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1、一.目的Objective规范拖把、抹布的清洁程序,防止交叉污染。Standardizethecleaningprocedureofmopsandragsandavoidcross-contamination.二.适用范围Scope生产区所用的拖把、抹布的清洁、消毒和日常管理。Applytothecleaning,disinfectionanddailymanagementofthemopsandragsintheproductionarea.三.责任者Responsibilities操作人员、卫生员:按照本规程实施拖把、抹布的清洁、消毒或灭菌。Theoperator,thesanitatio

2、nman:responsiblefortheimplementationofmopsandragscleaninganddisinfectinginaccordancewiththisprocedure.班长、IPC:按照本规程对拖把、抹布的清洁和消毒效果进行检查。Themonitor,IPC:responsibleforcheckingthecleaninganddisinfectioneffectinaccordancewiththisprocedure.四.相关定义Definition无。Nocontent.五.工作程序Procedure1 .一般原则Generalprinciple1.

3、1. 洁净区内拖把、抹布应使用无脱落物、易清洗、易消毒或灭菌的材料。Thematerialofthemopsandragsshouldbenoexfoliation,easilycleaned,easilydisinfectedorsterilized.1.2. 拖把、抹布用后应在规定的清洁间内及时清洗,每次消毒、灭菌后填写车间拖把、抹布消毒/灭菌记录10080。Themopsandragsshouldbecleanedanddisinfectedintheirrespectivecleaningroomsimmediatelyafterused.And<thecleaningrecor

4、dsofthemopsandragsinworkshop10080>shouldbetimelyfilled.1.3. 不同洁净级别区域的拖把、抹布不得混用。针对不同用途的抹布需根据颜色进行区分使用,并在洁具架上标明用途,分类挂放。Mopsandragsincleanareaswithdifferentcleaninglevelshouldnotbeintermixed.Thedifferentuseofragsshouldbedistinguishedbetweenaccordingtothedifferentcolors,andmarkedtheusesonthesanitaryap

5、plianceshelf,hungthemaccordingtotheircategories.1.4. 抹布使用要求Operatingrequirementsoftherags1.4.1. 用于擦拭与产品直接接触部位的抹布要专用,并与擦拭其它部位的抹布要分开洗涤、消毒或灭菌、存放和使用。Theragswhichdirectlycontactwiththeproductshouldbeexclusivelyused,andseparatedfromtheragsusedinwipingotherpartstoclean,disinfectionorsterilization,storeandu

6、se.1.4.2. 抹布需定期进行更换,C、D级洁净区抹布三个月或出现明显破损时进行更换,A/B级洁净区抹布三个月或灭菌90次时进行更换,同时在车间拖把、抹布消毒/灭菌记录10080»备注中进行记录。ChangetheragseverythreemonthsorwhichisbrokeninC,Dcleanarea,andeverythreemonthsorwhichissterilizedupto90timesinA/Bcleanarea.Whenchangetheragsshouldbenotedin<thecleaningrecordsofthemopsandragsin

7、workshop10080>.1.5. 拖把使用要求Operatingrequirementsofthemops1.5.1. 拖把应进行编号管理,编号方式为“使用区域-两位数的流水号”,使用区域有:一般区(简称YBQ)、(D或C或A/B)级洁净区(简称D或C或A/BJJQ)。具体形式如:YBQ-01、DJJQ-01、CJJQ-01、A/BJJQ-01。Numberthemopsbyusedrange-doubledigitserialnumber“andusedrangecontainsgeneralarea(abbreviatedtoYBQ)andD,C,A/Bcleanarea(ab

8、breviatedtoD,C,A/BJJQ),suchasYBQ-01,DJJQ-01,CJJQ-01,A/BJJQ-01.1.5.2. 拖把柄上用标签打印机打印并张贴该拖把的用途,形式为“用途:*",具体用途可根据实际使用区域进行简短描述。Printlabelsbyusage:*"whichisdescribedsimplyaccordingtousedrange,andpasteittothemopstick.1.5.3. 拖把在清洁时,若该区域有双桶式榨水车,可先用榨水车对拖把进行初洗,然后再用“2.洗涤方法”中的方法进行彻底清洗。Cleanthemopsbythem

9、opwringerwithdoublebucketfirstwhenthereisamopwringerwithdoublebucketinthearea,andthencleanthemopsby2.cleaningmethods”thoroughly.1.5.4. 清洁、消毒后的拖把应头朝下悬挂在指定洁具架上,洁具架下方应当有集水槽收集水滴,集水槽应定期进行清洁(一般区为7天,洁净区为3天)。Hangthemopsontheframesintheirownstorageroomofcleaningtoolsandcollectwaterbythetank.Thetankshouldbecl

