纯化水的检测

1、STANDARDOPERATINGPROCEDURE题目：纯化水系统的质量监测TitleMONITORINGTHEPURIFIEDWATERSYSTEM起草/修订人：日期:AuthorDate部门主管审查：日期:Dept.HeadApprovalDateQA批准：日期:ApprovedbyQADate分发：QA、QC、工程Distribution: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:Thisdocumentdefinestheprocedureforroutinequalitymonitoringandd

2、eviationdispositiononpurifiedwatersystemtoensurethepurifiedwaterqualitymeetstherequirement.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,usepoin

3、tsandsamplingpoints)Duringthenon-routinemonitoringperiod(suchasvalidation,re-validationandspecialstudies),themonitoringwillbeconductedinaccordancewiththespecificprotocol.Theroutinemonitoringcanbepausedduringsuchnon-routinemonitoringperiod.REFERENCEANDATTACHMENT:SOP/题目SOP/TITLE1-3002偏差调查DeviationInve

4、stigations参考文件：记录/附件/题目FORMS/ATTACHMENTS/TITLE附件1:纯化水系统中的使用点和取样点Attachment1:Point-of-useandsamplingpointlocationsinthepurifiedwatersystemF-02-014纯化水系统取样记录Purifiedwatersystemsamplinglogbook定义：N/ADEFINITIONS:规程：PROCEDURE:STANDARDOPERATINGPROCEDURE题目：纯化水系统的质量监测TitleMONITORINGTHEPURIFIEDWATERSYSTEM责任人操作

5、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-useandsamplingpointlo

6、cationsinthepurifiedwatersystempleaseseeAttachment1.2. 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23天1次)取木¥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)fornor

7、malworkweeksoffourtosevendays.Iftheworkweekisthreedaysorless,collectsamplesonceperweek.Ifthewaterisnotbeingusedduetoashutdown,routinesamplingmaynotbeperformed.2.1.2.1.1 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.

8、2.1.2 其余使用点/取样点：每次从其中随机抽取一点。Otherpoints-of-useandsamplingpoints:onepointwillbesampledrandomeachtime.STANDARDOPERATINGPROCEDURE题目：纯化水系统的质量监测TitleMONITORINGTHEPURIFIEDWATERSYSTEM责任人操作RESPONSIBILITYACTION2.1.2制备系统（仅供参考）Generatorsystem（forinformationonly）2.2.2.1 每月（一般为每月的第一个工作周）取样监测1次。Collectwatersample

9、sonceamonth（normally,thefirstweekeverymonth）.2 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 保安过滤器出水OutputwateraftertheSafetyfilter2.2.2.2 每2周取样监测1次。Collectwatersamplesonceper

10、twoweeks2.1.2.1.2精密过滤器出水Outputwaterafterthefinefilter2.2监测项目Testitems3.3.1.0 微生物限度Microbiallimittest3 细菌、霉菌、酵母菌：“2.1”中的所有监测点Bacteria,MildewandMicrozyme:Allmonitoringpointsdescribedin2.1”.3 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,loopreturnandOutputwaterafterthefinefiltershouldbetestedoncea

11、quarter.2.2.2理化指标Chemicaltestitems4 总回水、精密过滤器出水：每2周检测一次。Loopreturn,Outputwaterafterfinefilterwillbetestedoncepertwoweeks.QC3.取样、检验SAMPLINGANDTESTING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。Microbiologist3.1.2Followtheminimumgowningrequirementsfortheareabeingsampledorwearacleanlabcoat.在取水样时，应遵循无菌

12、操作方法。Followaseptictechniquewhencollectingwatersamples.STANDARDOPERATINGPROCEDURE题目：纯化水系统的质量监测TitleMONITORINGTHEPURIFIEDWATERSYSTEM责任人操作RESPONSIBILITYACTION菌检操作员Microbiologist3.1.33.1.4在取水样时，应肉眼检查是否有水滴泄漏，或有可见的破损。Whencollectingwatersamples,visuallyinspectthewaterdropsforleakingorvisibledamage.将理化检验样品送

13、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,thesesamplesmustbestoredintherefrigeratorandmustbetestedw

