-
In line monitoring of the powder flow behavior and drug content in a Fette 3090 feed frame at different operating conditions using Near Infrared spectroscopy
09 Jun 2023 | Contributor(s):: Sierra-Vega, Nobel, Sánchez-Paternina, Adriluz, Maldonado, Nadja, Cárdenas, Vanessa, Romañach, Rodolfo, Mendez, Rafael
Near infrared (NIR) spectroscopy was used to determine the drug concentration in 3% (w/w) acetaminophen blends within the complex flow regime of the tablet press feed frame just before tablet compaction. NIR spectra also provided valuable information on the powder flow behavior within the feed...
-
Analysing drying unit performance in a continuous pharmaceutical manufacturing line by means of mass - Energy balances
09 Jun 2023 | Contributor(s):: Mortier, Severine Therese F. C., Gernaey, Krist V., De Beer, Thomas, Nopens, Ingmar
The current trend in the pharmaceutical industry to move from batch-wise to continuous production processes strengthens the need for monitoring and controlling the process in-line. The ConsiGma(Tm) continuous tableting line collects data of the different subunits in real-time, but these are not...
-
Analysis of powder phenomena inside a Fette 3090 feed frame using in-line NIR spectroscopy
09 Jun 2023 | Contributor(s):: Mateo-Ortiz Daniel, Colon, Yleana, Romañach, Rodolfo, Mendez, Rafael
New analytical methods are needed to understand and optimize the processes by which tablets are produced. Fette 3090 tablet presses are commonly used in the pharmaceutical industry. A near-infrared (NIR) probe was installed into a Fette 3090 feed frame to understand and monitor the die filling...
-
An engineering study on the enhanced control and operation of continuous manufacturing of pharmaceutical tablets via roller compaction
09 Jun 2023 | Contributor(s):: R Singh, M Ierapetritou, R Ramachandran
A novel manufacturing strategy based on continuous processing integrated with online monitoring tools coupled with efficient automatic feedback control system is highly desired for efficient Quality by Design (QbD) based manufacturing ofthe next generation of pharmaceutical products with optimal...
-
A PAT-based qualification of pharmaceutical excipients produced by batch or continuous processing
09 Jun 2023 | Contributor(s):: Hertrampf A., Müller H., Menezes J.C., Herdling T.
Pharmaceutical excipients have an influence on the main requirements for medicinal products (viz., quality, safety and efficacy) but also on their manufacturability. During product lifecycle it may become necessary to introduce minor changes (e.g., to continuously improve it) or major changes in...
-
A flowsheet model for the development of a continuous process for pharmaceutical tablets: An industrial perspective
09 Jun 2023 | Contributor(s):: Garcia-Munoz, Salvador, Butterbaugh, Adam Leavesley, Ian Manley, Leo Francis, Slade, David, Bermingham, Sean
A dynamic model of a continuous direct compression process for pharmaceutical tablets is presented. The objective is to assess the impact of the variability from the feeder system on the concentration of drug in the powder in the feed frame of a tablet press. The model is based on principles of...