世界卫生组织HVAC非无菌制药指南(中英对照)WHO-937VIP免费

WHO937Annex附件2Supplementaryguidelinesongoodmanufacturingpracticesforheating,ventilationandair-conditioningsystemsfornon-sterilepharmaceuticaldosageforms在GMP的基础上补充指导药剂生产的供暖，通风，空调系统的指导条例。1.Introduction介绍2.Scopeofdocument文本范围3.Glossary术语表4.Protection保护4.1Productsandpersonnel产品和人员4.2Airfiltration空气过滤4.3Unidirectionalairflow单向空气流4.4Infiltration渗透4.5Cross-contamination交叉污染4.6Temperatureandrelativehumidity温度和相对湿度5.Dustcontrol固体颗粒污染物控制6.Protectionoftheenvironment环境保护6.1Dustinexhaustair排气中的固体颗粒6.2Fumeremoval烟尘的祛除7.Systemsandcomponents系统和构造7.1General概论7.2Recirculationsystem循环系统7.3Fullfreshairsystems送风系统8.Commissioning,qualificationandmaintenance运转，资格和维护8.1Commissioning运转8.2Qualification资格8.3Maintenance维护References文献451.Introduction介绍Heating,ventilationandair-conditioning(HVAC)playanimportantroleinensuringthemanufactureofqualitypharmaceuticalproducts.AwelldesignedHVACsystemwillalsoprovidecomfortableconditionsforoperators.加热，通风，空调（HVAC）系统在保证药品质量的生产上起着至关重要的作用。同时，设计完善的系统也会给操作人员提供舒适的工作环境。Theseguidelinesmainlyfocusonrecommendationsforsystemsformanufacturersofsoliddosageforms.Theguidelinesalsorefertoothersystemsorcomponentswhicharenotrelevanttosoliddosageformmanufacturingplants,butwhichmayassistinprovidingacomparisonbetweentherequirementsforsoliddosage-formplantsandothersystems.这些条例主要是针对固体药剂生产车间而提出的。但同时在涉及到与固体药剂生产无关的其它生产中，这些条例可以比较固体药剂生产车间和其它车间生产规格上的具体要求。HVACsystemdesigninfluencesarchitecturallayoutswithregardtoitemssuchasairlockpositions,doorwaysandlobbies.Thearchitecturalcomponentshaveaneffectonroompressuredifferentialcascadesandcross-contaminationcontrol.HVAC系统的设计与建筑规划有关，比如气阀、门口、出入口。这些物件的设计对房间气压差的形成和交叉污染的控制都起着重要作用。Thepreventionofcontaminationandcross-contaminationisanessentialdesignconsiderationoftheHVACsystem.污染和交叉污染的防制是HVAC系统设计的重点考虑因素。Inviewofthesecriticalaspects,thedesignoftheHVACsystemshouldbeconsideredattheconceptdesignstageofapharmaceuticalmanufacturingplant.鉴于这些关键点，在药品生产车间的设计阶段，HVAC系统的设计规划就应被考虑进去。Temperature,relativehumidityandventilationshouldbeappropriateandshouldnotadverselyaffectthequalityofpharmaceuticalproductsduringtheirmanufactureandstorage,ortheaccuratefunctioningofequipment.适当的温度、相对湿度和良好的通风条件无论是在药品的生产和储藏阶段，都会影响药品质量。Thisdocumentaimstogiveguidancetopharmaceuticalmanufacturersandinspectorsofpharmaceuticalmanufacturingfacilitiesonthedesign,installation,qualificationandmaintenanceoftheHVACsystems.本文献的目的是给药品生产和质检人员提供便利，在HVAC系统的设计、设备安装、资质条件以及系统维护方面。TheseguidelinesareintendedtocomplementthoseprovidedinGoodmanufacturingpracticesforpharmaceuticalproducts(1)andshouldbereadinconjunctionwiththeparentguide.这些条例也是（药品生产GMP）（1）的补充说明，在总条例的中也会读到。Theadditionalstandardsaddressedbythepresentguidelinesshouldthereforebeconsideredsupplementarytothegeneralrequirementssetoutintheparentguide.现在这些增加的标准也应考虑作为制定总条例的重要补充部分。2.Scopeofdocument文献范围Theseguidelinesfocusprimarilyont...