Thesis (Ph. D.)--University of California, San Francisco with the University of California, Berkeley, 2008. / Source: Dissertation Abstracts International, Volume: 69-12, Section: B, page: 7645. Adviser: Francis C. Szoka.

Thesis (Ph. D.)--University of Illinois at Urbana-Champaign, 2007. / Source: Dissertation Abstracts International, Volume: 69-02, Section: B, page: 1255. Adviser: Jennifer A. Lewis. Includes bibliographical references (leaves 117-122). Available on microfilm from Pro Quest Information and Learning.

Neste trabalho, foram projetados protótipos de uma extrusora e de um equipamento para produção de filmes por laminação e posterior evaporação do solvente. Após os cálculos necessários para montagem dos equipamentos, os desenhos foram feitos em CAD (Software SolidWorks versão 2009). Definidas as combinações ideais entre polímero e plastificante, foram selecionadas as melhores condições de produção para os filmes. O tamanho básico do equipamento de extrusão foi em proporção direta à medida da lâmina e à produção total desejada. Projetou-se a matriz em razão do formato do filme, e a rosca tendo alma cônica, passo constante e diâmetro constante. Para a produção dos filmes por evaporação, após os cálculos de transferência de massa por convecção em escoamento externo, montou-se uma estrutura em acrílico como sistema de secagem e laminadores em diferentes espessuras. Os filmes por extrusão foram preparados a partir de maltodextrina, glicerina e celulose microcristalina, enquanto para a produção de filmes por evaporação de solvente, o pululano foi o polímero de escolha. Verificou-se que pelo método de extrusão, conseguiu-se uma maior produtividade, mas, em contrapartida, pelo método de evaporação de solvente, obteve-se uma qualidade muito maior, isso por ter sido possível desenvolver filmes de características organolépticas melhores, menor espessura, o que consequentemente gerou produtos com um tempo de desintegração menor. Com relação ao método de evaporação, concluiu-se ainda que tanto a técnica de secagem quanto a espessura de laminação são etapas críticas para produção dos filmes, já que, se realizadas inadequadamente, podem afetá-los tanto no aspecto visual, como nas propriedades mecânicas, peso médio, e tempo de desintegração. / The aim of this work was the development of prototypes of an extruder and an equipment for production of films by lamination and solvent casting. After the calculations required for assembly the equipments, the drawings were done in CAD (SolidWorks Software version 2009). Once defined the optimal combinations of polymer and plasticizer, the best conditions for film production were done. The basic size of the extrusion equipment was in direct proportion to the extent of the blade and the desired total output of product. The result was a matrix with a definied format, and a screw with constant pitch and constant diameter. For the production of films by solvent evaporation, after the calculations of mass transfer by convection at external flow, a structure was set up in acrylic serving as a system for drying and rolling using mills with different thicknesses. The films for extrusion were prepared from maltodextrin, microcrystalline cellulose and glycerin, while for the production of films by solvent evaporation, the polymer choise was pullulan. It was found that the extrusion method allowed good productivity, but in return, by the method of solvent evaporation, we obtained a higher quality, and the possibility of making films with better organoleptic characteristics. The films were thinner, which in turn leds to shorter disintegration time. Concerning the method of solvent evaporation, it was concluded that drying and lamination are critical steps for the production, since if not properly performed, both can affect visual appearance, mechanical properties, weight and disintegration time.

Neste trabalho, foram projetados protótipos de uma extrusora e de um equipamento para produção de filmes por laminação e posterior evaporação do solvente. Após os cálculos necessários para montagem dos equipamentos, os desenhos foram feitos em CAD (Software SolidWorks versão 2009). Definidas as combinações ideais entre polímero e plastificante, foram selecionadas as melhores condições de produção para os filmes. O tamanho básico do equipamento de extrusão foi em proporção direta à medida da lâmina e à produção total desejada. Projetou-se a matriz em razão do formato do filme, e a rosca tendo alma cônica, passo constante e diâmetro constante. Para a produção dos filmes por evaporação, após os cálculos de transferência de massa por convecção em escoamento externo, montou-se uma estrutura em acrílico como sistema de secagem e laminadores em diferentes espessuras. Os filmes por extrusão foram preparados a partir de maltodextrina, glicerina e celulose microcristalina, enquanto para a produção de filmes por evaporação de solvente, o pululano foi o polímero de escolha. Verificou-se que pelo método de extrusão, conseguiu-se uma maior produtividade, mas, em contrapartida, pelo método de evaporação de solvente, obteve-se uma qualidade muito maior, isso por ter sido possível desenvolver filmes de características organolépticas melhores, menor espessura, o que consequentemente gerou produtos com um tempo de desintegração menor. Com relação ao método de evaporação, concluiu-se ainda que tanto a técnica de secagem quanto a espessura de laminação são etapas críticas para produção dos filmes, já que, se realizadas inadequadamente, podem afetá-los tanto no aspecto visual, como nas propriedades mecânicas, peso médio, e tempo de desintegração. / The aim of this work was the development of prototypes of an extruder and an equipment for production of films by lamination and solvent casting. After the calculations required for assembly the equipments, the drawings were done in CAD (SolidWorks Software version 2009). Once defined the optimal combinations of polymer and plasticizer, the best conditions for film production were done. The basic size of the extrusion equipment was in direct proportion to the extent of the blade and the desired total output of product. The result was a matrix with a definied format, and a screw with constant pitch and constant diameter. For the production of films by solvent evaporation, after the calculations of mass transfer by convection at external flow, a structure was set up in acrylic serving as a system for drying and rolling using mills with different thicknesses. The films for extrusion were prepared from maltodextrin, microcrystalline cellulose and glycerin, while for the production of films by solvent evaporation, the polymer choise was pullulan. It was found that the extrusion method allowed good productivity, but in return, by the method of solvent evaporation, we obtained a higher quality, and the possibility of making films with better organoleptic characteristics. The films were thinner, which in turn leds to shorter disintegration time. Concerning the method of solvent evaporation, it was concluded that drying and lamination are critical steps for the production, since if not properly performed, both can affect visual appearance, mechanical properties, weight and disintegration time.

