Granulation Systems by L.B. Bohle

Consistent, high product quality depends on the uniform quality of the granules. This is reflected in auniform particle size distribution, a constant Bulk Density, and a defined residual moisture content of the granules. Equally important is the reproducibility of results in batch production and continuous processes.

Modern Process Analytical Technology (PAT) enables the continuous monitoring and control of Process Parameters. Through in-line measurements—such as those of moisture content and Particle Size, or using NIR and Raman Spectroscopy—the granulation process can be monitored and controlled.

It is also essential to precisely define and control all Process Parameters, such as Blending Time, liquid addition, roller pressure, or sieve speed. Only through stable parameter control can consistent product quality be ensured.

All processes must be validatable in order to meet regulatory requirements and ensure safe, reproducible pharmaceutical production.

A GMP-compliant design forms the foundation for hygienic and safe production processes. All system components are designed to be free of dead spaces and feature smooth, easy-to-clean surfaces.

Only high-quality, corrosion-resistant stainless steels and pharmaceutical-grade seals are used in the selection of materials. This ensures a long service life for the system and compliance with the strictest hygiene requirements.

To ensure efficient and safe cleaning, modern granulation systems feature integrated WIP (Wash-in-Place) or CIP (Clean-in-Place) cleaning capabilities. These enable automated cleaning processes without disassembly, thereby significantly reducing the risk of Cross-contamination.

In addition, the systems are designed for quick product changeovers: Thanks to easy disassembly and optimized cleaning concepts, downtime can be reduced to a minimum and system availability significantly increased.

A key criterion for modern granulation systems isoccupational safety for operating personnel and the surrounding environment. This includes, above all, a high level of containment, which ensures the safe processing of highly active or toxic Active Pharmaceutical Ingredients (APIs). Systems with containment levels up to OEB 5 reliably protect employees from exposure and ensure a closed, controlled process flow.

Dust-free operation is achieved through fully enclosed system designs, integrated filtration systems, and optional vacuum conveying.

Equally important is ergonomic operation: All relevant components are easily accessible, maintenance work can be performed safely and efficiently, and intuitive control via modern user interfaces significantly simplifies operation.

Furthermore, the systems meet the requirements for explosion protection (ATEX). Consistent compliance with the relevant Ex-zone specifications and safety guidelines ensures safe plant operation even when processing potentially explosive substances.

Modern granulation systems are characterized by short processing times, achieved through optimized mixing, granulation, and drying phases. Efficient drive and control technologies ensure that each process step is precisely coordinated and that downtime is reduced to a minimum.

Another key factor is high Throughput combined with low energy consumption. Intelligent process control, precise temperature regulation, and energy-efficient components maximize productivity without increasing energy or operating costs.

In addition, the focus is on resource efficiency: The use of solvents is reduced to the technically necessary minimum, while air and water consumption are significantly reduced through closed-loop systems and optimized drying systems. In this way, the systems combine cost-effectiveness, Sustainability, and the highest product quality.

Comprehensive documentation and traceability are essential in pharmaceutical production. Modern granulation systems therefore feature automated formulation and batch management that centrally records, stores, and makes all process data available for analysis. This allows production processes to be monitored transparently and controlled in a reproducible manner.

Systems must be capable of operating under comparable conditions at both the laboratory and production scales so that Process Parameters are directly transferable. This scalability ensures the efficient development of new formulations and a smooth transition to commercial production.

Thanks to their modular design, the systems can be flexibly adapted to different process requirements. They can be seamlessly combined with upstream or downstream process steps, enabling a continuous, integrated production chain.

Furthermore, the well-designed system architecture allows for integration into complete process lines and higher-level MES systems.