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Granulation line for oral solid dosage production
Syntegon expands its GranuLean portfolio with integrated granulation solutions and lifecycle services for pharmaceutical manufacturing from lab to large-scale production.
www.syntegon.com
Syntegon has expanded its GranuLean granulation line portfolio through a strategic technology transfer from its Schopfheim, Germany, site to its manufacturing facility and Customer Center in Hangzhou, China. The GranuLean system is engineered for oral solid dosage (OSD) production, integrating high-shear mixing, fluid bed drying, and material handling within a unified, compact footprint. This expansion allows international pharmaceutical companies, generic manufacturers, and CDMOs to access CE-compliant granulation technology in four standardized sizes, ranging from 150 to 1,200 liters.
Core Process Components and Fluid Bed Technology
The GranuLean line utilizes a horizontal product flow designed to optimize throughput while minimizing space requirements. The system's technical relevance is defined by its integrated processing modules:
- High-Shear Mixing: Employs the proprietary Gentlewing impeller, which facilitates efficient mixing and granulation while maintaining the physical integrity of sensitive particles.
- Calibration and Milling: Includes a wet mill for initial calibration and a dry mill for final product discharge, ensuring consistent particle size distribution.
- Fluid Bed Drying: Features a star balloon filter system designed to maximize yields by minimizing product loss during the drying phase.
- Alternative Granulation: The system supports tangential spray granulation using three-component nozzles (microclimate), allowing for direct granulation within the fluid bed as an alternative to the high-shear mixer method.
Scalability and Control System Architecture
The platform is engineered to support a seamless scale-up from laboratory trials to large-scale industrial production. This is facilitated by an innovative control system equipped with an intuitive Human-Machine Interface (HMI) that allows for open recipe creation and management. For technical teams, this enables rapid product development and the ability to optimize process parameters in a pilot environment (such as the GranuLean 150) before transitioning to high-volume manufacturing.
Integration within the Digital Supply Chain
The high degree of standardization in the GranuLean line addresses the need for rapid deployment within the digital supply chain of pharmaceutical manufacturing. By offering standardized configurations, Syntegon reduces the lead times associated with custom engineering while maintaining compliance with international safety and quality standards. The system’s compact dimensions allow for easy integration into both greenfield projects and existing brownfield production facilities, ensuring that space-constrained environments can maintain high-quality granulation processes.
Global Lifecycle Services and Regional Sourcing
With the expansion to Hangzhou, Syntegon provides customers with flexible sourcing options for peripheral equipment and lifecycle services. Laboratory testing capabilities are now available in both Germany and China, allowing for localized process verification within the automotive data ecosystem equivalent of the pharmaceutical sector. This regional availability ensures that technical support, spare parts, and maintenance services are accessible regardless of the customer's geographical location, supporting the entire lifecycle of the granulation system.
Edited by Romila DSilva, Induportals Editor, with AI assistance.
The platform is engineered to support a seamless scale-up from laboratory trials to large-scale industrial production. This is facilitated by an innovative control system equipped with an intuitive Human-Machine Interface (HMI) that allows for open recipe creation and management. For technical teams, this enables rapid product development and the ability to optimize process parameters in a pilot environment (such as the GranuLean 150) before transitioning to high-volume manufacturing.
Integration within the Digital Supply Chain
The high degree of standardization in the GranuLean line addresses the need for rapid deployment within the digital supply chain of pharmaceutical manufacturing. By offering standardized configurations, Syntegon reduces the lead times associated with custom engineering while maintaining compliance with international safety and quality standards. The system’s compact dimensions allow for easy integration into both greenfield projects and existing brownfield production facilities, ensuring that space-constrained environments can maintain high-quality granulation processes.
Global Lifecycle Services and Regional Sourcing
With the expansion to Hangzhou, Syntegon provides customers with flexible sourcing options for peripheral equipment and lifecycle services. Laboratory testing capabilities are now available in both Germany and China, allowing for localized process verification within the automotive data ecosystem equivalent of the pharmaceutical sector. This regional availability ensures that technical support, spare parts, and maintenance services are accessible regardless of the customer's geographical location, supporting the entire lifecycle of the granulation system.
Edited by Romila DSilva, Induportals Editor, with AI assistance.
