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Cleaning of direct compression continuous manufacturing equipment through displacement of API residues by excipients
23 Jul 2024 | Contributor(s):: Patel, Dhavalkumar S, Méndez, Rafael, Romañach, Rodolfo J
This feasibility study evaluates a cleaning process designed to avoid the use of detergents and reduce operator exposure to the active pharmaceutical ingredient (API). The continuous manufacturing equipment was cleaned using excipients to displace ibuprofen residues from the system. The cleaning...
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Spectroscopic characterization of tablet properties in a continuous powder blending and tableting process
09 Jun 2023 | Contributor(s):: Nagy, Brigitta, Farkas, Attila, Magyar, Krisztina, Démuth, Balázs, Marosi, György
By the advent of continuous pharmaceutical manufacturing, fast and accurate characterization of product quality has become of a major interest. Although it also promotes the real-time release testing approach, so far mainly content uniformity studies were performed by near-infrared (NIR)...
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Sample Mass Estimate for the Use of Near-Infrared and Raman Spectroscopy to Monitor Content Uniformity in a Tablet Press Feed Frame of a Drug Product Continuous Manufacturing Process
09 Jun 2023 | Contributor(s):: Hetrick, Evan, Castillo, Ismael, Rehrla, Jakob, Sagmeistera, Peter, Lebl, René, Kruisza, Julia, Celikovic, Selma, Sipek, Martin, Williams, Myers, David P
Recently, feed frame-based process analytical technology measurements used to assure product quality during continuous manufacturing processes have received significant attention. These measurements are able to accurately determine uniformity of the powder blend before compression, and in these...
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Raman spectroscopy as a process analytical technology for pharmaceutical manufacturing and bioprocessing
09 Jun 2023 | Contributor(s):: Esmonde-White, Karen A, Cuellar, Maryann, Uerpmann, Carsten, Lenain, Bruno., Lewis, Ian R.
Adoption of Quality by Design (QbD) principles, regulatory support of QbD, process analytical technology (PAT), and continuous manufacturing are major factors effecting new approaches to pharmaceutical manufacturing and bioprocessing. In this review, we highlight new technology developments, data...
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Raman Spectroscopy for Process Analytical Technologies of Pharmaceutical Secondary Manufacturing
09 Jun 2023 | Contributor(s):: Nagy, Brigitta, Farkas, Attila, Borbás, Enikő, Vass, Panna, Nagy, Zsombor Kristóf, Marosi, György
As the process analytical technology (PAT) mindset is progressively introduced and adopted by the pharmaceutical companies, there is an increasing demand for effective and versatile real-time analyzers to address the quality assurance challenges of drug manufacturing. In the last decades, Raman...
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Real-time assessment of critical quality attributes of a continuous granulation process
09 Jun 2023 | Contributor(s):: Fonteyne, Margot, Vercruysse, Jurgen, Díaz, Damián Córdoba, Gildemyn, Delphine, Vervaet, Chris, Remon, Jean Paul, De Beer, Thomas
There exists the intention to shift pharmaceutical manufacturing of solid dosage forms from traditional batch production towards continuous production. The currently applied conventional quality control systems, based on sampling and time-consuming off-line analyses in analytical laboratories,...
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Prediction of quality attributes of continuously produced granules using complementary PAT tools
09 Jun 2023 | Contributor(s):: Fonteyne, Margot, Soares, Sandra, Vercruysse, Jurgen, Peeters, Elisabeth, Burggraeve, Anneleen, Vervaet, Chris, Remon, Jean Paul, Sandler, Niklas, De Beer, Thomas
Manufacturers of pharmaceutical solid dosage forms aim for a reduced production time and a shorter‘‘time-to-market.’’ Therefore, continuous manufacturing gains increasing interest in the pharmaceutical industry. For continuous manufacturing, the quality of produced pharmaceuticals should be...
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Optimization of a semi-batch tablet coating process for a continuous manufacturing line by design of experiments
09 Jun 2023 | Contributor(s):: Barimani, Shirin, Šibanc, Rok, Kleinebudde, Peter
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In-line Raman spectroscopic monitoring and feedback control of a continuous twin-screw pharmaceutical powder blending and tableting process
09 Jun 2023 | Contributor(s):: Nagy, Brigitta, Farkas, Attila, Gyurkes, Martin, Komaromy-Hiller, Szofia, Demuth, Balazs, Szabo, Bence, Nusser, David, Borbas, Eniko, Marosi, Gyorgy, Nagy, Zsombor Kristof
The integration of Process Analytical Technology (PAT) initiative into the continuous production of pharmaceuticals is indispensable for reliable production. The present paper reports the implementation of in-line Raman spectroscopy in a continuous blending and tableting process of a...
