2019
DOI: 10.1016/j.xphs.2018.09.014
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A Proposed Complete Methodology to Predict Gravity Flow Obstruction of Pharmaceutical Powders in Drug Product Manufacturing

Abstract: We present herein a comprehensive methodology to evaluate the risks involved in gravity-driven flow of pharmaceutical powders, including mass flow/funnel flow pattern, arch formation under active stress state (initial discharging) and passive stress state (following initial discharging), and rathole formation. Built on original theories underpinning the hopper design procedure, the methodology was modified to accommodate practices of pharmaceutical powder handling. All data required are generated from conventi… Show more

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Cited by 16 publications
(5 citation statements)
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“…Based on Jenike’s pioneering works [ 29 , 30 ] designing hoppers with different hopper outlet angles and diameters has been a routine practice, however requiring a careful understanding of the powder properties. A flow chart along with a straightforward step-by-step procedure to solve the complex calculations for hopper wall steepness and outlet dimensions was first presented by Mehos [ 31 ]; see also Leung et al’s [ 32 ] risk assessment methodology. Without considerations of air resistance, Hancock [ 33 ] highlighted how blends may require hoppers with steeper walls and more smoothly polished surfaces to minimize the risk of erratic flows, sifting segregation, and yield losses.…”
Section: Modeling Of Batch Processesmentioning
confidence: 99%
“…Based on Jenike’s pioneering works [ 29 , 30 ] designing hoppers with different hopper outlet angles and diameters has been a routine practice, however requiring a careful understanding of the powder properties. A flow chart along with a straightforward step-by-step procedure to solve the complex calculations for hopper wall steepness and outlet dimensions was first presented by Mehos [ 31 ]; see also Leung et al’s [ 32 ] risk assessment methodology. Without considerations of air resistance, Hancock [ 33 ] highlighted how blends may require hoppers with steeper walls and more smoothly polished surfaces to minimize the risk of erratic flows, sifting segregation, and yield losses.…”
Section: Modeling Of Batch Processesmentioning
confidence: 99%
“…In other words, all material properties affecting the stress of powder inside the IBC, which include the wall friction angle f 0 , effective angle of internal friction d, and powder density r, are needed. These properties were obtained for all pharmaceutical powders used in this study, and are presented in Table 2 (due to the stress-dependence of wall friction angle, f 0 values at normal stress of 0.2 kPa is presented, as 0.2 kPa is an appropriate approximation of the powder stress under the passive stress state 6,7 ; other material properties are generally stress-independent within the stress regime relevant to powder flow). Of all the 13 pharmaceutical powders tested, the wall friction angles underwent a monotonic decrease with increasing normal stress.…”
Section: Characterization Of Powder Properties With Respect To Flow Pattern E Stress-dependence Of Wall Friction Angle Is Importantmentioning
confidence: 99%
“…The same observations were reported by other researchers studying wall frictions of pharmaceutical powders. 6,9,13 Accounting for the stress-dependence of the wall friction angle is critical for the study of the powder flow pattern. This is because the stress of powders inside the IBC is strongly affected by wall friction angle, which itself is a function of powder stress.…”
Section: Characterization Of Powder Properties With Respect To Flow Pattern E Stress-dependence Of Wall Friction Angle Is Importantmentioning
confidence: 99%
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