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-contaminat...
