K10动态环境监测方案设计.doc

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1、word1 / 71 1目的目的/PURPOSE/PURPOSE由于产品的本身属性，培养基产品PPM= pre-poured media 对生产的洁净度要求需要控制在 ISO7 的环境下进展,因此该方案定义了如何在 PPM 生产动态情况下进展环境监测，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。RevisionhistoryRevisionhistory: :ReleaseRelease 1.0:1.0: Initial ReleaseReleaseRelease 1.1:1.1: 1. .Add the number of maximum participants in

2、room in the record 2.Add the identification of mold and spore in the recordNameName FunctionFunctionSignatureSignature andand DateDateAuthorAuthorKnight WANGQuality ControlJay SUNValidation EngineerHong WEIQC SupervisorReviewer(s)Reviewer(s)Jackie PENGProduction ManagerApproverApproverYinzi DIAOQA &

3、 QC Managerword2 / 7As a result of the product itself attributes, PPM product need ISO 7 requirements for production. The protocol defines how to monitor the environment in a PPM production dynamic environment, including samples method, samples point and samples frequency of floating bacteria, settl

4、ing bacteria and contact experiments 2 2X X 围围/SCOPE/SCOPE该方案仅可以适用于梅里埃某某生物制品某某培养基产品PPM的生产区域，其位于某某梅里埃的生产楼一楼。This protocol is applicable to the PPM Production area in BSB only, which is located on the first floor of production building in BSB3 3职责职责/RESPONSIBILITIES/RESPONSIBILITIES4 4实验方案实验方案/EXPERIM

5、ENTS/EXPERIMENTS PROTOCOLPROTOCOL4.14.1浮游菌检测浮游菌检测/floating/floating bacteriabacteria testtest4.1.1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。Sampler should be clean with disinfectant from sterilization disinfection room first before entering the room, and then it should be entered to UV wind

6、ows.2. 用消毒剂擦净培养皿的外外表。Clean the plate of outside surface with disinfectant3. 采样前，先用消毒剂清洗采样器的顶盖，转盘以与罩子的内外面，采样完毕，再用消毒剂轻轻喷射罩子的内壁和转盘。Clean the cap, turntable and cover of sampler with disinfectant before and after sampled4. 采样口使用前必须高温灭菌。如用消毒剂对采样口的外壁与内壁进展消毒时，应将其残留液倒掉并晾干。Cover of Sampler should be high tem

7、perature sterilization. If the inside and outside wall is disinfected, it should be dried5. 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。部门部门/Dept/Dept职责职责/RESPONSIBILITIES/RESPONSIBILITIESQC 团队/QC team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Preparing the protocol, training the Productio

8、n operator to collect the samplesPerforming the sample incubation and recordplete the dynamic environment of trend analysis and report生产团队/Production team完成动态环境的取样Performing the sample collection in the dynamic environmentword3 / 7Sampler should worn corresponding work clothes in the clean area. Han

9、ds should be disinfected with disinfectant and wear sterile gloves before used the sampler6. 采样仪器经消毒后先不放入培养皿，开启浮游菌采样器，使仪器中的剩余消毒剂蒸发，时间不少于 5 分钟，并检查流量根据采样量调整设定采样时间。The sampler should be open without plate more than 5 minutes in order to evaporate residual disinfectant and check the sampling time and sa

10、mpling amount.7. 关闭浮游菌采样器，放入 NUT 或 COS 或 TSA3P 培养皿，盖上盖子。Turn off the sampler and put the NUT or COS and TSA3P and replace the cap8. 置采样口于采样点后，开启浮游菌采样器进展采样。Turn on the sampler to start sampling in the sampling point9. 在整个实验过程中拿取培养基时都应用手指捏着培养皿以确保培养基不受污染。In the whole test process, when taking plates sh

11、ould to fingers hold dish ensure medium from pollution.10.最小采样量 Minimum sample quantity洁净度级别 Cleanliness Class采样量 L/次 Sample Quantity L/times10010001000050010000010030000010011.每个采样点一般采样一次.One sampling in every sample point generally.4.1.2培养 Incubation1. 全部采样完毕后，将培养皿倒置于恒温培养箱中培养At the end of the samp

12、ling, inversed the plates in the incubator to incubate2. 30-35 度培养箱中培养，时间不少于 2 天Incubating the plates in the 30-35 incubator and more than 2 days3. 每批培养基应有对照实验，检验培养根本身是否污染。 Every batch of plates should be reference in order to check the quality of plates itself 4.1.3菌落计数 Bacteria counting1. 用肉眼对培养皿上

