-
Spectroscopic characterization of tablet properties in a continuous powder blending and tableting process
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)...
-
Robustness of a continuous direct compression line against disturbances in feeding
Contributor(s):: Karttunen A.-P., Poms J., Sacher S., Sparén A., Ruiz Samblás C., Fransson M., Martin De Juan L., Remmelgas J., Wikström H., Hsiao W.-K., Folestad S., Korhonen O.
The aim of the current study was to characterize the robustness of an integrated continuous direct compression (CDC) line against disturbances from feeding, i.e. impulses of API and short step disturbances. These disturbances mimicked typical variations that can be encountered during long-term...
-
Process Analytical Technology for continuous manufacturing of solid-dosage forms
Contributor(s):: Fonteyne, Margot;, Vercrusysse, Jurgen, De Leersnyder, Fien, Van Snick, Bernd, Vervaet, Chris, Remon, Jean, De Beer, Thomas
Currently, pharmaceutical production is making the switch from batch processing towards continuous processing. The quality of intermediate and end products produced by batch processes is assured by off-line testing. It is obvious that off-line tests in analytical laboratories cancel out the...
-
Mapping key process parameters to the performance of a continuous dry powder blender in a continuous direct compression system
Contributor(s):: Palmer, J, Reynolds, GK, Tahir, F, Yadav, IK, Meehan, E, Holman, J, Bajwa, G
This work aims to expand the typical raw material attributes that can successfully be processed on a continuous direct compression line with a particular focus on the continuous dry powder blender. Three grades of Acetaminophen were investigated as model active pharmaceutical ingredients and...
-
In-line Raman spectroscopic monitoring and feedback control of a continuous twin-screw pharmaceutical powder blending and tableting process
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...
-
Impact of blend properties and process variables on the blending performance
Contributor(s):: Bekaert, B, Grymonpre, W, Novikova, A, Vervaet, C, Vanhoorne, V
In this study, quantitative relationships were established between blend properties, process settings and blending responses via multivariate data-analysis. Four divergent binary blends were composed in three different ratios and processed at various throughputs and impeller speeds. Additionally,...
-
Continuous blending monitored and feedback controlled by machine vision-based PAT tool
Contributor(s):: Lászlo Galata, Dorián, Mészaros, Lilla, Ficzere Máté, Vass, Panna, Nagy, Brigitta, Szabó, Edina, Domokos, András, Farkas, Attila, Csontos, István, Marosi, György, Nagy, Zsombor Kristóf
In a continuous powder blending process machine vision is utilized as a Process Analytical Technology (PAT) tool. While near-infrared (NIR) and Raman spectroscopy are reliable methods in this field, measurements become challenging when concentrations below 2 w/w% are quantified. However, an...
-
Comparison between integrated continuous direct compression line and batch processing - The effect of raw material properties
Contributor(s):: Karttunen, AP, Wikstrom, HTajarobi, P, Fransson, M, Sparen, A, Marucci, M, Ketolainen, J, Folestad, S, Korhonen, O, Abrahmsen-Alami, S
There is a current trend in pharmaceutical manufacturing to shift from traditional batch manufacture to continuous manufacturing. The purpose of this study was to test the ability of an integrated continuous direct compression (CDC) line, in relation to batch processing, to achieve consistent...
-
A very boring 120 h: 15million tablets under a continuous state of control
Contributor(s):: Holman, James, Tantuccio, Anthony, Palmera, Jhon, Doninck, Tom van, Meyer, Robert
The aimof this study is to showthe robustness of a commercial direct compression system running continuously under relevant process conditions for over 120 h. The study will apply a representative commercial control strategy including real time monitoring of process parameters, rejection of OOS...