生物发酵系统工艺设计优化

Optimization of Process Design for Biological Fermentation System

结合新版GMP和ASME BPE等法规对生物发酵系统的要求,运用新的生物反应器和发酵系统设计理念,对传统的生物发酵系统的接种、取样、补料、移种、CIP在位清洗、废液及尾气处理等工艺设计进行优化,使其符合相关法规要求,更好地应用于原料药、生物制品等行业的发酵生产。

According to the requirements of the new GMP and ASME BPE regulations for the biological fermentation system,the new bioreactor and the design concept of the fermentation system are used to optimize the traditional biological fermentation system,such as inoculation,sampling,feeding,seed transfer,Clean In Place,waste liquid and exhaust gas treatment,so that it meets the requirements of relevant laws and regulations.It can be better applied to the fermentation production of active pharmaceutical ingredients,biological products and other products.