湖南佑華醫(yī)療用品有限公司輻照火菌過程控制規(guī)范Irradiationsterilizationprocesscontrolspecification版權(quán)所有，注意保密YH-MOS-QP-111RevA第1頁共12頁版本號(hào)VersionNo修改日期ModifiedDate修改內(nèi)容描述DescriptionaboutmodifiedcontentA2020316首次發(fā)布InitialReleased制定：審核：批準(zhǔn)：簽名簽名簽名發(fā)放部門Distributiondepartment研發(fā)中心、質(zhì)量法規(guī)、生產(chǎn)運(yùn)營、物料管理R&D,Qualityregulation,Operationdepartment. Materialmanagementdepartment.湖南佑華醫(yī)療用品有限公司輻照火菌過程控制規(guī)范Irradiationsterilizationprocesscontrolspecification版權(quán)所有，注意保密YH-MOS-QP-111RevA第2頁共12頁1.0目的Purpose對(duì)輻照滅菌進(jìn)行控制，保證文件的適用性和有效性。ControlofIrradiationsterilizationtoensurethesuitabilityandeffectivenessofthedocumentation2.0范圍Scope適用于本公司輻照滅菌產(chǎn)品控制。Suitableforthecontrolofourcompany'sIrradiationsterilizationproducts.3.0職責(zé)Responsibility3.1研發(fā)中心：負(fù)責(zé)提供產(chǎn)品材料所能夠承受的滅菌方式，且滿足設(shè)定的滅菌條件。R&D:Responsibleforprovidingthesterilizationmethodthattheproductmaterialscanwithstandandmeetthesetsterilizationconditions.3.2生產(chǎn)運(yùn)營：負(fù)責(zé)準(zhǔn)備滅菌的產(chǎn)品。Operationdepartment:Responsibleforpreparingproductsforsterilization3.3質(zhì)量法規(guī)：負(fù)責(zé)滅菌供商的審核，滅菌驗(yàn)證；滅菌前、后產(chǎn)品指標(biāo)的檢測，審核滅菌公司提供滅菌報(bào)告。Qualityregulations:responsiblefortheauditofsterilizationsuppliers,sterilizationverification;testingofproductindicatorsbeforeandaftersterilization,andinspectionofsterilizationreportsprovidedbythecompany3.4物料管理部：負(fù)責(zé)外包裝后，產(chǎn)品放行前（滅菌前、后）的隔離，滅菌貨物的運(yùn)輸、與滅菌公司的滅菌協(xié)議簽訂和溝通。Materialmanagement:Afterbeingresponsiblefortheouterpackaging,theproductisreleasedbeforetherelease（beforeandaftersterilization）,thetransportationofthesterilizedgoods,andthesterilizationagreementwiththesterilizationcompany.4.0程序Process定義definition4.1.1滅菌批：在同一滅菌柜內(nèi)，同一滅菌條件下，滿足同滅菌要求的一定量的產(chǎn)品。Sterilizationbatch:acertainamountofproductsthatmeetthesterilizationrequirementsunderthesamesterilizationconditionsinthesamesterilizer4.1.2SAL=SterilityAssuraneeLevel 無菌保證水平，表示已滅菌物品的微生物存活的概率。Asepticassurancelevel,indicatingtheprobabilityofmicrobialsurvivalofsterilizeditems.4.1.3生物負(fù)載：一件產(chǎn)品和（或）無菌屏障系統(tǒng)上存活的微生物的總數(shù)。Bioburden:Thetotalnumberofmicroorganismsaliveonaproductand/orsterilebarriersystem滅菌供商選擇及評(píng)價(jià) Sterilizationsupplierselectionandevaluation4.2.1對(duì)供貨商的質(zhì)量管理和生產(chǎn)能力評(píng)估（查看供商的資質(zhì)、現(xiàn)場審核等方式） 。