Continuous Granulation and Pharmaceutical Manufacturing
Summary
Continuous granulation has emerged as a cornerstone of modern pharmaceutical manufacturing, transforming the traditional batch paradigm into an uninterrupted, end-to-end process. By integrating unit operations such as powder feeding, wet granulation, drying, milling and tableting into a seamless line, manufacturers achieve tighter control over granule size distribution, density and moisture content. The adoption of twin-screw wet granulators enables precise binder addition and shear management, while advanced process analytical technology (PAT) gives real-time insight into critical quality attributes (CQAs). This data-driven approach underpins Quality by Design (QbD) principles, allowing risk-based process optimisation and real-time release testing. Continuous granulation also brings substantial economic and environmental benefits: reduced footprint, lower energy consumption, minimal waste and accelerated time to market. Globally, these advances support flexible production scales, personalised dosing and decentralised supply chains, enhancing resilience against disruption and meeting evolving regulatory expectations for product quality and patient safety.
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Continuous Granulation and Pharmaceutical Manufacturing publication trend
The graph below shows the total number of articles in continuous granulation and pharmaceutical manufacturing across all publications each year (not limited to Nature Index journals).
Technical terms
Continuous granulation: A processing technique in which powders are continuously agglomerated into granules by controlled binder addition under steady material flow.
Process Analytical Technology (PAT): A framework of in-line or at-line analytical tools used to monitor and control critical process parameters and quality attributes in real time.
Quality by Design (QbD): A systematic, risk-based approach to product development that emphasises understanding of process variables and their impact on predefined quality targets.
Critical Process Parameters (CPPs): Process variables whose variation has a direct impact on critical quality attributes and must be controlled to ensure consistent product quality.
Critical Quality Attributes (CQAs): Physical, chemical or biological properties or characteristics that must be maintained within specific limits to guarantee the desired product quality.
References
- Employing a multi-resonance microwave sensor for in-line moisture monitoring of fluidized bed agglomeration. Chemical Engineering Journal (2024).
- Drugs need to be formulated with scale-up in mind. Journal of Controlled Release (2024).
- Dynamic Flowsheet Model Development and Sensitivity Analysis of a Continuous Pharmaceutical Tablet Manufacturing Process Using the Wet Granulation Route. Processes (2019).
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