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Tags: critical quality attributes

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  1. Common CM Abbreviations - Input Needed

    Forum › defaultsection › general

    Hi all, We are collecting commonly used abbreviations in PCM. This will serve as a useful reference for anyone reviewing PCM materials and studies. We’ve started a list but would like to...

    https://cmkc.usp.org/forum/defaultsection/general/36

  2. Mechanistic modelling of industrial-scale roller compactor ‘Freund TF-MINI model’

    Contributor(s):: Sajjia, Mustafa, Shirazian, Saeed Egan, David Iqbal, Javed, Albadarin, Ahmad, Southern, Mark, Walker, Gavin

    A pharmaceutical roller compaction process was modelled using the Johanson powder mechanics model, which may be employed to achieve desired process performance. Mathematical modelling of the compaction of microcrystalline cellulose (PH102) was used to determine optimal process conditions for an...

  3. Breakage and drying behaviour of granules in a continuous fluid bed dryer: Influence of process parameters and wet granule transfer

    Contributor(s):: De Leersnyder, F., Vanhoorne, V., Bekaert, H., Vercruysse, J., Ghijs, M., Bostijn, N., Verstraeten, M., Cappuyns, P., Van Assche, I., Vander Heyden, Y., Ziemons, E., Remon, J. P., Nopens, I., Vervaet, C., De Beer, T.

    Although twin screw granulation has already been widely studied in recent years, only few studies addressed the subsequent continuous drying which is required after wet granulation and still suffers from a lack of detailed understanding. The latter is important for optimisation and control and,...

  4. A Validated Model for Design and Evaluation of Control Architectures for a Continuous Tablet Compaction Process

    Contributor(s):: Nunes de Barros, Fernando, Bhaskar, Aparajith, Singh, Ravendra

    The systematic design of an advanced and efficient control strategy for controlling critical quality attributes of the tablet compaction operation is necessary to increase the robustness of a continuous pharmaceutical manufacturing process and for real time release. A process model plays a very...