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Development of a tool for the environmental evaluation of the resource and energy consumption in the pharmaceutical industry at the process, plant and system level

Geert Van der Vorst UGent (2010)
abstract
In this dissertation, a tool for the evaluation of the resource requirements of pharmaceutical production processes is presented. The pharmaceutical industry consumes a lot of resources for the synthesis of active pharmaceutical ingredients (API’s). Many efforts are made to reduce this resource consumption. Second generation processes as well as new technologies are implemented to replace the current processes. Before implementation, the potential of improvement is however to be quantified. The tool developed and presented in this dissertation allows the assessment of the resource requirements of new and existing processes and technologies. The resource requirements are calculated based on the inputs from existing batch production reports and the knowledge of the chemical reaction mechanisms. Resources are expressed using thermodynamics. Exergy analysis allows a coherent and scientifically sound way of evaluating different kind of resources on one single scale. The evaluation occurs at three different levels, being the process, gate-to-gate and cradle-to-gate level. At these three levels, the resource requirements can be calculated and evaluated for different kind of processes. In this dissertation, first an introduction is given about the state of the art concerning the environmental sustainability assessment in chemical and more specific the pharmaceutical industry (chapter 2). The currently available environmental sustainability concepts and metrics (green chemistry, LCA, exergy...) are discussed. After this introduction, chapter 3 goes more into detail and focuses on the different advantages of using exergy analysis for the evaluation of resource consumption at different levels. It is shown that the exergy approach, based on the fundamental laws of thermodynamics, is applicable as sustainability metric in the field of environmental technology. In chapter 4, a methodology is presented for setting up process specific mass and energy balances over different system boundaries in the pharmaceutical industry. This methodology is the basis for the resource evaluation tool as presented in chapter 5. Combining the mass and energy balance (chapter 4) with an environmental impact assessment methodology, in this case exergy analysis (chapter 3) results in a resource evaluation tool which only requires the input from batch production reports and the chemical reaction pathway. This resource evaluation tool is tested for 5 different cases from Janssen Pharmaceutica, part of the Johnson and Johnson Group. Results are presented for different system boundaries. In chapter 6 and 7; two extensions for the resource evaluation tool as available in chapter 5 are presented. In chapter 6, two new technologies are evaluated using similar principles as used in the evaluation tool. Prep-HPLC is compared with prep-SFC on their resource efficiency. Again exergy analysis over different system boundaries has proven to be a valuable resource evaluation assessment methodology. In chapter 7 the resource requirement for the treatment of an on-site distillation is compared with an off-site incineration. Here the importance of defining a good functional unit and system boundaries is illustrated. These treatment options for waste solvents can be inserted in the resource evaluation tool, together with new technologies as SFC, HPLC, but also microreactor technologies. Overall, it can be concluded that the resource evaluation tool as presented in chapter 5 allows a faster evaluation of specific pharmaceutical processes thanks to the reduced data requirement. The evaluation of the resource consumption over three different system boundaries using exergy analysis has added value for the selection and comparison of specific pharmaceutical production processes. It can be concluded that taking into account resource requirements over different system boundaries gives a more complete and more reliable view on the resource consumption than an approach at the narrow system boundary. This tool will help to reduce the integral resource consumption of specific production processes by pinpointing the major resource consumers and indicating potential improvements. In this way, this tool can contribute to a more environmentally sustainable API production. From chapter 6 and 7, it can however be concluded that the methods used for the development of this tool are also applicable on other cases. In best case, these cases can also be added into the resource evaluation tool resulting in a continually growing and improving calculation tool for evaluation of pharmaceutical production processes.
Please use this url to cite or link to this publication:
author
promoter
UGent and Wim Aelterman
organization
alternative title
Ontwikkeling van een tool voor de evaluatie van energie- en grondstofverbruik in de farmaceutische industrie op het proces, plant en systeem niveau
year
type
dissertation (monograph)
subject
pages
IX, 153 pages
publisher
Ghent University. Faculty of Bioscience Engineering
place of publication
Ghent, Belgium
defense location
Gent : Faculteit Bio-ingenieurswetenschappen (A0.030)
defense date
2010-09-08 16:00
ISBN
9789059893917
language
English
UGent publication?