14、ithin24hoursaftersampling.理化检验样品的取样。SamplesforChemicalsTesting.Followthesesteps.在取样前，不需用75%乙醇擦拭取样口。Donotneedtosanitizethesamplingportwith75%ethanolpriortocollectingthewatersample.用两个洁净的500ml带盖三角瓶。Usetwoclean500mlflaskswithcap.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(such

15、asbuilding,room,etc).取样前，将三角瓶至少淋洗3次。Rinsetheflaskatleastthreetimesbeforecollectingthesample.取至少550ml水，以确保检验所需的足够体积。Collectatleast550mlofwatertoensureanadequatesamplevolumefortesting.微生物检验样品的取样。SamplesforMicrobiologicalTesting.Followthesesteps.使用洁净的，已灭菌的带盖250ml三角瓶或25ml试管。Useaclean,sterilized250mlflas

16、kor25mltubewithclosure.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(suchasbuilding,room,etc).保持样品收集三角瓶密闭直至装样。Keepthesamplecollectionflask/tubecloseduntilitistobefilled.在取样前，用75%乙醇擦拭消毒取样口。Sanitizethesamplingportwith75%ethanolpriortocollectingthewatersample.如果是通过水系统上的软

17、管取样的：Ifasampleiscollectedusingawatersystemhose:STANDARDOPERATINGPROCEDURE题目：纯化水系统的质量监测TitleMONITORINGTHEPURIFIEDWATERSYSTEM责任人操作RESPONSIBILITYACTION当软管是附在使用点上时，用连接在上面的软管进行取样。Whenahoseisattachedtothedrop,usetheattachedhosetoperformthesampling.当没有软管连接在使用点上时，使用一洁净专用的软管。当没有软管连接在使用点上时，在同一天，同一根软管可用于同一区域中的

18、多个使用点/管路。Whennohoseisattachedtothedrop,useacleananddedicatedhose.Thesamehosecanbeusedformultipledrops/loopswithinthesameareaonthesamedaywhennohoseisattachedtothedrop.用75%乙醇擦拭消毒将要连接到水系统上的软管尾部。将软管连接到使用点上并可靠连接。用75%乙醇擦拭消毒软管尾部。Sanitizetheendofthehosetobeattachedtothewatersystemwith75%ethanol.Attachthehos

19、etothewaterdropandsecuretheconnection.Sanitizetheendofthehosewith75%ethanol.打开水，冲洗使用点，当使用点放出一部分水（将阀门与循环管路之间的水放净）后，取样；如取样时使用到软管，则软管应用纯化水冲洗至少3次（确保软管的内壁被彻底冲洗到）。Beforesampling,openthevalvetoflushtheuseofpoint,onlyacertainquantityofpurifiedwater(thewaterbetweenthevalveandthemaindistributionloopshouldbedr

20、oppedoff)hasbeendischarged,thenthepurifiedwatercansampled;ifahoseisused,thehoseshouldbeflushedatleast3timeswithpurifiedwater(toensurethattheinsidewallhasbeencompletelyrinsed).将水流速减小，以使装水时不泼洒(若需要)。Reducethewaterflowtopermitfillingwithoutsplashing(ifnecessary).打开取样三角瓶/试管，用无菌操作方法收集水样。Openthesampleflask

21、/tubeandcollectthewatersampleusingaseptictechnique.取至少20ml水，以确保检验所需的足够体积。Collectatleast20mlofwatertoensureanadequatesamplevolumefortesting.在取样容器上注明取样时间。Labelthesamplecontainerwiththetimeofsampling.作好取样记录。Recordthesamplingeventsinthewatersamplingform.STANDARDOPERATINGPROCEDURE题目：纯化水系统的质量监测TitleMONITO

22、RINGTHEPURIFIEDWATERSYSTEM责任人操作RESPONSIBILITYACTION4.结果报告和评价TESTRESULTSREPORTINGANDEVALUATINGQC主管或其4.1指定人员QCSupervisororDesigneeQC主管或其指定人员QCSupervisororDesignee化验室主管或其指定人员对检验结果进行审核，确定数据是否超出下列的任何一项：Reviewthetestresultsanddetermineifdataexceedanyofthefollowing:4.1.1大肠杆菌检测1个/mlE.Colitest=1Coliform/ml细菌