13、所有的菌落直接计数，标记或在菌落计器上点计。Count directly all the colonies on petri dishes with the eye or count in the colony meter2. 假如平板上有 2 个或 2 个以上的菌落重叠，可分辨时仍以 2 个或 2 个以上菌落计数If two or more than two colonies overlap on the plate, count them into the number if possible to recognize。3. 菌落计数时确认霉菌和芽孢数量(如有)Identify the m

14、old and spore number when counting the colony (If needs)word4 / 74.24.2接触实验检测接触实验检测 ContactContact ExperimentExperiment TestTest4.2.1取样 Sampling用 COS 或 NUT 或 CT3P 平板接触将要离开罐装间的操作员口罩，肘，手套，鞋套和写字台*，直接接触采样点持续 10 秒留下痕迹，取样完毕后盖上皿盖。在整个实验过程中拿取培养基时都应用手指捏着培养皿以确保培养基不受污染。Contacting to the operators gloves, elbow,

15、 mask， shoes and desk* with COS or NUT or CT3P about 10 seconds and pressureleave a trace.The operator will be left the filling roomHolding the plates in order to protect the plates from pollution in the process.4.2.2培养 Incubation1. 全部采样完毕后，将培养皿倒置于恒温培养箱中培养。At the end of the sampling, inversed the pl

16、ates in the incubator to incubate2. 在 30-35 度培养箱中培养，时间不少于 2 天。Incubating the plates in the 30-35 incubator and more than 2 days3. 每批培养基应有对照实验，检验培养根本身是否污染。Every batch of plates should be reference in order to check the quality of plates itself 4.2.3菌落计数 Bacteria counting1. 用肉眼对培养皿上所有的菌落直接计数，标记或在菌落计器上

17、点计。Count directly all the colonies on petri dishes with the eye or count in the colony meter2. 假如平板上有 2 个或 2 个以上的菌落重叠，可分辨时仍以 2 个或 2 个以上菌落计数If two or more than two colonies overlap on the plate, count them into the number if possible to recognize3. 菌落计数时确认霉菌和芽孢数量如有 Identify the mold and spore number

18、when counting the colony (If needs)*当用 COS 或 NUT 接触台面时需使用一次性无菌棉签蘸取无菌生理盐水在大约 1cm2直径，再涂布于培养基。CT3P 培养基无需使用棉签取样，可直接接触When using COS or NUT contact to the desk, we need use disposable sterile cotton swabs to dip in sterile saline in about 1 cm2 diameter, then coated in the culture medium. (CT3P medium wi

19、thout using swab sampling, it can be directly contact)4.34.3沉降菌检测沉降菌检测 SettlingSettling bacteriabacteria testtest4.3.1取样 Sampling用 NUT 或 COS 培养基，将碟子暴露在指定位置，在空气中暴露 4 小时，盖上盖子。放入干净密封袋中，带出取样区至培养箱中培养。在整个实验过程中拿取培养基时都应用手指捏着培养皿以确保培养基不受污染。word5 / 7Exposing the dishes in the designated position in four hours

20、with the NUT or COS plates 4 hours. Put into the clean sealing bag and incubate in the incubator. Holding the plates in order to protect the plates from pollution in the process.4.3.2培养 Incubation1. 全部采样完毕后，将培养皿倒置于恒温培养箱中培养。At the end of the sampling, inversed the plates in the incubator to incubate2

21、. 在 30-35 度培养箱中培养，时间不少于 2 天。Incubating the plates in the 30-35 incubator and more than 2 days3. 每批培养基应有对照实验，检验培养根本身是否污染。Every batch of plates should be reference in order to check the quality of plates itself 4.3.3菌落计数 Bacteria counting1. 用肉眼对培养皿上所有的菌落直接计数，标记或在菌落计器上点计。Count directly all the colonies

22、 on petri dishes with the eye or count in the colony meter2. 假如平板上有 2 个或 2 个以上的菌落重叠，可分辨时仍以 2 个或 2 个以上菌落计数If two or more than two colonies overlap on the plate, count them into the number if possible to recognize3. 菌落计数时确认霉菌和芽孢数量如有 Identify the mold and spore number when counting the colony (If needs

