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Using PAT to accelerate the transition to continuous API manufacturing
09 Jun 2023 | Contributor(s):: Gouveia, Francisca, Rahbek, Jesper, Mortensen, Asmus, Pedersen, Mette, Felizardo, Pedro, Bro, Rasmus, Mealy, Michael
Significant improvements can be realized by converting conventional batch processes into continuous ones. The main drivers include reduction of cost and waste, increased safety, and simpler scale-up and tech transfer activities. Redesigning the process layout offers the opportunity to incorporate...
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Near-infrared Spectroscopy for the In-line Characterization of Powder Voiding Part I: Development of the Methodology
09 Jun 2023 | Contributor(s):: Ropero, Jorge, Beach, Lauren, Alcala, Manel, Rentas, Raizza, Dave, Rajesh N., Romanach, Rodolfo J.
In-line near-infrared spectroscopy (NIR) spectra were acquired and analyzed to assess the relationship between physical and chemical properties of voiding powders and their spectral changes. NIR spectra were obtained for powders voiding from a conical glass funnel while the powder flow was...
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Implementation of Near-Infrared Spectroscopy for In-Line Monitoring of a Dehydration Reaction in a Tubular Laminar Reactor
09 Jun 2023 | Contributor(s):: Mitic, A, Cervera-Padrell, AEMortensen, AR, Skovby, T, Dam-Johansen, K, Javakhishvili, I, Hvilsted, S, Gernaey, KV
Production of active pharmaceutical ingredients (APIs), fine chemicals, food products, and so on has in recent years been focused on implementing process intensification and process optimization tools. Lower costs and higher selectivity as well as better sustainability and competitiveness are the...
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Concentration monitoring with near infrared chemical imaging in a tableting press
09 Jun 2023 | Contributor(s):: Dalvi, Himmat, Fauteux-Lefebvre, Clémence, Guay, Jean-Maxime, Abatzoglou, Nicolas, Gosselin, Ryan
Monitoring powder potency and homogeneity is important in achieving real-time release testing in a continuous tablet manufacturing operation. If quality related issues are encountered, monitoring powder potency inside a feed frame offers a last opportunity to intervene in the process before...