Neste trabalho, foram projetados protótipos de uma extrusora e de um equipamento para produção de filmes por laminação e posterior evaporação do solvente. Após os cálculos necessários para montagem dos equipamentos, os desenhos foram feitos em CAD (Software SolidWorks versão 2009). Definidas as combinações ideais entre polímero e plastificante, foram selecionadas as melhores condições de produção para os filmes. O tamanho básico do equipamento de extrusão foi em proporção direta à medida da lâmina e à produção total desejada. Projetou-se a matriz em razão do formato do filme, e a rosca tendo alma cônica, passo constante e diâmetro constante. Para a produção dos filmes por evaporação, após os cálculos de transferência de massa por convecção em escoamento externo, montou-se uma estrutura em acrílico como sistema de secagem e laminadores em diferentes espessuras. Os filmes por extrusão foram preparados a partir de maltodextrina, glicerina e celulose microcristalina, enquanto para a produção de filmes por evaporação de solvente, o pululano foi o polímero de escolha. Verificou-se que pelo método de extrusão, conseguiu-se uma maior produtividade, mas, em contrapartida, pelo método de evaporação de solvente, obteve-se uma qualidade muito maior, isso por ter sido possível desenvolver filmes de características organolépticas melhores, menor espessura, o que consequentemente gerou produtos com um tempo de desintegração menor. Com relação ao método de evaporação, concluiu-se ainda que tanto a técnica de secagem quanto a espessura de laminação são etapas críticas para produção dos filmes, já que, se realizadas inadequadamente, podem afetá-los tanto no aspecto visual, como nas propriedades mecânicas, peso médio, e tempo de desintegração. / The aim of this work was the development of prototypes of an extruder and an equipment for production of films by lamination and solvent casting. After the calculations required for assembly the equipments, the drawings were done in CAD (SolidWorks Software version 2009). Once defined the optimal combinations of polymer and plasticizer, the best conditions for film production were done. The basic size of the extrusion equipment was in direct proportion to the extent of the blade and the desired total output of product. The result was a matrix with a definied format, and a screw with constant pitch and constant diameter. For the production of films by solvent evaporation, after the calculations of mass transfer by convection at external flow, a structure was set up in acrylic serving as a system for drying and rolling using mills with different thicknesses. The films for extrusion were prepared from maltodextrin, microcrystalline cellulose and glycerin, while for the production of films by solvent evaporation, the polymer choise was pullulan. It was found that the extrusion method allowed good productivity, but in return, by the method of solvent evaporation, we obtained a higher quality, and the possibility of making films with better organoleptic characteristics. The films were thinner, which in turn leds to shorter disintegration time. Concerning the method of solvent evaporation, it was concluded that drying and lamination are critical steps for the production, since if not properly performed, both can affect visual appearance, mechanical properties, weight and disintegration time.

