Efficient, flexible and user-friendly while offering short development times and a fast transfer from development to production – these are the pharmaceutical industry’s criteria for the production of oral solid dosage (OSD) forms. With “Continuous Processing”, processes can be further accelerated and optimized. In contrast to batch production, feeding of the starting materials and removal of the finished product are done simultaneously.
“Instead of producing a set amount of batches in separate production steps, the processes occur one after the other without interruption. This results in shorter throughput times, lower production costs, as well as high flexibility,” explains Fritz-Martin Scholz, product manager at Bosch Packaging Technology. Current continuous production systems for wet granulation usually rely on continuous twin screw granulators. The biggest challenge is the precise dosing of the starting materials, which have to be continuously dosed in a constant mass flow rate of milligrams per second.
Integrated tableting with Xelum
The new Xelum system from Bosch tackles this challenge in a new way. It doses and mixes individual packages, so-called X-Keys, which continuously run through the process chain and are successively removed from the system. “Even the smallest amounts of active ingredients can be dosed precisely, and all starting materials can be traced in the production line,” Scholz explains. Instead of the usual twin screw granulators, the Xelum platform relies on fluid bed processors – based on the established technology developed by the Bosch subsidiary Hüttlin. In the fluid bed, granulation and drying take place in the same process chamber. This eliminates the need to transfer wet granulate, which in turn has a positive effect on the system’s reliability. In the final processing step, the tableting takes place in the integrated Xelum tablet press. “Continuous Manufacturing will play an important role alongside batch production. Which process is used for which product has to be decided on an individual basis,” Scholz summarizes.
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