| 专用非无菌原料药生产设备清洗方法和验证 |
| |
| 引用本文： | 王文. 专用非无菌原料药生产设备清洗方法和验证[J]. 广西商业高等专科学校学报, 2010, 0(2): 9-11,27 |
| |
| 作者姓名： | 王文 |
| |
| 作者单位： | 天方药业股份有限公司,河南驻马店463000 |
| |
| 摘 要： | 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。
|
| 关 键 词： | 非无菌原料药 特殊设备 清洗验证 残留量 |
Cleaning Methods and Verification of Production Equipment for Special-purpose Non-aseptic Pharmaceutical Ingredient |
| |
| Wang Wen. Cleaning Methods and Verification of Production Equipment for Special-purpose Non-aseptic Pharmaceutical Ingredient[J]. Journal of Guangxi Commercial College, 2010, 0(2): 9-11,27 |
| |
| Authors: | Wang Wen |
| |
| Affiliation: | Wang Wen (Arabia Pharmaceutical Industry Limited Liability Company Zhumadian,Henan 463000) |
| |
| Abstract: | 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. |
| |
| Keywords: | non-aseptic pharmaceutical ingredient special equipment cleansing verification residue |
| 本文献已被 维普 等数据库收录！ |
|
