Mechanistic Modelling to De-risk Process Scale-up

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Process Scale-up</title> <meta name="description" content="Mechanistic Modelling to De-risk Process Scale-up"> <meta name="keywords" content="active pharmaceutical ingredient, baffles, computational fluid dynamics, mixing, modelling"> <meta name="viewport" content="width=device-width, initial-scale=1, minimum-scale=1, maximum-scale=1, user-scalable=no"> <meta charset="utf-8"> <link href="https://cdn.waset.org/favicon.ico" type="image/x-icon" rel="shortcut icon"> <link href="https://cdn.waset.org/static/plugins/bootstrap-4.2.1/css/bootstrap.min.css" rel="stylesheet"> <link href="https://cdn.waset.org/static/plugins/fontawesome/css/all.min.css" rel="stylesheet"> <link href="https://cdn.waset.org/static/css/site.css?v=150220211555" rel="stylesheet"> </head> <body> <header> <div class="container"> <nav class="navbar navbar-expand-lg navbar-light"> <a class="navbar-brand" href="https://waset.org"> <img src="https://cdn.waset.org/static/images/wasetc.png" alt="Open Science Research 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to De-risk Process Scale-up</h5> <div class="card-body"> <p class="card-text"><strong>Authors:</strong> <a href="https://publications.waset.org/abstracts/search?q=Edwin%20Cartledge">Edwin Cartledge</a>, <a href="https://publications.waset.org/abstracts/search?q=Jack%20Clark"> Jack Clark</a>, <a href="https://publications.waset.org/abstracts/search?q=Mazaher%20Molaei-Chalchooghi"> Mazaher Molaei-Chalchooghi</a> </p> <p class="card-text"><strong>Abstract:</strong></p> The mixing in the crystallization step of active pharmaceutical ingredient manufacturers was studied via advanced modeling tools to enable a successful scale-up. A virtual representation of the vessel was created, and computational fluid dynamics were used to simulate multiphase flow and, thus, the mixing environment within this vessel. The study identified a significant dead zone in the vessel underneath the impeller and found that increasing the impeller speed and power did not improve the mixing. A series of sensitivity analyses found that to improve mixing, the vessel had to be redesigned, and found that optimal mixing could be obtained by adding two extra cylindrical baffles. The same two baffles from the simulated environment were then constructed and added to the process vessel. By identifying these potential issues before starting the manufacture and modifying the vessel to ensure good mixing, this study mitigated a failed crystallization and potential batch disposal, which could have resulted in a significant loss of high-value material. <iframe src="https://publications.waset.org/abstracts/165825.pdf" style="width:100%; height:400px;" frameborder="0"></iframe> <p class="card-text"><strong>Keywords:</strong> <a href="https://publications.waset.org/abstracts/search?q=active%20pharmaceutical%20ingredient" title="active pharmaceutical ingredient">active pharmaceutical ingredient</a>, <a href="https://publications.waset.org/abstracts/search?q=baffles" title=" baffles"> baffles</a>, <a href="https://publications.waset.org/abstracts/search?q=computational%20fluid%20dynamics" title=" computational fluid dynamics"> computational fluid dynamics</a>, <a href="https://publications.waset.org/abstracts/search?q=mixing" title=" mixing"> mixing</a>, <a href="https://publications.waset.org/abstracts/search?q=modelling" title=" modelling"> modelling</a> </p> <a href="https://publications.waset.org/abstracts/165825/mechanistic-modelling-to-de-risk-process-scale-up" class="btn btn-primary btn-sm">Procedia</a> <a href="https://publications.waset.org/abstracts/165825.pdf" target="_blank" class="btn btn-primary btn-sm">PDF</a> <span class="bg-info text-light px-1 py-1 float-right rounded"> Downloads <span class="badge badge-light">97</span> </span> </div> </div> </div> </main> <footer> <div id="infolinks" class="pt-3 pb-2"> <div class="container"> <div style="background-color:#f5f5f5;" class="p-3"> <div class="row"> <div class="col-md-2"> <ul class="list-unstyled"> About <li><a href="https://waset.org/page/support">About Us</a></li> <li><a href="https://waset.org/page/support#legal-information">Legal</a></li> <li><a target="_blank" rel="nofollow" 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Mechanistic Modelling to De-risk Process Scale-up