制药用压缩空气质量标准及制备系统技术的探讨

Discussion on the Quality Standard of Compressed Air for Pharmaceutical Industry and Its Preparation System

随着制药生产技术的不断升级,洁净压缩空气作为工艺源气越来越广泛地应用于药品制造,因直接接触原辅料及内包装材料而成为直接影响产品质量的重要因素。目前,国内外还没有统一法定的医药级压缩空气质量标准,各企业标准和制备技术参差不齐,严重影响药品质量。本文探讨了制药用压缩空气质量标准和制备系统,介绍了影响压缩空气洁净度的主要指标,如悬浮微粒、压力露点、含油量和微生物限度等,推荐了医药级洁净压缩空气质量标准和相应的制备技术。

With the development of pharmaceutical technology, clean compressed air as a process gas source is used more and more widely in the field of pharmaceutical industry. Clean compressed air has become an important influence factor for quality of pharmaceutical products because it contact directly with raw materials and packaging materials. However, there is no legal standards of compressed air for pharmaceutical use in domestic and foreign countries. As a result, the quality of pharmaceutical products are seriously affected due to the difference of enterprise standards and preparation methods. So, the quality standard and preparation system of clean compressed air are discussed in this paper. Several indexes （such as suspended particles, pressure dew point, oleaginousness and microbial limit） affected the grade of cleanliness of compressed air are introduced. The standard and the corresponding preparation technology for the clean compressed air are also recommended.