Xelum Continuous Manufacturing

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. Syntegon 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. Syntegon 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.

Unique and proven technology
Syntegon 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. 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.

Benefits:

  • Smart control strategy
  • APIs of less than 1% can be dosed precisely
  • Granules with superior characteristics due to fluid bed granulation
  • No scale-up, direct transfer of process parameters
  • Traceability based on X-key principle
  • Minimized start-up and shut-down losses
  • Good clean ability
  • Nominal capacity 30 kg/h
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