Continuous Oral Solid Dose Manufacturing Systems For Pharmaceutical Production
Continuous manufacturing is changing 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. In continuous manufacturing, the processes occur one after the other without interruption while the product is charged and discharged simultaneously. The main challenge with traditional solutions is the precise dosing of the starting materials in a constant mass flow rate of milligrams per second.
Syntegon is tackling the challenges in continuous manufacturing with a different approach, called Xelum.
The Xelum platform doses active ingredients and excipients as discrete masses and not as a continuous mass flow. This way, even smallest amounts of APIs of less than 1% can be dosed precisely. 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.
Unique and proven technology
The Xelum platform is based on the robust and proven fluid bed processors that Syntegon has been refining for over 30 years. They cover granulation and drying in the same process chamber. This eliminates the need to transfer wet granulate, benefitting the system’s reliability. Xelum achieves high granulation yields with the desired characteristics – including unimodal particle size distribution, as well as excellent flow and tableting properties. The platform further ensures lower production costs and high flexibility. The same holds true for the Xelum R&D and pilot unit, your point of entry into continuous manufacturing.
You can precisely dose APIs of less than 1% while ensuring high content uniformity for your final product.
Thanks to a direct transfer from R&D to production, you don’t require scale-up.
The Xelum platform supports you with easy and reliable quality control as well as integrated traceability.