During the regulatory requested process validation of pharmaceutical manufacturing processes, companies aim to identify, control, and continuously monitor process variation and its impact on critical quality attributes (CQAs) of the final product. It is difficult to directly connect the impact of single process parameters (PPs) to final product CQAs, especially in biopharmaceutical process development and production, where multiple unit operations are stacked together and interact with each other. Therefore, we want to present the application of Monte Carlo (MC) simulation using an integrated process model (IPM) that enables estimation of process capability even in early stages of process validation. Once the IPM is established, its capability in risk and criticality assessment is furthermore demonstrated. IPMs can be used to enable holistic production control strategies that take interactions of process parameters of multiple unit operations into account. Moreover, IPMs can be trained with development data, refined with qualification runs, and maintained with routine manufacturing data which underlines the lifecycle concept. These applications will be shown by means of a process characterization study recently conducted at a world-leading contract manufacturing organization (CMO). The new IPM methodology therefore allows anticipation of out of specification (OOS) events, identify critical process parameters, and take risk-based decisions on counteractions that increase process robustness and decrease the likelihood of OOS events.
La transferencia de tecnología sostenible es compleja para las firmas de construcción. Una posible solución es analizar esa clase de transferencia como una red social ya que, si se identifican las diferentes relaciones entre los actores del sector construcción, es posible evaluar la capacidad de adaptación tecnológica de dichos actores. El objetivo fue evaluar la transferencia de tecnología sostenible entre empresas constructoras internacionales que se dedican a construir vivienda social o accesible. Para esto, se identificaron dos países con capacidad de transferencia de tecnología sostenible (Reino Unido y Estados Unidos) y dos países de menor capacidad tecnológica y con potencial de adaptarse a dichas tecnologías (Brasil y Colombia); posteriormente, se seleccionaron cinco firmas constructoras por cada país, con las cuales se hizo un análisis de redes (brasilbragrado, intensidad, cercanía y densidad), y luego, procesos de simulación. Como resultado se identificó la capacidad de transferencia tecnológica que tienen las empresas latinoamericanas para aceptar y adaptar tecnologías de empresas de países industrializados, y se espera poder desarrollar indicadores de medición de transferencia tecnológica que permitan comprender mejor la complejidad de la vivienda social.
Novel concepts for energy systems increasingly focus on solutions that go beyond the scope of traditional engineering domains. Unfortunately, there is still a lack of appropriate modeling and simulation tools for applications in energy-related multidomain systems. However, well-established methods from other scientific and industrial areas provide promising approaches to overcome the associated challenges.This paper explores the applicability of the Functional Mockup Interface (FMI) specification within this context. To this end, a versatile simulation environment prototype is presented, which is dedicated to investigate and utilize the full range of possibilities offered by the FMI specification. The presented examples demonstrate the potential of including well-established tools and models from multiple domains with minimal effort into a modern FMI-based simulation framework.
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