药品质量源于设计(Quality by Design,QbD)鼓励采用创新制药工艺、技术和装备提高药品质量和生产效率。连续制造(Continuous Manufacturing)指在一段时间内不间断提供原料并生产出终产品的过程。与间歇(Batch)生产相比,连续制造具有占...药品质量源于设计(Quality by Design,QbD)鼓励采用创新制药工艺、技术和装备提高药品质量和生产效率。连续制造(Continuous Manufacturing)指在一段时间内不间断提供原料并生产出终产品的过程。与间歇(Batch)生产相比,连续制造具有占地面积少、生产周期缩短、智能化程度高、工艺易放大、产品质量一致性高等特点,符合未来药品生产发展趋势和需求。本文总结了连续制药过程关键技术和方法,包括连续喂料、连续混合、连续制粒等单元型连续制药过程,以及口服固体制剂、化学药合成和生物制品的全程型连续生产过程,介绍了停留时间分布分布(RTD)模型和过程分析技术(PAT)等先进控制方法在连续制药过程中的应用,以期对我国药品和中药生产的发展提供借鉴。展开更多
The residence-time distribution （RTD） and the compartment model were applied to characterizing the flow regions in red mud separation thickener’s feedwells. Combined with the experimental work, validated mathematic...The residence-time distribution （RTD） and the compartment model were applied to characterizing the flow regions in red mud separation thickener’s feedwells. Combined with the experimental work, validated mathematical model as well as three-dimensional computational fluid dynamics （CFD） model was established to analyze the flow regions of feedwells on an industrial scale. The concept of RTD, although a well-known method for the characterization of mixing behavior in conventional mixers and reactors, is still a novel measure for the characterization of mixing in feedwells. Numerical simulation results show that the inlet feed rate and the aspect ratio of feedwells are the most critical parameters which affect the RTD of feedwell. Further simulation experiments were then carried out. Under the optimal operation conditions, the volume fraction of dead zone can reduce by10.8% and an increasement of mixing flow volume fraction by 6.5% is also observed. There is an optimum feed inlet rate depending on the feedwell design. The CFD model in conjunction with the RTD analysis then can be used as an effective tool in the design, evaluation and optimization of thickener feedwell in the red mud separation.展开更多
A resident time model is proposed to evaluate the performance of agitated extraction columns. In this model, the resident time of dispersed drops is simulated with the discrete phase modeling, where the continuous pha...A resident time model is proposed to evaluate the performance of agitated extraction columns. In this model, the resident time of dispersed drops is simulated with the discrete phase modeling, where the continuous phase and the dispersed phase （drops） are described by the single-phase Navier-Stokes （turbulence） model and Lagrangian model, respectively. The interaction of dispersed phase and continuous phase is neglected for the low concentration of drop in the cases studied. The statistical parameters of drops （the average resident time and standard deviation） under different operation conditions are computed for four columns. The relation of the above statistical parameters with the performance of columns is discussed and the criterions for an optimal compartment are outlined. Our results indicate that the resident time model is useful to evaluate the performance and optimize the design of extraction columns.展开更多
文摘药品质量源于设计(Quality by Design,QbD)鼓励采用创新制药工艺、技术和装备提高药品质量和生产效率。连续制造(Continuous Manufacturing)指在一段时间内不间断提供原料并生产出终产品的过程。与间歇(Batch)生产相比,连续制造具有占地面积少、生产周期缩短、智能化程度高、工艺易放大、产品质量一致性高等特点,符合未来药品生产发展趋势和需求。本文总结了连续制药过程关键技术和方法,包括连续喂料、连续混合、连续制粒等单元型连续制药过程,以及口服固体制剂、化学药合成和生物制品的全程型连续生产过程,介绍了停留时间分布分布(RTD)模型和过程分析技术(PAT)等先进控制方法在连续制药过程中的应用,以期对我国药品和中药生产的发展提供借鉴。
基金Project (50876116) supported by the National Natural Science Foundation of China
文摘The residence-time distribution （RTD） and the compartment model were applied to characterizing the flow regions in red mud separation thickener’s feedwells. Combined with the experimental work, validated mathematical model as well as three-dimensional computational fluid dynamics （CFD） model was established to analyze the flow regions of feedwells on an industrial scale. The concept of RTD, although a well-known method for the characterization of mixing behavior in conventional mixers and reactors, is still a novel measure for the characterization of mixing in feedwells. Numerical simulation results show that the inlet feed rate and the aspect ratio of feedwells are the most critical parameters which affect the RTD of feedwell. Further simulation experiments were then carried out. Under the optimal operation conditions, the volume fraction of dead zone can reduce by10.8% and an increasement of mixing flow volume fraction by 6.5% is also observed. There is an optimum feed inlet rate depending on the feedwell design. The CFD model in conjunction with the RTD analysis then can be used as an effective tool in the design, evaluation and optimization of thickener feedwell in the red mud separation.
基金Supported by the National Natural Science Foundation of China (No. 20376053).
文摘A resident time model is proposed to evaluate the performance of agitated extraction columns. In this model, the resident time of dispersed drops is simulated with the discrete phase modeling, where the continuous phase and the dispersed phase （drops） are described by the single-phase Navier-Stokes （turbulence） model and Lagrangian model, respectively. The interaction of dispersed phase and continuous phase is neglected for the low concentration of drop in the cases studied. The statistical parameters of drops （the average resident time and standard deviation） under different operation conditions are computed for four columns. The relation of the above statistical parameters with the performance of columns is discussed and the criterions for an optimal compartment are outlined. Our results indicate that the resident time model is useful to evaluate the performance and optimize the design of extraction columns.