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Development of an in-line Raman spectroscopic method for continuous API quantification during twin-screw wet granulation
09 Jun 2023 | Contributor(s):: Harting Julia, Kleinebudde, Peter
Raman spectroscopy was evaluated as a process analytical technology (PAT) tool for continuous API quantification during twin-screw wet granulation. Therefore, a Raman probe was implemented in front of the granulator barrel. This setup enabled the collection of Raman spectra upon a constant...
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Continuous manufacturing of a pharmaceutical cream: Investigating continuous powder dispersing and residence time distribution (RTD)
09 Jun 2023 | Contributor(s):: Bostijn, N, Van, Renterghem, JVanbillemont, B, Dhondt, W, Vervaet, C, De;Beer, T
Recently, an innovative continuous manufacturing technology for a pharmaceutical oral suspension was proposed, based on two consecutive mixing units. A limitation of this technology is the need to dissolve or disperse powder-based raw materials in a liquid via a batch step before continuous...
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Continuous Manufacturing of a Polymer Stabilized Emulsion Monitored with Process Analytical Technology
09 Jun 2023 | Contributor(s):: Qwist, PK, Sander, CBostijn, N, Jessen, V, Rantanen, J, de;Beer, T
Moving from batch to continuous manufacturing (CM) requires implementation of process analytical technology (PAT), as it is crucial to monitor and control these processes. CM of semi-solids has been demonstrated but implementation of a broader range of PAT tools with in- or on-line process...
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Characterization of Near-Infrared and Raman Spectroscopy for In-Line Monitoring of a Low-Drug Load Formulation in a Continuous Manufacturing Process
09 Jun 2023 | Contributor(s):: Harms, Zachary, Shi, Zhenqi: Kulkarni, Rajesh, Myers, David P.
Reflectance spectroscopy is an excellent candidate for process analytical technology (PAT) applications in continuous manufacturing of pharmaceutical tablets. Spectroscopic methods provide a real-time, nondestructive measurement of the active pharmaceutical ingredient (API) concentration in order...
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Application of Ultra-Performance Liquid Chromatography as an Online Process Analytical Technology Tool in Pharmaceutical Crystallization
09 Jun 2023 | Contributor(s):: Yang, Yang, Zhang, Chuntao Pal, Kanjakha Koswara, Andy, Quon, Justin, Mckeown, Rahn, Goss, Charles, Nagy, Zoltan K
Concentration is often an important process parameter in pharmaceutical crystallization processes. In this work, an ultra-performance liquid chromatography (UPLC) system designed for process monitoring (Waters PATROL UPLC) was applied online as a process analytical technology tool for real-time...
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A review of PAT strategies in secondary solid oral dosage manufacturing of small molecules
09 Jun 2023 | Contributor(s):: Laske, Stephan, Paudel, Amrit, Scheibelhofer, Otto, Sacher, Stephan, Hoermann, Theresa, Khinast, Johannes, Kelly, Adrian, Rantannen, Jukka, Korhonen, Ossi, Stauffer, Fanny, De Leersnyder, Fien, De Beer, Thomas, Mantanus, Jerome, Chavez, Pierre-Francois, Thoorens, Benjamin, Ghiotti, Patrizia, Schubert, Martin, Tajarobi, Pirjo, Haeffler, Gunnar, Lakio, Satu, Fransson, Magnus, Sparen, Anders, Abrahmsen-Alami, Susanna, Folestad, Staffan, Funke, Adrian, Backx, Ivo, Kavsek, Barbara, Kjell, Francois, Michaelis, Marc, Page, Trevor, Palmer, John, Schaepman, Alexander, Sekulic, Sonja, Hammond, Steve, Braun, Birgit, Colegrove, Brenda
Pharmaceutical solid oral dosage product manufacturing is a well-established, yet revolutionizing area. To this end, process analytical technology (PAT) involves interdisciplinary and multivariate (chemical, physical, microbiological and mathematical) methods for material (e.g. materials,...
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A continuous manufacturing concept for a pharmaceutical oral suspension
09 Jun 2023 | Contributor(s):: Bostijn, N, Van, Renterghem, JDhondt, W, Vervaet, C, De;Beer, T
The aim of this study was to investigate the applicability of an innovative continuous manufacturing system for semi-solid and liquid pharmaceutical formulations. A commercially available pharmaceutical oral suspension was selected as model formulation. Premixes of the raw materials were dosed...