Efficient Engineering and Production Concepts for Products in Regulated Environments – Dream or Nightmare?

Abstract

Manufacturing of chemical-pharmaceutical products is moving increasingly fast on a global scale. Therefore, developing and starting up production facilities fast, with high quality, and at reasonable costs has become extremely challenging.Engineering concepts like modularization, standardization and simultaneous/parallel engineering are discussed as methods for speeding up process design and filing for regulatory approval. Transfer from batch to continuous operation mode of production is pointed out as the key-issue in such strategies.

Roadmap for a Smart Factory: A Modular, Intelligent Concept for the Production of Specialty Chemicals

“…[40] On the other hand, the conventional plant achieves higher gains as the production time increases. [3] Angewandte Chemie These and similar effects were also shown by Seifert et al, Brodhagen et al,a nd Strube et al [41,42] Strube et al focused on the economic evaluation of continuous small-scale plants to derive the benefit for small and medium-sized businesses. [42] Furthermore,b ased on ar eal options evaluation, it could be demonstrated that modular plants are advantageous even at low levels of uncertainties because of their higher degree of flexibility.…”

Trends in Upstream and Downstream Process Development for Antibody Manufacturing

“…To reduce production volumes, the need for facility flexibility and faster turnarounds will increase. This can lead towards implementation of disposables in manufacturing [2,80], continuous processing [143,144] and dedicated but decentralized manufacturing concepts in containers [145].…”

Auf dem Weg zur Smart Factory: modulare, intelligente Konzepte für die Produktion von Spezialchemikalien der Zukunft

“…sowie Strube et al. gezeigt . Letztere konzentrieren sich auf die wirtschaftliche Bewertung von kleinskaligen Anlagen im kontinuierlichen Betrieb, um daraus den Nutzen für mittelständische Unternehmen abzuleiten .…”

“…gezeigt . Letztere konzentrieren sich auf die wirtschaftliche Bewertung von kleinskaligen Anlagen im kontinuierlichen Betrieb, um daraus den Nutzen für mittelständische Unternehmen abzuleiten . Mittels der Realoptionen konnte weiterhin illustriert werden, dass modulare Anlagen durch Ihren Flexibilitätsmehrwert bereits bei geringen Unsicherheiten vorteilhaft werden …”