At production scale, it is important to ensure that the crystallization process is robust and reproducible by ensuring consistency from batch to batch. This presentation discusses how to further optimize this process at scale to improve filtration and drying times while controlling the particle size to the desired specification.
English
Crystallization processes designed at small scale regularly behave completely differently when scaled initially to pilot plant, and finally to full scale commercial production. This scale up can create significant changes in critical particle properties such as the crystal size, shape, purity and polymorphic form, subsequently impacting the downstream operations. The pilot plant is vital in achieving key objectives such as process development, clinical supply manufacture, scale up and transfer. Information on the crystallization step at this stage can decrease the development time required in the pilot plant while subsequently gaining a valuable insight into the impact of scale up on the process. |
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