New In-Line Granulation Measurement System for Pharmaceutical Development

METTLER TOLEDO has launched the new FBRM® C35 Ex in-line granulation measurement system. The robust granulation monitoring provided by the FBRM C35 Ex tracks changes to granule distribution in real-time. This enables formulators and engineers to adjust for changes in particle count and dimension during cohesive wet or dry particle processing.

Results using the FBRM C35 Ex include an improved ability to ensure targeted granule size and consistent granule distribution – both of which are especially critical in fluid-bed coating and high-shear wet granulation applications.

“The FBRM C35 Ex is an important development for particle system characterization in a variety of manufacturing environments because it helps formulators and engineers seamlessly scale-up granulation batches from lab-scale to pilot-scale, and then from pilot-scale to production,” says Eric Hukkanen, Ph.D., Product Manager at METTLER TOLEDO. “The Ex model is ideal for granulation environments that require ATEX gas and dust certification as well.”

The type of inline measurement provided by FBRM C35 Ex allows Quality by Design (QbD) throughout product development, scale-up, and manufacturing. Users can identify a distribution that corresponds to the ideal batch end-point. Real-time distribution can then be tracked relative to this targeted end-point to ensure consistent downstream particle flow. Trends let engineers and formulators identify and troubleshoot unexpected changes. This helps minimize batch failures and improve yield while also ensuring smoother scale-up and technology transfer.

While the FBRM C35 has many far-reaching manufacturing applications, METTLER TOLEDO developed the new particle system characterization series with pharmaceutical formulations in mind.Scientists running pharmaceutical processes – which are typically wet-granulation – used to rely on empirical data and quality control because reliable design and scale-up criteria were missing.

With the launch of the METTLER TOLEDO FBRM C35 series, formulation scientists and engineers are now able to quickly correlate particle system dynamics to processing conditions while running fewer experiments. This helps improve time-to-market by ensuring downstream particle flow as well as consistent tablet roller-compaction and subsequent dissolution results. Additionally, the in situ design of the FBRM C35 allows for improved understanding and optimization of manufacturing processes. In situ analysis produces a more consistent end-result, because samples isolated from the primary manufacturing environment may not give researchers the precision they require.

For manufacturing situations where view-probe window fouling is an issue, a proprietary, patent-pending scraper keeps the FBRM C35 probe window clean. This allows the FBRM C35 to track agglomeration, compaction and breakage directly in the processing vessel in even the most cohesive particle conditions.