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Application of quality by design in the current drug development 被引量:13
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作者 Lan Zhang Shirui Mao 《Asian Journal of Pharmaceutical Sciences》 SCIE CAS 2017年第1期1-8,共8页
Quality by Test was the only way to guarantee quality of drug products before FDA launched current Good Manufacturing Practice. To clearly understand the manufacture processes, FDA generalized Quality by Design(QbD) i... Quality by Test was the only way to guarantee quality of drug products before FDA launched current Good Manufacturing Practice. To clearly understand the manufacture processes, FDA generalized Quality by Design(QbD) in the field of pharmacy, which is based on the thorough understanding of how materials and process parameters affect the quality profile of final products. The application of QbD in drug formulation and process design is based on a good understanding of the sources of variability and the manufacture process. In this paper,the basic knowledge of QbD, the elements of QbD, steps and tools for QbD implementation in pharmaceutics field, including risk assessment, design of experiment, and process analytical technology(PAT), are introduced briefly. Moreover, the concrete applications of QbD in various pharmaceutical related unit operations are summarized and presented. 展开更多
关键词 QUALITY by design(QbD) Process analytical technology(PAT) Critical QUALITY attributes(CQA) DESIGN of experiment(doe) Risk assessment Near infrared(NIR)spectroscopy
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Performance Analysis and Improvement of Flat Torque Converters Using DOE Method 被引量:5
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作者 Guang-Qiang Wu Jie Chen Wen-Jie Zhu 《Chinese Journal of Mechanical Engineering》 SCIE EI CAS CSCD 2018年第4期101-109,共9页
Automotive torque converters have recently been designed with an increasingly narrower profile for the purpose of achieving a smaller axial size and reducing weight. Design of experiment(DOE) and computational fluid d... Automotive torque converters have recently been designed with an increasingly narrower profile for the purpose of achieving a smaller axial size and reducing weight. Design of experiment(DOE) and computational fluid dynamics(CFD) techniques are applied to improve the performance of a flat torque converter. Four torque converters with different flatness ratios(0.204, 0.186, 0.172, and 0.158) are designed and simulated first to investigate the effects of flatness ratio on their overall performance, including efficiency, torque ratio, and impeller torque factor. The simulation results show that the overall performance tends to deteriorate as the flatness ratio decreases. Then a parametric study covering six geometric parameters, namely, inlet and outlet angles of impeller, turbine, and stator is carried out. The results demonstrate that the inlet and outlet angles play an important role in determining the performance characteristics of a torque converter. Furthermore, the relative importance of the six design parameters is investigated using DOE method for each response(stall torque ratio and peak efficiency). The turbine outlet angle is found to exert the greatest influence on both responses. After DOE analysis, an optimized design for the flat torque converter geometry is obtained. Compared to the conventional product, the width of the optimized flat torque converter torus is reduced by about 20% while the values of stall torque ratio and peak efficiency are only decreased by 0.4% and 1.7%, respectively.The proposed new optimization strategy based on DOE method together with desirability function approach can be used for performance enhancement in the design process of flat torque converters. 展开更多
