冻干工艺的优化 冷冻干燥工艺.pptVIP

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不足以支持生物生长和发生化学反应的程度 Definition of Freeze Drying冷冻干燥的定义 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. 冷冻干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不足以维持生物生长和发生化学反应的程度。 Basic Difference基本差别 Lyophilization – product remains frozen during the drying process 冻干-干燥过程中产品保持冷冻 Freeze Drying – product may not remain frozen during the drying process 冷冻干燥-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限定干燥过程参数 Defines the freeze drying equipment requirements 限定冷冻干燥设备要求 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干燥 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