Framework for the determination of yield limits In pharmaceutical operations
Name
714254959-MIT.pdf
Description
Full printable version
Size
8.55 MB
Format
Adobe PDF
Checksum (MD5)
47cb39908071d16948c616f141140ccd
Author(s)
Liow, Yuh Han John
Advisor(s)
Stanley B. Gershwin.
Date Issued
2010
Publisher
Massachusetts Institute of Technology
Abstract
The manufacturing production of active pharmaceutical ingredients often involve a series of processing stages in which yield limits are prescribed to ensure that the target yield has been achieved for a batch and that the workers may proceed to the next batch of materials. Such yield limits is comprised of a maximum value for yields above 100% and a minimum value for yields of lower than 100%. These yield limits for each of the processing steps are conventionally prescribed based on accumulated experiences with production after an extended period of time. This paper is based on an internship project at a major pharmaceutical firm in Singapore, and it discusses the sources of yield losses and the reasons behind yield excursions which have not been well documented within the production facility. In doing so, the paper attempts to provide insights into the possible explanations for the current maximum and minimum yield limits application. Furthermore, using the yield limit values as applied for certain products, a preliminary framework is developed to provide a set of recommendations for the adjustment of conventional yield limit values to suit similar processing stages for the manufacturing of a novel drug product. This framework should prove to be useful in meeting the uncertainties inherent in the production of new products and in making initial recommendations for yield limits since there is usually limited experience from drug developments and clinical manufacture.
Description
Thesis (M. Eng. in Manufacturing)--Massachusetts Institute of Technology, Dept. of Mechanical Engineering, 2010.
Cataloged from PDF version of thesis.
Includes bibliographical references (p. 57).
Subjects
Mechanical Engineering.
MIT Department
Massachusetts Institute of Technology. Department of Mechanical Engineering
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