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Formulation and validation of a population balance model for powder mixing process
Descriptive
TitleInfo
Title
Formulation and validation of a population balance model for powder mixing process
Name
(type = personal)
NamePart
(type = family)
John
NamePart
(type = given)
Joyce
NamePart
(type = date)
1987-
DisplayForm
JOYCE JOHN
Role
RoleTerm
(authority = RULIB)
author
Name
(type = personal)
NamePart
(type = family)
Ramachandran
NamePart
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Rohit
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Rohit Ramachandran
Affiliation
Advisory Committee
Role
RoleTerm
(authority = RULIB)
chair
Name
(type = personal)
NamePart
(type = family)
Dutt
NamePart
(type = given)
Meenakshi
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Meenakshi Dutt
Affiliation
Advisory Committee
Role
RoleTerm
(authority = RULIB)
internal member
Name
(type = personal)
NamePart
(type = family)
LIU
NamePart
(type = given)
XUE
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XUE LIU
Affiliation
Advisory Committee
Role
RoleTerm
(authority = RULIB)
internal member
Name
(type = personal)
NamePart
(type = family)
VANARASE
NamePart
(type = given)
ADITYA
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ADITYA VANARASE
Affiliation
Advisory Committee
Role
RoleTerm
(authority = RULIB)
outside member
Name
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NamePart
Rutgers University
Role
RoleTerm
(authority = RULIB)
degree grantor
Name
(type = corporate)
NamePart
Graduate School - New Brunswick
Role
RoleTerm
(authority = RULIB)
school
TypeOfResource
Text
Genre
(authority = marcgt)
theses
OriginInfo
DateCreated
(qualifier = exact)
2013
DateOther
(qualifier = exact);
(type = degree)
2013-05
Place
PlaceTerm
(type = code)
xx
Language
LanguageTerm
(authority = ISO639-2b);
(type = code)
eng
Abstract
(type = abstract)
Pharmaceutical processing is much more stringent with regulatory requirements for the processing and handling stages and the product quality specifications must be met at every step during the manufacturing operation. In the pharmaceutical manufacturing, the unit operation that is one among the most widely used, is the powder blending operation. The scope of this work is to characterize and document the complex powder blending process by means of a robust predictive model and use it to enhance operational efficiency and improve on the established monitoring and control strategies. The implementation of QbD (Quality by Design) strategies [1] to continuous processing stages allows for improved process control, higher cost-efficiency without compromising on the quality or efficacy of the final product. It also would alleviate the need for further scale up studies. In this work, a population balance model (PBM) has been formulated and validated to model the complex dynamics within a continuous powder mixing process, with the focus on the blending operation taking place within pharmaceutical tablet manufacturing. PBM modeling was selected to model the blending unit operation as it not only serves as a dynamic and highly effective tool, but also due to its relative computational simplicity. The model was designed to determine the critical quality attributes (such as RTD (residence time distribution), API composition and RSD (relative standard deviation) of the product by incorporating the key process parameters such as the impeller RPM, dimensions of the blender and design parameters such as the number of compartments (both axial and radial), etc. The model obtained has been subsequently validated to check the fit between the predicted values of these CQAs (Critical Quality Attributes) against experimentally obtained data during the same time intervals. The model has the potential use for process improvement by implementation in a PAT (Process Analytical Technique) system for designing improved monitoring, control and optimization techniques. [2]
Subject
(authority = RUETD)
Topic
Chemical and Biochemical Engineering
Subject
(authority = ETD-LCSH)
Topic
Pharmaceutical industry
Subject
(authority = ETD-LCSH)
Topic
Powders (Pharmacy)--Mixing
Subject
(authority = ETD-LCSH)
Topic
Tablets (Medicine)
RelatedItem
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TitleInfo
Title
Rutgers University Electronic Theses and Dissertations
Identifier
(type = RULIB)
ETD
Identifier
ETD_4619
PhysicalDescription
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electronic resource
InternetMediaType
application/pdf
InternetMediaType
text/xml
Extent
xi, 62 p. : ill.
Note
(type = degree)
M.S.
Note
(type = bibliography)
Includes bibliographical references
Note
(type = vita)
Includes vita
Note
(type = statement of responsibility)
by Joyce John
Identifier
(type = hdl)
http://hdl.rutgers.edu/1782.1/rucore10001600001.ETD.000068889
RelatedItem
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TitleInfo
Title
Graduate School - New Brunswick Electronic Theses and Dissertations
Identifier
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rucore19991600001
Location
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(displayLabel = Rutgers, The State University of New Jersey)
NjNbRU
Identifier
(type = doi)
doi:10.7282/T3BZ64N9
Genre
(authority = ExL-Esploro)
ETD graduate
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Rights
RightsDeclaration
(ID = rulibRdec0006)
The author owns the copyright to this work.
RightsHolder
(type = personal)
Name
FamilyName
JOHN
GivenName
JOYCE
Role
Copyright Holder
RightsEvent
Type
Permission or license
DateTime
(encoding = w3cdtf);
(qualifier = exact);
(point = start)
2013-04-10 15:33:40
AssociatedEntity
Name
JOYCE JOHN
Role
Copyright holder
Affiliation
Rutgers University. Graduate School - New Brunswick
AssociatedObject
Type
License
Name
Author Agreement License
Detail
I hereby grant to the Rutgers University Libraries and to my school the non-exclusive right to archive, reproduce and distribute my thesis or dissertation, in whole or in part, and/or my abstract, in whole or in part, in and from an electronic format, subject to the release date subsequently stipulated in this submittal form and approved by my school. I represent and stipulate that the thesis or dissertation and its abstract are my original work, that they do not infringe or violate any rights of others, and that I make these grants as the sole owner of the rights to my thesis or dissertation and its abstract. I represent that I have obtained written permissions, when necessary, from the owner(s) of each third party copyrighted matter to be included in my thesis or dissertation and will supply copies of such upon request by my school. I acknowledge that RU ETD and my school will not distribute my thesis or dissertation or its abstract if, in their reasonable judgment, they believe all such rights have not been secured. I acknowledge that I retain ownership rights to the copyright of my work. I also retain the right to use all or part of this thesis or dissertation in future works, such as articles or books.
Copyright
Status
Copyright protected
Availability
Status
Open
Reason
Permission or license
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Technical
RULTechMD
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ContentModel
ETD
OperatingSystem
(VERSION = 5.1)
windows xp
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