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Charles Cooney and Roy Welsch. Setty, Prashant (Prashant Neelappanavara) Leaders for Global Operations Program. Leaders for Global Operations Program at MIT Massachusetts Institute of Technology. Department of Chemical Engineering Sloan School of Management 2013-09-24T19:37:28Z 2013-09-24T19:37:28Z 2013 2013 http://hdl.handle.net/1721.1/81020 857790428 Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Dept. of Chemical Engineering; in conjunction with the Leaders for Global Operations Program at MIT, 2013. Cataloged from PDF version of thesis. Includes bibliographical references (p. 32-33). This thesis investigates best practices for Highly Active Pharmaceutical Ingredient (HAPI) milling and blending. We utilize a qualitative analysis centering on a benchmarking study and quantitative analyses using a probabilistic capacity simulation and tradeoff methodology. The analyses indicate that the growing number of HAPI products in a manufacturer's portfolio may result in capacity constraints. Therefore, we recommend that manufacturers pursue process improvement technologies. Suggested process improvements include implementing online particle size measurement and Wash in Place (WIP) and Clean in Place (CIP) cleaning systems. Online particle size measurement allows for better process control and eliminates the need for HAPI blending for homogenization. Automated WIP and CIP systems decrease changeover time and allow for higher equipment availability. Additionally, the results of the analyses suggest that manufacturers consider standardizing transportation containers with the upstream vendors and downstream consumers. Lastly, from an organizational standpoint, we recommend that manufacturers include both subject matter experts and operations personnel when developing and implementing internal guidelines so as to ensure the guidelines are practical and uniformly applied. by Prashant Setty. S.M. M.B.A. 33 p. eng Massachusetts Institute of Technology M.I.T. theses are protected by copyright. They may be viewed from this source for any purpose, but reproduction or distribution in any format is prohibited without written permission. See provided URL for inquiries about permission. http://dspace.mit.edu/handle/1721.1/7582 Sloan School of Management. Chemical Engineering. Leaders for Global Operations Program. Optimal handling of Highly Active Pharmaceutical Ingredients during milling and blending operations Thesis application/pdf false Publication unknown unknown <Publication xmlns="https://www.openaire.eu/cerif-profile/1.1/" id="2d7b7038-bb1c-4d7e-b68e-1f146ad129f0"> <Type xmlns="https://www.openaire.eu/cerif-profile/vocab/COAR_Publication_Types">http://purl.org/coar/resource_type/c_1843</Type> <Language>eng</Language> <Title>Optimal handling of Highly Active Pharmaceutical Ingredients during milling and blending operations</Title> <PublishedIn> <Publication> </Publication> </PublishedIn> <PublicationDate>2013</PublicationDate> <Authors> <Author> <DisplayName>Setty, Prashant (Prashant Neelappanavara)</DisplayName> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> </Authors> <Editors> </Editors> <Publishers> <Publisher> <DisplayName>Massachusetts Institute of Technology</DisplayName> <OrgUnit /> </Publisher> </Publishers> <License>http://dspace.mit.edu/handle/1721.1/7582</License> <Keyword>Sloan School of Management.</Keyword> <Keyword>Chemical Engineering.</Keyword> <Keyword>Leaders for Global Operations Program.</Keyword> <Abstract>This thesis investigates best practices for Highly Active Pharmaceutical Ingredient (HAPI) milling and blending. We utilize a qualitative analysis centering on a benchmarking study and quantitative analyses using a probabilistic capacity simulation and tradeoff methodology. The analyses indicate that the growing number of HAPI products in a manufacturer&apos;s portfolio may result in capacity constraints. Therefore, we recommend that manufacturers pursue process improvement technologies. Suggested process improvements include implementing online particle size measurement and Wash in Place (WIP) and Clean in Place (CIP) cleaning systems. Online particle size measurement allows for better process control and eliminates the need for HAPI blending for homogenization. Automated WIP and CIP systems decrease changeover time and allow for higher equipment availability. Additionally, the results of the analyses suggest that manufacturers consider standardizing transportation containers with the upstream vendors and downstream consumers. Lastly, from an organizational standpoint, we recommend that manufacturers include both subject matter experts and operations personnel when developing and implementing internal guidelines so as to ensure the guidelines are practical and uniformly applied.</Abstract> <Access xmlns="http://purl.org/coar/access_right" > </Access> </Publication>