Dissertations / Theses on the topic 'Process analytical technologies (PAT)'
Create a spot-on reference in APA, MLA, Chicago, Harvard, and other styles
Consult the top 27 dissertations / theses for your research on the topic 'Process analytical technologies (PAT).'
Next to every source in the list of references, there is an 'Add to bibliography' button. Press on it, and we will generate automatically the bibliographic reference to the chosen work in the citation style you need: APA, MLA, Harvard, Chicago, Vancouver, etc.
You can also download the full text of the academic publication as pdf and read online its abstract whenever available in the metadata.
Browse dissertations / theses on a wide variety of disciplines and organise your bibliography correctly.
Schneid, Stefan Christian. "Investigation of novel process analytical technology (PAT) tools for use in freeze-drying processes." kostenfrei, 2009. http://d-nb.info/999755315/34.
Full textMetze, Sabrina [Verfasser]. "Scalability of single-use biopharmaceutical manufacturing processes using process analytical technology (PAT) tools / Sabrina Metze." Hannover : Gottfried Wilhelm Leibniz Universität Hannover, 2020. http://d-nb.info/1204459495/34.
Full textDai, Bin. "SIMULATIONS-GUIDED DESIGN OF PROCESS ANALYTICAL SENSOR USING MOLECULAR FACTOR COMPUTING." UKnowledge, 2007. http://uknowledge.uky.edu/gradschool_diss/483.
Full textPowell, Keddon A. "Improving continuous crystallisation using process analytical technologies : design of a novel periodic flow process." Thesis, Loughborough University, 2017. https://dspace.lboro.ac.uk/2134/23982.
Full textSimone, Elena. "Application of process analytical technology (PAT) tools for the better understanding and control of the crystallization of polymorphic and impure systems." Thesis, Loughborough University, 2015. https://dspace.lboro.ac.uk/2134/20098.
Full textSchaefer, Cédric. "A Process Analytical Technology (PAT) approach involving near infrared spectroscopy to control the manufacturing of an active pharmaceutical ingredient : development, validation and implementation." Thesis, Aix-Marseille, 2013. http://www.theses.fr/2013AIXM4375.
Full textPharmaceutical companies are progressively adopting and introducing the Process Analytical Technology (PAT) concept to control and ensure in real-time product quality in development and manufacturing. PAT is a key component of the Quality-by-Design (QbD) framework promoted by the regulatory authorities, aiming the building of product quality based on both a strong scientific background and a quality risk management approach.An analytical method based on near infrared (NIR) spectroscopy was developed as a PAT tool to control on-line an API (active pharmaceutical ingredient) crystallization. During this process the API and residual solvent contents need to be precisely determined to reach a predefined seeding point. An original methodology based on the QbD principles was applied to conduct the development and validation of the NIR method and to ensure that it is fitted for its intended use. Partial least squares (PLS) models were developed and optimized through chemometrics tools in order to quantify the 2 analytes of interest. The method was fully validated according to the official requirements using the accuracy profile approach. Besides, a real-time process monitoring was added to the validation phase to prove and document that the method is fitted for purpose.Implementation of this method as an in-process control at industrial plant from the launch of this new pharmaceutical process will enable automatic control of the crystallization step in order to ensure a predefined quality level of the API. Other valuable benefits are expected such as reduction of the process time, and suppression of a difficult sampling and tedious off-line analyzes
Brestrich, Nina [Verfasser], and J. [Akademischer Betreuer] Hubbuch. "Development of process analytical technologies for chromatography based protein purification / Nina Brestrich. Betreuer: J. Hubbuch." Karlsruhe : KIT-Bibliothek, 2016. http://d-nb.info/1108450806/34.
Full textHelmdach, Lydia Verfasser], Joachim [Akademischer Betreuer] Ulrich, Martin [Akademischer Betreuer] Feth, and Ulrich [Akademischer Betreuer] [Teipel. "Application of process analytical technology (PAT) tools to develop and monitor scalable crystallization processes of pharmaceuticals / Lydia Helmdach. Betreuer: Joachim Ulrich ; Martin Feth ; Ulrich Teipel." Halle, Saale : Universitäts- und Landesbibliothek Sachsen-Anhalt, 2013. http://d-nb.info/1046563432/34.
Full textBellamy, Luke J. "Application of non-invasive process analytical technologies to characterise the factors influencing mixing and measurement of powders." Thesis, University of Strathclyde, 2006. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.426355.
