Validating a Numerical Simulation of the ConsiGma(R) Coater
Continuous manufacturing is increasingly used in the pharmaceutical industry, as it promises to deliver better product quality while simultaneously increasing production flexibility. GEA developed a semi-continuous tablet coater which can be integrated into a continuous tableting line, accelerating...
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Veröffentlicht in: | AAPS PharmSciTech 2020-11, Vol.22 (1), p.10-10, Article 10 |
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creator | Boehling, Peter Jacevic, Dalibor Detobel, Frederik Holman, James Wareham, Laura Metzger, Matthew Khinast, Johannes G. |
description | Continuous manufacturing is increasingly used in the pharmaceutical industry, as it promises to deliver better product quality while simultaneously increasing production flexibility. GEA developed a semi-continuous tablet coater which can be integrated into a continuous tableting line, accelerating the switch from traditional batch production to the continuous mode of operation. The latter offers certain advantages over batch production,
e.g.
, operational flexibility, increased process/product quality, and decreased cost. However, process understanding is the key element for process control. In this regard, computational tools can improve the fundamental understanding and process performance, especially those related to new processes, such as continuous tablet coating where process mechanics remain unclear. The discrete element method (DEM) and computational fluid dynamics (CFD) are two methods that allow transition from empirical process design to a mechanistic understanding of the individual process units. The developed coupling model allows to track the heat, mass, and momentum exchange between the tablet and fluid phase. The goal of this work was to develop and validate a high-fidelity CFD-DEM simulation model of the tablet coating process in the GEA ConsiGma® coater. After the model development, simulation results for the tablet movement, coating quality, and heat and mass transfer during the coating process were validated and compared to the experimental outcomes. The experimental and simulation results agreed well on all accounts measured, indicating that the model can be used in further studies to investigate the operating space of the continuous tablet coating process. |
doi_str_mv | 10.1208/s12249-020-01841-7 |
format | Article |
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e.g.
, operational flexibility, increased process/product quality, and decreased cost. However, process understanding is the key element for process control. In this regard, computational tools can improve the fundamental understanding and process performance, especially those related to new processes, such as continuous tablet coating where process mechanics remain unclear. The discrete element method (DEM) and computational fluid dynamics (CFD) are two methods that allow transition from empirical process design to a mechanistic understanding of the individual process units. The developed coupling model allows to track the heat, mass, and momentum exchange between the tablet and fluid phase. The goal of this work was to develop and validate a high-fidelity CFD-DEM simulation model of the tablet coating process in the GEA ConsiGma® coater. After the model development, simulation results for the tablet movement, coating quality, and heat and mass transfer during the coating process were validated and compared to the experimental outcomes. The experimental and simulation results agreed well on all accounts measured, indicating that the model can be used in further studies to investigate the operating space of the continuous tablet coating process.</description><identifier>ISSN: 1530-9932</identifier><identifier>EISSN: 1530-9932</identifier><identifier>DOI: 10.1208/s12249-020-01841-7</identifier><identifier>PMID: 33244725</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Biochemistry ; Biomedical and Life Sciences ; Biomedicine ; Biotechnology ; Computer Simulation ; Pharmaceutical Preparations ; Pharmacology/Toxicology ; Pharmacy ; Reproducibility of Results ; Research Article ; Tablets ; Theme: Modeling and Simulations of Drug Product Manufacturing Unit Operations</subject><ispartof>AAPS PharmSciTech, 2020-11, Vol.22 (1), p.10-10, Article 10</ispartof><rights>The Author(s) 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c446t-bc077566d9042c605e8aa93dc3612c5228e5188ad969648c52f5eba9d5632be3</citedby><cites>FETCH-LOGICAL-c446t-bc077566d9042c605e8aa93dc3612c5228e5188ad969648c52f5eba9d5632be3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1208/s12249-020-01841-7$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1208/s12249-020-01841-7$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,780,784,885,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33244725$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Boehling, Peter</creatorcontrib><creatorcontrib>Jacevic, Dalibor</creatorcontrib><creatorcontrib>Detobel, Frederik</creatorcontrib><creatorcontrib>Holman, James</creatorcontrib><creatorcontrib>Wareham, Laura</creatorcontrib><creatorcontrib>Metzger, Matthew</creatorcontrib><creatorcontrib>Khinast, Johannes G.</creatorcontrib><title>Validating a Numerical Simulation of the ConsiGma(R) Coater</title><title>AAPS PharmSciTech</title><addtitle>AAPS PharmSciTech</addtitle><addtitle>AAPS PharmSciTech</addtitle><description>Continuous manufacturing is increasingly used in the pharmaceutical industry, as it promises to deliver better product quality while simultaneously increasing production flexibility. GEA developed a semi-continuous tablet coater which can be integrated into a continuous tableting line, accelerating the switch from traditional batch production to the continuous mode of operation. The latter offers certain advantages over batch production,
e.g.
