Fundamentals towards a Modular Microstructured Production Plant

Abstract

For years, microtechnology is being considered as an emerging technique for chemical engineering tasks to overcome safety issues corresponding to high volumes and gaining higher selectivities and yields in reaction technology. Whereas in reaction technology a broad variety of microstructured equipment is available, in product purification/separation adequate equipment is missing. Research is focused on modular fast and flexible smaller production plants being operated continuously instead of batchwise in order to reduce engineering efforts and time‐to‐process. To cope with these demands, an appropriate definition of modules, which could be easily chosen and combined, is inevitable. In addition, these modules have to be well characterized concerning fluid dynamics and separation performance. This paper focuses on the characterization of available modules/devices. A standard method and analysis of the results concerning manufacturing accuracy and operation range is proposed. Miniplant technology is described as an efficient tool to validate process concepts proposed by process simulation studies. Necessary model parameters are determined for industrial complex mixtures in miniaturized laboratory equipment. Parameters are calculated model based to gain maximal accuracy. State of the art of miniplant technology is described and basic characteristic data are presented.

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

“…Simply transferring batch concepts into a continuous micro process will not be sufficient for optimal process conditions. Efforts in process development and engineering are transferred to the user, which does neither speed up the process nor does it reduce the efforts [39,43]. Again, investing upfront efforts into modularization and characterization of equipment pieces, which are not directly project-based and -financed, seems to be unrealistic for companies.…”

“…This leaves only 6 years of production under patent protection. Therefore, innovative formulations, or new therapeutic areas to file patent extensions, are critical to allow an appropriate margin to refinance more than 1 billion u average development costs for each therapeutic drug successfully brought to market [43]. Detail engineering and procurement have about 3 years to deliver a qualified plant after the therapeutic dose is found in phase 2 clinical trials, because following phase 3 clinical trials the product has to be delivered to market.…”

“…-First approaches to develop such innovative manufacturing plant concepts are under construction already. But still the technical transfer into industrialization under resource-and energy-efficient optimization strategies needs improvement [39,43,50,52,57,58]. Maturing manufacturing technologies tend to move from batch to continuous operation, often driven by economy-ofscale scenarios.…”

Multi‐Stage Aqueous Two‐Phase Extraction for the Purification of Monoclonal Antibodies

“…The mixer-settler battery and the extraction column are part of the mini-plant station at the Institute for Separation and Process Technology at the Clausthal University of Technology [23,24]. Both systems are made of glass vessels and polytetrafluoroethylene (PTFE) tubing.…”

Separation Characteristics of Crystalline Amino Acids with Regard to the Modularization Idea

“…Helling et al summarized progress in modularization in process engineering [11]. As a first attempt at modularization in thermal process engineering, distillation and extraction operations are described.…”