The ConsiGma™ continuous tableting line (CTL) is a multipurpose platform that has been designed to transfer powder into coated tablets in development, pilot, clinical and production volumes in a single integrated unit.
The ConsiGma™ system is designed for plug flow, first-in first-out production (avoiding back mixing), providing consistent quality and allowing for the inline control of critical quality attributes.
The system can be configured to perform dosing and mixing of raw materials, wet or melt granulation (using the same co-rotating twin screw granulation unit), drying (cooling for melt granulation), tableting, coating and quality control, all in one line.
By producing granules continuously, batch sizes are determined by how long you run the machine or by how much inbound material is supplied; and, because of ConsiGma™’s innovative design, the amount of waste produced during start-up and shut down is significantly reduced compared with conventional methods. Quality is measured throughout the process and, as such, drastically reduces the cost per tablet. Critical quality attributes are measured second-by-second and any deviation from the norm is immediately reported to the operator.
ConsiGma™ was developed in compliance with the FDA’s QbD initiative. It satisfies the industry’s need for reduced risk and higher quality while avoiding lengthy and costly validation and scale-up to bring products to market faster and cheaper. The inherent flexibility enables manufacturers to meet demand, keep expensive cleanroom space to a minimum and reduce inventory costs.
Optionally integrated advanced process control and PAT tools enable monitoring during production, so quality can be designed into products from the start. ConsiGma™ provides maximum output in an energy efficient way, has been tested using more than 120 different formulations and is already being used by several large pharmaceutical companies, and both ethical and generic research and manufacturing centres worldwide.
ConsiGma™ offers
To enhance flexibility even further, the ConsiGma™ can also be configured for dry and melt granulation. The system can also be connected to the GEA MODUL™ tablet presses with an Exchangeable Compression Module (ECM) and a double drum ConsiGma™ coater to form a truly continuous tableting line.
The ConsiGma™ continuous high shear granulation and drying system is a multipurpose platform that consists of several modular blocks, which can be combined to form the continuous production line.
In the granulation module, up to four dry ingredients, or a premixed powder, are individually dosed and delivered to the continuous high shear granulator. The granulation liquid is also accurately dosed and thoroughly mixed with the dry components, resulting in a continuous flow of wet granules — of constant quality and density — that is subsequently transferred to the dryer. There are no over-sized agglomerates so a wet mill is not required.
The dryer module, based on the classic fluid bed drying principle, splits the continuous flow of granules into sections of the dryer. The sections are emptied and the product transferred to the evaluation module. The drying curve of each sample is monitored.
In the evaluation module, dried granules are received for dry milling. Here, critical quality attributes such as particle size distribution, humidity and content uniformity can be measured inline.
All captured data can be analyzed by the control system and parameters can be adjusted to keep the process within a narrow band of defined quality parameters.
The ConsiGma™ can process capacities from 500g up to tonnes, with time being the only variable. Batch size is determined simply by how long you run the machine.
With its light weight, ultra small size and modular construction, ConsiGma™ fits perfectly into every R&D department or existing tablet production room. No need to change the building, just wheel it in, connect the power and an air supply and off you go. Installation time and costs are reduced to a fraction of the current benchmark.
Feeding & blending module: If more than four components need to be mixed continuously, the ConsiGma™ line can be extended with a module to incorporate more ingredients. Dosing is achieved using loss-in-weight feeders that supply a low shear inline blender, which, in turn, feeds the high shear granulator.
Tablet compression module: The MODUL™ P rotary tablet press can be connected to the system to immediately convert the produced granules into tablets. The MODUL™ P offers equal final compression forces for all tablets and adjustable dwell times at pre- and final compression.
Tablet relaxation & coating module: If the final dosage form is a coated tablet, a continuous coater can also be integrated. As some tablets require "relaxation" time before coating to ensure optimal quality, a suitable system can be included.
Kurumsal basın bülteni
Wommelgem, Belgium
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