作者:
Puneet MishraAlison NordonWestCHEM
Department of Pure and Applied Chemistry and Centre for Process Analytics and Control Technology University of Strathclyde Glasgow UK
We present a shared industry-academic perspective on the principles and opportunities for Quality by Digital Design (QbDD) as a framework to accelerate medicines development and enable regulatory innovation for new me...
We present a shared industry-academic perspective on the principles and opportunities for Quality by Digital Design (QbDD) as a framework to accelerate medicines development and enable regulatory innovation for new medicines approvals. This approach exploits emerging capabilities in industrial digital technologies to achieve robust control strategies assuring product quality and patient safety whilst reducing development time/costs, improving research and development efficiency, embedding sustainability into new products and processes, and promoting supply chain resilience. Key QbDD drivers include the opportunity for new scientific understanding and advanced simulation and model-driven, automated experimental approaches. QbDD accelerates the identification and exploration of more robust design spaces. Opportunities to optimise multiple objectives emerge in route selection, manufacturability and sustainability whilst assuring product quality. Challenges to QbDD adoption include siloed data and information sources across development stages, gaps in predictive capabilities, and the current extensive reliance on empirical knowledge and judgement. These challenges can be addressed via QbDD workflows; model-driven experimental design to collect and structure findable, accessible, interoperable and reusable (FAIR) data; and chemistry, manufacturing and control ontologies for shareable and reusable knowledge. Additionally, improved product, process, and performance predictive tools must be developed and exploited to provide a holistic end-to-end development approach.
The cost of implementing real-time monitoring and control of industrial processes is a significant barrier for many companies. Acoustic techniques provide complementary information to optical spectroscopic sensors and...
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The cost of implementing real-time monitoring and control of industrial processes is a significant barrier for many companies. Acoustic techniques provide complementary information to optical spectroscopic sensors and have a number of advantages: they are relatively inexpensive, can be applied non-invasively, are non-destructive, multi-point measurements are possible, opaque samples can be analysed in containers that are made from opaque materials (e.g. steel or concrete) and the analysis can be conducted in real-time. In this paper a new theoretical model is proposed which describes the transport of particles in a stirred reactor, their collision with the reactor walls, the subsequent vibrations which are then transmitted through the vessel walls, and their detection by an ultrasonic transducer. The particle-wall impact is modelled using Hertz-Zener impact theory. Experimental data is then used in conjunction with this (forward) model to form an inverse problem for the particle size distribution using a least squares cost function. Application of an integral smoothing operator to the power spectra greatly enhances the accuracy and robustness of the approach. One advantage of this new approach is that since it operates in the frequency domain, it can cope with the industrially relevant case of many particle-wall collisions. The technique will be illustrated using data from a set of controlled experiments. In the first instance a set of simplified experiments involving single particles being dropped in air onto a substrate are utilised. The second set of experiments involves particles in a carrier fluid being stirred in a reactor vessel. In each case the approach is able to successfully recover the associated particle size
Analytic expressions are found for the amplitude of the first and second harmonics of the Ultrasound Contrast Agent’s (UCA’s) dynamics when excited by a chirp. The dependency of the second harmonic amplitude on the ...
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Analytic expressions are found for the amplitude of the first and second harmonics of the Ultrasound Contrast Agent’s (UCA’s) dynamics when excited by a chirp. The dependency of the second harmonic amplitude on the system parameters, the UCA shell parameters, and the insonifying signal parameters is then investigated. It is shown that optimal parameter values exist which give rise to a clear increase in the second harmonic component of the UCA’s motion.
In a typical forensic investigation, fabric analysis plays a vital role in solving different crimes. Several types of textile fibre materials (cotton, polyester, denim, polypropylene, polycotton, and viscose) were ana...
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