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 34 for “"process analytical technology"”.
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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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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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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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Application of through-vial impedance spectroscopy as a novel process analytical technology for freeze drying
… develop applications for a novel impedance-based process analytical technology for monitoring the attributes of the product during the entire freeze-drying process (from pre-freezing and annealing to primary and then secondary drying). This measurement approach involves the application of foil …
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Through Vial Impedance Spectroscopy (TVIS): A novel process analytical technology for investigating the thawing of frozen cell suspensions.
… activities before and after the freeze-thawing process, the primary aim of this project is to establish the methods of analysis of the impedance spectra of these systems, and what parameters might be extracted, with a future view to deploy this technique in the evaluation of cryopreservation …
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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
… to develop and use of more science-based analytical tools, and the pharma industries are searching hard for a better alternative. This project was initiated to use a scientifically sound hand-held analytical tool to validate/verify equipment cleanliness in real-time without sampling and …
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A Novel Acetaminophen Soft-Chew Formulation Produced Via Hot Melt Extrusion With Inline Near-Infrared Monitoring As A Process Analytical Technology Tool
… were used in seven formulations. The extrusion process temperature of formulation 1-6 and formulation 7 were 90 ëšc and 140 ëšc, respectively. Near-infrared spectra were collected during extrusion to monitor the quality consistency. Scanning electronic microscopy images of tablets' cross-section …
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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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The development and application of online modelling methods
… (DOE) are fast becoming integral parts of process analysis and incorporated into the resulting advances in technology. To this end, two major studies were undertaken to explore the existing methods of modelling using both traditional and modern forms of process analytical technology, and to …
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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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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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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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Development of dielectric spectroscopic monitoring methods for the prediction of viable cell density and volume in mammalian cell culture
… the United States Food and Drug Administration’s Process Analytical Technology framework. It was found that interferences to the Biomass Monitor include proximity of the biomass probe to vessel walls, pO2 probe and sparger with the bubbles from aeration having a significant effect on the signal. …
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The powerful combination of novel organosulfur methodology and continuous flow technology
… methodologies in the form of continuous flow technology, FlowNMR, and FlowIR, as well as traditional batch techniques, to deliver powerful transformations based on organosulfur chemistry. The main objective of this work was the synthesis of key building-blocks for biologically relevant …
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