Digitisation of Development and Manufacturing, where are you on the journey?

 

Digitisation of Fluid Bed Processes, where are you on the journey?

SmartFBx is an accelerated development and advanced manufacturing platform for Fluid Bed Systems enabling faster more systematic process development and a more robust automated approach to manufacturing. The system aggregates Fluid Bed Process Data, PAT sensor data and other QC analytical or other relevant data as required within a single vertical system. SmartFBx includes integration of data analytics tools and a module for automation using sophisticated process logic for advanced dynamic control. Selected Batch specific data can also be transferred to EBR/MES, LIMS or other corporate information management and compliance systems. SmartFBx is scalable and can be used to connect multiple new or existing Fluid Bed Systems in development and manufacturing. The platform is suitable for Fluid Bed Granulation, Fluid Bed Drying and Fluid Bed Coating(Wurster). 

 
Greater Process Understanding and Actionable Insight

A Modular Digital Platform for Faster Development to More Efficient Production

There is increasing pressure to develop products faster with an ever-greater level of process understanding required to justify a proposed control strategy. Easy access to time aligned PAT sensor and process equipment sensor data during development, scale up and transfer activities for optimisation and comparability saves time and reduces error. The capability to schedule, manage and monitor development, technical and manufacturing batches across locations combined with functionality to trend batch to batch performance means greater efficiency and better data-driven decisions. Increasingly advanced control strategies using hard and soft sensor data are being implemented with an increasing interest in automation based on advanced logic and dynamic control.

SmartFBx Platform Overview

In Oral Solid Dose (OSD) fluid bed processes are often considered higher risk during technical and quality assessments as they are complex with multiple steps or phases during processing.  Process robustness, scalability and transferability has a major impact on product quality, QA operations, plant throughput and utilisation, and batch cycle time and yield. Batch Unit operations remain the most common development and manufacturing platform even though there is a trend to assess the potential of continuous processing in drug product manufacturing.

In 2015, Innopharma Technology began a Research and Development program to develop a 4.0/IIOT enabling platform for Fluid Bed Systems bringing together PAT and process equipment sensor information, data aggregation, analytics and visualisation tools, and an automation package for advanced dynamic control. The program includes Innopharma Technology’s PAT sensors for powder and solids processes which complement existing process machine sensors by providing additional information on critical quality attributes such as particle size and moisture for a deeper process understanding. Eyecon and Multieye platforms are used on many processes for increased process understanding during risk-based product development whether quality by design (QbD) or a prior knowledge driven approach supported by experimental batch data. The process data generated by PAT sensors and process equipment sensors during development activities result in a better data-driven decision on control strategy. The system is scalable and can be used to connect multiple Fluid Fed Systems to securely aggregate Fluid Bed Process Data, PAT sensor data and other QC analytical or other relevant data as required within a single vertical system. SmartFB x includes integration of data analytics tools and a module for automation using advanced dynamic control. Selected Batch specific data can also be transferred to EBR/MRS, LIMS or other corporate information management and compliance systems.

 File Faster, More Efficient Systematic Process Development