Global ETD Search
Search theses and dissertations gathered from participating repositories worldwide. Every result links back to the library that holds it. No account is needed.
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Showing 1 to 20 of 20 for “"Process analytical technology (PAT)"”.
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Near-Infrared (NIR) Spectroscopy-based Pharmaceutical Process Analytical Technology (PAT) Systems: Risk and Performance
<p>Process Analytical Technology (PAT) systems are used in the pharmaceutical industry to enhance the understanding and control the manufacturing processes. They are defined as systems for designing, analyzing, and controlling manufacturing operations through timely measurements of critical quality …
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Implementing process analytical technology (PAT) tools for the analysis and control of manufacturing processes during hot-melt extrusion
… hot-melt extrusion (HME) was coupled with process analytical technology (PAT) tools in order to investigate drug interactions during processing, identify drug/excipient interactions and monitor the quality of the extruded products. In order to ensure the quality of the products, X-ray …
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Investigation of a process analytical technology (PAT) for rapid cleaning verification in the pharmaceutical industry to reduce product changeover time
… misleading results and ultimately could put patient's lives at risk. This has been proved by the FDA’s recent citation where it said, most of the drug manufacturing-related problems leading to product recalls and manufacturing disruption are caused by cross-contamination. Another immense …
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MANUFACTURE OF INDIVIDUALIZED DOSING: DEVELOPMENT AND CONTROL OF A DROPWISE ADDITIVE MANUFACTURING PROCESS FOR MELT BASED PHARMACEUTICAL PRODUCTS
… (FDA) introduced the Quality by Design (QbD) and Process Analytical Technology (PAT) guidelines to encourage innovation and efficiency in pharmaceutical development, manufacturing and quality assurance. As a result of emerging technologies and encouragement from the regulatory authorities, the …
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Process Analytical Technology in biopharmaceutical manufacturing
Process Analytical Technology (PAT) became a well-defined concept within the pharmaceutical industry as a result of a major initiative by the FDA called "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach." The FDA defines PAT as "a system for designing, analyzing, and controlling …
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Industry 4.0 in Biomanufacturing: Predictive Real-Time Models Using Process Analytical Technology
In biomanufacturing, process analytical technology (PAT) has become an essential tool for improving product quality, reducing costs, and increasing efficiency. In this thesis, we collect capacitance and optical density data from two in-line sensors in production bioreactors to compute real-time …
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Development of In Situ Monitoring and Data-Driven Modeling for Complex Systems: Case Study on Simulant Mixtures of Nuclear Waste
… waste, which calls for extensive sampling during processing. In this thesis, the use of Process Analytical Technology (PAT), including in-situ infrared and Raman spectroscopy, is demonstrated for Real-Time In-Line Monitoring (RTIM) of simulated nuclear waste. In-situ monitoring will facilitate the …
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Applications of ultrasound in pharmaceutical processing and analytics.
Innovations and process understanding is the current focus in pharmaceutical industry. The objective of this research was to explore application of high power ultrasound in the slurry crystallisation and application of low power ultrasound (3.5 MHz) as process analytical technology (PAT) tool to …
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Implementation of the new FDA quality by design guidance in pharmaceutical production
… to implement changes to a pharmaceutical process. Even small change request approvals can require months of effort for pharmaceutical companies and regulatory agencies. This resource intensive process discourages continuous improvement and often results in outdated and inefficient …
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Investigation of a solvent-free continuous process to produce pharmaceutical co-crystals. Understanding and developing solvent-free continuous cocrystallisation (SFCC) through study of co-crystal formation under the application of heat, model shear and twin screw extrusion, including development of a near infrared spectroscopy partial least squares quantification method
… co-crystals. The objectives were to optimize the process towards achieving high co-crystal yields and to understand the behaviour of co-crystals under different conditions. Particular attention was paid to the development of near infrared (NIR) spectroscopy as a process analytical technology …
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A Raman Spectroscopic Study of Solid Dispersions and Co-crystals During the Pharmaceutical Hot melt Extrusion Process
Process Analytical Technology (PAT) is framed with the objective of the design and development of processes to ensure predefined quality of the product at the end of manufacturing. PAT implementation includes better understanding of process, reduction in production time with use of in-line, at-line …
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Automated Execution and Optimization of Flow Chemistry on a Robotic Platform with Integrated Analytics
… optimization, and characterization of chemical processes for the synthesis of organic compounds, which play a key role in society as medicines and materials, is currently an expensive and laborious enterprise. These inefficiencies are driving efforts to develop automated, data-rich …
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Process analytical technology in tablet manufacturing
Process Analytical Technology (PAT) is the important tools to understand the process, obtaining critical process parameters and used as process monitoring following by quality by design (QbD) concept. It has been applied to the pharmaceutical manufacturing especially in every step of tablet …
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Antisolvent crystallisation in oscillatory baffled platforms
… number of advantages, such as more controllable processes and allows particle attributes to be attained that would otherwise be unattainable. Antisolvent crystallisation is a widely used method of crystallisation in both academia and industry. It is employed to crystallise compounds that are not …
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Data-driven Dynamic Control Scheme for Antibody Producing CHO Cell Cultures in Fed-batch
Effective process control is a basic requirement for biopharmaceutical manufacturing to achieve high efficiency and enhanced quality control. High non-linearity and uncertainties associated with bioprocesses challenge the ability of traditional controllers to deliver satisfactory performance, …
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Model-based Design and Control of Biopharmaceutical Manufacturing Processes
… manufacturing provide opportunities for process systems engineering to make major advances in biomanufacturing: (1) process analytical technology (PAT) is providing on-line measurements of critical quality attributes (CQAs) for constructing first-principles and data-based models of each …
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Combining Chemometrics and non-target GC-IMS gas phase analysis for improved bioprocess monitoring
Industrial biotechnology uses microbial fermentation processes to develop or modify products and is a major contributor to the production of high-value goods, including pharmaceutical active ingredients, feed nutrients, and flavor and fragrance compounds. Process Analytical Technology (PAT) is …
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Development and manufacture of novel amorphous Itraconazole drug products using quality by design principles
… using continuous manufacture with novel in-line process analytical technology (PAT) to monitor quality. The solubility parameter () of ITZ and polymers, Kollidon® VA64 (KOL), hydroxypropylmethylcellulose acetate succinate (HPMCAS) and polyvinylacetate (PVA) were screened using group contribution …
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Espacio de diseño con métodos de inversión de modelos de regresión sobre variables latentes
… en el cual la Tecnología Analítica de Procesos (PAT) y la Calidad Diseñada (QbD) definen un contexto más allá del modelado matemático puro de un proceso. Se desarrolla una alternativa novedosa para la inversión de modelos predictivos del tipo PLS (Partial Least Squares) mediante un procedimiento …
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The Development of Hybrid Process Control Systems For Fluidized Bed Pellet Coating Processes
… basic control for pharmaceutical batch processes has several drawbacks. The basic control often uses constant process settings discovered by trial and error. The rigid process operation provides limited process understanding and forgoes the opportunities of process optimization. Product …