Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.GEA Pharma Systems, a manufacturer of process equipment, has presented an update on its patent pending ConsiGma Continuous Tableting Line at Continuous Manufacturing One Day Symposium held by FDA in Maryland.
Subscribe to our email newsletter
The presentation emphasized that in the view of the FDA the use of continuous processing in pharmaceutical production will lead to an improvement in product quality.
A further presentation on behalf of the FDA highlighted the advantages 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 of 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 the company allowing continuous production from powder to tablets in only 20 minutes.
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 were the two aspects that gained most importance. Here more than 960 CQA such as Loss in Drying (LOD) or particle size distribution were determined in-line while the content uniformity of the final tablets was assed in-line more than 100 times.
The brand portfolio of the GEA Pharma Systems includes: Aeromatic-Fielder and Collette-batch and continuous granulation, drying, pelletizing and coating; Buck – contained materials handling; Courtoy-tablet compression; and Lyophil-pharmaceutical freeze drying.