-
Modelling the primary drying step for the determination of the optimal dynamic heating pad temperature in a continuous pharmaceutical freeze-drying process for unit doses
09 Jun 2023 | Contributor(s):: De Meyer, Laurens, Lammens, Joris, Mortier, Severine Therese F. C., Vanbillemont, Brecht, Van Bockstal, Pieter Jan, Corver, Jos, Nopens, Ingmar, Vervaet, Chris, De Beer, Thomas
In the pharmaceutical industry, traditional freeze-drying of unit doses is a batch-wise process associated with many disadvantages. To overcome these disadvantages and to guarantee a uniform product quality and high process efficiency, a continuous freeze-drying process is developed and...
-
Mechanistic modelling of infrared mediated energy transfer during the primary drying step of a continuous freeze-drying process
09 Jun 2023 | Contributor(s):: Van Bockstal, Pieter-Jan, Mortier, Severine Therese F. C., De Meyer, Laurens, Corver, Jos, Vervaet, Chris, Nopens, Ingmar, De Beer, Thomas
Conventional pharmaceutical fieeze-drying is an inefficient and expensive batch-wise process, associated with several disadvantages leading to an uncontrolled end product variability. The proposed continuous alternative, based on spinning the vials during freezing and on optimal energy supply...
-
Evaluation of spin freezing versus conventional freezing as part of a continuous pharmaceutical freeze-drying concept for unit doses
09 Jun 2023 | Contributor(s):: De Meyer, L., Van Bockstal, P. -J., Corver, J., Vervaet, C., Remon, J. P., De Beer, T.
Spin-freezing as alternative freezing approach was evaluated as part of an innovative continuous pharmaceutical freeze-drying concept for unit doses. The aim of this paper was to compare the sublimation rate of spin-frozen vials versus traditionally frozen vials in a batch freeze-dryer, and its...
-
Dual chamber cartridges in a continuous pharmaceutical freeze-drying concept: Determination of the optimal dynamic infrared heater temperature during primary drying
09 Jun 2023 | Contributor(s):: De Meyer, Laurens, Lammens, Joris, Vanbillemont, Brecht, Van Bockstal, Pieter Jan, Corver, Jos, Vervaet, Chris, Friess, Wolfgang, De Beer, Thomas
The applicability of DCCs in a continuous freeze-drying concept based on spin freezing and infrared heating was evaluated. Maximum applicable filling volume was evaluated. Secondly the mechanistic model for the determination of the optimal dynamic infrared heater temperature during primary drying...
-
Developing a framework to model the primary drying step of a continuous freeze-drying process based on infrared radiation
09 Jun 2023 | Contributor(s):: Van Bockstal, Pieter-Jan, Corver, Jos, Mortier, Severine Therese F. C., De Meyer, Laurens, Nopens, Ingmar, Gernaey, Krist V., De Beer, Thomas
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...
-
A primary drying model-based comparison of conventional batch freeze-drying to continuous spin-freeze-drying for unit doses
09 Jun 2023 | Contributor(s):: Leys, L., Vanbillemont, B., Van Bockstal, P. J., Lammens, J., Nuytten, G., Corver, J., Vervaet, C., De Beer, T.
An innovative continuous spin-freeze-drying technology for unit doses was recently developed. For this technology, a mechanistic primary drying model was developed allowing the calculation of the optimal dynamic drying trajectory for spin-frozen formulations. In this work, a model-based and...
-
A NIR-Based Study of Desorption Kinetics during Continuous Spin Freeze-Drying
09 Jun 2023 | Contributor(s):: Leys, Laurens, Nuytten, Gust, Lammens, Joris, Van Bockstal, Pieter-Jan, Corver, Jos, Vervaet, Chris, De Beer, Thomas
The pharmaceutical industry is progressing toward the development of more continuous manufacturing techniques. At the same time, the industry is striving toward more process understanding and improved process control, which requires the implementation of process analytical technology tools (PAT)....