Qualitymanagement andproduction capacityassessmentforsuppliers（checksupplierqualifications,on-siteaudits,etc.）4.2.2對(duì)滅菌廠商評(píng)估的項(xiàng)目：ProjectforevaluationofsterilizationmanufacturersA） 確認(rèn)滅菌設(shè)備是經(jīng)過安裝驗(yàn)證和運(yùn)行驗(yàn)證。ConfirmthatthesterilizationequipmentisverifiedbyinstallationandverifiedbyoperationB） 確認(rèn)滅菌操作員是經(jīng)過專業(yè)培訓(xùn)并持有上崗證。ConfirmthatthesterilizationoperatorisprofessionallytrainedandholdsacertificateofemploymentC） 確認(rèn)質(zhì)量體系相關(guān)文件的建立。ConfirmtheestablishmentofrelevantdocumentsofthequalitysystemD） 滅菌過程是經(jīng)過確認(rèn)，并能夠提供符合要求的報(bào)告。ThesterilizationprocessshouldbeconfirmedandcanprovideareportthatmeetstherequirementsE） 當(dāng)更換滅菌公司或者出現(xiàn)無菌不合格情況時(shí)，需要重新進(jìn)行滅菌驗(yàn)證。Whenthesterilizationcompanyisreplacedorthesterilityisunqualified,thesterilizationverificationneedstoberepeated.。滅菌確認(rèn)流程Sterilizationconfirmationprocess滅菌確認(rèn)常規(guī)滅菌控制滅菌有效性保持滅菌確認(rèn)Sterilizationconfirmation產(chǎn)品定義Productdefinition產(chǎn)品定義時(shí)，包括對(duì)包裝的確定。同時(shí)應(yīng)對(duì)產(chǎn)品包裝或產(chǎn)品在包裝中的裝載模式加以規(guī)定。如果為一個(gè)產(chǎn)品族建立滅菌劑量，需要定義產(chǎn)品族。Productdefinitionincludesthedeterminationofpackaging.Atthesametime,theproductpackagingortheloadingmodeoftheproductinthepackaging shallbespecified.Ifasterilizationdoseisestablishedforaproductfamily,theproductfamilyneedstobedefined過程定義Processdefinition建立最大可接受劑量 Establishamaximumacceptabledose可根據(jù)包裝材料以及產(chǎn)品原材料供應(yīng)商的一些實(shí)驗(yàn)數(shù)據(jù)確定或進(jìn)行滅菌實(shí)驗(yàn)，考察產(chǎn)品的最大可接受劑量。Determineorcarryoutsterilizationexperimentsbasedonsomeexperimentaldataofpackagingmaterialsandproductrawmaterialsupplierstoexaminethemaximumacceptabledoseoftheproduct建立滅菌劑量Establishsterilizationdose按照ISO11137-1建立滅菌劑量，應(yīng)從兩種方法中選一種建立滅菌劑量的方法:EstablishasterilizationdoseinaccordancewithISO11137-1.Oneoftwomethodsshouldbeusedtoestablishasterilizationdose.獲得并利用生物負(fù)載數(shù)量和 /或輻射抗力的信息建立滅菌劑量；Obtainanduseinformationonbioburdenquantityand/orradiationresistancetoestablishsterilizationdoses。選擇并證實(shí)15kGy或25kGy的滅菌劑量；在證實(shí)15kGy或25kGy時(shí)，通過劑量實(shí)驗(yàn)提供證據(jù)證明所選擇的滅菌劑量能夠滿足規(guī)定的無菌要求。Selectandconfirm15kGyor25kGysterilizationdose;whenconfirming15kGyor25kGy,provideevidencethroughdoseexperimentstoprovethattheselectedsterilizationdosecanmeetthespecifiedsterilityrequirements以多批次VDmax25為例：(其他情況請(qǐng)參照ISO11137-2)VDmax25證實(shí)方法的程序-適用于多個(gè)生產(chǎn)批次。