双扉真空灭菌柜灭菌性能验证

编号No.：编号No.：PQP-1527-1.01of7起草于2023年04月PreparedApril2023Title-灭菌性能确认AutoclaveBacteriaChallengeRoomNo验证的仪器、设备或程序tobeValidatedPulsationVacuumTest1283EquipmentNumberSuppliedby:山东华医疗器械股instrumentCo.,Ltd.EquipmentRegister:20232261MEO-09-01ApprovaloftheValidationProtocolSignhereafterreviewingandapprovingtheSOPs,standardsandschedulesTitleName签名Signature 日期DateWrittenBy:VDHaiyangWangApprovedBy:SupervisorHaiyangWangQAQAManagerZhenchaoLiuTestfacilitymanagerYuyeXiaTableofContents\l“_TOC_250012“通用说明和先决条件GeneralInstructionsandPrerequisite 3\l“_TOC_250011“目的Objective 3\l“_TOC_250010“设备描述EquipmentDescription 3\l“_TOC_250009“术语和定义 3责任 3\l“_TOC_250008“文件和标准操作规程DocumentsandStandardOperatingProcedures 4\l“_TOC_250007“完本钱文件CompletionofthisDocument 4\l“_TOC_250006“文件列表QualificationDocuments 4\l“_TOC_250005“使用的仪器和标准品TestInstrumentationandStandardsUsedintheQualification 4\l“_TOC_250004“性能确认Performancequalification 5\l“_TOC_250003“缺陷报告附件列表DeficiencyReportAttachmentsList 5\l“_TOC_250002“批准Approvals 6\l“_TOC_250001“临时批准InterimApproval 6\l“_TOC_250000“最终批准FinalApproval 6通用说明和先决条件GeneralInstructionsandPrerequisiteObjective这份方案描述脉动真空双扉灭菌柜MEO-09-01的灭菌性能确认程序。这台设备1283。将会确认设备在正常操作条件下，关键变量能在允许的公差范围内持续稳定的重现。ThisprotocolwilldefinetheproceduretobefollowedforthePerformanceQualificationofthePulsationVacuumAutoclaveNo:MEO-09-01.ItislocatedinRoom1283.Itwillverifythatthevariables,criticaltotheoperation,consistentlyoperatewithinaspecifiedtolerancerangewhenoperatedundernormalconditions.设备描述EquipmentDescriptionXG1.DWF-1.5B，由山东华医疗器械股份供给。其使用ModelofthisequipmentisXG1.DWF-1.5B,it’ssuppliedbySHINVAmedicalinstrumentCo.,Ltd.ItisusedtosterilizetheitemstobeusedinSPFarea.术语和定义-在关键缺陷工程被〔解决〕完成之前，验证工作不能签署通过。CriticalDeficiency–Validationmaynotbesignedoffuntiltheitemisclosedout.非关键缺陷-验证工作可以签署通过，可是连续使用没有被缺陷影响的工程。Non–CriticalDeficiency–Validationmaybesignedoffand(continued)useoftheitemisnotimpactedbythedeficiency.责任

Activity

责任方ResponsibleParty起草和批准方案Prepareandapproveprotocol协调验证活动CoordinateValidationProtocolActivities供给使用仪器或设备的许可Provideaccesstoitem供给效劳支持许可Providecontractorsupportandaccess安排测试〔假设需要〕Arrangelaboratorytesting(asrequired)执行方案和起草报告ExecuteProtocolandpreparereport起草最终报告Preparefinalreport批准最终报告Approvefinalreport

苏州华测生物技术CTIBIOTECHNOLOGY(SUZHOU)Co.,Ltd.VD-HaiyangWang-李永超Maintainer-YongchaoLi山东华医疗器械股份SHINVAmedicalinstrumentCo.,Ltd.VD-王海洋VD-HaiyangWang验证负责人VD-王海洋VD-HaiyangWang-李永超Participant-YongchaoLiWang-Participant-YingJiangVD-HaiyangWang验证负责人VD-王海洋VD-HaiyangWang机构负责人TFM-Yuyexia文件DocumentsandStandardOperatingProcedures完本钱文件CompletionofthisDocument签名和署日期。Thisdocumentisnottobecopied.Allresultsmustbecompletedontheoriginaldocumentoronsupplementaryrecordsattachedtothisdocument.Eachattachmentmustbesignedanddated.NA。AllspacesprovidedinthePQdocumentmustbecompleted.Ifaresultisnotapplicableornotrequiredthisshouldbestatedinthespaceprovided.Ifanumberofspacesarenotrequired,adiagonallinethroughallspaceswithaNotApplicablesignmaybeused.Thisdocumentmustbecompletedinblackpenonly.文QualificationDocumentsPQThefollowingdocumentsarerequiredforcompletionofthePQ文件Document

文件号和/或文件名Document#and/orTitle

Verifiedby:运行确认 需填入文件名或编号OperationQualification使用与维护规程Operation WI-BTC-EQU-011andmaintenanceSOPCalibrationSOPTrainingRecord设备或仪器的使用日志Equipment/InstrumentLogBooks

N/ABTC-MAN-0305-1.2BTC-EQU-0301-1.0使用的仪器和标准品TestInstrumentationandStandardsUsedintheQualification列举执行运行确认所需的测量仪器和标准品。ListoftestinstrumentsandreferencestandardsrequiredfortheexecutionofthePQ.仪器或标准品仪器或标准品InstrumentorStandard生化培育箱杆菌指示剂序列号SerialNo.证书编号CertificateNo.计量日期DateCalibrated计量有效期至CalibrationDueDate确认人Verifiedby:12070015NA批号：NANANA性能确认Performancequalification为系统关键参数的运行范围和牢靠性供给可信依据。Toprovideconfidenceinthereliabilityandoperatingrangescriticaloperatingvariablesofthesystem.Listtheteststobecompletedhere测试号 关键变量 期望的运行范围Test# CriticalVariable AnticipatedOperatingRanges

责任安排ResponsibilitytoComplete灭菌性能确认 嗜热脂肪芽胞杆菌指示剂呈蓝紫色 王雨蒙和姜英BacteriaChallenge ColorofBacillusstearothermophilus YumengWang&Test isBluetoPurple YingJiangInserttestsheetsandresultformatsperattachmentA.DeficiencyReportAttachmentsList一份显示安装确认过程中产生的缺陷报告和缺陷报告状态的列表。ListdeficiencyreportsproducedduringtheInstallationQualificationandtheirstatus.Refertoattacheddetailedreports.缺陷报告号缺陷报告号DeficiencyReport#DeficiencyDescriptionSummaryCloseoutClassification检查人Checkedby日期DateCriticalNonCriticalCriticalNonCriticalCriticalNonCritical批准ApprovalsInterimApproval有非关键缺陷存在就执行临时批准，但不能执行最终批准。IftherearenooutstandingCriticalValidationDeficiencyInvestigationsgotofinalapproval.Iftherearecriticaldeficiencieswithholdapprovals.Ifthedeficienciesarenon-criticalprovideinterimapprovalbutnotfinalapproval.Title验证负责人VDQAQAManager机构负责人TFMName刘振超ZhenchaoLiuYuyeXiaSignatureDateFinalApproval执行最终批准，当全部的缺陷都已经解决和完成。ProvidefinalapprovalwhenALLdeficienciesareresolvedandclosedout.Title验证负责人VDQAQAManager机构负责人TFMNameHaiyangWangZhenchaoLiuYuyeXiaSignatureDateSheetofsignatures