Traditionally, the pharmaceutical industry has relied on batch manufacturing processes to produce drugs wherein materials are charged before the start of the process and discharged at the end. Ironically, most other, less regulated industries transitioned to continuous manufacturing (CM) at the time of the industrial revolution. CM, during which material is simultaneously charged and discharged from the process, is generally considered to be more efficient as it consistently delivers a higher quality product.
The ConsiGma™ Solution
At GEA, we believe that continuous processing improves the quality of pharmaceutical end products: by focusing on quality during the whole product lifecycle, not just “tested in” quality; and by understanding the capability of your processes, managing sources of variability and decreasing any associated risks.
Tablet presses have always operated continuously; until now, however, they have mainly been used in batch mode — because of regulatory restrictions and the fact that the granules were delivered to the press in batches. Both of these hurdles to continuous tableting have been removed in recent years.
The ConsiGma™ is a multipurpose platform that has been designed to transfer powder into coated tablets in development, pilot, clinical and production volumes in a single compact unit. The system can perform dosing and mixing of raw materials, wet or dry granulation, drying, tableting and quality control, all in one line. By producing granules continuously, batch sizes are determined by how long you run the machine; 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.
Multiple Dispensing Options
The full tablet production line consists of the ConsiGma™ high shear granulator and dryer, combined with a MODUL™ P rotary tablet press. A special in-line blender mixes in the external phase between the systems. The granulator and dryer section has three modules: a wet high-shear granulation module, a segmented dryer module and an evaluation module.
The MODUL™ P rotary tablet press is based on the innovative Exchangeable Compression Module (ECM) concept. The ECM is completely isolated from the remainder of the machine, contains all product contact parts and can easily be removed from the press in a contained way. This means that the press itself remains powder-free and requires no cleaning. The six compression modes available in the press make it ideally suited for this continuous tableting line, allowing easy R&D and perfect production, with dual control for independent weight and hardness control, and equal porosity tableting. The constant dwell time regardless of throughput fits perfectly in a continuous line because it enables the press to change its speed when necessary – for example, when a sample is taken in between drying and tableting.
Low Risk, High Compliance
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 the maximum output in an energy efficient way, has been tested using more than 100 different formulations and is already being used by several large pharmaceutical companies, and ethical and generic research and manufacturing centres worldwide.