10、eanedregularly(7daysingeneralareaand3daysincleanarea).1.5.5. 拖把(指拖把头)需定期进行更换,C、D级洁净区拖把三个月或出现明显破损时进行更换、A/B级洁净区拖把三个月或灭菌90次时进行更换,同时在车问拖把、抹布消毒/灭菌记录10080»备注中进行记录。ChangethemopseverythreemonthsorwhichisbrokeninC,Dcleanarea,andeverythreemonthsorwhichissterilizedupto90timesinA/Bcleanarea.Whenchangethera

11、gsshouldbenotedin<thecleaningrecordsofthemopsandragsinworkshop10080>.1.6. 清洁剂和消毒剂的使用要求参见清洁剂和消毒剂使用规程1-00016。TheuserequirementofdetergentanddisinfectantseetheSOPforUsingDetergentandDisinfectant1-00016”.2 .洗涤方法Cleaningmethods2.1. 一般区Generalarea2.1.1. 拖把、抹布使用后先用饮用水加清洁剂洗涤,再用饮用水冲洗至冲洗水澄清、挤干。Themopsan

12、dragsshouldbewashedfirstindrinkingwaterwithdetergents,rinsetheminjustdrinkingwatertotheflushwaterclear,andthensqueezethewater.2.1.2. 拖把、抹布每周用消毒剂浸泡消毒一次,每次半小时,再用饮用水冲洗至冲洗水澄清、最后挤干。Themopsandragsshouldbedisinfectedonceaweekanddiptheminthedisinfectorforhalfanhoureverytime,rinsetheminjustdrinkingwatertothe

13、flushwaterclearandthensqueezethewater.2.1.3. 洗涤后的拖把悬挂于指定洁具存放间的存放架上、抹布搭在挂钩上自然晾干。Hangthemopsandragsontheframesintheirownstorageroomofcleaningtools,anddrythemintheopenairjustaftercleaning.2.2. 三十万级、十万级、D级洁净区(2010版GMP)Threehundredthousand,onehundredthousandgradeandDcleanarea(the2010versionoftheGMP)2.2.1

14、. 拖把、抹布用后先用纯化水冲洗,再加清洁剂洗涤,最后用纯化水冲洗至冲洗水澄清、挤干。Themopsandragsshouldbewashedfirstinpurifiedwaterwithdetergent,rinsetheminpurifiedwatertotheflushwaterclear,andthensqueezethewater.2.2.2. 拖把、抹布每周用消毒剂浸泡消毒一次,每次半小时。再用纯化水冲洗至冲洗水澄清、挤干。Themopsandragsshouldbedisinfectedonceaweekanddiptheminthedisinfectorforhalfanho

15、ureverytime,rinsetheminpurifiedwatertotheflushwaterclear,andthensqueezethewater.2.2.3. 洗涤后的拖把、抹布悬挂于指定洁具存放间的存放架上、抹布搭在挂钩上自然晾干或烘干。Hangthemopsandragsontheframesintheirownstorageroomofcleaningtoolsaftercleaning,anddrythemintheopenairorbydrier.2.3. C级洁净区(2010版GMP)Cgradecleanarea(the2010versionoftheGMP)2.3

16、.1. 拖把、抹布使用后先用纯化水加清洁剂擦洗,再用纯化水冲洗至冲洗水澄清、挤干。Themopsandragsshouldbewashedfirstinpurifiedwaterwithdetergent,rinsetheminpurifiedwatertotheflushwaterclear,andthensqueezethewater.2.3.2. 拖把、抹布每周用消毒剂浸泡消毒一次,每次半小时。再用纯化水冲洗至冲洗水澄清、挤干。Themopsandragsshouldbedisinfectedonceaweek,anddiptheminthedisinfectorforhalfanhou

17、reverytime,rinsetheminpurifiedwatertotheflushwaterclear,andthensqueezethewater.2.3.3. 洗涤后的拖把、抹布悬挂于本区域洁具存放间的存放架上,抹布挂在挂钩上自然晾干或采用适宜的设备进行干燥。Hangthemopsandragsontheframesintheirownstorageroomofcleaningtoolsaftercleaning.Drythemintheopenairorbyappropriateequipment.2.4. A/B级洁净区(2010版GMP)A/Bgradecleanarea(t

18、he2010versionoftheGMP)2.4.1. 拖把、抹布使用后,经无菌区与低级别洁净区的传递窗传递至相应辅助区域进行清洗。Afterused,themopsandragsarecleanedinthecorrespondingsecondaryzonetowhichpassedbythetransferwindowbetweensterileareaandcleanareaofthelow-level.2.4.2. 将拖把、抹布先用纯化水加清洁剂洗涤,再用纯化水冲洗至冲洗水澄清,最后用注射用水冲洗一遍,挤干,存放于洁具存放架上。Firstly,washingthemopsandra

