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Developing a framework to model the primary drying step of a continuous freeze-drying process based on infrared radiation.
Van Bockstal, Pieter-Jan; Corver, Jos; Mortier, Séverine Thérèse F C; De Meyer, Laurens; Nopens, Ingmar; Gernaey, Krist V; De Beer, Thomas.
Afiliação
  • Van Bockstal PJ; Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium. Electronic address: pieterjan.vanbockstal@ugent.be.
  • Corver J; Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium. Electronic address: jos.corver@RheaVita.nl.
  • Mortier STFC; Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium; BIOMATH, Department of Mathematical Modelling, Statistics and Bioinformatics, Faculty of Bioscience En
  • De Meyer L; Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium. Electronic address: laurens.demeyer@ugent.be.
  • Nopens I; BIOMATH, Department of Mathematical Modelling, Statistics and Bioinformatics, Faculty of Bioscience Engineering, Ghent University, Coupure Links 653, 9000 Ghent, Belgium. Electronic address: ingmar.nopens@ugent.be.
  • Gernaey KV; Process and Systems Engineering Center (PROSYS), Department of Chemical and Biochemical Engineering, Technical University of Denmark, Building 229, 2800 Kgs. Lyngby, Denmark. Electronic address: KVG@kt.dtu.dk.
  • De Beer T; Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium. Electronic address: thomas.debeer@ugent.be.
Eur J Pharm Biopharm ; 127: 159-170, 2018 Jun.
Article em En | MEDLINE | ID: mdl-29476909
ABSTRACT
The continuous freeze-drying concept based on spinning the vials during freezing and on non-contact energy transfer via infrared (IR) radiation during drying, improves process efficiency and product quality (uniformity) compared to conventional batch freeze-drying. Automated control of this process requires the fundamental mechanistic modelling of each individual process step. Therefore, a framework is presented for the modelling and control of the continuous primary drying step based on non-contact IR radiation. The IR radiation emitted by the radiator filaments passes through various materials before finally reaching the spin frozen vial. The energy transfer was computed by combining physical laws with Monte Carlo simulations and was verified with experimental data. The influence of the transmission properties of various materials on the emitted IR radiation profile was evaluated. These results assist in the selection of proper materials which could serve as IR window in the continuous freeze-drying prototype. The modelling framework presented in this paper fits the model-based design approach used for the development of this prototype and shows the potential benefits of this design strategy by establishing the desired engineering parameters and by enabling the engineer to assess mechanical tolerances and material options.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Liofilização Tipo de estudo: Health_economic_evaluation / Prognostic_studies Idioma: En Ano de publicação: 2018 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Liofilização Tipo de estudo: Health_economic_evaluation / Prognostic_studies Idioma: En Ano de publicação: 2018 Tipo de documento: Article