Continuous manufacturing is leading to fundamental changes in oral solid dosage (OSD) production. Higher flexibility, shorter development times with minimum API usage, and a direct transfer from development to production without scale-up are among the primary requirements of pharmaceutical manufacturers. Bosch Packaging Technology is tackling these challenges with a novel approach called Xelum. In continuous manufacturing, the processes occur one after the other without interruption, the product is charged and discharged simultaneously. The main challenge is the precise dosing of the starting materials in a constant mass flow rate of milligrams per second. Bosch uses a different approach.
The Xelum platform doses active ingredients and excipients as discrete masses and not as a continual mass flow. The system doses, mixes and granulates individual packages, so-called X-keys, which continuously run through the process chain and are discharged successively as granules, tablets or capsules. This way, even smallest amounts of APIs of less than 1% can be dosed precisely.
Bosch relies on a unique and proven technology. As opposed to the usual twin screws, the Xelum platform works with the more robust fluid bed processors. These processors are based on the well-known technology developed by the esteemed Bosch subsidiary Huttlin.
In the fluid bed, granulation and drying take place in the same process chamber. This eliminates the need to transfer wet granulate, which has a positive effect on the system's reliability. Pharmaceutical manufacturers obtain granules with the desired characteristics - including unimodal particle size distribution, as well as excellent flow and tableting properties combined with high production yields. Xelum ensures lower production costs and high flexibility. The same is true for the Xelum R&D and pilot unit - an ideal start to the realm of continuous manufacturing.
It is the first R&D machine to combine charging, dosing of several ingredients and blending, with granulation, drying and discharging in one unit.
It is also the first unit that allows the user to develop formulations for both batch and continuous manufacturing on the same machine. Thanks to a reduction insert, the minimum amount of product that can be produced on the machine is 250g. In an automatic cycle, however, the Xelum R&D can run products at a rate of 10kg/h, which makes it useful not only for R&D but also for pilot production. As a fully closed and contained unit, it is also perfectly suited for the development of very potent APIs. Transferring processes from laboratory to production is a further challenge when it comes to traditional batch processes. This risky and time-critical stage is eliminated in the Xelum R&D system.
Since it uses exactly the same components as the Xelum production platform, process parameters are identical and can be directly transferred 1:1. Scale-up becomes obsolete, which significantly reduces development time, as well as API usage.
In this way, the Xelum platform fulfills all the requirements to realise a modern pharmaceutical OSD development and production.