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L.B. Bohle White Paper: Direct Compression Tableting as a Continuous Production process
The latest technical study from L.B. Bohle Maschinen und Verfahren GmbH (L.B. Bohle) demonstrates how direct compression (DC) tableting can be adapted to work as a genuine Continuous Production (CP) process in pharma manufacturing.
The White Paper Continuous Direct Compression of a High-dose Drug Evaluation of Process and Quality Attributes is authored by an L.B. Bohle research team comprising Dr. Robin Meier, Andreas Teske, and Diploma Engineer Daniel Bexte, joined by Pharmacist Juliana Kotthoff from the Institute of Pharmaceutics and Biopharmaceutics at Heinrich Heine University, Dusseldorf.
The overall aim of the study was to show whether a CP system could ensure consistent product quality over an entire production shift, since continuous production is increasingly being adopted by the pharma industry, supported by Quality by Design (QbD) development and process analytical technology (PAT) manufacturing design and monitoring.
The study team designed and measured a dry granulation DC tableting process for carried out under a CP regime managed by the QbCon® DC platform at L.B. Bohle’s Test and Research Facility, using ASS acetylsalicylic acid/corn starch mix to represent API with Vivapur MCC used as dry binder and PRUV sodium stearyl fumarate as lubricant.
To simulate a typical CP facility, Volkmann vacuum conveyers were used to feed material via normal hose lines and a dosing station to Gericke twin-screw gravimetric powder feeders and continuous blender with near infra-red (NIR) scanning of mixed powder for blend quality as it passed along conveyors into the filler hopper of a KORSCH XL-200 tablet press, with an attached Kraemer UTS tablet tester to measure produced tablets for size, weight, and breaking force as part of an overall control loop. The L.B. Bohle QbCon® automation platform provided strict PAT process monitoring and control over the entire process, with data recording and visualization.
The study results were highly encouraging with consistent results achieved and critical tablet quality attributes maintained over almost the entire eight hour tableting run, apart from fluctuations at commencement and termination of run that could be fully explained from the recorded data. Additionally, the study demonstrates that it is possible to detect inaccurate intermediate and final products via PAT techniques and process parameters. For example, initial powder feed with insufficient API concentrations could be detected using NIR scanning and QbCon® control/monitoring. Overall, this latest White Paper provides a valuable guide in designing an effective continuous production direct tableting manufacturing solution.