19、gswithpurifiedwateraddingdetergent,andthenrinsethemwithpurifiedwatertorinsewaterclarification,andfinallywashedagainwiththewaterforinjection,squeezed,storedontheframes.2.4.3. 拖把、抹布使用前应灭菌:将拖把、抹布放于呼吸袋中送入灭菌柜,按设定的灭菌程序进行灭菌并干燥(织物程序,根据灭菌设备不同可设定为:121c灭菌20min,干燥20min或121c灭菌30min,干燥30min),将灭菌后的拖把、抹布放于层流罩下备用。Be

20、foreusing,theragsshouldbecleaned,driedandsterilized:theragwillbeputintothesterilizerbythebreathbaginthespecifiedcontainer,andshouldbesterilizedanddriedinthesterilizationproceduresset(fabricprogramcanbesetaccordingtothesterilizationequipmentasfollows:121Csterilizationfor20min,drying20min,or121Csteril

21、izationfor30minanddrying30min).Aftersterilization,theragisputinthelaminarflowhoodforspare.3 .清洁后存放期限Timelimitforstorageaftercleaning3.1. 一般区拖把、抹布清洁后存放时间不超过一周。Inthecommonarea,forthemopsandragsthetimelimitshouldbelessthanaweekaftercleaning.3.2. 三十万级、十万级、C/D级区(2010版GMP)拖把、抹布清洁后存放时间不超过72h。Inthreehundred

22、thousand,onehundredthousand,andC/Dgrade(2010GMP),forthemopsandragsthetimelimitshouldbelessthan72haftercleaned.3.3. A/B级区(2010版GMP)拖把、抹布灭菌后存放时间原则上不应超过8h或经验证的有效存放时间。A/BGrade(2010versionoftheGMP),inprinciple,theragsstoragetimeaftersterilization,shouldbelessthan8horeffectivestoragetimeproven.3.4. 超过上述规定

23、时间,应重新进行清洁、消毒或灭菌。Ifitismorethantheallottedtime,itshouldbere-cleaned,disinfectedorsterilized.4 .双桶式榨水车使用要求Theuserequirementofthemopwringerwithdoublebucket4.1. 在两个桶(A桶、B桶)中放入适量相应区域使用的工艺用水(一般区为饮用水,洁净区为纯化水),将拖把先放入A桶内浸湿,然后榨干,污水流入A桶;再将拖把放入B桶浸湿,再榨干,污水流入A桶,拖把可开始拖地。Puttherequiredamountofprocesswaterofcorresp

24、ondingregionsused(thegeneralareafordrinkingwater,cleanareaforpurifiedwater)intothetwobuckets(Abucket,Bbucket),andputthemopintotheAbuckettosoakfirst,thendryitandmakethesewageflowintotheAbucket.ThenputthemopintotheBbuckettosoak,anddryit,makethesewageflowintotheAbucket,thenthemopcanbeused.4.2. 拖把使用后需要清

25、洗时先放入A桶中浸泡清洗,榨干后污水流入A桶,然后将拖把放入B桶浸泡清洗再榨干,污水流入A桶,拖把可再次开始拖地。ThemopshouldbeputintotheAbuckettosoakandcleanifitisnecessaryafterusing,thendriedtomakethesewageflowintotheAbucket.Afterthat,putthemopintotheBbuckettosoakandclean,thendryittomakethesewageflowintotheAbucket.Thenthemopcanbeusedagain.4.3. 两个桶中的工艺用

26、水影响清洁效果时需及时更换。Theprocesswaterinthetwobucketsshouldbechangedtimelyifitimpactthecleaningeffect.4.4. 双桶式榨水车使用后清洁方法Thecleaningmethodofthemopwringerwithdoublebucketafterusing一用工艺用水将两个桶内外表面冲洗至无可见污迹(必要时用抹布进行擦拭清洁)。Theinternalandexternalsurfacesofthetwobucketsshouldberinsedtonovisiblestainsbyprocesswater(wip

27、eandcleanwitharagifnecessary)一用抹布将车身表面擦拭至无可见污迹。Wipethebodysurfaceofthemopwringerwitharagtonovisiblestains.一用蘸有消毒剂的抹布擦拭双桶内外表面及车身进行消毒。Usetheragwhichmoistenedwiththedisinfectanttowipetheinternalandexternalsurfacesofthetwobucketsandthebodysurfacesofthemopwringer.一清洁榨水车用的抹布需单独使用。Theragusedincleaningmopwringershou

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