Simulation of freezing step in vial lyophilization using finite element method

Muzzio, Cristian R.; Dini, Nicolás G.

doi:10.1016/j.compchemeng.2010.10.009

Cited by 12 publications

(5 citation statements)

References 16 publications

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“…This is attributed to these cells' exposure to both the upper plate's radiation and air convective effects, unlike the interior and base cells, which are solely subjected to conductive heat. Consequently, the surface temperature of the carrot is consistently higher than its core and underside, aligning with Muzzio and Dini's study [36]. When sublimation drying is performed for up to 60 min (Figure 3c), the upper and lateral cells are the first to transition into the dried state.…”

Section: Simulation Resultssupporting

confidence: 87%

Study on Sublimation Drying of Carrot and Simulation by Using Cellular Automata

Shao,

Jiao,

Nie

et al. 2023

Processes

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Vacuum freeze-dried products exhibit properties characteristic of porous media, rendering them superior in both drying and rehydration capabilities. However, the process of sublimation drying is constrained by its substantial time and energy costs. To comprehensively grasp its technological process and identify the optimal process parameters, the cellular automata method was employed for sublimation process simulation. Carrot slices, measuring 10 mm in thickness and 40 mm in radius, were selected for both simulation and experimentation. The sublimation process was characterized using a two-dimensional heat and mass transfer equation, inclusive of a dusty gas model. Additionally, a cellular automaton model was applied to simulate the mass transfer process, temperature, and moisture content changes in the sublimation drying stage. Then, the accuracy of the model was verified through experimentation. There was a remarkable alignment between simulation and experimental outcomes, with determination coefficients R2 of 99.4% for moisture content and 97.6% for temperature variations.

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Section: Simulation Resultssupporting

confidence: 87%

Study on Sublimation Drying of Carrot and Simulation by Using Cellular Automata

Shao,

Jiao,

Nie

et al. 2023

Processes

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“…Mathematically, the two-phase moving boundary problem consisting of a frozen porous matrix undergoing sublimation and the low pressure binary gas mixture was reduced to a model consisting of just a second-order differential equation with two initial conditions for the location of sublimation front. Muzzio et al [76] have successfully used the dynamic axisymmetric finite element model to simulate temperature of each point in the vial and position of liquid-solid interface, without the necessity of fitting parameters or questionable assumptions. They used the model to study final product morphology as well as the crystal size in the product format and by enhancing process understanding across scales from "miniaturized lab-scale" through pilot scale and ultimately to manufacturing scale.…”

Section: Resultsmentioning

confidence: 99%

“…In addition, primary drying duration, end point of primary drying at specific temperature, and chamber pressure are also important to determine the process characteristics. Different modeling approaches have been taken to tackle each of these problems [63,69,[71][72][73][74][75][76]. Optimizing and/or troubleshooting the drying portion of a freeze-drying process can be simplified to an exercise in coupled heat and mass transfer, since a majority of the primary drying stage can be approximated to a "pseudo steady state," the heat input from the shelves to the product exactly balances the heat removed by sublimation (i.e., the heat needed to change the temperature of the product is negligible).…”

Section: Finite Element Modeling Of Lyophilization Processmentioning

confidence: 99%

Application of Mechanistic Models for Process Design and Development of Biologic Drug Products

Chen

Gandhi

et al. 2016

J Pharm Innov

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Modeling approaches play a valuable role at various stages of development and life-cycle management of biopharmaceutical products. In Quality-by-Design (QbD) paradigm, quality needs to be designed into the product rather than merely confirming it through end product testing; this requires in-depth understanding of the product quality and impact of manufacturing process on product quality (Group IEW 2005. Modeling strategies in support of QbD paradigm for biologics are particularly important because of the costs involved in the development of biologic products (Group CBW 2009; Fissore and Antonello (Qual Des Biopharm Drug Prod Dev 18:565-93, 2015)). This mini-review focuses on the application of mechanistic models in the development of biologic drug products as ready-to-use solutions or lyophilized drug products. The choice of the modeling approach is dependent on the specific processes involved in the unit operation as well as intent of application of modeling. The application of models to unit operations in biologics drug product processing such as mixing (compounding), membrane transfer (ultrafiltration/diafiltration), freeze-thaw, and lyophilization, to characterize the quality risks, define the design space, provide input to control strategy, and build robustness in the process will be discussed.

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“…Other objects can also be added to the slurry to introduce a customised heat flow [40]. Furthermore, instead of designing the freezing system based on trial and error, heat transfer simulations can be used to predict the thermal gradient, hence the final orientation of the aligned pores [18,[40][41][42][43]. This accelerates the mould design for ice templating and helps to unleash its potential with more complicated thermal gradients.…”

Section: Introductionmentioning

confidence: 99%

Mimicking Transmural Helical Cardiomyofibre Orientation Using Bouligand-like Pore Structures in Ice-Templated Collagen Scaffolds

Zhang,

Sinha,

Cameron

et al. 2023

Polymers

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The helical arrangement of cardiac muscle fibres underpins the contractile properties of the heart chamber. Across the heart wall, the helical angle of the aligned fibres changes gradually across the range of 90–180°. It is essential to recreate this structural hierarchy in vitro for developing functional artificial tissue. Ice templating can achieve single-oriented pore alignment via unidirectional ice solidification with a flat base mould design. We hypothesise that the orientation of aligned pores can be controlled simply via base topography, and we propose a scalable base design to recapitulate the transmural fibre orientation. We have utilised finite element simulations for rapid testing of base designs, followed by experimental confirmation of the Bouligand-like orientation. X-ray microtomography of experimental samples showed a gradual shift of 106 ± 10°, with the flexibility to tailor pore size and spatial helical angle distribution for personalised medicine.

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Simulation of freezing step in vial lyophilization using finite element method

Cited by 12 publications

References 16 publications

Study on Sublimation Drying of Carrot and Simulation by Using Cellular Automata

Study on Sublimation Drying of Carrot and Simulation by Using Cellular Automata

Application of Mechanistic Models for Process Design and Development of Biologic Drug Products

Mimicking Transmural Helical Cardiomyofibre Orientation Using Bouligand-like Pore Structures in Ice-Templated Collagen Scaffolds

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