关键词 Torque converter Flatness ratio Computational fluid dynamics(CFD) Parametric study Design of experiment(doe)
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Analytical quality-by-design approach for sample treatment of BSA-containing solutions 被引量:2
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作者 Lien Taevernier Evelien Wynendaele +1 位作者 Matthias D'Hondt Bart De Spiegeleer 《Journal of Pharmaceutical Analysis》 SCIE CAS 2015年第1期27-32,共6页
The sample preparation of samples conlaining bovine serum albumin(BSA),e.g..as used in transdermal Franz diffusion cell(FDC) solutions,was evaluated using an analytical qualily-by-design(QbD)approach.Traditional... The sample preparation of samples conlaining bovine serum albumin(BSA),e.g..as used in transdermal Franz diffusion cell(FDC) solutions,was evaluated using an analytical qualily-by-design(QbD)approach.Traditional precipitation of BSA by adding an equal volume of organic solvent,often successfully used with conventional HPLC-PDA,was found insufficiently robust when novel fused-core HPLC and/or UPLC-MS methods were used.In this study,three factors(acetonitrile(%).formic acid(%) and boiling time(min)) were included in the experimental design to determine an optimal and more suitable sample treatment of BSAcontaining FDC solutions.Using a QbD and Derringer desirability(D) approach,combining BSA loss,dilution factor and variability,we constructed an optimal working space with the edge of failure defined as D〈0.9.The design space is modelled and is confirmed to have an ACN range of 83 ± 3% and FA content of 1 ±0.25%. 展开更多
关键词 Bovine serum albumin(BSA)solutions Franz diffusion cell(FDC) Analytical quality-by-design(QbD) Sample preparation Design of experimentdoe Derringer desirability(D)
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Theoretical and experimental study of surface texturing with laser machining 被引量:2
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作者 Ya-Zhou Mao Jian-Xi Yang Jin-Chen Ji 《Advances in Manufacturing》 SCIE EI CAS CSCD 2021年第4期538-557,共20页
To explore the forming process and mechanism of the surface texture of laser micropits,this paper presents the thermal model of laser machining based on the Neumann boundary conditions and an investigation on the effe... To explore the forming process and mechanism of the surface texture of laser micropits,this paper presents the thermal model of laser machining based on the Neumann boundary conditions and an investigation on the effects of various parameters on the processing.The surface profile and quality of the formed micropits were analyzed using NanoFocus 3D equipment through a design of experiment(DOE).The results showed that more intense melting and splashing occurred with higher power density and narrower pulse widths.Moreover,the compressive stress is an important indicator of the damage effects,and the circumferential thermal stress is the primary factor influencing the diameter expansion.During the process of laser machining,not only did oxides such as CuO and ZnO generate,the energy distribution also tended to decrease gradually from region#1 to region#3 based on an energy dispersive spectrometer(EDS)analysis.The factors significantly affecting the surface quality of the micropit surface texture are the energy and pulse width.The relationship between taper angle and energy is appropriately linear.Research on the formation process and mechanism of the surface texture of laser micropits provides important guidance for precision machining. 展开更多
