Pharmaceutical client needed the system to be flexible and compact
Hosokawa Micron recently helped a leading pharmaceutical manufacturer to address stringent production demands and personnel protection requirements during the design of an R&D batch milling and pack off system for processing HAPI materials of a specific particle size.
The system design was further complicated by the dimensional constraints of the existing facility and the need to achieve the most ergonomic working environment for all workers across multi-shift operations.
Hosokawa Micron engineers designed a two-storey, contained system that met all the customer’s requirements and allowed considerable production flexibility, from processing small R&D batches to operating as a continuous manufacturing system.
The combined batch milling and packing system features an upper tier, high containment isolator with integrated pharmaceutical hammer mill. This feeds directly into the flexible, continuous liner, filling and weighing system contained within a lower tier laminar flow booth, complete with HMI containment screens.
The system offers containment to Level 4 OEB, which will repeatedly achieve containment between 1-10µg/m3 and can handle batches of up to 500 litres from the dryer above.
If required, the system can be operated under an inert atmosphere by purging all internal areas with nitrogen offering further flexibility should the products be hygroscopic or explosive.
Hosokawa Micron designed a two-storey, contained system that met all the customer’s requirements and allowed considerable flexibility
The milling isolator provides a fully contained environment during active product handling giving total barrier isolation. The isolator is integrated into an existing product flow from a dryer positioned above the unit with HAPI material fed from the dryer through hygienic rotary valves at a controlled rate into the pharmaceutical hammer mill, which can run at speeds of up to 6000rpm, depending on the particle size required.
The integrated mill has a series of interchangeable meshes to give variable particle size and shapes that add increased operational flexibility to the system. It is easy to dismantle for cleaning and mesh changing.
The pharmaceutical hammer mill delivers a range of particle sizes, typically less than 50 micron with low quantities of ultrafines. Temperature monitoring at the hammer mill ensures that material stays within temperature tolerances to prevent degradation of the product and is interlocked within the system.
The filling and weighing system is integrated within a laminar flow booth directly below the milling isolator giving direct material discharge to the filling packing head and maintaining the benefits of the compact, small footprint within the space limitations. Milled material is gravity fed into continuous liner, single liners or 23-litre charge bottles, located on the fill/weigh platform, via a 100mm charge point valve; to deliver low containment product transfer.
A containment screen located at the compact inward sealer offers additional barrier protection to operators from the potential risk of airborne particles within the laminar flow booth by increasing the face velocity during the actual pack off process.
All internal composition of the system is designed for minimal operator intervention and minimal material handling. The system is fully WIP with integrated spay guns positioned to ensure efficient clean down.