摘要
目的探讨湿度对制剂室洁净度的影响，提高洁净室（区）的空气洁净度，确保所生产药物的质量。方法洁净区其它各参数都在规定范同的条件下，在45％～65％不同的湿度条件，对洁净室洁净度进行检测。结果各湿度条件下≥0．5μm的悬浮粒子数、浮游菌及沉降菌均符合要求；在湿度条件较少（接近45％）时，≥5μm的悬浮粒子数不达标；而在湿度条件较大（靠近65％）时，≥5μm的悬浮粒子数符合规定。结论对洁净室的日常运作、维护工作中，在所生产的制剂无特别湿度要求时，在规定的范同内，适当增加洁净空凋的湿度，可有效控制悬浮粒子数，有利于洁净度的提高，确保所生产药物的质量。
Objective To find out the influences humidity to the air cleanliness in drug manufacturing room, and to improve the air cleanliness in clean area to ensure the quality of the preparation. Methods Detecting the air cleanliness through different humidity conditions ranging from 45% to 65% by working within the controlled parameter. Results Suspended particles, floating bacteria together with settling bacteria larger than 0.5p.m are under controlled in various humidity conditions. The amount of the suspended particles larger than 5μm has gone beyond the limit when the humidity is lower （ near 45% ）.Meanwhile, when the humidity is higher to be close to 65%, the amount of the suspended particles larger than 5ttm conforms to the standard. Couclusion When there is no special humidity requirement in the drug manufacturing room, therefore, increasing the humidity in daily work is beneficial to the well controlling of the amount of the suspended particles, as well as the improvement of the air cleanliness and the good quality of the preparation products.
出处
《国际医药卫生导报》
2011年第6期699-702,共4页
International Medicine and Health Guidance News
关键词
洁净度
悬浮粒子
湿度
影响
Cleanliness
Suspended particles
Humidity
Influence