Takemulti-batchVDmax25asanexample:(PleaserefertoISO11137-2inothercases)ProcedureforVDmax25verificationmethod-applicabletomultipleproductionbatches注：本方法僅適用于產(chǎn)品平均生物負(fù)載 <1000bNote:Thismethodisonlyapplicabletoproductswithanaveragebiologicalloadof <1000步驟1：產(chǎn)品樣本的獲得Step1:Obtainproductsamples從三個(gè)獨(dú)立生產(chǎn)批次的產(chǎn)品中，每批至少獲取 10個(gè)單元產(chǎn)品。Getatleast10unitproductsfromeachofthreeindependentproductionbatches步驟2:確定平均生物負(fù)載Step2:Determinetheaveragebioburden按照ISO11737-1確定產(chǎn)品的平均生物負(fù)載；確定批平均生物負(fù)載（每生產(chǎn)批產(chǎn)品的生物負(fù)載的算術(shù)平均值）與總平均生物負(fù)載（所有產(chǎn)品的生物負(fù)載算術(shù)平均值） ；DeterminetheaveragebioburdenoftheproductinaccordancewithISO11737-1;determinetheaveragebioburdenofthebatch(arithmeticaverageofthebioburdenperproductionbatch)

andthetotalaveragebioburden(thearithmeticaverageofthebioburdenofallproducts)a)如果一個(gè)或多個(gè)批平均 >2(總平均生物負(fù)載)，取最高批平均。Ifoneormorebatchesaverage>2x(totalaveragebioburden),takethehighestbatchaverageb）如果每一批的批平均v2x（總平均生物負(fù)載），取總平均值。Ifthebatchaverageofeachbatchis<2（totalaveragebioburden）,takethetotalaverage當(dāng)SIP=1.0，如果表1中沒有要查的平均生物負(fù)載，使用表中生物負(fù)載值最近的且大于計(jì)算的生物負(fù)載值。WhenSIP=1.0,ifthereisnoaveragebioburdentobecheckedinTable1,themostrecentbioburdenvalueinthetableisgreaterthanthecalculatedbioburdenvalue.當(dāng)SIPv1.0，用SIP平均生物負(fù)載除以SIP得到完整產(chǎn)品的生物負(fù)載。如果表 1中沒有計(jì)算的平均生物負(fù)載，使用表中最近的且大于計(jì)算生物負(fù)載值的列表生物負(fù)載值查找 SIP=1.0VDmax25值和相關(guān)的減少因子。WhenSIP<1.0,dividetheaveragebioburdenofSIPbySIPtogetthebioburdenofthecompleteproduct.IfthereisnocalculatedaveragebioburdeninTable1,usethemostrecentlistofbioburdenvaluesgreaterthanthecalculatedbioburdenvalueinthetabletofindtheSIP=1.0VDmax25valueandtherelatedreductionfactor步驟3:確定VDmax25Step3:DetermineVDmax25根據(jù)產(chǎn)品平均生物負(fù)載結(jié)合表 1，按照SIPVDmax25=(SIP=1.0VDmax25)+(SIPDoseReductionFactorxlogSIP)公式,計(jì)算SIPVDmax25。CalculateSIPVDmax25accordingtotheaveragebioburdenoftheproductinconjunctionwithTable1,andaccordingtotheformulaSIPVDmax25=(SIP=1.0VDmax25)+(SIPDoseReductionFactorxlogSIP)步驟4:完成驗(yàn)證劑量實(shí)驗(yàn)Step4:Completetheverificationdoseexperiment以VDmax25輻照10個(gè)單元產(chǎn)品，要求輻照劑量合格，應(yīng)滿足如下條件：Irradiate10unitproductswithVDmax25,therequiredradiationdoseisqualified,andthefollowingconditionsshouldbemet實(shí)施到單元產(chǎn)品上的最高劑量 <VDnax25*(1.0+10%)；Thehighestdoseappliedtotheunitproduct<VDmax25Thehighestdoseappliedtotheunitproduct<VDmax25*(1.0+10%)2）實(shí)施到單元產(chǎn)品上的最高劑量與最低劑量的算術(shù)平均值〉 90%ofVDmax25Thearithmeticmeanofthehighestandlowestdosesappliedtotheunitproductis>90%ofVDmax25按照ISO11737-2完成10個(gè)單元產(chǎn)品的無菌檢測。