Full textWarth, Benedikt. "Design and Application of Software Sensors in Batch and Fed-batch Cultivations during Recombinant Protein Expression in Escherichia coli." Thesis, Linköping University, The Department of Physics, Chemistry and Biology, 2008. http://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-12530.
Full textSoftware sensors are a potent tool to improve biotechnological real time process monitoring and control. In the current project, algorithms for six partly novel, software sensors were established and tested in a microbial reactor system. Eight batch and two fed-batch runs were carried out with a recombinant Escherichia coli to investigate the suitability of the different software sensor models in diverse cultivation stages. Special respect was given to effects on the sensors after recombinant protein expression was initiated by addition of an inducer molecule. It was an objective to figure out influences of excessive recombinant protein expression on the software sensor signals.
Two of the developed algorithms calculated the biomass on-line and estimated furthermore, the specific growth rate by integration of the biomass changes with the time. The principle of the first was the application of a near infrared probe to obtain on-line readings of the optical density. The other algorithm was founded on the titration of ammonia as only available nitrogen source. The other two sensors analyzed for the specific consumption of glucose and the specific production of acetate and are predicted on an in-line HPLC system.
The results showed that all software sensors worked as expected and are rather powerful to estimate important state parameters in real time. In some stages, restrictions may occur due to different limitation affects in the models or the physiology of the culture. However, the results were very convincing and suggested the development of further and more advanced software sensor models in the future.
Leitão, Tiago Miguel Dinis. "Aplicações da espectroscopia de infravermelho próximo em ciências farmacêuticas." Master's thesis, [s.n.], 2012. http://hdl.handle.net/10284/3761.
Full textA espectroscopia de infravermelho próximo (NIRS) é uma técnica de análise bastante conhecida e utilizada em diversas indústrias, tais como a alimentar, química, petroquímica, agroquímica. É também usada na indústria farmacêutica desde há alguns anos (EMEA, 2003). A Farmacopeia Americana - United States Pharmacopeia (USP) considera a NIRS um ramo da espectroscopia vibracional, partilhando aplicações e princípios com muitas medições espectroscópicas. As suas aplicações utilizam espectros medidos em comprimento de onda. A interacção entre a radiação NIR e a matéria pode fornecer informação qualitativa e quantitativa avaliada a partir da composição química e física de amostras. A técnica é rápida, simples, não destrutiva e analisa múltiplos componentes em praticamente qualquer matriz, com níveis de exactidão e precisão comparáveis aos métodos de referência primários. Não é necessária qualquer preparação ou manipulação da amostra, nem utilização de reagentes (Foss, 2002). Na indústria farmacêutica, o método de análise NIRS vem sendo aplicado há mais de 20 anos, estando inicialmente focalizado na análise de matérias-primas, mais recentemente tem sido também aplicado na análise de formulações sólidas e liquidas para controlo de qualidade do produto final, bem como para monitorização de operações de produção. As amostras de material recebido são inspeccionadas por este método, e a identidade e qualidade do mesmo é confirmada, a partir de algoritmos de padrões conhecidos. O método fornece informação quase em tempo real para controlo de processos de produção, como sejam identificação de matériasprimas, sistemas de recuperação de solventes ou secagem da mistura, por intermédio de técnicas de regressão estatística (Reich, 2005). Para que um processo de análise se possa implementar em processos industriais é necessário assegurar a sua robustez, pelo que um método NIRS deve ser desenvolvido tendo em conta requisitos considerados na produção e controlo, como características ópticas da amostra, sensibilidade e selectividade para o analito (Foss,2002). Os principais objectivos deste trabalho monográfico consistem: Estudo da técnica em análise, espectroscopia de infravermelho próximo; As suas aplicações nas diversas fases do processo de produção; Caracterizar o potencial da tecnologia em estudo, na análise dos diversos processos de controlo e produção farmacêutica. A elaboração deste trabalho de revisão bibliográfica foi efectuada através duma pesquisa sobre a temática, em publicações científicas, livros da especialidade e monografias. Os artigos consultados foram pesquisados, na sua maioria, em motores de busca disponibilizados pela Universidade Fernando Pessoa. As palavraschave utilizadas na realização da pesquisa foram as seguintes: “Espectroscopia de Infravermelho Próximo”, “Indústria Farmacêutica ”, “Aplicações NIRS”, “Tecnologias de Análise de Processos PAT”, “Monitorização de Processos”. Near infrared spectroscopy (NIRS) is an analyses technique very well known and used in many industries, like the chemical, petrochemical, biochemical and food