世界卫生组织HVAC非无菌制药指南(中英对照)WHO_.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