k10动态环境监测方案设计

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1、实用文案Revisionhistory:Release1.0:InitialReleaseRelease1.1:1.Addthenumberofmaximumparticipantsinroomintherecord2.AddtheidentificationofmoldandsporeintherecordNameFunctionSignatureandDateAuthorKnightWANGQualityControlReviewer(s)JaySUNValidationEngineerHongWEIQCSupervisorJackiePENGProductionManagerA

2、pproverYinziDIAOQA&QCManager1目的/PURPOSE由于产品的本身属性，培养基产品（PPM=pre-pouredmedia）对生产的洁净度要求需要控制在ISO7的环境下进行,因此该方案定义了如何在PPM生产动态情况下进行环境监测，其中包括浮游菌,沉降菌和接触试验的取样方法，取样点和取样频率。标准实用文案Asaresultoftheproductitselfattributes,PPMproductneedISO7requirementsforproduction.TheprotocoldefineshowtomonitortheenvironmentinaP

3、PMproductiondynamicenvironment,includingsamplesmethod,samplespointandsamplesfrequencyoffloatingbacteria,settlingbacteriaandcontactexperiments1范围/SCOPE该方案仅可以适用于梅里埃（上海）生物制品有限公司培养基产品（PPM）的生产区域，其位于上海梅里埃的生产楼一楼。ThisprotocolisapplicabletothePPMProductionareainBSBonly,whichislocatedonthefirstfloorofpro

4、ductionbuildinginBSB2职责/RESPONSIBILITIES部门/Dept职责/RESPONSIBILITIESQC团队/QCteam准备动态环境取样方案,培训生产操作员取样方法完成动态环境监测的孵育和读数记录完成动态环境监测的趋势分析和报告Preparingtheprotocol,trainingtheProductionoperatortocollectthesamplesPerformingthesampleincubationandrecordCompletethedynamicenvironmentoftrendanalysisandreport生产团队

5、/Productionteam完成动态环境的取样Performingthesamplecollectioninthedynamicenvironment3实验方案/EXPERIMENTSPROTOCOL3.1浮游菌检测/floatingbacteriatest3.1.1取样Sampling1.采样器进入被测房间前先用消毒房间的消毒剂灭菌,然后在紫外传递窗进入罐装间。Samplershouldbecleanwithdisinfectantfromsterilizationdisinfectionroomfirstbeforeenteringtheroom,andthenitshould

6、beenteredtoUVwindows.2.用消毒剂擦净培养皿的外表面。Cleantheplateofoutsidesurfacewithdisinfectant3.采样前，先用消毒剂清洗采样器的顶盖，转盘以及罩子的内外面，采样结束，再用消毒剂轻轻喷射罩子的内壁和转盘。Cleanthecap,turntableandcoverofsamplerwithdisinfectantbeforeandaftersampled4.采样口使用前必须高温灭菌。如用消毒剂对采样口的外壁及内壁进行消毒时，应将其残留液倒掉并晾干。CoverofSamplershouldbehightemperatur

7、esterilization.Iftheinsideandoutsidewallisdisinfected,itshouldbedried5.采样者应穿戴与被测洁净区域相应的工作服，在操作前，双手用消毒剂消毒并戴无菌手套操作。标准实用文案Samplershouldworncorrespondingworkclothesinthecleanarea.Handsshouldbedisinfectedwithdisinfectantandwearsterileg