industry. It is also being used in pharmaceutical industries in the recent years (EMEA, 2003). The United States Pharmacopeia (USP) considers NIRS as a branch of vibrational spectroscopy, sharing applications and principles with many spectroscopic measurements. Its applications use spectra measured in wavelength. The interactions between NIR radiation and matter may provide qualitative and quantitative information evaluated from the chemical and physical composition of the samples. This technique is fast, simple, non destructive and also analyzes multiple components in virtually any matrix, providing levels of precision and accuracy comparable with the primary reference methods. It’s not necessary any preparation or manipulation of the sample, and the reagent application is also discarded (Foss, 2002). In the pharmaceutical industry, NIRS method has been used for more than twenty years, initially focused in the analysis of raw materials, and more recently applied also to solid and liquid drug analysis, in the purpose of final quality control, and as well in the production line processes monitoring. Samples of incoming materials are inspected with this method, and the process of identity and quality of those products is assured, being compared with tables from confirmed acceptable samples. The process produces information almost in real time, using regression analysis, in the processes monitoring applications, as in raw material identification, solvent recovery systems or drying processes (Reich, 2005). For the application of the processes in industrial environment it is necessary to assure its strength, for that the NIRS must be developed bearing in mind the requirements considered in the production and control, as in the optical features of the sample, sensibility and selectiveness of the analyte (Foss, 2002). The main objectives of this monograph consist of: Study of the analysis technique, near infrared spectroscopy; Its applications in various stages of production; To characterize the potential of the technology under study, the analysis of the various control processes and pharmaceutical production. The development of this literature review was conducted through a survey on the topic in scientific publications, specialty books and monographs. The selected papers were searched, mostly in search engines provided by the University. The keywords used in the research were as follows: "Near Infrared Spectroscopy", "Pharmaceutical Industry", "NIR Application", "Process Analytical Technology PAT", "Process Monitoring".
Fukuda, Isa Martins. "Desenvolvimento e otimização de protetores solares empregando os conceitos de qualidade por design (QbD) e tecnologia analítica de processos (PAT)." Universidade de São Paulo, 2018. http://www.teses.usp.br/teses/disponiveis/9/9139/tde-12112018-145821/.
Full textThe sunscreens are great responsible for the skin protection when it is exposed to direct sunlight, so it means a great importance of health to optimize the development of type II cosmetic and monitor for it to be effective in its purpose. The objective of this work is to apply the concepts of Quality by Design and statistical tools of experimental design (DoE - Design of experiments), as well as applying the process analytical technology (PAT - Process Analytical Technology) concept for formulation and manufacturing process development of a topical sunscreen being able to modernize the cosmetic industry processing, including real time analyses and eliminating quarantine step, which waits analysis approval performed by the quality assurance, and then release the product for sale. As it is a systematic development, where critical quality attributes and risk assessment were performed to evaluate over obtained data. During experimental phase, the factorial design was used as a statistical tool for design of experiments implementation, and the responses were analyzed by response surface methodology (RSM - Response Surface Methodology). This mapping is critical to determination of the product design (design space), i.e. get sunscreen with the best physical and chemical characteristics and processing within the outlined scope. For in line methodology development, UV spectrometry was opted to be used due to less effort in sample preparation and due to great easiness to turn it into a PAT tool. For this, chemometrics was used, which brings together chemical and statistical elements to obtain three main elements: empirical modeling, multivariate modeling and chemical data, making it able to model systems that are unknown and complex, as a sunscreen, getting direct answers as product release approval before being packed, for example. The presented approach was based on the construction of quality throughout the sunscreen development and optimization making possible the real time quality monitoring.
Fekete, David [Verfasser], and Gottfried [Akademischer Betreuer] Vossen. "The Goal-oriented Business Intelligence Architectures Method : A Process-based Approach to Combine Traditional and Novel Analytical Technologies / David Fekete ; Betreuer: Gottfried Vossen." Dortmund : readbox unipress in der readbox publishing GmbH, 2020. http://d-nb.info/1212626044/34.
