The machine is capable of doing particle design in addition to having the capacity to mimic traditional batch granulation. Adoption of continuous processes would be welcomed by sections of the industry, particularly at the FDA. The FDA has stated that it believes pharmaceutical companies should be doing more to convert to more efficient continuous processes. In a white paper on pharmaceutical manufacturing improvement the FDA stated that "pharmaceutical manufacturing operations are inefficient and costly…Low efficiency is predominantly due to 'self imposed' constraints in the system…These constraints keep the system in corrective action mode." Collette claims that Consigma will consistently produce higher quality results than its competitors, with Griet Van Vaerenbergh, PDC lab manager at Collette, describing it as "revolutionary". Speaking to in-PharmaTechnologist.com Wim Van der Goten, GEA Pharma Systems sales director, said: "All systems that were presented up till now were either semi-continuous processes or included process elements where "back -mixing" was possible. Plug flow is required to control every detail of the process. "Consigma is a real continuous process without back-mixing. It includes an extremely compact continuous High Shear Granulator which can inline dry mix and granulate powders to a desired content uniformity and particle size distribution." This should reduce rejections in the tableting process, meaning "tablet presses run more efficiently, at maximum speed with hardly any weight adjustments required" according to Collette. The superior results are attributed to the machine's continuous production set-up and 'risk based approach' to good manufacturing practice. To ensure that the granulation process runs smoothly it can be continuously monitored using an optional inline measurement of critical quality attributes which are relayed back to the control system. One Consigma machine can run 500g in R&D but also has the capacity to run clinical trial, launch size, and any production scale batches. There is no process scale-up when using Consigma, which Collette claims will enable companies to bring products to market more quickly and for less cost. Consigma is aimed at R&D and production teams and it should conveniently fit into companies existing set-ups, said the company. It is a quarter of the size and lighter than a conventional granulation machine and consequently can be relatively easily wheeled in and connected to the power and air supply. The system uses the principal "wash off-line" for cleaning in which "contaminated parts are removed in a contained way and immediately replaced by clean parts" Mr Van der Goten told in-PharmaTechnologist.com. Machine parts are then taken off-site to be cleaned. Interested parties will have the opportunity to take a look at the system at Interpack, which this year takes place on 24-30 April.
GEA Pharma Systems' Collette unit will present Consigma, its new continuous high shear granulation and drying system, at the Interpack exhibition in Düsseldorf later this month.