【摘要】 基于对现代冻干技术进展研究和多年生物制品实际冻干经验,探讨了影响冻干的重要因素、环节以及技术和对策。冷冻干燥技术研发和工业化是复杂的系统工程,仅靠传统方法已难于有效控制,应建立以科学为基础,通过质量设计、风险评估和过程控制,优化和控制冻干过程,获取优良冻干产品,提高生产效率,降低成本。通过冻干应用技术研究,为生物制品冻干研发和生产以及产品的质量控制提供参考。更多还原

【Abstract】 Based on research on development of modern freeze drying technology and the experience in actual freezing and drying of biological products for years,this paper discusses important factors affecting freeze-dried effect,technologies and strategies.Freeze drying technology development and industrialization is a complex system engineering,traditional methods alone are difficult to effectively control.A kind of scientific basis should be established,the freeze drying process is optimized and controlled by quality design,risk assessment and process quality control to get excellent freeze dried product,improve freeze-dehydration production time,reduce costs.Through the research on application of the freeze drying technology,it provides the reference for freeze-dried biologicals development,production and product quality control.更多还原