Full textCurtivo, Cátia Panizzon Dal. "Avaliação do processo de fabricação de comprimidos de Captopril (25 mg): aplicação da tecnologia analítica de processo e de ferramentas da qualidade e estatística." Universidade de São Paulo, 2011. http://www.teses.usp.br/teses/disponiveis/9/9139/tde-14092012-111612/.
Full textThe Good Manufacturing Practices (GMP) for Medicinal Products point out that the pharmaceutical industry must direct efforts to understand the variation of the processes, including the sources, the level of variation and the variation impact on the process in characteristics of the product. The manufacturing process has shown meaningful changes, especially in the introduction of new analytical technologies that allow the process control in real time. The approach based on risk analyses and on the new Pharmaceutical Quality System is a central key for the GMP for the XXI century. The Regulatory Agencies have demanded the pharmaceutical industry to adhere the continuous improvement related to the performance of its processes and, consequently, the product quality. Thus, the present paper aimed the development and validation of the analytical method employing NIR spectroscopy as the assessment of manufacturing process of Captopril 25 mg tablets, using rational scientific approach. Regarding the process assessment, the following tools were adopted: analysis of failure modes and effects analysis (FMEA), control charts, capability indexes, as well as analysis of variance (ANOVA). The near-infrared spectroscopy was selected due to its greater speed in getting the results, simplicity in sample preparation, and multiplicity of analysis from a single reading and provide non-invasive feature. The results confirmed the suitability of this technology in quantitative assessment of Captopril on the steps of mixing powders and compression. The relative standard deviations for the determination of Captopril uniformity in the post mixtures and in the tablets employing NIR were 3,15 e 0,18%, respectively. In reference to the stability assessment and process capacity, the tools adopted permitted the understanding of the sources of variability, as well as the determination of their level in different phases of the process. The capacity indexes relating to Captopril uniformity (% p/v) in the powder mixture, the average weight of the tablet, the content uniformity and the % (p/v) dissolved Captopril, in the dissolution assay were 0,70, 1,94, 1,80 and 2,19, respectively.
Björk, Anders. "Chemometric and signal processing methods for real time monitoring and modeling : applications in the pulp and paper industry." Doctoral thesis, KTH, Kemi, 2007. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-4383.
Full textVid framställning av pappersprodukter är kvaliteten på massan en viktig faktor för produktiviteten och kvalitén på slutresultatet. Det är därför viktigt att ha tillgång till tillförlitliga mätningar av massakvalitet i realtid. En möjlighet är att använda akustik- eller vibrationssensorer i lämpliga positioner vid enhetsoperationer i massaprocessen. Selektiviteten hos dessa mätningar är emellertid relativt låg i synnerhet om mätningarna är passiva. Därför krävs avancerad signalbehandling och multivariat kalibrering. Det nu presenterade arbetet har varit fokuserat på kalibreringsmetoder för extraktion av information ur akustiska mätningar samt på algoritmer för signalbehandling som kan ge förbättrad informationsselektivitet. Multivariata metoder som Principal Component Analysis (PCA), Partial Least Squares (PLS) and Orthogonal Signal Correction (OSC) har använts för visualisering och kalibrering. Signalbehandlingsmetoderna Fast Fourier Transform (FFT), Fast Wavelet Transform (FWT) och Continuous Wavelet Transform (CWT) har använts i utvecklingen av nydanande metoder för signalbehandling anpassade till att extrahera information ur signaler från vibrations/akustiska sensorer. En kombination av OSC och PLS applicerade på FFT-spektra från raffineringen i en Termo Mechnaical Pulping (TMP) process ger lägre prediktionsfel för Canadian Standard Freeness (CSF) än enbart PLS. Kombinationen av FFT och PLS har vidare använts för monitorering av malning av sulfatmassa och monitorering av silning. Ordinära FFT-spektra av t.ex. vibrationssignaler är delvis överlappande. För att komma runt detta har två signalbehandlingsmetoder utvecklats, Wavelet Transform Multi Resolution Spectra (WT-MRS) baserat på kombinationen av FWT och FFT samt Continuous Wavelet Transform Fibre Length Extraction (CWT-FLE) baserat på CWT. Tillämpning av WT-MRS gav enklare PLS-modeller med lägre prediktionsfel för CSF jämfört med att använda normala FFT-spektra. I en annan tillämpning på en massaström med relativt hög koncentration (Medium Consistency, MC) kunde prediktioner för CSF samt ljushet erhållas med prediktionsfel jämförbart med referensmetodernas fel. Metoden CWT-FLE validerades mot en kommersiell fiberlängdsmätare med god överensstämmelse. CWT-FLE-kurvorna skulle därför kunna användas i stället för andra fiberdistributionskurvor för processtyrning. Vidare användes CWT-FLE kurvor för PLS modellering av dragstyrka samt optiska egenskaper med goda resultat. Utöver de nämnda resultaten har en omfattande litteratursammanställning gjorts över området och relaterade applikationer.
