Integrated continuous manufacturing in pharmaceutical industry: current evolutionary steps toward revolutionary future

2019 ◽  
Vol 8 (4) ◽  
pp. 139-161 ◽  
Author(s):  
Nada A Helal ◽  
Ola Elnoweam ◽  
Heba Abdullah Eassa ◽  
Ahmed M Amer ◽  
Mohamed Ashraf Eltokhy ◽  
...  

Continuous manufacturing (CM) has the potential to provide pharmaceutical products with better quality, improved yield and with reduced cost and time. Moreover, ease of scale-up, small manufacturing footprint and on-line/in-line monitoring and control of the process are other merits for CM. Regulating authorities are supporting the adoption of CM by pharmaceutical manufacturers through issuing proper guidelines. However, implementation of this technology in pharmaceutical industry is encountered by a number of challenges regarding the process development and quality assurance. This article provides a background on the implementation of CM in pharmaceutical industry, literature survey of the most recent state-of-the-art technologies and critically discussing the encountered challenges and its future prospective in pharmaceutical industry.

Processes ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 464
Author(s):  
Xingren Jiang ◽  
Ning Yang ◽  
Rijie Wang

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.


Author(s):  
Thomas Mainka ◽  
David Weirathmüller ◽  
Christoph Herwig ◽  
Stefan Pflügl

Abstract Saline wastewater contaminated with aromatic compounds can be frequently found in various industrial sectors. Those compounds need to be degraded before reuse of wastewater in other process steps or release to the environment. Halophiles have been reported to efficiently degrade aromatics, but their application to treat industrial wastewater is rare. Halophilic processes for industrial wastewater treatment need to satisfy certain requirements: a continuous process mode, low operational expenditures, suitable reactor systems and a monitoring and control strategy. The aim of this review is to provide an overview of halophilic microorganisms, principles of aromatic biodegradation, and sources of saline wastewater containing aromatics and other contaminants. Finally, process examples for halophilic wastewater treatment and potential process monitoring strategies are discussed. To further illustrate the significant potential of halophiles for saline wastewater treatment and to facilitate development of ready-to-implement processes, future research should focus on scale-up and innovative process monitoring and control strategies.


1995 ◽  
Vol 117 (3) ◽  
pp. 323-330 ◽  
Author(s):  
P. Banerjee ◽  
S. Govardhan ◽  
H. C. Wikle ◽  
J. Y. Liu ◽  
B. A. Chin

This paper describes a method for on-line weld geometry monitoring and control using a single front-side infrared sensor. Variations in plate thickness, shielding gas composition and minor element content are known to cause weld geometry changes. These changes in the weld geometry can be distinctly detected from an analysis of temperature gradients computed from infrared data. Deviations in temperature gradients were used to control the bead width and depth of penetration during the welding process. The analytical techniques described in this paper have been used to control gas tungsten arc and gas metal arc welding processes.


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