23、)4.44.4取样点取样点/Samples/Samples pointpoint4.4.1浮游菌取样点位置/floating bacteria samples position注：根据预实验结果分析：取样点 1，2，5 为生产线入口处，人员和物料流动较大，浮游菌数量易上升；取样点3，4 为生产线出口和人员目检口，浮游菌数量也比拟高，因此把此作为浮游菌取样点 Note: according to the preliminary experiment results analysis: sample points 1,2,5 are the entrance of production line,

24、 more operator and material is near these points , the number of floating bacteria is higher; Sampling word6 / 7points 3, 4 are the export of the production line and visual inspection point, the number of floating bacteria is higher also, so these points was chosen as the sampling points 4.4.2沉降菌取样点

25、位置/Settling bacteria samples position参见 020950- Site Procedure for PPM Products Production Area Environment Monitoring Operation Procedures PPM 产品生产区域环境监测操作规程 SP-4.2 的 01-32 房间4.4.3接触实验取样点/Contact experiment samples point随机 3 个将要离开罐装间的生产部操作员的帽子，手套，手肘，鞋套和写字台进展取样.Chosen 3 production operators hat, glo

26、ves, elbow, shoes and desk to sample randomly. The operator will be left the filling room ,4.54.5取样频率取样频率/Samples/Samples frequencyfrequency每个月进展至少一次动态环境取样，取样必须在生产活动进展时实施。The sampling need to be done once a month and when the production is performing5 5参考标准参考标准 /REFERENCE/REFERENCE CRITERIACRITERIAI

27、SOISO 分级分级ISOISO LevelLevel浮游菌浮游菌动态动态CFU/mCFU/m3 3FloatingFloating bacteria(Dynamic)CFU/bacteria(Dynamic)CFU/m m3 3沉降菌沉降菌/4/4 小时小时动态动态(CFU/4h)(CFU/4h)SettlingSettling bacteria/4bacteria/4 hour(Dynamic)hour(Dynamic) (CFU/4h)(CFU/4h)接触实验接触实验 contactcontact experimentexperiment77警戒值警戒值100100505088行动值行动

28、值200200100100仅供参考仅供参考 onlyonly forfor referencereference6 6参考法规和文件参考法规和文件/REFERENCE/REFERENCE DOCUMENTSDOCUMENTS医疗器械生产质量管理规 X 体外诊断试剂现场检查指导原如此食药监械监2015218 号附件 4GBT 16294-2010 医药工业洁净室(区)沉降菌的测试方法GBT 16293-2010 医药工业洁净室区浮游菌的测试方法020950 - Site Procedure for PPM Products Production Area Environment Monitori

29、ng Operation Procedures PPM 产品生产区域环境监测操作规程 SPword7 / 7SAMPLINGSAMPLING DATE/TIMEDATE/TIMENUMBERNUMBER OFOF MAXIMUMMAXIMUM PARTICIPANTSPARTICIPANTSPLATE/BATCH/SHELFPLATE/BATCH/SHELF LIFELIFETESTTEST TYPETYPETESTTEST POINTPOINTCFUCFU*2*2BACILLUSBACILLUS OROR MOLDMOLDREADER/TIMEREADER/TIME01-32101-3210

30、1-32201-32201-32301-32301-32401-32401-32501-32501-32601-32601-32701-32701-32801-32801-32901-32901-321001-321001-321101-321101-321201-321201-321301-321301-321401-3214SettlingSettling bacteriabacteria01-321501-3215OperatorOperator glove(1)glove(1)OperatorOperator clothes(1)clothes(1)OperatorOperator s

31、hoe(1)shoe(1)OperatorOperator mask(1)mask(1)OperatorOperator glove(2)glove(2)OperatorOperator clothes(2)clothes(2)OperatorOperator shoe(2)shoe(2)OperatorOperator mask(2)mask(2)OperatorOperator glove(3)glove(3)OperatorOperator clothes(3)clothes(3)OperatorOperator shoe(3)shoe(3)OperatorOperator mask(3

32、)mask(3)ContactContact PlatePlateDeskDesk1 12 23 34 4floatingfloating bacteriabacteria5 51 1ReferenceReference2 2RemarkRemark：*2*2: :菌落计数时如发现霉菌或芽孢存在，需分辨类型菌落计数时如发现霉菌或芽孢存在，需分辨类型。/IF/IF MOLDMOLD OROR BACILLUSBACILLUS ISIS FOUNDFOUND WHENWHEN COUNTINGCOUNTING THETHE COLONIES,COLONIES, ITIT WILLWILL BEBE IDENTIFIEDIDENTIFIED TYPE.TYPE.