yes
classification
D1
additional info
dissertation consists of copyrighted materials
copyright statement
I have transferred the copyright for this publication to the publisher
id
1036271
handle
http://hdl.handle.net/1854/LU-1036271
date created
2010-09-02 15:51:10
date last changed
2010-09-02 16:22:50
@phdthesis{1036271,
  abstract     = {In this dissertation, a tool for the evaluation of the resource requirements of pharmaceutical production processes is presented. The pharmaceutical industry consumes a lot of resources for the synthesis of active pharmaceutical ingredients (API{\textquoteright}s). Many efforts are made to reduce this resource consumption. Second generation processes as well as new technologies are implemented to replace the current processes. Before implementation, the potential of improvement is however to be quantified. The tool developed and presented in this dissertation allows the assessment of the resource requirements of new and existing processes and technologies. The resource requirements are calculated based on the inputs from existing batch production reports and the knowledge of the chemical reaction mechanisms. Resources are expressed using thermodynamics. Exergy analysis allows a coherent and scientifically sound way of evaluating different kind of resources on one single scale. The evaluation occurs at three different levels, being the process, gate-to-gate and cradle-to-gate level. At these three levels, the resource requirements can be calculated and evaluated for different kind of processes.
In this dissertation, first an introduction is given about the state of the art concerning the environmental sustainability assessment in chemical and more specific the pharmaceutical industry (chapter 2). The currently available environmental sustainability concepts and metrics (green chemistry, LCA, exergy...) are discussed. After this introduction, chapter 3 goes more into detail and focuses on the different advantages of using exergy analysis for the evaluation of resource consumption at different levels. It is shown that the exergy approach, based on the fundamental laws of thermodynamics, is applicable as sustainability metric in the field of environmental technology. In chapter 4, a methodology is presented for setting up process specific mass and energy balances over different system boundaries in the pharmaceutical industry. This methodology is the basis for the resource evaluation tool as presented in chapter 5. Combining the mass and energy balance (chapter 4) with an environmental impact assessment methodology, in this case exergy analysis (chapter 3) results in a resource evaluation tool which only requires the input from batch production reports and the chemical reaction pathway. This resource evaluation tool is tested for 5 different cases from Janssen Pharmaceutica, part of the Johnson and Johnson Group. Results are presented for different system boundaries. In chapter 6 and 7; two extensions for the resource evaluation tool as available in chapter 5 are presented. In chapter 6, two new technologies are evaluated using similar principles as used in the evaluation tool. Prep-HPLC is compared with prep-SFC on their resource efficiency. Again exergy analysis over different system boundaries has proven to be a valuable resource evaluation assessment methodology. In chapter 7 the resource requirement for the treatment of an on-site distillation is compared with an off-site incineration. Here the importance of defining a good functional unit and system boundaries is illustrated. These treatment options for waste solvents can be inserted in the resource evaluation tool, together with new technologies as SFC, HPLC, but also microreactor technologies.
Overall, it can be concluded that the resource evaluation tool as presented in chapter 5 allows a faster evaluation of specific pharmaceutical processes thanks to the reduced data requirement. The evaluation of the resource consumption over three different system boundaries using exergy analysis has added value for the selection and comparison of specific pharmaceutical production processes. It can be concluded that taking into account resource requirements over different system boundaries gives a more complete and more reliable view on the resource consumption than an approach at the narrow system boundary. This tool will help to reduce the integral resource consumption of specific production processes by pinpointing the major resource consumers and indicating potential improvements. In this way, this tool can contribute to a more environmentally sustainable API production. From chapter 6 and 7, it can however be concluded that the methods used for the development of this tool are also applicable on other cases. In best case, these cases can also be added into the resource evaluation tool resulting in a continually growing and improving calculation tool for evaluation of pharmaceutical production processes.},
  author       = {Van der Vorst, Geert},
  isbn         = {9789059893917},
  language     = {eng},
  pages        = {IX, 153},
  publisher    = {Ghent University. Faculty of Bioscience Engineering},
  school       = {Ghent University},
  title        = {Development of a tool for the environmental evaluation of the resource and energy consumption in the pharmaceutical industry at the process, plant and system level},
  year         = {2010},
}

Chicago
Van der Vorst, Geert. 2010. “Development of a Tool for the Environmental Evaluation of the Resource and Energy Consumption in the Pharmaceutical Industry at the Process, Plant and System Level”. Ghent, Belgium: Ghent University. Faculty of Bioscience Engineering.
APA
Van der Vorst, G. (2010). Development of a tool for the environmental evaluation of the resource and energy consumption in the pharmaceutical industry at the process, plant and system level. Ghent University. Faculty of Bioscience Engineering, Ghent, Belgium.
Vancouver
1.
Van der Vorst G. Development of a tool for the environmental evaluation of the resource and energy consumption in the pharmaceutical industry at the process, plant and system level. [Ghent, Belgium]: Ghent University. Faculty of Bioscience Engineering; 2010.
MLA
Van der Vorst, Geert. “Development of a Tool for the Environmental Evaluation of the Resource and Energy Consumption in the Pharmaceutical Industry at the Process, Plant and System Level.” 2010 : n. pag. Print.