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1、一.目的Objective規(guī)范拖把、抹布的清潔程序,防止交叉污染。Standardizethecleaningprocedureofmopsandragsandavoidcross-contamination.二.適用范圍Scope生產(chǎn)區(qū)所用的拖把、抹布的清潔、消毒和日常管理。Applytothecleaning,disinfectionanddailymanagementofthemopsandragsintheproductionarea.三.責(zé)任者Responsibilities操作人員、衛(wèi)生員:按照本規(guī)程實(shí)施拖把、抹布的清潔、消毒或滅菌。Theoperator,thesanitatio
2、nman:responsiblefortheimplementationofmopsandragscleaninganddisinfectinginaccordancewiththisprocedure.班長、IPC:按照本規(guī)程對(duì)拖把、抹布的清潔和消毒效果進(jìn)行檢查。Themonitor,IPC:responsibleforcheckingthecleaninganddisinfectioneffectinaccordancewiththisprocedure.四.相關(guān)定義Definition無。Nocontent.五.工作程序Procedure1 .一般原則Generalprinciple1.
3、1. 潔凈區(qū)內(nèi)拖把、抹布應(yīng)使用無脫落物、易清洗、易消毒或滅菌的材料。Thematerialofthemopsandragsshouldbenoexfoliation,easilycleaned,easilydisinfectedorsterilized.1.2. 拖把、抹布用后應(yīng)在規(guī)定的清潔間內(nèi)及時(shí)清洗,每次消毒、滅菌后填寫車間拖把、抹布消毒/滅菌記錄10080。Themopsandragsshouldbecleanedanddisinfectedintheirrespectivecleaningroomsimmediatelyafterused.And<thecleaningrecor
4、dsofthemopsandragsinworkshop10080>shouldbetimelyfilled.1.3. 不同潔凈級(jí)別區(qū)域的拖把、抹布不得混用。針對(duì)不同用途的抹布需根據(jù)顏色進(jìn)行區(qū)分使用,并在潔具架上標(biāo)明用途,分類掛放。Mopsandragsincleanareaswithdifferentcleaninglevelshouldnotbeintermixed.Thedifferentuseofragsshouldbedistinguishedbetweenaccordingtothedifferentcolors,andmarkedtheusesonthesanitaryap
5、plianceshelf,hungthemaccordingtotheircategories.1.4. 抹布使用要求Operatingrequirementsoftherags1.4.1. 用于擦拭與產(chǎn)品直接接觸部位的抹布要專用,并與擦拭其它部位的抹布要分開洗滌、消毒或滅菌、存放和使用。Theragswhichdirectlycontactwiththeproductshouldbeexclusivelyused,andseparatedfromtheragsusedinwipingotherpartstoclean,disinfectionorsterilization,storeandu
6、se.1.4.2. 抹布需定期進(jìn)行更換,C、D級(jí)潔凈區(qū)抹布三個(gè)月或出現(xiàn)明顯破損時(shí)進(jìn)行更換,A/B級(jí)潔凈區(qū)抹布三個(gè)月或滅菌90次時(shí)進(jìn)行更換,同時(shí)在車間拖把、抹布消毒/滅菌記錄10080»備注中進(jìn)行記錄。ChangetheragseverythreemonthsorwhichisbrokeninC,Dcleanarea,andeverythreemonthsorwhichissterilizedupto90timesinA/Bcleanarea.Whenchangetheragsshouldbenotedin<thecleaningrecordsofthemopsandragsin
7、workshop10080>.1.5. 拖把使用要求Operatingrequirementsofthemops1.5.1. 拖把應(yīng)進(jìn)行編號(hào)管理,編號(hào)方式為“使用區(qū)域-兩位數(shù)的流水號(hào)”,使用區(qū)域有:一般區(qū)(簡稱YBQ)、(D或C或A/B)級(jí)潔凈區(qū)(簡稱D或C或A/BJJQ)。具體形式如: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. 拖把柄上用標(biāo)簽打印機(jī)打印并張貼該拖把的用途,形式為“用途:*",具體用途可根據(jù)實(shí)際使用區(qū)域進(jìn)行簡短描述。Printlabelsbyusage:*"whichisdescribedsimplyaccordingtousedrange,andpasteittothemopstick.1.5.3. 拖把在清潔時(shí),若該區(qū)域有雙桶式榨水車,可先用榨水車對(duì)拖把進(jìn)行初洗,然后再用“2.洗滌方法”中的方法進(jìn)行徹底清洗。Cleanthemopsbythem
9、opwringerwithdoublebucketfirstwhenthereisamopwringerwithdoublebucketinthearea,andthencleanthemopsby2.cleaningmethods”thoroughly.1.5.4. 清潔、消毒后的拖把應(yīng)頭朝下懸掛在指定潔具架上,潔具架下方應(yīng)當(dāng)有集水槽收集水滴,集水槽應(yīng)定期進(jìn)行清潔(一般區(qū)為7天,潔凈區(qū)為3天)。Hangthemopsontheframesintheirownstorageroomofcleaningtoolsandcollectwaterbythetank.Thetankshouldbecl