Completethesterilitytestof10unitsaccordingtoISO11737-2步驟5:結(jié)果判定Step5:Resultsjudgment如果10個(gè)單元產(chǎn)品的無菌檢測的陽性份數(shù)不多于 1.0個(gè)，則證實(shí)25kGy作為滅菌劑量，即日常輻照加工的最低吸收劑量要求為 25.0kGy;Ifthenumberofpositivetestsforaseptictestingof10unitproductsisnotmorethan1.0,then25kGyisconfirmedasthesterilizationdose,thatis,theminimumabsorbeddoserequiredfordailyirradiationprocessingis25.0kGy如果10個(gè)單元產(chǎn)品的無菌檢測的陽性份數(shù)為 2.0個(gè)，則執(zhí)行劑量驗(yàn)證實(shí)驗(yàn)；Ifthenumberofpositivetestsforthesterilitytestof10unitproductsis2.0,thenperformadoseverificationexperiment如果10個(gè)單元產(chǎn)品的無菌檢測的陽性份數(shù)多于 2.0個(gè)，則驗(yàn)證無效。Ifthenumberofpositivetestsforsterilitytestof10unitproductsismorethan2.0,theverificationisinvalid.表1對(duì)于平均生物負(fù)載W1000CFU時(shí)VDmax25和劑量減少因子的值25ValuesforVDmaxanddosereductionfactoratanaveragebioburden w1000CFUAverageBioburdenSIP=1.0VDmax25(kGy)SIPDoseReductionFactor(kGy)AverageBioburdenSIP=1.0VDmax25(kGy)SIPDoseReductionFactor(kGy)0.100.0n/aa508.83.250.150.9n/aa558.93.230.201.4n/aa608.93.210.251.8n/aa659.03.200.302.2n/aa709.13.190.352.5n/aa759.13.170.402.7n/aa809.23.150.452.9n/aa859.13.110.503.1n/aa909.13.080.603.4n/aa959.13.050.703.6n/aa1009.03.010.803.8n/aa1109.02.96湖南佑華醫(yī)療用品有限公司輻照火菌過程控制規(guī)范Irradiationsterilizationprocesscontrolspecification版權(quán)所有，注意保密YH-MOS-QP-111RevA第7頁共12頁AverageBioburdenSIP=1.0VDmax25(kGy)SIPDoseReductionFactor(kGy)AverageBioburdenSIP=1.0VDmax25(kGy)SIPDoseReductionFactor(kGy)0.904.0n/aa1209.02.911.04.24.171308.92.861.54.84.051408.92.832.05.23.971508.92.792.55.53.911608.82.763.05.73.861708.82.723.55.93.821808.82.694.06.13.791908.72.674.56.23.762008.72.645.06.33.732208.72.605.56.53.712408.62.566.06.63.692608.62.526.56.73.672808.62.497.06.73.653008.62.467.56.83.643258.52.438.06.93.623508.52.408.57.03.613758.52.379.07.03.594008.42.349.57.13.584258.42.32107.13.574508.42.30117.23.554758.42.28127.33.535008.42.26137.43.515258.32.24147.53.505508.32.22157.63.485758.32.21167.63.476008.32.19177.73.466508.32.16187.83.457008.22.14197.83.437508.22.12207.93.428008.22.09228.03.408508.22.07248.13.399008.12.05268.13.379508.12.04288.23.3610008.12.02308.33.34NOTEifVDmax25=0.0kGy,productitemsarenot358.43.31irradiated.aNotapplicable;408.63.29intherangeofaverage458.73.27uiuuuiueii 0u.a,iiieeniiie piuuuci 廠一i.u丿 isusedandhencetheSIPDoseReductionFactorisnotgiven.