Flexibility can be achieved throughout the process – including high shear granulation, pelletisation and blending – in a totally contained environment
The Buck Valve MC, part of the pilot granulation system for materials that must be contained
GEA Pharma Systems showed its contained pilot granulation system at Interpack, Düsseldorf in May. The complete production plant takes the process from dispensed raw materials to finished tablet.
The system demonstrates the flexibility that can be achieved throughout the process – including high shear granulation, pelletisation and blending – in a totally contained environment.
It is aimed at producers of small quantities of highly potent compounds. The intelligent contained handling systems inherent in the GEA pilot plant allow it to be flexible, efficient, clean and safe without the need for expensive, bulky and difficult-to-clean isolator systems. Furthermore, the level of containment avoids the need for costly and uncomfortable airsuits, allowing the users to focus on the product, creating faster and more secure results.
At the heart of the production plant is PharmaConnect, GEA’s innovative, modular granulation and blending system offering a range of process types and capacities; in addition it houses FlexStream, a leading process technology for spray granulation and pellet coating that is said to deliver benefits in terms of greater productivity, lower running costs and a robust and scaleable process.
The system includes examples of both rigid and disposable product transfer technology offering containment down to low nanogram levels. These options include: the disposable Hicoflex system with significantly lower capital and running costs compared with rigid IBC technology, and rapid product changeover for improved plant utilisation; the modular Buck MC valve with its simple design that enables complete container-to-container transfer flexibility; and the Buck TC Valve, a high performing split valve. By introducing a wash step prior to valve separation, the Buck TC Valve is capable of performance to the low nanogram level.
All these technologies were brought together in an integrated process system that mimics the hundreds of large-scale plants provided by GEA Pharma Systems globally. It epitomises the approach of ensuring customers receive the same technology from the laboratory through to production, using the same containment and process technologies to ensure seamless scale-up and the most flexible blend of process capabilities.