QC 20100629
Демидова, Р. Э., and R. E. Demidova. "Автоматизация бизнес-процесса по работе с клиентами с применением CRM-системы : магистерская диссертация." Master's thesis, б. и, 2020. http://hdl.handle.net/10995/93437.
Full textIn the modern world, the photographic services market is developing by leaps and bounds. Photo salons and photo studios are especially relevant among novice businessmen. To boost sales, many companies are increasingly offering the option to sign up a customer online using CRM. The CRM system is relevant for various reasons: the development of business processes, the role of the Internet and the use of mobile devices in business, the development and reduction of the cost of data processing technologies and IT infrastructure. And, of course, the fact that the technical capabilities of CRM systems have reached perfection played an important role. They allow you to track the path of the buyer from the moment of the first contact with him for resale. It creates sales technology by linking advertising, analytical tools and the sales system itself into a single system. The results of the final qualifying work will be used in the photo studio when implementing the AppEvent CRM system.
Yekpe, Kétsia. "Relier les attributs de matériaux et les paramètres de procédés de fabrication à un test de contrôle qualité, une application du concept du quality by design." Thèse, Université de Sherbrooke, 2014. http://hdl.handle.net/11143/5397.
Full textІванівна, Кереуш Дар'я. "Методологія ефективного використання земельних ресурсів для розвитку сонячної енергетики на основі дистанційного зондування Землі та ГІС-технологій." Diss., Національний університет "Львівська політехніка", 2019. https://ena.lpnu.ua/handle/ntb/45641.
Full textCournoyer, Antoine. "Développement d'une technique optique ayant pour but l'analyse de procédés en ligne de comprimés pharmaceutiques." Thèse, 2008. http://hdl.handle.net/1866/8083.
Full textKelly, Adrian L., Timothy D. Gough, Mohammad Isreb, Ravindra S. Dhumal, J. W. Jones, S. Nicholson, A. B. Dennis, and Anant R. Paradkar. "In-process rheometry as a PAT tool for hot melt extrusion." 2017. http://hdl.handle.net/10454/14086.
Full textReal time measurement of melt rheology has been investigated as a Process Analytical Technology (PAT) to monitor hot melt extrusion of an Active Pharmaceutical Ingredient (API) in a polymer matrix. A developmental API was melt mixed with a commercial copolymer using a heated twin screw extruder at different API loadings and set temperatures. The extruder was equipped with an instrumented rheological slit die which incorporated three pressure transducers flush mounted to the die surface. Pressure drop measurements within the die at a range of extrusion throughputs were used to calculate rheological parameters such as shear viscosity and exit pressure, related to shear and elastic melt flow properties respectively. Results showed that the melt exhibited shear thinning behavior whereby viscosity decreased with increasing flow rate. Increase in drug loading and set extrusion temperature resulted in a reduction in melt viscosity. Shear viscosity and exit pressure measurements were found to be sensitive to API loading. These findings suggest that this technique could be used as a simple tool to measure material attributes in-line, to build better overall process understanding for hot melt extrusion.
Schneid, Stefan Christian [Verfasser]. "Investigation of novel process analytical technology (PAT) tools for use in freeze-drying processes / vorgelegt von Stefan Christian Schneid." 2010. http://d-nb.info/999755315/34.
Full textParker, Joana Ventura. "Process Analytics for Chemical Reactions Modelling." Master's thesis, 2020. http://hdl.handle.net/10316/92103.