关键词 Laser machining Thermal stress damage Surface texturing Design of experiment(doe) Micropit
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Design of experiment study on hardness variations in friction stir welding of AM60 Mg alloy 被引量:2
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作者 S.Richmire K.Hall M.Haghshenas 《Journal of Magnesium and Alloys》 SCIE EI CAS 2018年第3期215-228,共14页
Identification of process parameters,their effects and contributions to the outcomes of the system using experimental approach could be a daunting,time consuming,and costly course.Using proper statistical methods,i.e.... Identification of process parameters,their effects and contributions to the outcomes of the system using experimental approach could be a daunting,time consuming,and costly course.Using proper statistical methods,i.e.,Taguchi method,could significantly reduce the number of required experiments and statistical significance of the parameter can be identified.Friction stir welding is one of those welding techniques with many parameters which have different effects on the quality of the welds.In friction stir welding the tool rotational speed(RPM)and transverse speed(mm/min)influence the strength(i.e.,hardness distribution)of the stirred zone.In this study,these two factors are investigated to determine the effect they will have on the hardness in the stirred zone of the friction stir welds and how the two factors are related to one another for as-cast magnesium alloy AM60 with nominal chemical composition of Mg-(5.5-6.5)Al-(0.24-0.6)Mn-0.22Zn-0.1Si.Experimental data was taken at three different tool rotational speeds and three different transverse speeds.The data obtained was then analyzed using a 32 factorial design to find the contribution of these parameters.It was determined that both tool rotational speed and transverse speed possess significant effects on the stir zone hardness.Also,the interactions between the two factors were statistically assessed. 展开更多
关键词 AM60 Mg alloy Design of experiment(doe) Statistical method Friction stir welding
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Applications of quality by design(QbD) and its tools in drug delivery 被引量:2
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作者 Lan Zhang Shirui Mao 《Asian Journal of Pharmaceutical Sciences》 SCIE CAS 2016年第1期144-145,共2页
Quality by Test (Qb T) was the only way to guarantee the quality of drug products before FDA launches current Good Manufacturing Practice (c GMP)[1], which is an approach without clear understanding of the processes. ... Quality by Test (Qb T) was the only way to guarantee the quality of drug products before FDA launches current Good Manufacturing Practice (c GMP)[1], which is an approach without clear understanding of the processes. In order to solve this problem,FDA generalized Quality by Design (QbD) in the field of pharmacy (2)In pharmaceutical industry, Qb D brings cost-efficiency and simplicity of manufacturing process into reality. 展开更多
关键词 QUALITY by Design(QbD) Critical QUALITY attributes(CQAs) DESIGN of experiment(doe) Process ANALYTICAL technology(PAT)
