专用非无菌原料药生产设备清洗方法和验证

Cleaning Methods and Verification of Production Equipment for Special-purpose Non-aseptic Pharmaceutical Ingredient

从清洗的目的和对生产的现实意义出发介绍了连续生产非无菌原料药设备清洗方法,化学残留量限度标准的确定,并对棉签擦拭法和淋洗水法两种验证取样方法进行了综述。详细分析了两种方法的利弊和注意事项。

The article,from the cleaning purpose and practical significance,introduces the cleaning methods of production equipment for non-aseptic pharmaceutical ingredient,and determination of the limit standard for chemical residue.It also makes an overview of the two verifying methods（cotton swab cleansing and water washing）and analyzes the advantages and disadvantages in these two methods.