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GEA Pharma Systems presented its latest update of ConsiGma™ Continuous Tableting Line (patents pending) to over 120 FDA participants
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The FDA recognises the value of continuous manufacturing and is working to raise the level of awareness of this technology amongst its review staff. As one initiative the 1st CONTINUOUS MANUFACTURING ONE DAY SYMPOSIUM was held, exclusively for FDA personnel, on March 11 2010 in Bethesda, MD.
There were a total of 124 people present: nearly all were from various FDA offices. Additionally 3 speakers from leading universities had been invited, 2 presentations came from Pfizer and GSK and as the only manufacturer of process equipment GEA Pharma Systems was invited to participate with a presentation.
The chairman's introductory presentation highlighted that in the view of the FDA the use of continuous processing in pharmaceutical production will lead to an improvement in product quality. Additionally the chairman stressed that the FDA encourages pharmaceutical companies to go that way and that the agency is very supportive on this.
A further presentation on behalf of the FDA highlighted the benefits of continuous manufacturing such as: easy or no scale up, flexible batch size, fast development with less product, and constant quality and so enhanced patient safety. It also stressed the importance of plug flow in such processes.
During their joint presentation Kris Schoeters (Product Manager - Continuous Processes at GEA Pharma Systems) and Dr. Harald Stahl (Senior Pharmaceutical Technologist at GEA Pharma Systems) first introduced ConsiGma™ Tableting Line as the solution developed by GEA Pharma Systems allowing continuous production from powder to tablets in only 20 minutes.
The presentation continued with the various control philosophies within the line - ranging from traditional fixed recipe control; via advanced process control with integrated feedback loops allowing compensation for fluctuations of e.g. incoming materials; up to Real Time Release - as all Critical Quality Attributes (CQA) can be measured in-line (on a much higher frequency as it would be possible by any batch process). The presentation was completed by a discussion of data generated by Pharma companies during extended runs. Meanwhile more than 50 companies have tested over 80 different formulations in the competence centre in Belgium.
Two aspects of the ConsiGma™ Continuous Processing approach were most well received. These were the assurance of plug flow over the entire process and the increased number of measurements of CQA which was confirmed by data from an uninterrupted 50h run resulting in 1.800.000 tablets. During the 50-hour test more than 960 in-line measurements were taken to determine critical quality attributes (CQA) such as Loss in Drying (LOD) or particle size distribution, while the content uniformity of the final tablets was assessed in-line more than 100 times.
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