The GEA equipment used in the study included a ConsiGma™ 25: a multi-purpose platform that, when combined with a Courtoy™ MODUL™ P rotary tablet press, processes powder into tablets in development, pilot, clinical and production volumes in a single compact unit. ConsiGma™ can produce granules continuously, with minimal waste during start-up and shut-down, while determining batch size only by the length of the run.
Online quality measurements were taken throughout the process facilitated by the GEA Lighthouse Probe™ that prevents product sticking to the observation windows of the process analyser.
The trial consisted of a series of test runs including one of ten hours, three repeat runs of five hours to prove repeatability and reproducibility, and finally a 16-hour run to assess the overall performance and online measuring techniques. The Critical Quality Attributes measured were moisture, particle size, blend uniformity and content uniformity. A Tandem system by Bruker Optics was used for the online measurement of the CQA’s of the tablets. The Siemens SIPAT® system was also selected as an advanced control system to gather and process all the data from the ConsiGma™ and the different online measurement devices.
The outcome of the trials led the Janssen team to conclude that the ConsiGma™ technology allows for process development in a very short time, for production cost reduction and for substantial time-to-market reduction. The agility of the system has allowed efficient and effective experiment design. The process stability and robustness was proven through the production of tablets of consistent quality.
Janssen believes that more intensive process monitoring and control will create a more stable and consistent process, faster development will lead to cost reductions, a smaller footprint to reduced investment, online monitoring and real-time release testing will reduce quality control costs, and the elimination of intermediate storage reduces inventory costs. As a result, obvious business value can be expected from this technology.
ConsiGma™ provides the maximum output while consuming less of the earth’s resources than any other system. It has been tested using over 100 different formulations and is already being used by several large pharmaceutical companies and research establishments worldwide.