Heat flux sensor to create a design space for freeze-drying development
| Autor: | Mónica Rosa, Andrea Hawe, Wolfgang Frieß, Marco Carfagna, Matthias Lucke |
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| Rok vydání: | 2020 |
| Předmět: |
Hot Temperature
Materials science business.industry Spectrum Analysis Process analytical technology Heat flux sensor Phase (waves) Process (computing) Pharmaceutical Science 02 engineering and technology General Medicine Heat transfer coefficient 021001 nanoscience & nanotechnology 030226 pharmacology & pharmacy Characterization (materials science) 03 medical and health sciences Freeze-drying Freeze Drying 0302 clinical medicine Technology Pharmaceutical Gravimetric analysis 0210 nano-technology Process engineering business Biotechnology |
| Zdroj: | European Journal of Pharmaceutics and Biopharmaceutics. 153:84-94 |
| ISSN: | 0939-6411 |
| DOI: | 10.1016/j.ejpb.2020.05.028 |
| Popis: | Freeze-drying methodology requires an in-depth understanding and characterization for optimal processing of biopharmaceuticals. Particularly the primary drying phase, the longest and most expensive stage of the process, is of interest for optimization. The currently used process analytical technology (PAT) tools give highly valuable insights but come with limitations. Our study describes, for the first time, the application of a heat flux sensor (HFS) to build a primary drying design space and predict the process evolution. First, the heat transfer coefficient (Kv) generated by HFS and by the most accurate, but time-consuming and invasive, gravimetric method were compared. Second, the applicability to generate a design space was tested and verified. Obtained results revealed a good agreement of the values generated from this new and fast HFS compared to the gravimetric determination. Additionally, residual moisture assessed by Karl-Fischer titration and frequency modulated spectroscopy (FMS) support the quality of the obtained predictions. Thus, the HFS approach can substantially accelerate evaluation, development and transfer of a freeze-drying cycle. |
| Databáze: | OpenAIRE |
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