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Development of a high-fidelity digital twin using the discrete element method for a continuous direct compression process. Part 1. Calibration workflow
Peer-reviewed journal | 24 Oct 2024 | Contributor(s):: Peter Toson, Marko Matić, Theresa Hörmann-Kincses, Michela Beretta, Jakob Rehrl, Johannes Poms, Thomas O’Connor, Abdollah Koolivand, Geng Tian, Scott M. Krull, Johannes G. Khinast, Dalibor Jajcevic, Johan Remmelgas
In this work, a high-fidelity digital twin was developed to support the design and testing of control strategies for drug product manufacturing via direct compression. The high-fidelity digital twin platform was based on typical pharmaceutical equipment, materials, and direct compression...
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Continuous Processing. Continuous Evolution
Magazine | 08 Oct 2024 | Contributor(s):: Douglas Hausner
Continuous processing for small molecule products has been a hot topic for years, but where does the industry stand with it today? We speak with Doug Hausner, Senior Manager, Continuous Manufacturing, Oral Solid Dose, Pharma Services at Thermo Fisher Scientific, to find out.
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Continuous micro feeding and mixing of solid dosage forms under vibrational excitation
Peer-reviewed journal | 08 Oct 2024 | Contributor(s):: Haifeng Lu, Liang Zhang, Hui Du, Xiaolei Guo, Haifeng Liu
Continuous manufacturing has intrigued many researchers in the pharmaceutical industry in the post-COVID-19 world. We experimentally studied the discharge characteristics of pharmaceutical excipients under vibrational excitation. The successful accurate dosing and filling of powders at fill...
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Systematic investigation of the impact of screw elements in continuous wet granulation
Peer-reviewed journal | 10 Sep 2024 | Contributor(s):: Katharina Kiricenko, Peter Kleinebudde, Robin Meier
Twin-screw wet granulation (TSG) is a continuous manufacturing technique either for granules as final dosage form or as an intermediate before tableting or capsule filling. A comprehensive process understanding is required to implement TSG, considering various parameters influencing granule and...
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Improvement of a pharmaceutical powder mixing process in a tote blender via DEM simulations
Peer-reviewed journal | 04 Jun 2024 | Contributor(s):: Benedict Benque, Luca Orefice, Thomas Forgber, Matthias Habeler, Beate Schmid, Johan Remmelgas, Johannes Khinast
An industrial-scale pharmaceutical powder blending process was studied via discrete element method (DEM) simulations. A DEM model of two active pharmaceutical ingredient (API) components and a combined excipient component was calibrated by matching the simulated response in a dynamic angle of...
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A modified Kushner-Moore approach to characterising small-scale blender performance impact on tablet compaction
Peer-reviewed journal | 03 Jun 2024 | Contributor(s):: Hikaru G. Jolliffe, Martin Prostredny, Carlota Mendez Torrecillas, Ecaterina Bordos, Collette Tierney, Ebenezer Ojo, Richard Elkes, Gavin Reynolds, Yunfei Li Song, Bernhard Meir, Sara Fathollahi, John Robertson
Continuous Direct Compaction (CDC) has emerged as a promising route towards producing solid dosage forms while reducing material, development time and energy consumption. Understanding the response of powder processing unit operations, especially blenders, is crucial. There is a substantial body...
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Apr 16 2024
Continuous Manufacturing of Oral Solid Dosage Forms
"Continuous manufacturing holds the promise of improved efficiency, enhanced quality, greater operational flexibility and accelerated development. At Hovione we are proud to be at the...
https://cmkc.usp.org/events/details/48
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Influence of refilling on dosing accuracy of loss-in-weight powder feeders in continuous manufacturing
Peer-reviewed journal | 19 Feb 2024 | Contributor(s):: Jochen Thies, Peter Kleinebudde, Fabiola N. Santamaría Alvarez
Continuous manufacturing is a novel concept to produce high quality drug products. The manufacture of solid dosage forms starts with the feeding of materials, which is consider a critical step because it could have a high influence on the quality of the final product. Therefore, this unit...
