世界卫生组织HVAC非无菌制药指南(中英对照)WHO_937技术报告.docVIP

WHO 937 Annex 附件2 Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms 在GMP的基础上补充指导药剂的供暖，通风，空调系统的指导条例。 1. Introduction 介绍 2. Scope of document 文本范围 3. Glossary 术语表 4. Protection 保护 4.1 Products and personnel 产品和人员 4.2 Air filtration 空气过滤 4.3 Unidirectional airflow 单向空气流 4.4 Infiltration 渗透 4.5 Cross-contamination 交叉污染 4.6 Temperature and relative humidity 温度和相对湿度 5. Dust control 固体颗粒污染物控制 6. Protection of the environment 环境保护 6.1 Dust in exhaust air 排气中的固体颗粒 6.2 Fume removal 烟尘的祛除 7. Systems and components 系统和构造 7.1 General 概论 7.2 Recirculation system 循环系统 7.3 Full fresh air systems 送风系统 8. Commissioning, qualification and maintenance 运转，资格和维护 8.1 Commissioning 运转 8.2 Qualification 资格 8.3 Maintenance 维护 References 文献 45 1. Introduction 介绍 Heating, ventilation and air-conditioning (HVAC) play an important role in ensuring the manufacture of quality pharmaceutical products. A well designed HVAC 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 for systems for manufacturers of solid dosage forms. The guidelines also refer to other systems or components which are not relevant to solid dosage form manufacturing plants, but which may assist in providing a comparison between the 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 with regard to items such as airlock positions, doorways and lobbies. The architectural components have an effect on room pressure 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-contamination is an essential design consideration of the HVAC system.