摘要
分析了制药系统污染物的来源与控制方法 ,介绍了ISPE规范中对不同工艺洁净区净化等级的划分和对制药洁净室材料的要求。对制药行业暖通空调系统设计中的一些问题进行了讨论 ,根据ISPE规范的相关规定 。
Analyses the sources and control methods of contamination in pharmacy. Presents the determination of clean level for different process cleanzones and the material requirement of pharmaceutical cleanrooms, which are defined in ISPE guideline. Analyses some issues existing in HVAC system design in pharmacy and gives corresponding advices according to related prescription in the ISPE guideline.
出处
《暖通空调》
北大核心
2003年第6期50-53,共4页
Heating Ventilating & Air Conditioning
关键词
ISPE规范
制药
洁净室
净化等级
污染物
暖通空调
ISPE guideline, pharmaceutical cleanroom, clean level, contamination control, HVAC
