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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 continuous upgrading of pharmaceutical production technology, clean compressed air as a source of process gas is more and more widely used in the manufacture of pharmaceuticals, which is an important factor that directly affects product quality due to direct contact with raw materials and inner packaging materials. At present, there is no unified statutory pharmaceutical-grade compressed air quality standards both at home and abroad. The standards and preparation technologies of enterprises are uneven, which seriously affect the quality of medicines. In this paper, the quality standards and preparation system of compressed air for pharmaceutical use are discussed. The main indexes that affect the cleanliness of compressed air are introduced, such as aerosols, pressure dew point, oil content and microbial limits. The recommended medical grade clean compressed air quality standards and corresponding Preparation technology.