The pharmaceutical industry is looking towards continuous processing to improve their production quality in the most efficient way to the level requested by the authorities today.
It allows for building quality into the process, to measure inline and to adjust parameters to drive the critical quality attributes to the requested target levels.
This is clearly also the opinion of the authorities. In order to give guidance to improve the overall production quality in the pharmaceutical industry the FDA issued the PAT document in 2004. The document states that the desired goal of the PAT framework is to design and develop processes that can consistently ensure a predefined quality at the end of the manufacturing process. One of the stated goals is to facilitate continuous processing to improve efficiency and manage variability.
With this target in mind Consigma was developed.
The Consigma continuous high shear granulation and drying system is designed for so-called plug flow, first-in first-out, avoiding back mixing providing a consistent quality and allowing for control of critical quality attributes in line
The Consigma consists of 3 modules: A wet high shear granulation module, a segmented dryer module and an evaluation module.
In the granulation module, dry ingredients are dosed individually or premixed in a very accurate way to the continuous high shear granulator. The granulation liquid is also dosed accurately and intensely mixed with the dry components. Result is a continuous flow of wet granules with a constant quality and constant density that is transferred to the dryer. There are no over-sized agglomerates so there is no wet mill.
In an ingenious way, the dryer module, based on the classic fluid bed drying principle, splits the continuous flow of granules into segments of the dryer. The segments are emptied and transferred to the evaluation module The drying curve of each package is monitored.
In the evaluation module dried granules are received for dry milling. Here we can measure critical quality attributes such as particle size distribution, humidity and content uniformity in line.
All data captured can be analyzed by the control system and parameters can be adjusted to keep the process in a narrow band of the desired quality specification.
The Consigma can handle capacities from 500 g up to tons. Time is the factor that matters. Being able to handle all these capacities, there is no scale-up anymore.
With its light weight, ultra small size and modular construction Consigma fits in perfectly in every R&D department or an existing tablet production room. No need to change the building, just wheel it in, connect the power an air supply and off you go. Installation time and cost are reduced to a fraction of the current benchmark.
It can perfectly operate in mixed environment, with the possibility to do a parametric release to the next step, a tableting process for instance.
Since the official launch on Interpack, 5 units have been sold : One multinational company in the US and one multinational in Europe bought the machine for their R&D department because of the proven improved quality of th end product after thorough investigation. Another important aspect in their decision process was avoiding scale up and fast deployment.
The 3 other machines were sold to generic suppliers in Europe and Mexico. Their decision was mainly based on 2 main factors:
GEA Pharma Systems, in line with the Consigma, have developed a continuous blender which can be used for premixing or mixing the external phase in to the granules in a continuous way. Courtoy developed advanced inline PAT on their tablet presses which allows us now to provide a full continuous production line of solid dosage forms. Such a line is currently under construction in our laboratory in Belgium.