纯化水的检测

Page:SOP#:Eff.Date:Supersedes:1/92-4001.022006.12.282006.7.1SSTTAANNDDAARRDDOOPPEERRAATTIINNGGPPRROOCCEEDDUURREE题目：Title纯化水系统的质量监测MONITORINGTHEPURIFIEDWATERSYSTEM起草/修订人：Author日期：Date部门主管审查：Dept.HeadApproval日期：DateQA批准：ApprovedbyQA日期：Date分发：Distribution:QA、QC、工程QA,QC,Engineering目的：制订纯化水系统的日常质量监测及偏差处理规程，确保纯化水的质量符合要求。PURPOSE:Thisdocumentdefinestheprocedureforroutinequalitymonitoringanddeviationdispositiononpurifiedwatersystemtoensurethepurifiedwaterqualitymeetstherequirement.范围：适用于公司内纯化水系统（包括纯化水制备系统、纯化水使用点及取样点）的日常质量监测。在非日常监测（如验证、再验证以及要求的研究）期间，根据具体的监测方案进行；在此期间相关的日常监测暂停。SCOPE:ThisSOPisapplicabletotheroutinemonitoringonpurifiedwatersystem(includingpurifiedwatergeneratorsystem,usepointsandsamplingpoints)Duringthenon-routinemonitoringperiod(suchasvalidation,re-validationandspecialstudies),themonitoringwillbeconductedinaccordancewiththespecificprotocol.Theroutinemonitoringcanbepausedduringsuchnon-routinemonitoringperiod.参考文件：REFERENCEANDATTACHMENT:SOP/题目SOP/TITLE记录/附件/题目FORMS/ATTACHMENTS/TITLE1-3002偏差调查附件1：纯化水系统中的使用点和取样点DeviationInvestigationsAttachment1:Point-of-useandsamplingpointlocationsinthepurifiedwatersystemF-02-014纯化水系统取样记录Purifiedwatersystemsamplinglogbook定义：N/ADEFINITIONS:规程：PROCEDURE:Page:SOP#:Eff.Date:Supersedes:2/92-4001.022006.12.282006.7.1SSTTAANNDDAARRDDOOPPEERRAATTIINNGGPPRROOCCEEDDUURREE题目：Title纯化水系统的质量监测MONITORINGTHEPURIFIEDWATERSYSTEM责任人操作RESPONSIBILITYACTION1.系统描述SYSTEMDESCRIPTION1.1纯化水系统由2部分组成：Purifiedwatersystemconsistsof2portions:1.1.1制备系统：包括相应的设备单元和管路。Generatorsystem：Elementsincludetheappropriateequipmentunitandthepipes.1.1.2循环管路系统：纯化水的循环分配管路。Pipeloop:Distributionloop.1.2纯化水系统中的使用点和取样点，见附件1。Thepoint-of-useandsamplingpointlocationsinthepurifiedwatersystempleaseseeAttachment1.2.日常监测ROUTINEMONITORING2.1监测点及监测频率Monitoringpointsandsamplingfrequency2.1.1循环管路Pipeloop2.1.1.1对于有4至7天的正常工作周，每周（至少每隔2～3天1次）取样监测2次。如果工作周为3天或更少，则每次取样1次。如果由于停产而不使用水，日常取样可不进行。Collectwatersamplestwiceperweek(atleastonceeverytwoorthreedays)fornormalworkweeksoffourtosevendays.Iftheworkweekisthreedaysorless,collectsamplesonceperweek.Ifthewaterisnotbeingusedduetoashutdown,routinesamplingmaynotbeperformed.2.1.1.1.1纯化水贮罐、循环管路紫外灯后出水、总回水：每次均取样。Storagetank,samplingpointafterUVsterilizerinthecirculatingsystem,loopreturn:shouldbesampledeachtime.2.1.1.1.2其余使用点/取样点：每次从其中随机抽取一点。Otherpoints-of-useandsamplingpoints:onepointwillbesampledrandomeachtime.Page:SOP#:Eff.Date:Supersedes:3/92-4001.022006.12.282006.7.1SSTTAANNDDAARRDDOOPPEERRAATTIINNGGPPRROOCCEEDDUURREE题目：Title纯化水系统的质量监测MONITORINGTHEPURIFIEDWATERSYSTEM责任人操作RESPONSIBILITYACTION2.1.2制备系统（仅供参考）Generatorsystem(forinformationonly)2.1.2.1每月（一般为每月的第一个工作周）取样监测1次。