冻干工艺的优化
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Copyright 2006 Phase Technologies, Inc
Copyright 2006 Phase Technologies, Inc
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
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
Copyright 2006 Phase Technologies, Inc
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
Degree of Crystallization 结晶度
Copyright 2006 Phase Technologies, Inc
Basic Definition of a Eutectic 共晶点的基本定义
That temperature at which the number of degrees of freedom in a system during freezing is zero. (f = 0) 冷冻过程中，该温度下系统的自由度为零
Most Important Step 最重要的步骤
Formulation 配方
Copyright 2006 Phase Technologies, Inc
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
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
Copyright 2006 Phase Technologies, Inc
Key Properties of the Formulation 配方的关键性质
Composition 组成 Stability 稳定性
Thermal Properties热性质
Copyright 2006 Phase Technologies, Inc
Optimization of the Lyophilization or Freeze
Drying Process 冻干工艺的优化
Copyright 2006 Phase Technologies, Inc
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.
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
Basic Differenwenku.baidu.come 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
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
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.
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
Copyright 2006 Phase Technologies, Inc
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
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
Copyright 2006 Phase Technologies, Inc
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
Degree of Crystallization 结晶度
Copyright 2006 Phase Technologies, Inc
Basic Definition of a Eutectic 共晶点的基本定义
That temperature at which the number of degrees of freedom in a system during freezing is zero. (f = 0) 冷冻过程中，该温度下系统的自由度为零
Most Important Step 最重要的步骤
Formulation 配方
Copyright 2006 Phase Technologies, Inc
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
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
Copyright 2006 Phase Technologies, Inc
Key Properties of the Formulation 配方的关键性质
Composition 组成 Stability 稳定性
Thermal Properties热性质
Copyright 2006 Phase Technologies, Inc
Optimization of the Lyophilization or Freeze
Drying Process 冻干工艺的优化
Copyright 2006 Phase Technologies, Inc
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.
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
Basic Differenwenku.baidu.come 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
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
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.
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