設(shè)備清潔驗(yàn)證方案

PROCEDURES/INSTRUCTIONS設(shè)備清潔驗(yàn)證方案EquipmentsCleaningQualificationProtocolDoc.No.:Revision:編輯Author審核Approvedby校對(duì)Reviewed編輯Author審核Approvedby校對(duì)Reviewedby日期EffectiveDateDescriptionDermasilOTC產(chǎn)品生產(chǎn)設(shè)備組由真空乳化攪拌鍋組和液體自動(dòng)填充機(jī)組成耐消毒。造型美觀大方，各系統(tǒng)轉(zhuǎn)動(dòng)靈敏、平穩(wěn)，溫度調(diào)整靈敏、易把握。該組設(shè)備主要生產(chǎn)活性成分一樣的護(hù)膚產(chǎn)品。微生物把握尤為重要。ManufacturingequipmentforDermasilOTCskincareproductincludesvacuumemulsificationmixtankgroup&LiquidAutomaticFillingMachine.Theseequipmentsadoptstainlesssteelmaterials,andfacilitatecleaningandresistdisinfection.Theyareeasytocontrolandhavegooddesign,flexibleandstablesystem,sensitivetemperatureadjusting.Theseequipmentsareusedtoproduceskincareproductswithsameactiveingredients.Controlthemicroorganismissignificant.Purpose檢查并確認(rèn)OTC生產(chǎn)設(shè)備清潔規(guī)程制定是否具有可操作性和科學(xué)性要求。ThisistocheckandverifyiftheseequipmentsforOTCproductsarescientificanddesignedtofacilitateoperation.ScopeDermasilOTC護(hù)膚產(chǎn)品生產(chǎn)設(shè)備的清潔驗(yàn)證。ThisprotocolisappliedforcleaningqualificationoftheseequipmentsforDemersilOTCSkincareproducts;ProjectPhysicaltest殘留物濃度限度Limitsofresidue

LimitsClean,dry,noscent目測(cè)干凈無色〔5.5〕Cleanandchromaticity(seesection5.5)Totalbacteria≤100CFU／mL〔washingwater〕微生物限度Microbialtest 細(xì)菌總數(shù)Totalbacteria≤50CFU／25cm2〔棉簽擦拭法cottonstickerwiping〕Role&ResponsibilitiesQAmanager負(fù)責(zé)指派驗(yàn)證小組組長，負(fù)責(zé)驗(yàn)證方案及報(bào)告批準(zhǔn)，發(fā)放驗(yàn)證證書，確認(rèn)再驗(yàn)證周期。Assignteamleader,approvevalidationprotocolandreports,issuevalidationcertificateanddecidere-validationfrequency.Teamleader即具體驗(yàn)證工程的主導(dǎo)人，主導(dǎo)和協(xié)調(diào)驗(yàn)證工作，負(fù)責(zé)方案的起草，記錄數(shù)據(jù)的收集以及報(bào)告整理。Teamleaderistheleaderofspecificqualificationprojects,leadtoandcoordinatequalificationassignment,drafttheprotocolandcollectthedataandrecordsandsortoutreports.負(fù)責(zé)首次清潔驗(yàn)證方案的起草，完成報(bào)告。并指導(dǎo)驗(yàn)證明施、培訓(xùn)及技術(shù)移轉(zhuǎn)。Draftfirstcleaningvalidationprotocolandcompletethereports,andguidetheimplementation,QA

trainingandtechnicaltransferofthequalification.負(fù)責(zé)驗(yàn)證數(shù)據(jù)及結(jié)果的審核，Reviewofqualificationdataandresults.負(fù)責(zé)驗(yàn)證過程的監(jiān)視和驗(yàn)證報(bào)告的審批。Supervisethequalificationandreviewvalidationreport.負(fù)責(zé)驗(yàn)證文件治理。Managequalificationdocuments.負(fù)責(zé)驗(yàn)證治理的日常工作，制定驗(yàn)證打算及監(jiān)視實(shí)施，驗(yàn)證方案治理，驗(yàn)證工作的協(xié)調(diào)，驗(yàn)證文件的治理。Developvalidationplanandsupervisetheimplementationofvalidationandmanagethedocuments.LAB負(fù)責(zé)制定清潔后殘留物〔產(chǎn)品殘留、微生物、清潔劑等〕的檢測(cè)方法和殘留限度。Developinspectionmethodsandlimitsofresidue(productsleft,microorganism,cleaningagent).Establishsamplingmethodsandsamplefortests,andevaluatethequalificationresults.Guidetheproductiondepartmenttochoosecleaningagentandcleaningmethods.Production負(fù)責(zé)制定清潔作業(yè)指導(dǎo)書，執(zhí)行清潔操作以及對(duì)操作人員的培訓(xùn)和考核。 Maketheprocedureforcleaningandconductcleaningactivitiesanddotrainingfortheoperators.協(xié)作協(xié)調(diào)時(shí)間及人員的安排。供給必要的資源。Arrangepersonnelandadjusttime,andprovidenecessaryresources.MaintenanceDotrainingofde-assemblyandinstallation.QualificationsFollowtheproceduretocleantheequipmentsafterproduction.最難清潔部位：PositionuneasytocleanEquipment真空乳化攪拌鍋組Homo-mixervacuumemulsificationmixtankgroup液體自動(dòng)填充機(jī)pipeLiquidAutomaticFillingMachine可承受的限度范圍標(biāo)準(zhǔn)：AcceptanceLimitsProjectPhysicaltestLimitsofresidueMicrobialtest

LimitsClean,dry,noscent目測(cè)干凈無色〔5.5〕Cleanandchromaticity(seesection5.5)Totalbacteria≤100CFU／mL〔washingwater〕Totalbacteria≤50CFU／皿物理外觀檢查：清洗后用含75%乙醇的藍(lán)色或者與產(chǎn)品不同顏色的無紡布〔已消毒〕擦拭外表Physicalinspection:usesterileblueorcolordifferentfromthatoftheproductclothwith75%ethanoltowipetheirsurfaces,noresidueisvisible。殘留物濃度限度：該組設(shè)備生產(chǎn)的產(chǎn)品所使用的活性成分均為二甲基硅油。均為無毒原料，安全性高。因此以物理外觀檢測(cè)干凈來代替。必要時(shí)送第三方檢測(cè)一次殘留物含量Residueconcentrationlimits:activeingredientsusedincludedimethicone,theyarehighlysaferawmaterialswithouttoxin.Soweusephysicalcheckaftercleaningisaccepted.Andifnecessarywewillsendonceto3rdpartyforcheckingresidue.Microorganismexamination真空乳化攪拌鍋組和液體自動(dòng)填充機(jī)承受淋洗水沖洗方法。在清潔工序完成后，用純化水淋洗均質(zhì)頭，然后參照WI-006《微檢室作業(yè)指導(dǎo)WI-006&WI-008。Vacuumemulsificationmixtankgroup&LiquidAutomaticFillingMachineusewashingwatertoclean.Aftercleanthetankandhomo-mixer,weusepurifiedwatertowashthehomo-mixer.SamplingsrefertoWI-006,andsenttomicrolab.MicrotestmethodreferstoWI-006&WI-008.Re-qualificationfrequencyQA部門依據(jù)驗(yàn)證結(jié)果確定設(shè)備再驗(yàn)證周期QAtodecidethere-qualificationfrequencyafterverifyingtheresults.DeviationHandling驗(yàn)證消滅偏差的指導(dǎo)原則，