Continuous Pharmaceutical Manufacturing: Design, Modeling, PAT, Monitoring, and Control

A special issue of Processes (ISSN 2227-9717). This special issue belongs to the section "Pharmaceutical Processes".

Deadline for manuscript submissions: closed (30 June 2021) | Viewed by 2808

Special Issue Editor


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Guest Editor
C-SOPS, Department of Chemical and Biochemical Engineering, Rutgers University, 98 Brett Road, Piscataway, NJ 08854, USA
Interests: Process System Engineering (PSE) including advanced process control, process modelling and simulation, process monitoring and PAT, QbD, practical implementation of control system into the plant. The current application domain is continuous pharmaceutical manufacturing
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Special Issue Information

Dear Colleagues,

Currently, pharmaceutical industries are going under paradigm shift from traditional batch to novel continuous manufacturing. Few pharmaceutical products have been recently approved by US Food and Drug Administration (FDA) to manufacture in continuous line and several others are on the way. Pharmaceutical industries as well as regulators (e.g., FDA) are strongly promoting smarter continuous manufacturing (CM). There are several advantages but also different scientific challenges regarding this paradigm shift. Efficient and optimum process design, process automation, real time monitoring and control, material traceability, diversion of non-confirming products, and real-time release are few of the CM advantages which are scientifically challenging to address. Systematic process system engineering (PSE) methods and tools are therefore needed to efficiently overcome the obstacles on the path of CM shift and thereby to develop smarter continuous pharmaceutical manufacturing process.

This Special Issue on “Continuous Pharmaceutical Manufacturing: Design, Modeling, PAT, Monitoring, and Control” aims to collect high-quality research studies addressing challenges on adapting the continuous pharmaceutical manufacturing process. The manuscript demonstrating the importance of system engineering to further modernize the continuous pharmaceutical manufacturing process are highly encouraged to submit. Topics include but are not limited to the following:

  • Design and operation of continuous pharmaceutical manufacturing process;
  • Dynamic modeling and simulation of continuous and/or batch pharmaceutical manufacturing process;
  • Optimization of continuous pharmaceutical manufacturing process;
  • Control of continuous pharmaceutical manufacturing process;
  • Process analytical technology (PAT);
  • Quality by Design (QbD);
  • Data science of continuous pharmaceutical manufacturing process;
  • Material characterization and pharmaceutical database.

Dr. Ravendra Singh
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Processes is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2400 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • continuous pharmaceutical manufacturing
  • dynamic modeling and simulation 
  • process control 
  • process analytical technology (PAT) 
  • Quality by Design (QbD) 
  • material attributes 
  • process and plant design 
  • data science

Published Papers (1 paper)

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Research

13 pages, 10720 KiB  
Communication
Effect of Aspect Ratio on the Mixing Performance in the Kenics Static Mixer
by Xingren Jiang, Ning Yang and Rijie Wang
Processes 2021, 9(3), 464; https://doi.org/10.3390/pr9030464 - 5 Mar 2021
Cited by 14 | Viewed by 2397
Abstract
Continuous manufacturing has received increasing interest because of the advantages of intrinsic safety and enhanced mass transfer in the pharmaceutical industry. However, the difficulty for scale-up has limited the application of continuous manufacturing for a long time. Recently, the tubular flow reactor equipped [...] Read more.
Continuous manufacturing has received increasing interest because of the advantages of intrinsic safety and enhanced mass transfer in the pharmaceutical industry. However, the difficulty for scale-up has limited the application of continuous manufacturing for a long time. Recently, the tubular flow reactor equipped with the Kenics static mixer appears to be a solution for the continuous process scale-up. Although many influence factors on the mixing performance in the Kenics static mixer have been investigated, little research has been carried out on the aspect ratio. In this study, we used the coefficient of variation as the mixing evaluation index to investigate the effect of the aspect ratio (0.2–2) on the Kenics static mixer’s mixing performance. The results indicate that a low aspect ratio helps obtain a shorter mixing time and mixer length. This study suggests that adjusting the aspect ratio of the Kenics static mixer can be a new strategy for the scale-up of a continuous process in the pharmaceutical industry. Full article
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