Full textA segurança dos pacientes e a eficácia dos medicamentos são as principais preocupações da indústria farmacêutica, para a qual a garantia da qualidade do produto é essencial.Convencionalmente, o processamento na indústria farmacêutica é realizado em regime descontínuo, sendo a qualidade dos lotes garantida através de testes laboratoriais a amostras recolhidas, por forma a monitorizar os atributos críticos de qualidade (CQAs) do produto.Contudo, ao longo dos anos, surgiram várias tecnologias que permitem maior conhecimento do produto e do processo de fabrico, possibilitando um melhor desenvolvimento, fabrico e garantia de qualidade através do controlo e da análise de dados do processo.Estas tecnologias, tecnologias analíticas de processo (PAT), utilizam instrumentação e modelação matemática para monitorizar continuamente os CQAs de um produto, permitindo a passagem de testar a qualidade do produto acabado com métodos analíticos off-line para assegurar a qualidade do produto através da monitorização contínua e em tempo real dos seus atributos.Os sensores on-line PAT fornecem a informação necessária para inferir as principais variáveis de controlo de qualidade do sistema, embora corrompida por ruídos, biases, e imprecisões de equipamento.A qualidade desta informação pode ser melhorada através da aplicação de um algoritmo de estimativa óptima, combinando as medições disponíveis com o conhecimento prévio do sistema e dos equipamentos de medição.Neste projecto, a espectroscopia de infravermelhos (IR) é utilizada para monitorizar a concentração do reagente limitante de uma reacção em tempo real.Um modelo PLS é calibrado a partir dos dados IR recolhidos para prever a concentração do reagente, e um modelo cinético para descrever o comportamento do sistema com base nos primeiros princípios é desenvolvido.Esta informação é combinada aplicando o algoritmo do filtro de Kalman estendido híbrido (HEKF).Este trabalho evidencia os resultados favoráveis da aplicação de algoritmos da família do filtro de Kalman para combinar informação resultante dos sensores e informação mecanística, que permitem obter previsões mais precisas do que as obtidas quando a mesma informação é utilizada individualmente.A aplicação do algoritmo HEKF produz uma melhoria de precisão de 50.3 % em relação ao modelo PLS, e uma melhoria de precisão de 80.0 % em relação ao modelo cinético.Esta aplicação permite também identificar o tempo final da reacção 15 minutos antes da sua ocorrência.
Patient safety and drug efficacy are the major concerns in the pharmaceutical industry, for which product quality assurance is essential.Conventionally, pharmaceutical manufacturing consists in batch processing with off-line laboratory testing conducted on collected samples to monitor the product's critical quality attributes (CQAs).However, throughout the years, several technologies with the potential to increase insight into the product and the manufacturing process have emerged, allowing for improved pharmaceutical development, manufacturing, and quality assurance through process control and analysis of process data.These technologies, process analytical technologies (PAT), employ instrumentation and mathematical modelling to continuously monitor the CQAs of a pharmaceutical product, allowing the shift from testing the quality of the finished drug product with off-line analytical methods to assuring the product’s quality by continuous, real-time monitoring of its attributes.PAT on-line sensors provide the information needed to infer key quality control variables of the system, albeit corrupted by noise, biases, and device inaccuracies.The quality of this information can be improved through application of an optimal estimation algorithm, by combining the available measurement data with prior knowledge of the system and of the measuring devices.In this project, infrared (IR) spectroscopy is used to monitor the concentration of the limiting reagent of a reaction in real-time.A PLS model is calibrated from the collected IR data to predict the concentration of the reagent and a kinetic model is developed to describe the behaviour of the system based on first principles. This information is combined applying the hybrid extended Kalman filter (HEKF) algorithm.This work evinces the favourable outcomes of applying Kalman-filter-like algorithms to combine sensor and mechanistic information, which yield predictions that are more accurate than those obtained by the same information, if individually used.The application of the HEKF algorithm yields an accuracy improvement of 50.3 % with respects to the PLS model, and an accuracy improvement of 80.0 % with respects to the kinetic model.This application also makes possible to identify the reaction's end time 15 minutes before the occurrence.
Trenfield, S. J., A. Goyanes, Richard Telford, D. Wilsdon, M. Rowland, S. Gaisford, and A. W. Basit. "3D printed drug products: Non-destructive dose verification using a rapid point-and-shoot approach." 2018. http://hdl.handle.net/10454/16553.