確認(rèn)滅菌工藝（滅菌供方完成）Confirmsterilizationprocess（completedbysterilizationsupplier）1） 設(shè)備安裝確認(rèn)（IQ）；2） 設(shè)備運(yùn)行確認(rèn)（OQ）；3） 產(chǎn)品合格性確認(rèn)（PQ）the該部分最主要的是確定劑量場分布，從而確定滅菌工藝。theThemainthinginthispartistodeterminethedistributionofthedosefieldandthussterilizationprocess.? 在輻照容器中，呈網(wǎng)絡(luò)分布的劑量計(jì)的分布圖；Distributiondiagramofdosimetersdistributedinanetworkinanirradiationcontainer?最大、最小劑量；Maximumandminimumdoses?最大、最小劑量的位置；Locationofmaximumandminimumdoses?使用的輻照裝置；Irradiationdevice?產(chǎn)品的裝箱模式；Productpackingmode? 劑量場分布或源排列的編號(hào)。Numberofdosefielddistributionorsourcearrangement滅菌確認(rèn)的審核和批準(zhǔn)Reviewandapprovalofsterilizationconfirmation質(zhì)量法規(guī)部將整個(gè)滅菌確認(rèn)過程進(jìn)行總結(jié)、形成滅菌確認(rèn)報(bào)告，并與滅菌供方確定常規(guī)滅菌工藝參數(shù)。TheQualityLawDepartmentsummarizestheentiresterilizationconfirmationprocess,formsasterilizationconfirmationreport,anddeterminesthegeneralsterilizationprocessparameterswiththesterilizationsupplier.常規(guī)滅菌控制Routinesterilizationcontrol4.5.1滅菌供應(yīng)商根據(jù)滅菌確認(rèn)形成的滅菌工藝參數(shù)和裝載方式等，進(jìn)行滅菌。bySterilizeaccordingtosterilization processparametersandloadingmethodsconfirmedbysterilization湖南佑華醫(yī)療用品有限公司輻照火菌過程控制規(guī)范Irradiationsterilizationprocesscontrolspecification版權(quán)所有，注意保密YH-MOS-QP-111RevA第9頁共12頁4.5.2生產(chǎn)人員按照SOP進(jìn)行日常滅菌裝箱操作。 滅菌裝箱方式如有變動(dòng)， 由質(zhì)量法規(guī)部人員進(jìn)行評(píng)估對(duì)滅菌有效性的影響。DailysterilizationandpackingoperationsinaccordaneewithSOP .Ifthereisachangeinthesterilizationandpackingmethod,theimpactoftheevaluationbythequalityandregulationsdepartmentontheeffectivenessofsterilization4.5.3采購應(yīng)與滅菌供方形成滅菌委托協(xié)議，在協(xié)議中明確滅菌要求和質(zhì)量責(zé)任。Procurementshouldformasterilizationentrustmentagreementwiththesterilizationsupplier,specifyingthesterilizationrequirementsandqualityresponsibilityintheagreement4.5.4生產(chǎn)部負(fù)責(zé)整理滅菌產(chǎn)品清單，并填寫《委外滅菌單》 ，將滅菌產(chǎn)品運(yùn)送或快遞至滅菌供方，滅菌供方根據(jù)滅菌協(xié)議進(jìn)行滅菌。Theproductiondepartmentisresponsibleforsortingthelistofsterilizedproducts,andfillingoutthe “ExternalSterilizationOrder ”,transportingordeliveringthesterilizpcbductstothesterilizingsupplier,andthesterilizingsuppliersterilizesaccordingtothesterilizationprotocol.4.5.5滅菌供方完成滅菌過程和劑量檢測后返回本公司，同時(shí)出具《輻照證明書》 。