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1. Introduction 介绍 Heating,ventilation and air-conditioning (HVAC) play an important role in ensuring themanufacture of quality pharmaceutical products. A well designedHVAC system will also provide comfortable conditions for operators. 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。 These guidelines mainly focus on recommendations forsystems for manufacturers of solid dosage forms. The guidelines also refer toother systems or components which are not relevant to solid dosage formmanufacturing plants, but which may assist in providing a comparison betweenthe requirements for solid dosage-form plants and other systems. 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。 HVAC system design infl uences architectural layouts withregard to items such as airlock positions, doorways and lobbies. Thearchitectural components have an effect on roompressure differential cascades and cross-contamination control. 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。 The prevention of contamination and cross-contaminationis an essential design consideration of the HVAC system. 污染和交叉污染的防制是HVAC系统设计的重点考虑因素。 In view of these critical aspects, the design of the HVACsystem should be considered at the concept design stage of a pharmaceuticalmanufacturing plant. 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, relative humidity and ventilation should beappropriate and should not adversely affect the quality of pharmaceuticalproducts during their manufacture and storage, or the accurate functioning ofequipment. 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。 This document aims to give guidance to pharmaceuticalmanufacturers and inspectors of pharmaceutical manufacturing facilities on thedesign, installation, qualification and maintenance of the HVAC systems. 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。 These guidelines are intended to complement thoseprovided in Good manufacturing practices for pharmaceutical products (1) and should be read inconjunction with the parent guide. 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。 The additional standards addressed by the presentguidelines should therefore be considered supplementary to the generalrequirements set out in the parent guide. 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。
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发表于 2013-5-13 10:06:51
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