Granulation systems from L.B. Bohle

Homogeneous pellet quality is crucial for consistently high product quality. This is reflected in auniform particle size distribution, a constant Bulk Density and a defined residual moisture content of the granulate. Equally important is the reproducibility of the results in batch production and continuous processes.

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

The precise definition and control of all Process Parameters, such as Blending Time, liquid addition, roller pressure or sieving speed, is also crucial. Stable parameter control is the only way to guarantee consistent product quality.

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

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

When selecting materials, only high-quality, corrosion-resistant stainless steels and pharmaceutically suitable seals are used. This ensures a long service life for the system and compliance with the strictest hygiene requirements.

For efficient and safe cleaning, modern granulation systems have integrated WIP (wash-in-place) or CIP (clean-in-place) cleaning systems. These enable automated cleaning processes without disassembly and thus significantly reduce the risk of Cross-contamination.

The systems are also designed for quick product changeovers: Thanks to simple disassembly and optimised cleaning concepts, downtimes can be reduced to a minimum and system availability significantly increased.

A central criterion of modern granulation systems isoccupational safety for the operating personnel and the environment. Above all, this includes a high containment capability that ensures the safe processing of highly active or toxic Active Pharmaceutical Ingredients (API). 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 concepts, integrated filter systems and optional vacuum conveyors.

Ergonomic operation is just as important: all relevant components are easily accessible, maintenance work can be carried out safely and efficiently, and intuitive control via modern user interfaces simplifies operation considerably.

In addition, the systems fulfil the requirements of explosion protection(ATEX). Consistent compliance with the relevant Ex zone specifications and safety guidelines ensures safe system operation, even when processing potentially explosive substances.

Modern granulation systems are characterised by short process times, which are achieved through optimised mixing, granulation and drying phases. Efficient drive and control technologies ensure that each process step is precisely synchronised and downtimes are reduced to a minimum.

Another key factor is high throughput combined with low energy consumption. Intelligent process management, precise temperature control and energy-efficient components maximise 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 is significantly reduced thanks to closed circuits and optimised drying systems. In this way, the systems combine cost-effectiveness, sustainability and the highest product quality.

CompleteDocumentation and traceability are essential in pharmaceutical production. Modern granulation systems therefore have an automated recipe and batch management system that records, stores and analyses all process data centrally. This allows production processes to be monitored transparently and controlled reproducibly.

Systems must be able to be operated under comparable conditions on both a laboratory and production scale so that Process Parameters can be transferred directly. This Scalability ensures efficient development of new formulations and a smooth transfer 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.

In addition, the sophisticated system architecture allows integration into complete process lines and higher-level MES systems.