10、eanedregularly(7daysingeneralareaand3daysincleanarea).1.5.5. 拖把(指拖把頭)需定期進(jìn)行更換,C、D級(jí)潔凈區(qū)拖把三個(gè)月或出現(xiàn)明顯破損時(shí)進(jìn)行更換、A/B級(jí)潔凈區(qū)拖把三個(gè)月或滅菌90次時(shí)進(jìn)行更換,同時(shí)在車問拖把、抹布消毒/滅菌記錄10080»備注中進(jìn)行記錄。ChangethemopseverythreemonthsorwhichisbrokeninC,Dcleanarea,andeverythreemonthsorwhichissterilizedupto90timesinA/Bcleanarea.Whenchangethera
11、gsshouldbenotedin<thecleaningrecordsofthemopsandragsinworkshop10080>.1.6. 清潔劑和消毒劑的使用要求參見清潔劑和消毒劑使用規(guī)程1-00016。TheuserequirementofdetergentanddisinfectantseetheSOPforUsingDetergentandDisinfectant1-00016”.2 .洗滌方法Cleaningmethods2.1. 一般區(qū)Generalarea2.1.1. 拖把、抹布使用后先用飲用水加清潔劑洗滌,再用飲用水沖洗至沖洗水澄清、擠干。Themopsan
12、dragsshouldbewashedfirstindrinkingwaterwithdetergents,rinsetheminjustdrinkingwatertotheflushwaterclear,andthensqueezethewater.2.1.2. 拖把、抹布每周用消毒劑浸泡消毒一次,每次半小時(shí),再用飲用水沖洗至沖洗水澄清、最后擠干。Themopsandragsshouldbedisinfectedonceaweekanddiptheminthedisinfectorforhalfanhoureverytime,rinsetheminjustdrinkingwatertothe
13、flushwaterclearandthensqueezethewater.2.1.3. 洗滌后的拖把懸掛于指定潔具存放間的存放架上、抹布搭在掛鉤上自然晾干。Hangthemopsandragsontheframesintheirownstorageroomofcleaningtools,anddrythemintheopenairjustaftercleaning.2.2. 三十萬級(jí)、十萬級(jí)、D級(jí)潔凈區(qū)(2010版GMP)Threehundredthousand,onehundredthousandgradeandDcleanarea(the2010versionoftheGMP)2.2.1
14、. 拖把、抹布用后先用純化水沖洗,再加清潔劑洗滌,最后用純化水沖洗至沖洗水澄清、擠干。Themopsandragsshouldbewashedfirstinpurifiedwaterwithdetergent,rinsetheminpurifiedwatertotheflushwaterclear,andthensqueezethewater.2.2.2. 拖把、抹布每周用消毒劑浸泡消毒一次,每次半小時(shí)。再用純化水沖洗至沖洗水澄清、擠干。Themopsandragsshouldbedisinfectedonceaweekanddiptheminthedisinfectorforhalfanho
15、ureverytime,rinsetheminpurifiedwatertotheflushwaterclear,andthensqueezethewater.2.2.3. 洗滌后的拖把、抹布懸掛于指定潔具存放間的存放架上、抹布搭在掛鉤上自然晾干或烘干。Hangthemopsandragsontheframesintheirownstorageroomofcleaningtoolsaftercleaning,anddrythemintheopenairorbydrier.2.3. C級(jí)潔凈區(qū)(2010版GMP)Cgradecleanarea(the2010versionoftheGMP)2.3
16、.1. 拖把、抹布使用后先用純化水加清潔劑擦洗,再用純化水沖洗至沖洗水澄清、擠干。Themopsandragsshouldbewashedfirstinpurifiedwaterwithdetergent,rinsetheminpurifiedwatertotheflushwaterclear,andthensqueezethewater.2.3.2. 拖把、抹布每周用消毒劑浸泡消毒一次,每次半小時(shí)。再用純化水沖洗至沖洗水澄清、擠干。Themopsandragsshouldbedisinfectedonceaweek,anddiptheminthedisinfectorforhalfanhou
17、reverytime,rinsetheminpurifiedwatertotheflushwaterclear,andthensqueezethewater.2.3.3. 洗滌后的拖把、抹布懸掛于本區(qū)域潔具存放間的存放架上,抹布掛在掛鉤上自然晾干或采用適宜的設(shè)備進(jìn)行干燥。Hangthemopsandragsontheframesintheirownstorageroomofcleaningtoolsaftercleaning.Drythemintheopenairorbyappropriateequipment.2.4. A/B級(jí)潔凈區(qū)(2010版GMP)A/Bgradecleanarea(t
18、he2010versionoftheGMP)2.4.1. 拖把、抹布使用后,經(jīng)無菌區(qū)與低級(jí)別潔凈區(qū)的傳遞窗傳遞至相應(yīng)輔助區(qū)域進(jìn)行清洗。Afterused,themopsandragsarecleanedinthecorrespondingsecondaryzonetowhichpassedbythetransferwindowbetweensterileareaandcleanareaofthelow-level.2.4.2. 將拖把、抹布先用純化水加清潔劑洗滌,再用純化水沖洗至沖洗水澄清,最后用注射用水沖洗一遍,擠干,存放于潔具存放架上。Firstly,washingthemopsandra
