摘要
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.关键词
冷冻干燥/生物制品/疫苗冻干/质量设计/过程控制Key words
Lyophilization/Biological products/Vaccine freeze drying/QbD/PAT分类
机械制造
