冻干工艺的优化ppt参考课件.pptVIP

What to consider for the Freezing Process冷冻过程中需要考虑的问题 Initial shelf surface temperature (formulation, fill volume, stability) 搁板表面的初始温度（配方，装料体积，稳定性） Initial shelf surface temperature (ambient, 4 - 8 oC, 0 oC) 搁板表面的初始温度（室温，4 - 8 oC, 0 oC) Shelf cooling rate (supercooling and fill volume) 搁板冷却速率（过冷河装料体积） Freezing temperature (eutectic or collapse temperature 10 oC lower – mobility of water is zero) 冷冻温度（共晶和塌陷温度10 oC更低-水的移动性为零 Time (fill volume)/ 时间（装料体积） * Effect of Freezing on the Product冷冻对产品的影响 Was there a change in the composition of the formulation?/ 配方的成分时候有变化 Any change in turbidity?/混浊度是否有变化 Nature of the frozen cake (uniform or crust or glaze) 冷冻饼状物的性质（均一或者硬壳或冻胶层） * Example of a Freezing Process冻干过程举例 Degree of Supercooling = 7 oC 过冷度= 7 oC Collapse temperature (Tc) = - 23 oC 塌陷温度= - 23 oC Freezing temperature – 35 oC 冷冻温度– 35 oC * Key Process Steps主要工艺步骤 Freezing 冷冻 Primary Drying 第一次干燥 * Primary Drying第一次干燥 Sublimation of ice from the matrix according to the phase diagram of water 根据水的相图使水从基质中升华 Lyophilization – frozen interstitial 冻干-脉间区冻结 Freeze Drying – frozen or not frozen interstitial region. 冷冻干燥-脉间区冻结或不冻结 * Key Primary Drying Parameters第一次干燥主要参数 Pc Ts Tp Pc = Chamber pressure/箱内压力 Ts = Shelf surface temperature/搁板表面温度 Tp = Product temperature/产品温度 * Select the Chamber Pressure选择箱内压力 Determine the vapor pressure of ice at 5 oC below the collapse or eutectic temperature 在低于塌陷温度或共晶点5 oC的温度下确定冰的蒸气压 * Select the Chamber Pressure选择箱内压力 Select a lower chamber pressure (Pc ) 选择较低的箱内压力(Pc ) A pressure that will give a difference in ice interface temperature (Ti ) (defined by the phase diagram of water) and the product temperature (Tp ) 箱内压力会使冰界面的温度（Ti）（由水的相图限定）和产品温度不同(Tp ) q = KA(Tp – Ti)/d cal./sec. Pc 100 mTorr to prevent backstreaming Pc 100 mTorr以阻止气体回流 * Example of Primary Drying第一次干燥举例 Tc = - 23 oC Tp = -28 oC Pp = 340 mTorr Pc = 100 mTorr Ti = -