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MOOC I Blending - Flow and Mixing Regime
Teaching Materials | 29 Nov 2023 | Contributor(s):: RCPE
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MOOC I Feeding - Refill Strategy
Teaching Materials | 29 Nov 2023 | Contributor(s):: RCPE
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MOOC I Blending Basics
Teaching Materials | 29 Nov 2023 | Contributor(s):: RCPE
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MOOC I Continuous Blender Types
Teaching Materials | 29 Nov 2023 | Contributor(s):: RCPE
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MOOC I Feeding - Twin Screw Feeder
Teaching Materials | 29 Nov 2023 | Contributor(s):: RCPE
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MOOC I Feeding - Disturbances
Teaching Materials | 29 Nov 2023 | Contributor(s):: RCPE
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MOOC I Continuous Blend Analysis
Teaching Materials | 29 Nov 2023 | Contributor(s):: RCPE
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Allan Clarke
Lead a project called Liquid Dispensing Technologies (LDT) in mid-2000's leading to a commercial-scale High-Potency-API continuous oral tablet manufacturing process. See chapter about...
https://cmkc.usp.org/members/1675
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Pharmaceutical Continuous Manufacturing: A Guide to Control Strategies for Solid Oral Dose Drugs
Technical Guides | 23 Aug 2023 | Contributor(s):: Atul Dubey
Advanced manufacturing technologies like pharmaceutical continuous manufacturing (PCM) can provide potential efficiencies for many medicines and their ingredients, thereby facilitating geographic diversity in manufacturing and supply chain resilience. One of the ways the U.S. Pharmacopeia (USP)...
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Common CM Abbreviations - Input Needed
Forum › defaultsection › general
Hi all,
We are collecting commonly used abbreviations in PCM. This will serve as a useful reference for anyone reviewing PCM materials and studies. We’ve started a list but would like to...
https://cmkc.usp.org/forum/defaultsection/general/36
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Variographic analysis: A new methodology for quality assurance of pharmaceutical blending processes
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Sánchez-Paternina, Adriluz, Sierra-Vega, Nobel O., Cárdenas, Vanessa, Méndez, Rafael, Esbensen, Kim H., Romañach, Rodolfo J.
Analytical methods for real time monitoring of pharmaceutical blending processes are thoroughly validated but not the sampling methods. Variographic analysis was investigated as a method to determine the sampling and analytical errors when the drug concentration of pharmaceutical powder blends is...
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Visualization and understanding of the granulation liquid mixing and distribution during continuous twin screw granulation using NIR chemical imaging
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Vercruysse, Jurgen, Toiviainen, Maunu, Fonteyne, Margot, Helkimo, Niko, Ketolainen, Jarkko, Juuti, Mikko, Delaet, Urbain, Van Assche, Ivo, Remon, Jean Paul, Vervaet, Chris, De Beer, Thomas
Over the last decade, there has been increased interest in the application of twin screw granulation as a continuous wet granulation technique for pharmaceutical drug formulations. However, the mixing of granulation liquid and powder material during the short residence time inside the screw...
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Wet Granulation in a Twin-Screw Extruder: Implications of Screw Design
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Thompson, M. R., Sun, J.
Wet granulation in twin-screw extrusion machinery is an attractive technology for the continuous processing of pharmaceuticals. The performance of this machinery is integrally tied to its screw design yet little fundamental knowledge exists in this emerging field for granulation to intelligently...
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WHAT are sampling errors-and WHAT can we do about them? Part 1
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Romañach, Rodolfo J., Joubert Castro, Aidalu, Esbensen, Kim H
The objective of this column is to provide easy-to-understand examples of sampling errors. Prompted by recent participationsand presentations at on-line conferences and meetings, we believe there is a need for a more fulfilling introduction andexemplification of the concept and real-world...
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Use of a continuous twin screw granulation and drying system during formulation development and process optimization
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Vercruysse, J., Peeters, E., Fonteyne, M., Cappuyns, P., Delaet, U., Van Assche, I., De Beer, T., Remon, J. P., Vervaet, C.
Since small scale is key for successful introduction of continuous techniques in the pharmaceutical industry to allow its use during formulation development and process optimization, it is essential to determine whether the product quality is similar when small quantities of materials are...
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Use of near-infrared spectroscopy to quantify drug content on a continuous blending process: Influence of mass flow and rotation speed variations
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Martínez, Lizbeth, Peinado, Antonio, Liesum, Lorenz, Betz, Gabriele
The aim of this study was to develop a quantitative Near-Infrared (NIR) method which monitors the homogeneity of a pharmaceutical formulation coming out of a continuous blender. For this purpose, a NIR diode array spectrometer with fast data acquisition was selected. Additionally, the dynamic...
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Use of the channel fill level in defining a design space for twin screw wet granulation
Peer-reviewed journal | 09 Jun 2023 | Contributor(s):: Gorringe, L. J., Kee, G. S., Saleh, M. F., Fa, N. H., Elkes, R. G.
Twin screw wet granulation is a key process in the continuous manufacture of oral solid dosage forms. Previous Research Article has qualitatively suggested that the channel fill level influences the granules produced. In this paper a quantitative measure of the total volumetric fraction of the...