L.B. Bohle QbCon® for a continuous pharma production line

L.B. Bohle’s innovative QbCon^® continuous manufacturing (CM) systems meet the increasing pharmaceutical industry need for a paradigm change from batch production to continuous production of oral pharmaceutical solids.

The QbCon® System allows for production of pharmaceutical solids from powder to coated tablets at throughputs of up to 25 kg/h, using a choice of continuous production processes: direct compression (DC), wet granulation, or dry granulation.

QbCon® design and features

QbCon^® is the only CM system for wet granulation processes worldwide that meets the quality demands of pharmaceutical manufacture, combining continuous granulation with integrated truly continuous drying and semi-continuous tablet pressing and coating.

The QbCon^® system adopts a highly modular design that ensures maximum flexibility and efficiency for the customer, combined with compact footprint platforms and ease of integration with existing equipment.

The system is also highly integrated with process analytical technology (PAT) with a higher-level control system ensuring complete digital integration of all components and monitoring of the entire QbCon® process for design, analysis, and control.

The in-process application of Process Analytical Technology (PAT) means that product quality is constantly monitored throughout the process through measurement of critical process parameters (CPPs) that affect critical quality attributes (CQAs). Any deviations from CPP can be immediately detected and corrected.

Benefits of CM and PAT

The ability to monitor a production process more closely using PAT, and to consistently produce high-quality products as a result, is the central aspect of L.B. Bohle’s QbCon® initiative. Indeed, end-to-end complete process monitoring is a decisive argument for adoption of continuous manufacturing approaches.

Applying PAT across the entire process allows consistent monitoring of product quality and instant detection and elimination of deviations. This eliminates the need to eject and dispose of entire defective batches, fewer rejections of out-of-specification (OOS) materials and increased product consistency.

Real-time analysis of process and product also makes possible real-time release of drugs by allowing 100% non-destructive inspection of all final products.

The combination of CM plus PAT therefore extends overall benefits to lower costs, enhanced patient safety, increased process understanding and optimised process control.

Continuous Manufacturing for Research and Development

In addition to systems for higher throughput per hour, L.B. Bohle also offers the QbCon® 1 System for R&D applications. This is unique as the world’s only platform that can achieve a truly continuous wet granulation and drying process.

QbCon® 1 is optimized for fast and efficient product development to deliver throughputs of 0.5-2.5 kg per hour.

Resources

Click on L.B. Bohle QbCon® Continuous Production for further details.
Click on Continuous Direct Compression of a High-dose Drug – Evaluation of Process and Quality Attributes to download QbCon® Direct Compression White Paper (sign up/login required).
Click on QbCon® 1 – Truly Continuous Wet Granulation and Drying to watch video of R&D CM unit in action.
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