Full textThree-dimensional printing (3DP) has the potential to cause a paradigm shift in the manufacture of pharmaceuticals, enabling personalised medicines to be produced on-demand. To facilitate integration into healthcare, non-destructive characterisation techniques are required to ensure final product quality. Here, the use of process analytical technologies (PAT), including near infrared spectroscopy (NIR) and Raman confocal microscopy, were evaluated on paracetamol-loaded 3D printed cylindrical tablets composed of an acrylic polymer (Eudragit L100-55). Using a portable NIR spectrometer, a calibration model was developed, which predicted successfully drug concentration across the range of 4–40% w/w. The model demonstrated excellent linearity (R2 = 0.996) and accuracy (RMSEP = 0.63%) and results were confirmed with conventional HPLC analysis. The model maintained high accuracy for tablets of a different geometry (torus shapes), a different formulation type (oral films) and when the polymer was changed from acrylic to cellulosic (hypromellose, HPMC). Raman confocal microscopy showed a homogenous drug distribution, with paracetamol predominantly present in the amorphous form as a solid dispersion. Overall, this article is the first to report the use of a rapid ‘point-and-shoot’ approach as a non-destructive quality control method, supporting the integration of 3DP for medicine production into clinical practice.
Open Access funded by Engineering and Physical Sciences Research Council United Kingdom (EPSRC), UK for their financial support (EP/L01646X).
Cordeiro, Pedro Miguel António. "Evaluation of the cost-benefit of the implementation of PAT systems for the production of solid forms in a pharmaceutical company." Master's thesis, 2016. http://hdl.handle.net/10451/28420.
Full textProcess Analytical Technology (PAT) is defined by the FDA in the PAT initiative issued in 2004 as ”a system for designing, analyzing, and controlling manufacturing through timelymeasurements (i.e.,during processing) of critical quality and performance attributes of raw and inprocess materials and processes, with the goal of ensuring the final product quality”. Since then, the pharmaceutical companies have been adopting gradually this technology in their manufacturing lines. PAT tools are indeed well recognized as a critical tool for achieving better process and product control leading to the possibility of real time release testing. This thesis evaluated the technical and economic feasibility of implementation of PAT systems into a Portuguese pharmaceutical company manufacturing line of solid forms. To accomplish this task, two products were used as models. These products were selected since they cover most unit operations of the solid forms installed manufacturing line. The work was divided in two parts. The first part is concerned with the identification of critical quality attributes (CQAs) and critical process parameters (CPPs) of the two model products in order for the proposition of opportunities of implementation of PAT strategies. These opportunities are described in detail and evaluated according to a series of criteria. Nine opportunities were identified, mainly involving NIR and RAMAN spectroscopy as suitable technology. The implementation of the identified opportunities, is expected to permit the possibility of real time release for the two products. The second part focuses on the economical feasibility of the identified PAT implementation. The economic analysis indicated that the implementation of all opportunities will reduce manufacturing / quality control time and costs substantially. The expectation of return-of-investmentis achieved in a time frame between 5 to 8 years respectively considering optimistic and pessimist scenarios.
Rodrigues, Inês Sofia Baptista. "Implementation of Quality-by-design in drug development: continuous manufacturing." Master's thesis, 2016. http://hdl.handle.net/10451/35845.
Full textPharmaceutical manufacturing has been changing over the last years, especially, due to significant advances in science and engineering. The lack of flexibility, quality consistency, robustness of manufacturing, the need to respond faster to market shortage and the necessity of better process control demanded the establishment of new technologies, such as Process Analytical Technology (PAT), Quality by Design (QbD) and, more recently, Continuous Pharmaceutical Manufacturing (CPM). Through these approaches became possible to design manufacturing processes using principles of engineering, material science and quality control to ensure acceptable and reproducible product quality and performance throughout a product's shelf life. Fundamentally, they allow an understanding of the product and manufacturing process, starting with product development and basically building quality in, not testing it. This review focuses on these three approaches, but specially on the continuous manufacturing process, that is starting to be incorporated and developed in some breakthrough pharmaceuticals. Companies, especially the ones with new biopharmaceuticals, have begun utilizing continuous manufacturing as an alternative to batch manufacturing in various parts of the production process. Continuous manufacturing allows that materials are sent directly and continuously to the next step for further processing, after reliably produce an intermediate material or product with acceptable characteristics, guaranteeing their consistent quality. Unfortunately, in Portugal, the development of these techniques still needs to be encouraged. This could happen because companies have the perception that the existing regulatory system is rigid and unfavorable to the introduction of innovative systems. On the contrary, regulatory entities support de introduction of these technologies, providing guidelines with models for an effective quality management system for the pharmaceutical and biotech industry.
