纯蒸汽测试报告

Page页码PAGE3ofNUMPAGES7TheQualityofPureSteamTestingReport纯蒸汽质量测试报告TheQualityofPureSteamTestingReport纯蒸汽质量测试报告Company/Title公司/职务Name姓名Signature签名Date日期Writtenby起草Reviewed审核Approved批准Index目录1. Purpose目的 32. Scope范围 33. SystemDescription系统描述 34. Responsibility职责 45. RegulationandGuidance法规和指南 46. TestResultsAnalysis测试结果分析 57. TestAppendicesList测试清单确认 78. DeviationList偏差清单 7

Purpose目的ThepurposeofthistestingreportistodemonstratethatthePureSteamGenerationandDistributionSystemofconsistentlyproducesPureSteamthatmeetstherequirementsspecifiedintheEN285.

该报告用于证明纯蒸汽制备和分配系统产生的纯蒸汽满足EN285相关规定和要求。Scope范围ThetestitemsincludedinthisreportarethetestitemsforpuresteamspecifiedinEN285,non-condensablegas,degreeofsuperheatanddryness.本测试项目为EN285中规定的纯蒸汽测试项目：不凝性气体、过热度、干度。TestItemsDescription测试项目描述Dryness-describesaqualityofsteamthathasbeensuperheated.Asthedrynessfactorofsteamincreases,thesuitabilityofthesteamasamediumformoist-heatsterilizationdiminishes.Drysteamissaidtobeadiabatically(orthermally)insulatedagainstheattransfer.蒸汽干度值：描述己过热的一定质量的蒸汽，随着蒸汽干燥值因子增加，作为湿热灭菌的蒸汽的适用性减少。干燥蒸汽以绝热（或热分解）的方式阻止热传递。SuperheatedSteam-Steamwhoseheat,atanygivenpressure,ishigherthanthatindicatedforthevaporizationcurveofwater.

过热蒸汽：在任何压力下，蒸汽的热度高于水的蒸发曲线。Non-condensablegases(NCGs)-aredefinedasgaseswhichcannotbeliquefiedbycompressionundertherangeofconditionsoftemperatureandpressureusedduringthesterilizationprocess.LowlevelsofNCGscontainedinsteamsuppliedtosterilizerscanmarkedlyaffecttheperformanceofthesterilizerandtheefficacyoftheprocess,causechamberoverheatingandleadtoinconsistenciesintheperformanceofairdetectorsandfailureoftheBowie-Dicktest.MajorNCGsareatmosphericairandcarbondioxide.

不凝性气体（NCGs）：在灭菌过程中，在一定温度和压力范围下，压缩后仍无法被液化的气体。灭菌蒸汽里少量的不凝性气体会对灭菌器和灭菌过程造成显著影响，造成腔体过热，空气探测器运作的不稳定，Bowie-Dick测试的失败。不凝性气体主要是空气和二氧化碳。Responsibility职责Austarresponsibility奥星的职责Testingexecution,datacollection

测试的实施，数据的收集Reportcompilation

报告的编写Clientresponsibility客户职责Supervisionoftestingprocess,reviewandapprovalofthisreport.

负责验证过程监督、报告的审核与批准，确保按批准的方案执行。Assessmentandhandlingofchangesanddeviationsoccurduringthistesting

负责对测试实施过程中出现的变更和偏差的评价和处理。Deviationreportcompilation

偏差报告的编写RegulationandGuidance法规和指南HTM2010

HTM2010BSEN2852006

BSEN2852006KSASteamQualityTestKitSQ1OperationProcedure:TSP-SOP-VTS-22

KSA蒸汽质量检测仪操作规程：TSP-SOP-VTS-22

TestResultsAnalysis测试结果分析ThetestingofthequalityofPureSteamformPureSteamGenerationandDistributionSystemhasbeenimplementedat2012/04/26.

在2012年04月26日对纯蒸汽制备和分配系统产生的纯蒸汽的质量进行了测试。TestNo.

测试编号Title名称DatesoftheTest

测试日期6.1CalibrationofInstrumentsandtestSOP测试仪器校验和SOP2012年04月26日Allthetestinginstrumentsarewiththeirrespectivecalibrationcertificatesandthecalibrationcertificatesarewithinthevalidcalibrationperiod.

所有测试仪器仪表均具有校验报告，且在有效期内。SOPlistfortheTesting.

以下为本次测试所需的SOP列表1.KSASteamQualityTestKitSQ1OperationProcedure1.KSA蒸汽质量检测仪操作规程Thetestis

测试结论为PASS合格

TestNo.

测试编号Title名称DatesoftheTest

测试日期6.2PureSteamQualityVerification纯蒸汽质量确认2012年04月26日ThePureSteambythePureSteamGenerationandDistributionSystemcanmeetthespecifiedqualityrequirements.

纯蒸汽制备和分配系统能够持续供应符合规定质量要求的纯蒸汽。Test测试AcceptanceCriteria验收标准Non-condensategas

不凝性气体<3.5%(V/V)Dryness

干度≥0.90Superheat.

过热度<25℃PureSteamNon-condensategastestmeetstherequirement.TestingphotosseetheAppendixD.纯蒸汽不凝性气体测试符合要求。PureSteamDrynesstestmeetstherequirement.纯蒸汽干度测试，符合要求。PureSteamSuperheattestmeetstherequirement..纯蒸汽过热度测试，符合要求。Thetestis

测试结论为PASS合格

TestAppendicesList测试清单确认TestNo.

测试编号AppendicesNo.

附件编号Title

名称Page