浅析新版《药品生产质量管理规范》标准下的洁净室改造

目的:为制药企业了解新版《药品生产质量管理规范》(GMP)的新要求,做好洁净室的改造工作提供参考。方法:在对比新、旧版GMP洁净要求的基础上,分析洁净室改造的考虑要点,并提出建议。结果与结论:新版GMP在洁净区级别、悬浮粒子测量、送风口风速、同一洁净级别的相邻房间的压力差等方面与旧版有所不同。压力差、送风量与回风量、气流组织形式、送风口出风风速、换气次数是洁净室改造的考虑要点。为此,洁净室改造要分改变风口数量和不改变风口数量2种情况进行设计。

Study on the Rebuilding of Clean Room under New Version of GMP

OBJECTIVE： To provide reference for pharmaceutical manufacturers to study the new requirements of new version of GMP and rebuild the clean room. METHODS ： By studying the relevant requirement of clean room in new and previous version of GMP, the factors which affected the development of clean room were analyzed to put forward suggestions. RESULTS ＆ CON- CLUSIONS ： New version of GMP is different from previous version in terms of clean area scale, determination of suspended parti- cle, wind speed of air outlet, pressure differential of adjoining room at same clean scale, etc. The key points to rebuild clean room are pressure differential, air output and input, air distribution way, wind speed of air outlet, ventilation rate, etc. So that, rebuild- ing of clean room can be achieved by 2 kinds of conditions, i.e. changing the number of air outlet or not.