<div>To continue the shift from batch operations to continuous operations for a wider range of products, advances in real-time process management (RTPM) are necessary. The key requirements for effective RTPM are to have reliable real-time data of the critical process parameters (CPP) and critical quality attributes (CQA) of the materials being processed, and to have robust control strategies for the rejection of disturbances and setpoint tracking.</div><div><br></div><div>Real-time measurements are necessary for capturing process dynamics and implement feedback control approaches. The mass flow rate is an additional important CPP in continuous manufacturing compared to batch processing. The mass flow rate can be used to control the composition and content uniformity of drug products as well as an indicator of whether the process is in a state of control. This is the rationale for investigating real-time measurement of mass flow of particulate streams. Process analytical technology (PAT) tools are required to measure particulate flows of downstream unit operations, while loss-in-weight (LIW) feeders only provide initial upstream flow rates. A novel capacitance-based sensor, the ECVT sensor, has been investigated in this study and demonstrates the ability to effectively measure powder mass flow rates in the downstream equipment.</div><div><br></div><div>Robust control strategies can be utilized to respond to variations and disturbances in input material properties and process parameters, so CQAs of materials/products can be maintained and the amount of off-spec production can be reduced. The hierarchical control system (Level 0 equipment built-in control, Level 1 PAT based PID control and Level 2 optimization-based model predictive control) was applied in the pilot plant at Purdue University and it was demonstrated that the use of active process control allows more robust continuous process operation under different risk scenarios compared to a more rigid open-loop process operation within predefined design space. With the aid of mass flow sensing, the control framework becomes more robust in mitigating the effects of upstream disturbances on product qualities. For example, excursions in the mass flow from an upstream unit operation, which could force a shutdown of the tablet press and/or produce off-spec tablets, can be prevented by proper control and monitoring of the powder flow rate entering the tablet press hopper.</div><div><br></div><div>In this study, the impact of mass flow sensing on the control performance of a direct compaction line is investigated by using flowsheet modeling implemented in MATLAB/Simulink to examine the control performance under different risk scenarios and effects of data sampling (sampling time, measurement precision). Followed by the simulation work, pilot plant studies are reported in which the mass flow sensor is integrated into the tableting line at the exit of the feeding-and-blending system and system performance data is collected to verify the effects of mass flow sensing on the performance of the overall plant-wide supervisory control.</div>

L’intégration d’une démarche orientée vers le développement durable (DD) dans les organisations implique au-delà des motivations, des méthodes structurées et structurantes. Ces méthodes que l’on pourrait nommer outils de mise en œuvre du DD sont orientées vers un objectif commun, une performance globale (PG). À ce jour très peu de méthodes sont proposées aux sociétés d’ingénierie pour atteindre cette PG. Sans doute est-ce dû aux spécificités typologiques de ce type d’organisation de maîtrise d’œuvre (MOE) qui est partagée entre deux univers que sont la maîtrise d’ouvrage (MOU) et un ensemble de parties prenantes complexes (PP). C’est dans ce contexte que nous abordons notre sujet de recherche : comment la réponse à des attentes de la société peut-être un élément de la stratégie économique de l’entreprise ? C’est pourquoi notre idée est de proposer des méthodologies applicables au métier de l’ingénierie afin que ces entreprises puissent intégrer une démarche volontaire dans leur organisation pour le DD par la RSE. Dans le cadre d’une recherche-intervention nous avons donc posé les bases de réflexions au développement de processus d’intégration de la RSE non pas à l’échelle de l’organisation mais à l’échelle du métier. Par le développement d’un outil d’intégration d’une démarche de RSE construit sur la base de la norme ISO 26000 et de la norme expérimentale Afnor X30-029 nous avons pu faire évoluer dans le contexte de l’ingénierie pharmaceutique, les bonnes pratiques d’ingénierie en créant un modèle d’ingénierie responsable donc durable. / The integration of a sustainable development gait (SD) in the organizations implies, beyond the incentives, structured and structuring methods. These methods that we could name tools of implementation of SD are oriented toward a common objective: the global performance. Today very few methods are proposed to the societies of engineering in order to reach this global performance. It is probably due to the typological specificities of this type of organization. In point of fact, these engineering enterprises are quite atypical because they are shared between two universes which are the client (for instance pharmaceutical industry) and a significant number of complex subcontractors (SC). In this context, we approach our topic of research: the enterprise must prove that it is “economically viable, socially responsible and environmental healthy” (Quairel-Lanoizelee 2004), even beyond its own frontiers. But the answer to society’s expectations is also an element of the enterprise’s economic strategy. That is why, our idea is to suggest methodologies that are applicable to the engineering profession, and therefore could be adapted to all types of engineering enterprises, so that it can integrate a voluntary gait for SD by The Social Responsibility (SR). The International Organization for Standardization (ISO) is developing an international standard in order to provide guidelines for adopting and disseminating social responsibility: ISO 26000, which was published in 2010. In our research we have considered that the SR will play a double role, as reformer of the classical practices of project management as well as a tool that could bring SD strategy inside and outside the engineering organization. The general idea is to conceive a new approach of the enterprise’s management philosophy, disinterested from the unique profit notion. This brings us to think about another dimension of the enterprise’s performance. This project lead us to asking the following question: is it possible to manage an engineering project by including the SR approach in classical methodology of project management?By a methodology of action-research and specifically intervention-research (I-R), we are going to build our investigation about an international engineering company, which has as pharmaceutical engineering activity. The objective is to analyze, and to understand the specificities of engineering enterprise’s model in order to known if it is possible to change this model by developing a new project management approach based on the SR and strategy innovation. The innovating methodology that we developed must allow us to integrate a gait of SR within the best practice of engineering project. In conclusion, the integration tool of a gait of SR which is today on the stage of prototype, built on ISO 26000 norms and on the experimental norm Afnor X30-029 basis, allowed us to develop the pharmaceutical engineering’s profession, by moving from the standard engineering best practice to the social responsible engineering best practice, for a sustainable development goal.

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