冻干工艺的优化演示幻灯片.pptVIP

Copyright ? 2006 Phase Technologies, Inc 31 Key Process Steps 主要冻干步骤 ? Freezing 冷冻 ? Primary Drying 第一次干燥 ? Secondary Drying 第二次干燥 Copyright ? 2006 Phase Technologies, Inc 1 Optimization of the Lyophilization or Freeze Drying Process 冻干工艺的优化 Copyright ? 2006 Phase Technologies, Inc 2 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 Copyright ? 2006 Phase Technologies, Inc 3 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。 Copyright ? 2006 Phase Technologies, Inc 4 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 Copyright ? 2006 Phase Technologies, Inc 5 Most Important Step 最重要的步骤 ? Formulation 配方 Copyright ? 2006 Phase Technologies, Inc 6 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 Copyright ? 2006 Phase Technologies, Inc 7 Key Properties of the Formulation 配方的关键性质 ? Composition 组成 ? Stability 稳定性 ? Thermal Properties 热性质