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Optimal handling of Highly Active Pharmaceutical Ingredients during milling and blending operations

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.

Identiferoai:union.ndltd.org:MIT/oai:dspace.mit.edu:1721.1/81020
Date January 2013
CreatorsSetty, Prashant (Prashant Neelappanavara)
ContributorsCharles Cooney and Roy Welsch., Leaders for Global Operations Program., Leaders for Global Operations Program at MIT, Massachusetts Institute of Technology. Department of Chemical Engineering, Sloan School of Management
PublisherMassachusetts Institute of Technology
Source SetsM.I.T. Theses and Dissertation
LanguageEnglish
Detected LanguageEnglish
TypeThesis
Format33 p., application/pdf
RightsM.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

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