2011
DOI: 10.1016/j.ejps.2010.10.013
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An integrated Quality by Design (QbD) approach towards design space definition of a blending unit operation by Discrete Element Method (DEM) simulation

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Cited by 98 publications
(48 citation statements)
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“…In recent years, the drastic increase in affordable computational power has allowed DEM simulations to become a versatile tool for industrial applications (2). DEM simulations have been used in various industrial fields to study processes such as mixing (3), granule breakage (4), silo filling and discharge (5,6), or milling (7). In the pharmaceutical industry, DEM simulations have been applied for nearly all major particulate processes.…”
Section: Introductionmentioning
confidence: 99%
“…In recent years, the drastic increase in affordable computational power has allowed DEM simulations to become a versatile tool for industrial applications (2). DEM simulations have been used in various industrial fields to study processes such as mixing (3), granule breakage (4), silo filling and discharge (5,6), or milling (7). In the pharmaceutical industry, DEM simulations have been applied for nearly all major particulate processes.…”
Section: Introductionmentioning
confidence: 99%
“…(2) and (3), where σ is the standard deviation of the concentration, n is the number of samples, W i is the concentration of sample i, and W is the mean concentration of the samples [40].…”
Section: Blendingmentioning
confidence: 99%
“…The RSD may be affected by the sample size, and Lacey's Index (M) is a metric that corrects for these effects [40,41], given in Eq. (4), where the subscript s denotes a completely segregated mixture and the subscript r denotes a perfectly random mixture.…”
Section: Blendingmentioning
confidence: 99%
“…From the perspective of pharmaceutical engineers, mathematical modeling methods play a prominent role in implementing the QbD initiative to develop a pharmaceutical process. 5 In recent years, several contributions have been reported to develop new processes under the framework of QbD using modeling methods including first-principle models, 6,7 response surface models based on design of experiments 8,9,10 and multivariate statistical models. 2,11,12 For developing a tablet production process which consists of multiple units, it is difficult to establish a deterministic model to describe the process comprehensively.…”
Section: Introductionmentioning
confidence: 99%