Design and Scale up of Bioreactors using Computational Fluid Dynamics
In Biopharmaceutical product development, scale-up and scale down are crucial to building a robust process and maintaining product quality. One of the parameters that should not be underestimated is the reactor geometry. Starting off with the proper bioreactor design can resolve several process issues before they arise. A properly designed bioreactor can lead to a reduced qualification and process validation timeframes, as well as increased process robustness and operational success.
The crystallization process is a complex process of heat transfer and mass transfer. In distinct physical and chemical environments, the control steps of the crystallization process may change and may reflect different crystallization behaviors. A robust modeling framework can prove to be a great advantage for optimization, designing a new type of crystallizer, and troubleshooting the crystallization process.
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Enhance Productivity with Asset Optimization
Manufacturing and other asset-intensive industries face a continual need to reduce costs while increasing operational reliability. The way many companies plan their requirements isn’t helping. The industry needs a better solution.
Asset optimization approach enables an organization to manage its various assets for the maximum financial benefit. Our team works with clients to improve the performance of their assets. Our industry-wise SME team will help in ‘Unit Operations Audit’ and characterize/validate them for better operation.
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Necessity to apply CFD-DEM two way coupling to the Pharmaceutical development process
Ultimately, simulations can reduce the experimental burden on the drug development process by significantly improving process insight. These insights helped to solve process challenges such as troubleshooting, scale-up and technology transfer. Standalone DEM has been used to model mixing, sieving, milling, tablet coating, hopper discharge, etc. If the fluid effects are important, like in wet granulation, drying, fluidized bed processes, wet milling, etc., then DEM-CFD two way coupling models can be used.
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Pharmaceutical Industry Brochure
QbD based process development being mandated by the FDA, there has been a drive in the pharmaceutical industry to identify the CPP and quantify their impact on the CQA of the product. Establishing the relationship between CPPs and CQAs using the conventional experimental approach tends to become more cumbersome, expensive and time consuming with the increasing scale of operation. The science-based advanced modeling approach practised by TSPL gives better insights in terms of process understanding, equipment selection and operation optimization.
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