Bosch Packaging Technology presents GranuLean, the new granulation unit developed by the Bosch subsidiary Hüttlin GmbH. It combines the process steps of mixing, granulating, and drying for the manufacturing of pharmaceutical granules.
With its 6-m length and 3.4-m height, GranuLean saves valuable production space. It can be easily integrated into production rooms and focuses on the basic requirements of pharmaceutical producers. The new development is available for three different batch sizes and is based on Hüttlin’s long-standing process technology.
The most important functions of GranuLean are installed by default. Thanks to the alignment of machine components on site, the granulation unit can be installed quickly and easily. All process and cleaning steps can be controlled via recipes. The operator interface is a 21-in. touchscreen with user-friendly navigation.
The process for manufacturing pharmaceutical granules begins by pneumatically
filling the high-shear mixer. The mixing device Gentlewing, which is driven from
below, mixes and granulates the active ingredients and excipients. The high-shear
mixer is emptied via the integrated wet mill. Communication between mill and Gentlewing ensures that only as much product is emptied as the mill is able to process, which prevents the mill from clogging.
A pneumatic transfer pipe subsequently transfers the wet product to the GranuLean fluid bed module, where it is dried through the inflow of the Diskjet distribution plate. The function of process filters is crucial to obtain high yields. For this reason, Bosch has developed a new process filter, where the elements are serially cleaned with compressed air pulses. At the end of the drying process, the product is emptied by a dry mill.
Apart from the high-shear mixer, granulation can also take place in the fluid bed by using a tangential or top spray process. GranuLean is available for a containment level of up to OEB3 (Operational Exposure Band). The machine remains closed during operation, while inflatable seals on the product containers provide optimum draught-proofing. Moreover, the integrated cleaning system ensures easier handling.
Suitable handling equipment makes it possible to combine the new granulation unit with a compact line; for instance with the new tablet presses of the Manesty TPR range. Alternatively, the granule can be filled into stick packs or capsules; for example with the new GKF 2600 capsule filling machine from Bosch.