The innovative characteristics of triamcinolone acetonide acetate aseptic API crystallization process: improve the aseptic guarantee level, keep the original state of drug crystal after drying, soft and non caking crystal form and crystal form, directly apply to the preparation in aseptic environment, reduce a series of problems brought by the crushing process of traditional process: caking, oxide, partial broken crystal needle, loss, microbial limit risk.





抗生素原料药结晶工艺是一个涉及技术面相当广泛的技术含量较高的创新产业,涵盖生物学、动力学、流体学、化学工程、机械制造、传感技术和计算机控制技术等。 本技术应用于醋酸曲安奈德API结晶工艺(爱尔凯因 干燥后直接应用到制剂FDA,国内应用 百度: xjzc.ink )。






中国制药工业智能制造-2020年,无菌API结晶创新工艺国内应用推广,不但运用于醋酸曲安奈德无菌API结晶、还应用于高附价值API产品; 清除基因毒(DMF、NDMA等)残留。 创新科技成果转化产品质量升级,企业获得研发费用加计扣除等税收政策支持,无菌API结晶新技术应用目前国内比较先进的专利技术,改变传统落后的生产模式


无菌API,一般是用来无菌粉针直接分装的原料,不同于那些可以最终灭菌的无菌制剂的API原料,所以它的无菌控制应该难度比较大,风险比较多。 无菌API流程的烘干出料、分装无菌保护环境一般要求B+A。

关键无菌区:烘干出料 、分装区域的RABS保护A级。就是B级背景下(或c级)的带垂帘的半开放式层流A级。



2、空调系统设置新风过滤、初效过滤、中效过滤, +末端高效过滤。






附1: 欧盟GMP 无菌药品的生产 第5章 洁净室条款


附2:部分醋酸曲安奈德产品  (源于网络)


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Posted in 一致性评价, 原创, 数据完整性, 药品记录 and tagged , , .


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