摘要
Isolator技术是国际上流行的无菌检测支持手段,对于确保无菌检测结果的准确性具有重要意义。USP30版1208章《STERILITY TESTING—VALIDATION OF ISOLATOR SYSTEMS》详细介绍了隔离器(isolator)的使用历史、结构和功能、验证过程和技术要求,以及日常使用过程中维护和管理细节。特撰文介绍此药典专论,希望可以为中国无菌制药技术发展有所裨益。
Isolator technique is a worldwide used support method for sterility testing. It plays important role in ensuring the correctness of sterility testing. In Chapter 1208 of USP version 30 ＂Sterility Testing-Validation of Isolator Systems＂ ,the application history,the structure,the functions,the validation process and the specification of the isolator were introduced in detail. Herein this pharmacopoeia was introduced,and it wished that this article will be helpful in the development of sterility pharmaceutical technology in China.
出处
《医药工程设计》
2010年第2期29-33,共5页
Pharmaceutical Engineering Design
