The Syntegon Xelum R&D continuous manufacturing system is built around our renowned Hüttlin fluid bed technology and a unique feeder/blender module which dispenses individually controlled x-keys of powder from 1-10kg.
We've eliminated scale up by pairing one blending module with up to 5 fluid beds and a TPR tablet press.
It's really a best of both worlds, taking the positives of CM like batch size flexibility, easier development, reduced footprint, PAT and the aspects of batch manufacturing that are just too valuable to leave behind. Such as formulations with sub 1% material concentrations, ability to adjust after dispensing issues, and a clear control strategy of a firmly defined aliquot of powder.
There are several different technologies out there for oral solid dosage CM, but they all are largely reliant on powder feeders dispensing an exact flow rate and concentration of material. Truly continuous powder unit operations are heavily influenced by throughput and the nature of pharmaceutical manufacturing does not allow for fluctuations in dispensed concentrations. We avoid these issues altogether by feeding to a target x-key mass with no dependence on time. There are also several benefits to fluid bed granulation over other truly continuous options on the market.
Syntegon has announced strategic partnerships with pharmaceutical giants like Bayer and Shanghai Pharmaceuticals, as well as several North American installations at a BlueChip Pharma company. Some of our customers have even produced stability and GMP batches with the Xelum R&D.
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