Pharma Dem

Scale Up Modelling, Digital Twins

Digital twins – Model driven process design & validation

Digital twins simulate and analyze the behavior of pharmaceuticals, including powders, tablets, and granules. By using real-time data and simulations, they optimize processes like mixing, coating, and granulation. This approach reduces the need for physical prototyping, lowers costs, and enhances product quality while improving overall operational efficiency and predictive accuracy.

Challenges in Scale Up Manufacturing Process

a. Powder Flowability: Powder flowability should be seen as the relative movement of a bulk of particles among neighboring particles and along the container wall surface. Alternatively, flowability is the ability of a powder to flow in a desired manner in a specific piece of pharmaceutical equipment used in pilot or commercial scale.
b. Particle Rheology: Particle rheology is study of particle flow. Rheology is a functional assessment with stress& strain nature of a particleacquired with complex microstructure to predict the mechanical behavior of particle(s). During the process it is important to understand the flow patterns, and the external forces which are influencing the particles
c. Shear Stress and Particle Characterization: Shear testing and powder characterization is an approach to characterize the powder and measuring powder behaviour as it transitions from no-flow to flow. This study helps in assessing powder behavior, and understanding the shear stress on particle during its flow.
d. Dead Zone identification: Dead zone formation is common issue in bulk powder mixing. These dead zones predictionsare made using advanced AI/ML & DEM technology by simulating the particle behavior, geometry of particle & blender, and establishing the physics based on powder geometry, powder rheology, and powder stress & strain.
e. Powder segregation & Agglomeration: Powder segregation and agglomeration are critical in dealing powdered materials which will impact product quality, efficiency, and other compliance. Detailed understanding on the powders, its trajectories, and particle interaction phenomenon helps in designing effective manufacturing processes

Our Simulation Expertise

1. Tablet Powder Mixing (Blend Uniformity, Content Uniformity): The powder materials used in blenders are of vide variety and composed of multiple components with various geometries and densities. Powder material shape, size, and density will enable to establish the correct simulation and physics between the various particles involved in the unit operation. This helps in advancing the understanding on blend & content uniformity for bulk mass materials of varied physical properties.
2. Tablet coating: Understanding the distribution of coating solution or suspension on tablet surfaces is critical. Modelling and simulations play a key role in assessing the airflow, liquid spray distribution, and drying kinetics
3. Tablet Die filling, and Compaction: Attaining the objective of consistent hardness of tablet will be difficult unless the compaction forces are well understood. Simulations of particle moment, compaction forces, die cavity, and powder flow behavior will help predict the uniform tablet compaction with uniform tablet weight and thickness distribution
4. Tablet Attrition and Capsule filling: Tablet attrition rate is a phenomenon where tableting went wear & breakage during tableting unit operation. Secondly, the distribution of particles or granules in capsule need to be uniform as part of compliance. Simulation helps in predicting the attrition rate and capsule filling phenomenon.