Mettler Toledo has launched the FBRM C35 Ex, an in-line granulation measurement system targeted at particle system characterisation in the pharmaceutical industry.
The robust granulation monitoring provided by the FBRM C35 Ex tracks changes to granule distribution in real time, enabling 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 critical in fluid-bed coating and high-shear wet granulation applications.
Eric Hukkanen PhD, product manager at Mettler Toledo, said: 'The FBRM C35 Ex is an important development for particle system characterisation 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.
'The Ex model is ideal for granulation environments that require Atex gas and dust certification as well,' he added.
The type of inline measurement provided by FBRM C35 Ex allows Quality by Design throughout product development, scale-up and manufacturing.
Users can identify a distribution that corresponds to the ideal batch endpoint.
Real-time distribution can then be tracked relative to this targeted endpoint to ensure consistent downstream particle flow.
Trends let engineers and formulators identify and troubleshoot unexpected changes.
This helps minimise batch failures and improve yield while also ensuring smoother scale-up and technology transfer.
Mettler Toledo developed the particle characterisation 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 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 optimisation 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 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.
When taken together, Mettler Toledo said the benefits offered by the FBRM C35 in-process particle characterisation system enable shorter development cycles and cost reductions through consistent results and fewer batch failures.