Thesterilizationsupplierreturnstothecompanyaftercompletingthesterilizationprocessanddosetesting,andissuesan"IrradiationCertificate"4.5.6質(zhì)量法規(guī)部負(fù)責(zé)對(duì)滅菌后的產(chǎn)品進(jìn)行檢驗(yàn)。Thequalityregulationdepartmentisresponsibleforinspectingthesterilizedproducts.滅菌有效性的保持 Maintenanceofsterilizationeffectiveness通過生物負(fù)載監(jiān)測、劑量審核及產(chǎn)品族的保持來確定滅菌劑量的持續(xù)有效，通過輻照條件的保持來確認(rèn)輻照加工的持續(xù)有效。Determine thecontinuedeffectiveness ofsterilization dosesthroughbioburdenmonitoring,doseaudits,andmaintenanceofproductfamilies,andconfirmthecontinuedeffectivenessofirradiationprocessingbymaintainingirradiationconditions產(chǎn)品生物負(fù)載的監(jiān)測 Productbioburdenmonitoring? 當(dāng)產(chǎn)品的平均生物負(fù)載大于或等于 1.5時(shí)，生物負(fù)載檢測的最大時(shí)間間隔為 3個(gè)月。Whentheaveragebioburdenoftheproductisgreaterthanorequalto1.5,themaximumtimeintervalforbioburdendetectionis3months? 當(dāng)產(chǎn)品的平均生物負(fù)載小于 1.5時(shí)，并且按Whentheaveragebioburdenoftheproductislessthan1.5,使用方法2(見GB18280.2)建立滅菌劑量，或Usemethod2(seeGB18280.2)toestablishasterilizationdose選用25kGy為滅菌劑量，生物負(fù)載檢測的最大時(shí)間間隔為 3個(gè)月。25kGyisselectedasthesterilizationdose,andthemaximumtimeintervalforbioburdendetectionis3months?當(dāng)產(chǎn)品的平均生物負(fù)載小于1.5時(shí)，并且按a)使用方法1(見GB18280.2)建立滅菌劑量，或b)選用15kGy為滅菌劑量，生物負(fù)載檢測的最大時(shí)間間隔為 1個(gè)月。Whentheaveragebioburdenoftheproductislessthan1.5,andaccordingtoa)usemethod1(seeGB18280.2)toestablishthesterilizationdose,orb)select15kGyasthesterilizationdose,themaximumtimeintervalforbioburdendetectionis1month.?如果產(chǎn)品批的時(shí)間間隔大于1個(gè)月，如適用，每個(gè)產(chǎn)品批應(yīng)檢測生物負(fù)載。Ifthebatchintervalisgreaterthan1month,eachproductbatchshouldbetestedforbioburden,ifapplicable? 如果生物負(fù)載實(shí)驗(yàn)的結(jié)果超過規(guī)定的限值， 則依據(jù)ISO11737-1的方法進(jìn)行調(diào)查。如果調(diào)查的結(jié)果顯示生物負(fù)載實(shí)驗(yàn)的結(jié)果是真實(shí)的，則采取措施并立即進(jìn)行滅菌劑量審核。Iftheresultsofthebioburdenexperimentexceedthespecifiedlimits,investigateaccordingtothemethodofISO11737-1.Iftheresultsoftheinvestigationshowthattheresultsofthebioburdenexperimentarereal,take actionandimmediatelyperformasterilization dosereview滅菌劑量審核 Sterilizationdoseconfirmation建立滅菌劑量后，在產(chǎn)品連續(xù)生產(chǎn)階段， 質(zhì)量法規(guī)部應(yīng)每3個(gè)月應(yīng)組織抽取代表產(chǎn)品進(jìn)行劑量審核，在連續(xù)生產(chǎn)一年后，如產(chǎn)品的生物負(fù)載監(jiān)測和劑量審核連續(xù)有效， 劑量審核的頻率減可少為半年一次， 但每年至少一次；在產(chǎn)品不連續(xù)生產(chǎn)階段， 質(zhì)量法規(guī)部負(fù)責(zé)在生產(chǎn)正式產(chǎn)品前應(yīng)完成劑量審核。 