Collectwatersamplesonceamonth(normally,thefirstweekeverymonth).2.1.2.1.1纯化水系统的原水（注：每年至少送卫生防疫部门检验一次）Sourcewaterofthegeneratorsystem(note:suchwatersamplewillbesenttothelocalgovernmentdepartmentofhygieneandepidemicfortestingannually,asaminimum.2.1.2.1.2保安过滤器出水OutputwateraftertheSafetyfilter2.1.2.2每2周取样监测1次。Collectwatersamplesoncepertwoweeks2.1.2.1.2精密过滤器出水Outputwaterafterthefinefilter2.2监测项目Testitems2.2.1微生物限度Microbiallimittest2.2.1.1细菌、霉菌、酵母菌：“2.1”中的所有监测点Bacteria,MildewandMicrozyme:Allmonitoringpointsdescribedin“2.1”.2.2.1.2大肠杆菌：纯化水贮罐、总回水、精密过滤器出水，每季度检测一次。E.Coli:Storagetank,loopreturnandOutputwaterafterthefinefiltershouldbetestedonceaquarter.2.2.2理化指标Chemicaltestitems2.2.2.1总回水、精密过滤器出水：每2周检测一次。Loopreturn,Outputwaterafterfinefilterwillbetestedoncepertwoweeks.QC3.取样、检验SAMPLINGANDTESTING3.1通则General菌检操作员3.1.1遵循取样区域的最低衣着要求，或穿洁净的化验室工作服。MicrobiologistFollowtheminimumgowningrequirementsfortheareabeingsampledorwearacleanlabcoat.3.1.2在取水样时，应遵循无菌操作方法。Followaseptictechniquewhencollectingwatersamples.Page:SOP#:Eff.Date:Supersedes:4/92-4001.022006.12.282006.7.1SSTTAANNDDAARRDDOOPPEERRAATTIINNGGPPRROOCCEEDDUURREE题目：Title纯化水系统的质量监测MONITORINGTHEPURIFIEDWATERSYSTEM责任人操作RESPONSIBILITYACTION菌检操作员3.1.3在取水样时，应肉眼检查是否有水滴泄漏，或有可见的破损。MicrobiologistWhencollectingwatersamples,visuallyinspectthewaterdropsforleakingorvisibledamage.3.1.4将理化检验样品送至化验室检验；将菌检样品送至菌检室检验。Takechemistrysamplestothelaboratoryfortesting,andSendmicrobiologysamplestomicrobiologicallaboratoryfortesting.3.1.4.1微生物限度检查的样品不能立即检验的，应存放于冰箱中冷藏，并于取样后24小时内完成检验。Ifthesamplesformicrobiologicaltestingcannotbetestedimmediately,thesesamplesmustbestoredintherefrigeratorandmustbetestedwithin24hoursaftersampling.3.2理化检验样品的取样。SamplesforChemicalsTesting.Followthesesteps.3.2.1在取样前，不需用75%乙醇擦拭取样口。Donotneedtosanitizethesamplingportwith75%ethanolpriortocollectingthewatersample.3.2.2用两个洁净的500ml带盖三角瓶。Usetwoclean500mlflaskswithcap.3.2.3在三角瓶上作好标记，注明日期、样品描述（如，建筑物、房间等）Labeltheflaskwithdate,sampledescription(suchasbuilding,room,etc).3.2.4取样前，将三角瓶至少淋洗3次。Rinsetheflaskatleastthreetimesbeforecollectingthesample.3.2.5取至少550ml水，以确保检验所需的足够体积。Collectatleast550mlofwatertoensureanadequatesamplevolumefortesting.3.3微生物检验样品的取样。SamplesforMicrobiologicalTesting.Followthesesteps.3.3.1使用洁净的，已灭菌的带盖250ml三角瓶或25ml试管。Useaclean,sterilized250mlflaskor25mltubewithclosure.3.3.3在三角瓶/试管上作好标记，注明日期、样品描述（如，建筑物、房间等）Labeltheflask/tubewithdate,sampledescription(su