Continuous manufacturing is based on a number of requirements driven by the Pharmaceutical industry; quality, efficiency and speed to market being some of these. Bosch fulfilled these requirements when it released Xelum in 2017. The Xelum platform allows for faster development times and a reduced risk by eliminating the need for scale up. Floor space is also optimized with Xelum requiring only 30% of the floor space of a traditional manufacturing suite. Quality is increased through inline quality verification systems, which ultimately leads to a higher degree of quality at the end of the batch.
Xelum addresses many of the challenges seen with continuous manufacturing today such as the dosing and verifying finite amounts of API, traceability of API in the system, and the need for resonance time distribution models. To overcome these challenges, Xelum implements a mass dosing approach, whereby API and excipients are dosed into X-Keys in a semi-continuous approach. This allows for full traceability and verification at each point during the production process.
Xelum is based on Bosch subsidiary Hüttlin’s core technology, which is the fluid bed. Fluid bed granulation allows for a robust process and produces a superior granular quality, which gives many benefits in the tablet press such as higher tensile strength tablets at lower compression forces and higher compression speeds.
Please click the video below for more information on Xelum and the benefits of continuous manufacturing vs. batch manufacturing.