摘要
对生产前及生产结束后按清洁规程对系统进行清洁,然后进行清洁灭菌效果的取样检测。无菌、pH、细菌内毒素、不溶性微粒、可见异物和产品残留量等各项检测项目均符合标准。表明现行的清洁规程能有效地清洁生产系统及设备,防止交叉污染,保证下批产品规定的疗效、质量和安全性的状态,符合GMP生产要求。
The production personnel clean the preparation filling system according to the cleaning procedures in pre-and post-production,and then carry on the sample examination to check effect of the cleaning and sterilization. The testing items such as sterility test,pH,bacterial endotoxin,insoluble particles,visible particles and residues of production meet to the standard of GMP. The present cleaning procedures can effectively clean production systems and equipment,prevent cross-contamination,ensure the next products under the provisions of the efficacy,quality and safety,meet to the GMP requirements of production.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2010年第9期704-708,共5页
Chinese Journal of Pharmaceuticals
关键词
冻干粉针剂
配制灌装系统
清洁验证
freeze-dried injection
preparation and filling system
cleaning validation