, operational flexibility, increased process/product quality, and decreased cost. However, process understanding is the key element for process control. In this regard, computational tools can improve the fundamental understanding and process performance, especially those related to new processes, such as continuous tablet coating where process mechanics remain unclear. The discrete element method (DEM) and computational fluid dynamics (CFD) are two methods that allow transition from empirical process design to a mechanistic understanding of the individual process units. The developed coupling model allows to track the heat, mass, and momentum exchange between the tablet and fluid phase. The goal of this work was to develop and validate a high-fidelity CFD-DEM simulation model of the tablet coating process in the GEA ConsiGma® coater. After the model development, simulation results for the tablet movement, coating quality, and heat and mass transfer during the coating process were validated and compared to the experimental outcomes. The experimental and simulation results agreed well on all accounts measured, indicating that the model can be used in further studies to investigate the operating space of the continuous tablet coating process.</description><subject>Biochemistry</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Biotechnology</subject><subject>Computer Simulation</subject><subject>Pharmaceutical Preparations</subject><subject>Pharmacology/Toxicology</subject><subject>Pharmacy</subject><subject>Reproducibility of Results</subject><subject>Research Article</subject><subject>Tablets</subject><subject>Theme: Modeling and Simulations of Drug Product Manufacturing Unit Operations</subject><issn>1530-9932</issn><issn>1530-9932</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><recordid>eNp9kE9LAzEQxYMotla_gAfZYz2s5v9uEAQpWoWioMVryGbTNmV3U5NdwW9vdGvRi6cZ5r15M_wAOEXwAmGYXwaEMRUpxDCFKKcozfbAEDECUyEI3v_VD8BRCGsIMUGCHIIBIZjSDLMhuHpVlS1Va5tlopLHrjbealUlL7buqjh2TeIWSbsyycQ1wU5rNX4-j71qjT8GBwtVBXOyrSMwv7udT-7T2dP0YXIzSzWlvE0LDbOMcV4KSLHmkJlcKUFKTTjCmmGcG4byXJWCC07zOFkwUyhRMk5wYcgIXPexm66oTalN03pVyY23tfIf0ikr_yqNXcmle5cZF4hAEgPG2wDv3joTWlnboE1Vqca4LkhMOYufihxHK-6t2rsQvFnsziAov6DLHrqM0OU3dJnFpbPfD-5WfihHA-kNIUrN0ni5dp1vIrP_Yj8BR6OMMw</recordid><startdate>20201126</startdate><enddate>20201126</enddate><creator>Boehling, Peter</creator><creator>Jacevic, Dalibor</creator><creator>Detobel, Frederik</creator><creator>Holman, James</creator><creator>Wareham, Laura</creator><creator>Metzger, Matthew</creator><creator>Khinast, Johannes G.</creator><general>Springer International Publishing</general><scope>C6C</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20201126</creationdate><title>Validating a Numerical Simulation of the ConsiGma(R) Coater</title><author>Boehling, Peter ; Jacevic, Dalibor ; Detobel, Frederik ; Holman, James ; Wareham, Laura ; Metzger, Matthew ; Khinast, Johannes G.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c446t-bc077566d9042c605e8aa93dc3612c5228e5188ad969648c52f5eba9d5632be3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Biochemistry</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Biotechnology</topic><topic>Computer Simulation</topic><topic>Pharmaceutical Preparations</topic><topic>Pharmacology/Toxicology</topic><topic>Pharmacy</topic><topic>Reproducibility of Results</topic><topic>Research Article</topic><topic>Tablets</topic><topic>Theme: Modeling and Simulations of Drug Product Manufacturing Unit Operations</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Boehling, Peter</creatorcontrib><creatorcontrib>Jacevic, Dalibor</creatorcontrib><creatorcontrib>Detobel, Frederik</creatorcontrib><creatorcontrib>Holman, James</creatorcontrib><creatorcontrib>Wareham, Laura</creatorcontrib><creatorcontrib>Metzger, Matthew</creatorcontrib><creatorcontrib>Khinast, Johannes G.</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>AAPS PharmSciTech</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Boehling, Peter</au><au>Jacevic, Dalibor</au><au>Detobel, Frederik</au><au>Holman, James</au><au>Wareham, Laura</au><au>Metzger, Matthew</au><au>Khinast, Johannes G.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Validating a Numerical Simulation of the ConsiGma(R) Coater</atitle><jtitle>AAPS PharmSciTech</jtitle><stitle>AAPS PharmSciTech</stitle><addtitle>AAPS PharmSciTech</addtitle><date>2020-11-26</date><risdate>2020</risdate><volume>22</volume><issue>1</issue><spage>10</spage><epage>10</epage><pages>10-10</pages><artnum>10</artnum><issn>1530-9932</issn><eissn>1530-9932</eissn><abstract>Continuous manufacturing is increasingly used in the pharmaceutical industry, as it promises to deliver better product quality while simultaneously increasing production flexibility. GEA developed a semi-continuous tablet coater which can be integrated into a continuous tableting line, accelerating the switch from traditional batch production to the continuous mode of operation. The latter offers certain advantages over batch production,
e.g.
, operational flexibility, increased process/product quality, and decreased cost. However, process understanding is the key element for process control. In this regard, computational tools can improve the fundamental understanding and process performance, especially those related to new processes, such as continuous tablet coating where process mechanics remain unclear. The discrete element method (DEM) and computational fluid dynamics (CFD) are two methods that allow transition from empirical process design to a mechanistic understanding of the individual process units. The developed coupling model allows to track the heat, mass, and momentum exchange between the tablet and fluid phase. The goal of this work was to develop and validate a high-fidelity CFD-DEM simulation model of the tablet coating process in the GEA ConsiGma® coater. After the model development, simulation results for the tablet movement, coating quality, and heat and mass transfer during the coating process were validated and compared to the experimental outcomes. The experimental and simulation results agreed well on all accounts measured, indicating that the model can be used in further studies to investigate the operating space of the continuous tablet coating process.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>33244725</pmid><doi>10.1208/s12249-020-01841-7</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Biochemistry Biomedical and Life Sciences Biomedicine Biotechnology Computer Simulation Pharmaceutical Preparations Pharmacology/Toxicology Pharmacy Reproducibility of Results Research Article Tablets Theme: Modeling and Simulations of Drug Product Manufacturing Unit Operations |
title | Validating a Numerical Simulation of the ConsiGma(R) Coater |
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