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Simulation on Remanufacturing Cost by Considering Quality Grade of Returns and Buffer Capacity
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作者 ZHENG Yuqiao ZHANG Chengcheng SU Chun 《Journal of Shanghai Jiaotong university(Science)》 EI 2019年第4期471-476,共6页
Selecting the remanufacturing system as object of the study, the buffer capacity is served as control variable, and design of experiment(DOE) and simulation are used to analyze the effect that uncertain quality of ret... Selecting the remanufacturing system as object of the study, the buffer capacity is served as control variable, and design of experiment(DOE) and simulation are used to analyze the effect that uncertain quality of returns acts on system performance. The remanufacturing time and the recovery rate in each station are used to represent the quality level of the returns, and the variance of remanufacturing time is used to denote the variability of returns’ quality. Three factors(the variability, the proportion and the recovery rate) of different quality levels in returns are considered. By analyzing the variance and the range of the simulation results, some important conclusions are obtained: recovery rate affects the remanufacturing cost by far, and the variability has the minimum influence;furthermore, for the returns, the more obvious of the dispersion degree, the higher proportion of the high-level quality, and the higher of the recovery rate, the lower the cost of remanufacturing will be. 展开更多
关键词 REMANUFACTURING BUFFER SIMULATION design of experiment(doe) quality GRADE
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Workshop Oriented Tolerance Synthesis for Spatial PKM
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作者 Jianguang Li Jian Ding +3 位作者 Yingxue Yao Zhaohong Yi Huaijing Jing Honggen Fang 《Journal of Harbin Institute of Technology(New Series)》 EI CAS 2015年第2期8-17,共10页
To promote the pose accuracy performance of a spatial parallel kinematic Mechanism( PKM) in service,a workshop oriented tolerance synthesis method based on design of experiment( DOE) is proposed,which involves two con... To promote the pose accuracy performance of a spatial parallel kinematic Mechanism( PKM) in service,a workshop oriented tolerance synthesis method based on design of experiment( DOE) is proposed,which involves two consecutive stages. In the first stage of DOE,the tolerance factor sensitivities are obtained according to initial tolerance settings with the consideration of the current manufacturing capacity,and the second stage of DOE makes use of them to produce multiple tolerance allocations which can adapt to current manufacturing capacity. A tolerance synthesis procedure is developed and integrated in tolerance design system for PKM. Comparing the results with peer method,the validity and practicability of this method is verified. 展开更多
关键词 parallel kinematics mechanism(PKM) design of experiment(doe) tolerance synthesis
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Lean System Design for Engineer-to-Order Manufacturing
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作者 周健 张勤 +1 位作者 王小虎 肖浩锋 《Journal of Shanghai Jiaotong university(Science)》 EI 2016年第6期702-712,共11页