A indústria farmacêutica tem vindo a sofrer mudanças nos últimos anos, especialmente, devido aos avanços na ciência e na engenharia. A falta de flexibilidade, consistência na qualidade dos produtos, robustez do processo de produção e a necessidade de responder, com brevidade, à falta de medicamentos e de ter um melhor controlo do processo exigiu o estabelecimento de novas tecnologias como o Process Analytical Technology (PAT), o Quality by Design (QbD) e, mais recentemente, a produção contínua. Através destas estratégias torna-se possível desenhar o processo de produção usando fundamentos de engenharia, ciência dos materiais e de controlo de qualidade, assegurando uma qualidade do produto aceitável e reprodutível e também a sua performace durante o ciclo de vida do medicamento. Fundamentalmente, estas permitem um conhecimento sobre o produto e o processo de produção, começando no desenvolvimento do produto e, desta forma, construindo qualidade e não apenas testando-a. Esta monografia tem como foco estas três abordagens, mas especialmente o processo de produção contínua que está a começar a ser incorporado e desenvolvido em alguns medicamentos de ponta. As indústrias, especialmente aquelas a produzir novos biossimilares já começaram a utilizar a produção contínua, como uma alternativa aos processos com lotes, em várias secções do processo de produção. A produção contínua permite que os materiais sejam enviados, directa e continuamente, para o próximo passo, depois de produzirem materiais intermédios ou o produto final com fiabilidade e características aceitáveis, garantindo uma qualidade consistente. Infelizmente, em Portugal, o desenvolvimento destas técnicas ainda precisa de ser encorajado. Isto poderá acontecer, já que as indústrias têm a percepção que o sistema regulatório é rígido e não vê de forma favorável a introdução de sistemas inovadores. Contrariamente, as entidades regulatórias incentivam a introdução das mesmas, providenciando guidelines com modelos para um sistema de controlo de qualidade efectivo para a indústria farmacêutica e biotecnológica.
Ramabitsa-Siimane, Ts’aletseng M. "The identification of environmentally sound technologies for healthcare waste management in Lesotho." Diss., 2005. http://hdl.handle.net/2263/24551.
Full textDissertation (MSc (Environmental Technology))--University of Pretoria, 2007.
Chemical Engineering
unrestricted
Митикасов, Андрій Миколайович. "Цифровізація виробничих і організаційних процесів в Концерні «Міські теплові мережі»." Магістерська робота, 2020. https://dspace.znu.edu.ua/jspui/handle/12345/4738.
Full textUA : Проведено аналіз теоретичних і практичних підходів до вирішення завдань адаптивного ціноутворення, складання ефективних планів закупівель товарно-матеріальних цінностей, системної структуризації техніко-економічних та управлінських бізнес-процесів. Обґрунтовано концептуальну ідею проведення комплексного аналізу перебігу бізнес-процесів, на базі запровадження спеціалізованих інформаційно-аналітичних систем, що реалізують комплекс техніко-економічних задач різного рівня складності. Здійснено формалізація структурно-функціональних, логічних, інформаційних описів об`єктів, процесів, організаційних процедур для здійснення постановок прикладних техніко-економічних та управлінських задач. Обґрунтовано рекомендації щодо вдосконалення системи управління з урахуванням перспектив створення та запровадження спеціалізованих інформаційно-аналітичних систем економічного аналізу для цифровізації його виробничих і організаційних бізнес-процесів.
EN : The analysis of theoretical and practical approaches to solving the problems of adaptive pricing for heat carriers, drawing up effective plans for the procurement of inventory, systemic structuring of technical, economic and managerial business processes associated with the marketing activities of the Concern "City Heating Networks". The conceptual idea of conducting a comprehensive analysis of the course of business processes, which are associated with marketing pricing for the services of the Concern "City Heating Networks", on the basis of the introduction of specialized information and analytical systems that implement a complex of technical and economic tasks of different levels of complexity has been substantiated. The formalization of structural and functional, logical, informational descriptions of objects, processes, organizational procedures for the implementation of the statement of applied technical, economic and managerial tasks has been carried out. Recommendations for improving the management system of the Concern «City Heating Networks» are substantiated, taking into account the prospects for the creation and implementation of specialized information and analytical systems of economic analysis for the digitalization of its production and organizational business processes.