劑量審核按照ISO11137-2要求需完成生物負(fù)載實(shí)驗(yàn)、 劑量實(shí)驗(yàn)及無菌實(shí)驗(yàn)。如劑量審核成功，則滅菌劑量持續(xù)有效。Afterthesterilizationdoseisestablished,inthecontinuousproductionphaseoftheproduct,theQualityandLawDepartmentshallorganizerepresentativeproductstobedosedevery3monthsforadoseaudit.Thefrequencyreductioncanbeaslowashalfayear,butatleastonceayear.Inthediscontinuousproductionstageoftheproduct,thequalityregulations departmentisresponsibleforcompletingthedoseauditbeforeproducingtheformalproduct.Thedoseauditshallcompletethebioburdentest,dosetestandsterilitytestinaccordaneewiththerequirementsofISO11137-2.Ifthedoseauditissuccessful,thesterilizationdosewillcontinuetobeeffective產(chǎn)品族的保持Productfamilyretention質(zhì)量法規(guī)部每年應(yīng)對(duì)產(chǎn)品族進(jìn)行審查，以確保產(chǎn)品族和代表產(chǎn)品族的產(chǎn)品持續(xù)有效。生產(chǎn)過程中，應(yīng)對(duì)生產(chǎn)條件、生產(chǎn)工藝發(fā)生改變的產(chǎn)品及新產(chǎn)品應(yīng)進(jìn)行初始污染檢測，確保代表產(chǎn)品的持續(xù)有效。湖南佑華醫(yī)療用品有限公司輻照火菌過程控制規(guī)范Irradiationsterilizationprocesscontrolspecification版權(quán)所有，注意保密YH-MOS-QP-111RevA第11頁共12頁Thequalityregulationsdepartmentshallreviewtheproductfamilyeveryyeartoensurethattheproductfamilyandtheproductsrepresentingtheproductfamilyarecontinuouslyeffective.Duringtheproduction process,productsthathavechangedproductionconditionsandproductionprocessesandnewproductsshouldbetestedforinitialpollutiontoensurethecontinuedeffectivenessoftherepresentativeproduct464輻照條件的保持 Maintenanceofirradiationconditions滅菌供方的輻照條件發(fā)生變化時(shí)，質(zhì)量法規(guī)部根據(jù)影響的結(jié)果進(jìn)行劑量分布實(shí)驗(yàn)或再確認(rèn)或更換輻照機(jī)構(gòu)。Whentheirradiationconditionsofthesterilizationsupplierchange,thequalityregulationsdepartmentwillconductdosedistributionexperimentsorreconfirmorreplacetheirradiationmechanismaccordingtotheresultsoftheimpact.滅菌過程重新確認(rèn) Reconfirmationofsterilizationprocess在發(fā)生以下情況時(shí)，質(zhì)量法規(guī)部需要評(píng)定影響并形成文件，需要時(shí)進(jìn)行重新確認(rèn)：Inthefollowingcases,thequalityregulationsdepartment needstoassesstheimpactanddocumentit,andreconfirmitifnecessary1） 輻照機(jī)構(gòu)發(fā)生變化時(shí)，需進(jìn)行輻照機(jī)構(gòu)確認(rèn)、輻照加工確認(rèn)；Whentheirradiationmechanismchanges,itisnecessaryto confirmthe irradiationmechanismandtheirradiationprocessing.2） 當(dāng)代表產(chǎn)品發(fā)生變化、劑量審核失敗導(dǎo)致重新建立滅菌劑量時(shí)，需進(jìn)行輻照劑量確認(rèn)；Whentherepresentativeproductchangesa