A five-step method framework is proposed by combing improved value stream mapping with simulation and design of experiment(DOE) to design the lean system for engineer-to-order(ETO) manufacturing,and lean practice impl... A five-step method framework is proposed by combing improved value stream mapping with simulation and design of experiment(DOE) to design the lean system for engineer-to-order(ETO) manufacturing,and lean practice implementation path is decided.Meanwhile,a real company case like HAVC is taken to display the application of the framework.The results indicate that compared to supermarket Kanban,constant work in process(Conwip) has the broader applicability in ETO manufacturing and the critical business process,like purchasing of key parts,and has more significant effects on value stream performance.Therefore,it should have priority in lean practice implementation. 展开更多
关键词 engineer-to-order(ETO) improved value stream mapping(IVSM) simulation optimization design of experiment(doe) implementation path
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基于正交试验的铝合金——高强钢异种金属自冲铆接工艺优化 被引量:52
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作者 金鑫 李永兵 +1 位作者 楼铭 王远 《汽车工程学报》 2011年第3期185-191,共7页
以铝合金AA6061-T6和双相钢DP590为研究对象,通过正交试验方法研究了铆钉长度、凹模中部直径和凹模凸台高度对铝合金-高强钢自冲铆接接头成形规律、接头几何特征量、拉剪强度以及失效模式的影响规律,分析了影响自冲铆接接头强度的关键... 以铝合金AA6061-T6和双相钢DP590为研究对象,通过正交试验方法研究了铆钉长度、凹模中部直径和凹模凸台高度对铝合金-高强钢自冲铆接接头成形规律、接头几何特征量、拉剪强度以及失效模式的影响规律,分析了影响自冲铆接接头强度的关键因素以及在2mm AA6061-T6+1.2mm DP590组合下的最优工艺参数组合,可为自冲铆接工艺优化提供有益的借鉴。 展开更多
关键词 铝钢异种连接 自冲铆接 汽车轻量化 正交试验设计
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中药生产过程质量控制关键技术研究进展 被引量:30
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作者 熊皓舒 田埂 +6 位作者 刘朋 赵万顺 李晨鸣 朱永宏 叶正良 章顺楠 闫凯境 《中草药》 CAS CSCD 北大核心 2020年第16期4331-4337,共7页
中医药发展已上升到国家战略层面,在医药行业贯彻实施"中国制造2025"战略的新形势下,中药生产过程质量控制是中药工业需要加快突破的关键领域之一。对中药生产过程质量控制领域在工艺设计、分析检测、过程建模、制造装备等方... 中医药发展已上升到国家战略层面,在医药行业贯彻实施"中国制造2025"战略的新形势下,中药生产过程质量控制是中药工业需要加快突破的关键领域之一。对中药生产过程质量控制领域在工艺设计、分析检测、过程建模、制造装备等方面的关键共性问题进行解析,综述了中药生产过程质量控制体系中工艺过程理解、生产过程实时分析方法开发、过程控制策略建立3个方面的研究进展;并结合企业研究实践,介绍了质量源于设计(quality by design,Qb D)、过程分析技术(process analytical technology,PAT)、实验设计(design of experiment,DOE)、多变量统计分析等关键技术在上述3个研究方向中的应用进展,分析了实际工业应用的难点问题并对其应用前景进行展望,旨在为中药企业应用和提升生产过程质量控制技术提供参考。 展开更多
关键词 中药生产过程 质量控制 质量源于设计 过程分析技术 实验设计 多变量统计分析
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车身低速碰撞吸能结构的优化设计 被引量:24
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作者 李亦文 徐涛 +2 位作者 徐天爽 李强 郝亮 《北京理工大学学报》 EI CAS CSCD 北大核心 2010年第10期1175-1179,共5页
针对汽车低速正面碰撞时车身部件的抗撞性优化问题,选择了碰撞盒结构作为研究对象,运用二次回归正交组合试验设计方法合理分布试验点,并结合最小二乘法构造出整体质量、吸能值及最大碰撞力关于板厚的响应面模型;综合考虑实际车身部件板... 针对汽车低速正面碰撞时车身部件的抗撞性优化问题,选择了碰撞盒结构作为研究对象,运用二次回归正交组合试验设计方法合理分布试验点,并结合最小二乘法构造出整体质量、吸能值及最大碰撞力关于板厚的响应面模型;综合考虑实际车身部件板厚范围及轻量化要求,采用自适应响应面法对响应面模型进行了优化设计.结果表明,提出的碰撞盒结构优化方法及流程具有较高的精确性和有效性. 展开更多
关键词 抗撞性 吸能 试验设计 响应面法 优化设计
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基于DOE及RSM的液力变矩器叶片数对性能的影响及优化 被引量:24
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作者 刘城 潘鑫 +1 位作者 闫清东 魏巍 《北京理工大学学报》 EI CAS CSCD 北大核心 2012年第7期689-693,共5页
为解决一维束流理论难以有效地对液力变矩器叶片数进行优化的问题,建立液力变矩器三维流动设计分析平台,利用实验设计方法,研究了各叶片数对液力变矩器性能的影响,并在响应曲面基础上对叶片数进行了优化.结果表明,泵轮、涡轮叶片数对最... 为解决一维束流理论难以有效地对液力变矩器叶片数进行优化的问题,建立液力变矩器三维流动设计分析平台,利用实验设计方法,研究了各叶片数对液力变矩器性能的影响,并在响应曲面基础上对叶片数进行了优化.结果表明,泵轮、涡轮叶片数对最高效率和起动转矩比有较大影响,泵轮、导轮叶片数对泵轮扭矩系数有较大影响.优化后,液力变矩器各性能指标均有提高. 展开更多
关键词 实验设计 响应曲面 液力变矩器 叶片数
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动力总成悬置系统解耦布置的鲁棒性分析 被引量:21
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作者 吴杰 上官文斌 +2 位作者 唐静 宋志顺 黄振磊 《振动与冲击》 EI CSCD 北大核心 2009年第9期15-20,共6页
基于实验设计方法,仿真分析了汽车动力总成悬置系统解耦布置的鲁棒性。以某款车的动力总成悬置系统为例,计算了悬置静刚度对悬置系统固有频率和解耦率变化的贡献率,识别出了对悬置系统解耦布置影响较大的悬置静刚度参数。算例结果表明,... 基于实验设计方法,仿真分析了汽车动力总成悬置系统解耦布置的鲁棒性。以某款车的动力总成悬置系统为例,计算了悬置静刚度对悬置系统固有频率和解耦率变化的贡献率,识别出了对悬置系统解耦布置影响较大的悬置静刚度参数。算例结果表明,悬置系统固有频率和解耦率的变化是多个刚度参数共同作用的结果,悬置系统三个平动方向的固有频率和解耦率受刚度参数变化的影响较小,三个转动方向的固有频率和解耦率受刚度参数变化的影响较大。该方法为设计解耦布置优良、稳健的动力总成悬置系统提供了一般的分析方法和理论依据。 展开更多
