无菌隔离器的发展和应用

Development and Application of Sterilized Isolator

无菌药品在制造过程中,需要采用各种方法来防止制品受到微生物的污染。无菌洁净室是药品制造过程中防止药品污染的一个非常重要的区域。在此区域的操作人员与药品直接接触,因此,操作人员便成为了药品的污染源。如何控制人员对药品的污染成为一个亟待解决的问题。同时,当药品存在对人体有很大伤害的特性时,如何有效的保护操作人员也是一个很重要的问题。隔离器技术正可以有效的防止人员与药品的交叉污染。介绍了:无菌隔离系统技术的原理;无菌隔离系统的特点;隔离系统在冻干机中的应用及未来的发展趋势。

Sterilized cleaning room is an important area used for protecting drug contamination in medicine production. In this area, operator will directly contact drugs, thus operator may become the source of contamination. How to control the contamination from operator is a problem which is urgently needed to solve. At the same times, when drug has the property of making harm to human, how to protecting the operators is also an important problem. The application of sterilized isolator technique can effectively protect cross contamination between human and drugs. In this article, the principle, characteristics, application and developing trend of sterilized isolator technique were introduced.