冻干工艺的优化培训课程.pptx

Optimization of the Lyophilization or Freeze Drying Process 冻干工艺的优化Definition of Lyophilization冻干的定义A stabilizing process in which the product is first frozen and then the amount of solvent is removed first by sublimation and then by desorption to values that will no longer support biological growth or chemical reactions. 冻干是一个使物质稳定化的过程，在该过程中，首先使产品冷冻，然后将溶剂升华和解吸附，使产品中的含水量减少到缺乏以支持生物生长和发生化学反响的程度 Definition of Freeze Drying冷冻枯燥的定义Freeze drying is a stabilizing process in which there is first crystallization of the solvent to form a structure in the product and then the amount of solvent is removed first by sublimation and then by desorption to values that will no longer support biological growth or chemical reactions. 冷冻枯燥是一个是物质稳定的过程，在该过程中，冻干的溶剂先结晶，在产品中形成一定的结构，然后靠升华和解吸附作用将溶剂的量减少至缺乏以维持生物生长和发生化学反响的程度。 Basic Difference根本差异Lyophilization – product remains frozen during the drying process 冻干-枯燥过程中产品保持冷冻Freeze Drying – product may not remain frozen during the drying process 冷冻枯燥-冻干过程中产品可能不是冷冻状态Key point is the term frozen “冻干〞这个词是关键点Most Important Step最重要的步骤Formulation配方Why is the Formulation so Important?为何配方如此重要Defines the freezing process 限定冷冻过程Defines the drying process parameters限定枯燥过程参数Defines the freeze drying equipment requirements 限定冷冻枯燥设备要求Defines the shelf-life of the product 限定产品的货架寿命Defines if the process is going to be lyophilized or freeze dried 限定产品是冻干还是冷冻枯燥Key Properties of the Formulation配方的关键性质Composition 组成Stability 稳定性 Thermal Properties热性质Key Thermal Properties主要的热性质Degree of Supercooling过冷度Eutectic or Collapse Temperature共晶或塌陷温度Degree of Crystallization结晶度Supercooling过冷度 The degree of supercooling is defined as the number of degrees below the equilibrium freezing temperature where ice first starts to form. 过冷度是指低于冰开始形成时的冷冻平衡温度的度数Key Thermal Properties主要的热性质Degree of Supercooling过冷度Eutectic or Collapse Temperature共晶或塌陷温度Degree of Crystallization结晶度Basic Definition of a Eutectic共晶点的根本定义That temperature at which the number of degrees of freedom in a sys