关键词 动力总成悬置系统 灵敏度分析 鲁棒性 实验设计
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驾驶室悬置隔振改进设计中DOE技术的研究应用 被引量:13
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作者 于昌阳 马力 《机械研究与应用》 2006年第2期40-41,51,共3页
将正交设计原理与ADAMS中的试验设计(DOE)技术相结合,对某典型商用车全浮式驾驶室悬置隔振系统与主悬架系统的参数匹配问题进行研究,并提出对原车的改进方案,分析结果表明改进方案取得了良好的效果。
关键词 驾驶室悬置 改进设计 试验设计(doe)
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基于Moldflow和DOE技术的翘曲变形工艺优化 被引量:17
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作者 张昉昀 钟汉如 《塑料》 CAS CSCD 北大核心 2011年第4期90-92,共3页
文章采用CAE模拟软件Moldflow结合DOE试验技术对开关上盖进行填充、保压、冷却以及翘曲的模拟分析,研究模具温度、熔体温度、保压压力和保压时间等不同成型工艺参数对翘曲指标的影响,通过对试验结果运用极差和方差进行分析,在试验范围... 文章采用CAE模拟软件Moldflow结合DOE试验技术对开关上盖进行填充、保压、冷却以及翘曲的模拟分析,研究模具温度、熔体温度、保压压力和保压时间等不同成型工艺参数对翘曲指标的影响,通过对试验结果运用极差和方差进行分析,在试验范围内获得最佳成型工艺参数组合。 展开更多
关键词 塑料工业 注塑成型 田口试验设计方法 翘曲 工艺优化
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基于Moldflow的注塑件翘曲优化及影响因素分析 被引量:15
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作者 吴真繁 孙宝寿 陈哲 《轻工机械》 CAS 2009年第6期5-9,12,共6页
结合Taguch i试验设计方法和注塑模拟Moldflow分析软件,对不同工艺条件下的塑件成型过程进行模拟分析,以减小翘曲量为质量目标对工艺参数进行优化。采用方差分析方法(ANOVA),分析了模具温度、熔体温度、注射时间、保压压力,保压时间等... 结合Taguch i试验设计方法和注塑模拟Moldflow分析软件,对不同工艺条件下的塑件成型过程进行模拟分析,以减小翘曲量为质量目标对工艺参数进行优化。采用方差分析方法(ANOVA),分析了模具温度、熔体温度、注射时间、保压压力,保压时间等工艺参数对塑件翘曲变形的影响,并通过绘制因素水平影响趋势图,分析得出最优的注塑参数组合方案,并对该工艺组合方案进行模拟验证。 展开更多
关键词 塑料工业 注塑成型 田口试验设计方法 翘曲 工艺参数 优化
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基于Matlab的柴油机建模及欧-Ⅵ标定方法研究 被引量:13
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作者 张斌 李见波 吴淑梅 《内燃机工程》 EI CAS CSCD 北大核心 2016年第2期101-104,110,共5页
基于欧-Ⅵ排放法规,将柴油机整个工况区按照稳态试验循环(world harmonized stationary cycle,WHSC)和瞬态测试循环(world harmonized transient cycle,WHTC)试验循环的散点分布及世界非超限排放(world not to exceed,WNTE)法规要求等... 基于欧-Ⅵ排放法规,将柴油机整个工况区按照稳态试验循环(world harmonized stationary cycle,WHSC)和瞬态测试循环(world harmonized transient cycle,WHTC)试验循环的散点分布及世界非超限排放(world not to exceed,WNTE)法规要求等划分为不同的区域,分区域选择合理且适量的工况点,寻找各工况其电控参数合适的边界,并基于V优选法进行试验设计;给定各区域拟达到的排放物控制范围,基于Matlab中基于模型标定(modelbased on calibration toolbox,MBC)工具箱对某高压共轨柴油机进行满足欧-Ⅵ排放法规要求且油耗最低的优化标定,获取各电控参数的全脉谱。并将其导入集成校准和应用工具(integrated calibration and application tools,INCA),且在试验台架上进行WHSC、WHTC及WNTE试验验证。试验结果表明:WHSC试验循环的氮氧化物(NO_x)排放和油耗率(有效燃油消耗率)与MBC模型预测值非常接近,偏差皆在1%以内,并满足欧-ⅥWHSC、WHTC及WNTE试验循环排放限值要求且油耗最低。 展开更多
关键词 内燃机 试验设计 基于模型标定 欧-Ⅵ排放法规 优化标定
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基于DOE的公差稳健设计方法研究 被引量:11
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作者 胡本峰 张娇娜 《农业装备与车辆工程》 2007年第3期29-32,共4页
针对目前公差设计中存在的问题,提出了一种基于试验设计(DOE)的公差稳健设计方法。分析了基于DOE进行公差设计的一般方法及步骤,并对试验设计的策略进行了研究,讨论了对试验结果进行分析的方法,最后用公差设计实例进行了验证,结果表明... 针对目前公差设计中存在的问题,提出了一种基于试验设计(DOE)的公差稳健设计方法。分析了基于DOE进行公差设计的一般方法及步骤,并对试验设计的策略进行了研究,讨论了对试验结果进行分析的方法,最后用公差设计实例进行了验证,结果表明该方法是合理有效的。 展开更多
关键词 公差设计 稳健设计 doe
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高电流密度通孔电镀铜影响因素的研究 被引量:12
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作者 陈杨 程骄 +3 位作者 王翀 何为 朱凯 肖定军 《电镀与精饰》 CAS 北大核心 2015年第8期23-27,共5页
印制电路板在垂直连续电镀生产线上镀铜,通过改进电镀槽结构,引入喷流加强溶液交换等措施,能够使用更大的电流密度,大幅度提高产能。由于搅拌强度、电流密度和阴阳极距离等工艺条件发生改变,为了使微通孔电镀铜效果达到最优,对镀液成分... 印制电路板在垂直连续电镀生产线上镀铜,通过改进电镀槽结构,引入喷流加强溶液交换等措施,能够使用更大的电流密度,大幅度提高产能。由于搅拌强度、电流密度和阴阳极距离等工艺条件发生改变,为了使微通孔电镀铜效果达到最优,对镀液成分配比进行优化实验。通过对镀铜层切片分析,确定光亮剂浓度和电流密度为影响电镀的显著因素。在优化控制条件下,采用的电镀液对厚径比为6.4∶1.0的通孔(d=0.25 mm)镀铜,铜层的均镀能力达到80%以上,具有很好的实用价值。 展开更多
关键词 印制电路板 高速电镀铜 优化实验设计 添加剂 均镀能力
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