的薄膜。F、Topassafluidthroughaporousmediumwherebybacteriaorotherparticlesareremovedfromthefluid.液体通过多孔基质而细菌和其他粒子被截留而从液体中除去。G、Atesttodeterminethesuitabilityandsizingofafilterwithagivenfluid.一种测试,用指定的液体测试滤器的孔径和适用性。H、Infiltration,theporousmaterialwhichretainsparticlesasafluidpassesthroughduringtheprocessoffiltration在过滤工艺中,能使液体通过并拦截颗粒的多孔材料。I、Thedegreetowhichafluidwillpassthroughaporoussubstanceunderspecifiedpressureandtemperatureconditions.液体在特定压力和温度下通过多孔物质的程度。J、Thetendencyofthesurfaceofaliquidtocontracttothesmallestareapossibleunderdefinedconditions.液体趋向于将表面积收缩到最小的一种力量。词组选择1.BubblePointTest起泡点试验2.EffectiveFiltrationArea有效过滤面积3.Adsorption吸附作用4.Filtration过滤法5.Membrane滤膜6.SurfaceTension表面张力7.FilterabilityTest过滤性能测试8.Medium介质9.Permeability渗透性10.Filter(verb)过滤(动词)----------------------------------------------------------------------------------------------------------------请按以下格式进行答题,把答案发至小编邮箱chengak@cpgj-pharm.com,我们将从所有答对者中抽出5位送上1个积分奖励。A—()B—()C—()D—()E—()F—()G—()H—()I—()J—()质量提升小组参考答案A—(3)B—(4)C—(1)D—(2)E—(5)F—(10)G—(7)H—(8)I—(9)J—(6)