23、、霉菌和酵母菌总数20CFU/ml,警戒限TotalcountofBacteria,MildewandMicrozyme>20CFU/ml,AlertLimit细菌、霉菌和酵母菌总数30CFU/ml,行动限TotalcountofBacteria,MildewandMicrozyme>20CFU/ml,ActionLimit细菌、霉菌和酵母菌总数100CFU/ml,标准规定TotalcountofBacteria,MildewandMicrozyme_100CFU/ml,Specification理化检验结果不符合放行标准。Chemicalresultsthatdonotmeetr

24、eleasespecifications如果数据是可以接受的，将数据和记录送QA归档。Ifdataareacceptable,sendthecompleteddataandrecordstoQAforfiling.QA4.3收集微生物检验数据，以季度为基础给出趋势分析。将该趋势分析抄送给菌检室和QA主管/经理。Collectdatafrommicrobiologicaltests.Performtrendingonaquarterlybasis.ForwardthetrendingtotheMicrobiologyLaboratoryandQASupervisor/Manager.QC如果数据

25、不可以接受，通知QA。Ifdataarenotacceptable,notifyQAManagement.QC4.4.1QC应将所有>20CFU/ml的检验结果立即通知QA,以便于采取适当的措施（若要求）。QCwillpromptlyinformQAofallmicrobiologicalresultsthatareobtainedthatare20CFU/mlsothatappropriateactioncanbetakenifrequired.STANDARDOPERATINGPROCEDURE题目：纯化水系统的质量监测TitleMONITORINGTHEPURIFIEDWATERS

26、YSTEM责任人操作RESPONSIBILITYACTIONQA4.4.2针对得到的微生物检验结果，QA将根据下面的要求决定是否采取相应的措施：Giventhemicrobialresults,QAwillconsideranyactiontotakeinthelightofthefollowing:对于任何单个点的微生物检验结果>20CFU/ml,但V30CFU/ml,记录结果，不需要采取措施。Foranysinglemicrobiologicalresultthatis>20CFU/mlbut<30CFU/ml,theresultwillberecordedbutnosp

27、ecificactiontaken.若所得连续3次的检验结果20CFU/ml,则纯化水系统应停止用于生产：If3consecutiveresultsareobtainedthatare>20CFU/ml,thentheuseofthepurifiedwaterforpharmaceuticalmanufacturingwillstop.QAQA填写偏差报告，并进行偏差调查以找出最有可能的根本原因(参见SOP1-3002)。QAwillraiseaDeviationReportandtheincidentinvestigatedtoidentifythemostprobablerootca

28、use(seeSOP1-3002).纯化水系统应用臭氧消毒后将水排空。Thepurifiedwatersystemwillbedrainedandsanitizedbyozone.纯化水系统重新注入纯化水，根据QA和QC菌检的要求进行取样检测。Thepurifiedwatersystemwillberefilled,sampledasspecifiedbyQAandQCMicrobiology.纯化水系统循环，但不得使用，直至菌检结果显示适于使用。ThePurifiedwatersystemwillbecirculatedwithoutuseuntilshowntobefitforusebyQ

29、CMicrobiology.同样，若所得的检验结果30CFU/ml,应按上面的操作执行。Assuch,ifthemicrobiologicalresultsthatare30CFU/ml,theaboveprocedureshouldbefollowed.注：对于仅用作淋症之用的，微生物数较高的纯化水；必须经明确的证明，并表明并不给产品带来风险；该批产品必须经QA适当的评价后才能被放行。Note:UseofpurifiedwaterwithhighmicrobialcountsforrinsingpurposesonlymustbeclearlyjustifiedanddemonstratednottopresentarisktotheproductandsuchproductsexposedmustbeappropriatelyassessedbyQApriortorelease.STANDARDOPERATINGPROCEDURE题目：纯化水系统的质量监测TitleMONITORINGTHEPURIFIEDWATERSYSTEMSUMMARYO