19、gswithpurifiedwateraddingdetergent,andthenrinsethemwithpurifiedwatertorinsewaterclarification,andfinallywashedagainwiththewaterforinjection,squeezed,storedontheframes.2.4.3. 拖把、抹布使用前應(yīng)滅菌:將拖把、抹布放于呼吸袋中送入滅菌柜,按設(shè)定的滅菌程序進(jìn)行滅菌并干燥(織物程序,根據(jù)滅菌設(shè)備不同可設(shè)定為:121c滅菌20min,干燥20min或121c滅菌30min,干燥30min),將滅菌后的拖把、抹布放于層流罩下備用。Be
20、foreusing,theragsshouldbecleaned,driedandsterilized:theragwillbeputintothesterilizerbythebreathbaginthespecifiedcontainer,andshouldbesterilizedanddriedinthesterilizationproceduresset(fabricprogramcanbesetaccordingtothesterilizationequipmentasfollows:121Csterilizationfor20min,drying20min,or121Csteril
21、izationfor30minanddrying30min).Aftersterilization,theragisputinthelaminarflowhoodforspare.3 .清潔后存放期限Timelimitforstorageaftercleaning3.1. 一般區(qū)拖把、抹布清潔后存放時(shí)間不超過一周。Inthecommonarea,forthemopsandragsthetimelimitshouldbelessthanaweekaftercleaning.3.2. 三十萬級(jí)、十萬級(jí)、C/D級(jí)區(qū)(2010版GMP)拖把、抹布清潔后存放時(shí)間不超過72h。Inthreehundred
22、thousand,onehundredthousand,andC/Dgrade(2010GMP),forthemopsandragsthetimelimitshouldbelessthan72haftercleaned.3.3. A/B級(jí)區(qū)(2010版GMP)拖把、抹布滅菌后存放時(shí)間原則上不應(yīng)超過8h或經(jīng)驗(yàn)證的有效存放時(shí)間。A/BGrade(2010versionoftheGMP),inprinciple,theragsstoragetimeaftersterilization,shouldbelessthan8horeffectivestoragetimeproven.3.4. 超過上述規(guī)定
23、時(shí)間,應(yīng)重新進(jìn)行清潔、消毒或滅菌。Ifitismorethantheallottedtime,itshouldbere-cleaned,disinfectedorsterilized.4 .雙桶式榨水車使用要求Theuserequirementofthemopwringerwithdoublebucket4.1. 在兩個(gè)桶(A桶、B桶)中放入適量相應(yīng)區(qū)域使用的工藝用水(一般區(qū)為飲用水,潔凈區(qū)為純化水),將拖把先放入A桶內(nèi)浸濕,然后榨干,污水流入A桶;再將拖把放入B桶浸濕,再榨干,污水流入A桶,拖把可開始拖地。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、洗時(shí)先放入A桶中浸泡清洗,榨干后污水流入A桶,然后將拖把放入B桶浸泡清洗再榨干,污水流入A桶,拖把可再次開始拖地。ThemopshouldbeputintotheAbuckettosoakandcleanifitisnecessaryafterusing,thendriedtomakethesewageflowintotheAbucket.Afterthat,putthemopintotheBbuckettosoakandclean,thendryittomakethesewageflowintotheAbucket.Thenthemopcanbeusedagain.4.3. 兩個(gè)桶中的工藝用
26、水影響清潔效果時(shí)需及時(shí)更換。Theprocesswaterinthetwobucketsshouldbechangedtimelyifitimpactthecleaningeffect.4.4. 雙桶式榨水車使用后清潔方法Thecleaningmethodofthemopwringerwithdoublebucketafterusing一用工藝用水將兩個(gè)桶內(nèi)外表面沖洗至無可見污跡(必要時(shí)用抹布進(jìn)行擦拭清潔)。Theinternalandexternalsurfacesofthetwobucketsshouldberinsedtonovisiblestainsbyprocesswater(wip
27、eandcleanwitharagifnecessary)一用抹布將車身表面擦拭至無可見污跡。Wipethebodysurfaceofthemopwringerwitharagtonovisiblestains.一用蘸有消毒劑的抹布擦拭雙桶內(nèi)外表面及車身進(jìn)行消毒。Usetheragwhichmoistenedwiththedisinfectanttowipetheinternalandexternalsurfacesofthetwobucketsandthebodysurfacesofthemopwringer.一清潔榨水車用的抹布需單獨(dú)使用。Theragusedincleaningmopwringershou
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