Producers of pharmaceuticals who have to deal with dust during their process know this. Where ATEX zone 20 applies, they must not compromise on explosion protection. By definition, this classification means that an explosive atmosphere caused by dust is to be expected "continuously, for long periods or frequently". Effective explosion protection is achieved, for example, by displacing the oxygen in the production area through inertisation. Or by using category 1 equipment. This category of equipment ensures that effective ignition sources are avoided even in the event of infrequent malfunctions.
This applies, for example, to the mixers that Gericke offers for the continuous production of solids. With a minimum ignition energy of one millijoule (mJ), they are approved for use when handling combustible dusts. These mixers therefore enable "continuous manufacturing" in the pharmaceutical industry, as recommended by the FDA, even when combustible dusts may occur.
More efficient production thanks to continuous mixers
Operational excellence is now feasible for numerous other pharmaceutical manufacturers. They can switch from the discontinuous batch to continuous production that has prevailed to date in the manufacture of granules and tablets. Not only the production process for active pharmaceutical ingredients (API), but also the mixing of excipients and active ingredients, benefits from the move away from the batch process. In GMP processes, the potential that other industries such as chemicals and food have long been utilising can be exploited.
Continuous processes
- allow smaller machines and therefore a reduced infrastructure, for example for temperature control.
- reduce unproductive times that occur in batch processes, for example due to emptying or cleaning the system.
- increase production output.
- ensure high product quality, as operating errors occur less frequently.
- reduce the consumption of cleaning agents.
- reduce maintenance and servicing costs, as pressure and temperature changes only occur when starting up and shutting down the systems.
Optimum mixing with low active ingredient content
Gericke combines radial and axial dispersion in its continuous mixers. According to the manufacturer, they guarantee a high degree of homogeneity, even for formulations with less than one per cent active ingredient content. The mixers can be integrated into a skid, the so-called Gericke Formulation Skid GFS. This creates an inline production line for oral solid dosage forms. Gericke also offers continuous mixers for laboratory use and for pilot plants.
Other suppliers of continuous mixers regularly exhibit at POWTECH TECHNOPHARM. However, it is important to take a close look: Do they have the appropriate ATEX approval? And are they also suitable for GMP processes in the pharmaceutical industry?
Shaft plus paddle for solids and liquids
Dinnissen Process Technology announced the new ATEX certification of its continuous mixers back in 2020. The Pegasus line has ATEX Zone 20 certification (inside). The mixers can be integrated into existing production lines. They are suitable for surface temperatures of up to 135 °C and a minimum ignition energy (MIE) of 3 millijoules (mJ). Pegasus continuous mixers work with a continuously rotating shaft with paddles. They are suitable for solid and liquid substances in various industries, including chemicals and minerals in addition to food and pharmaceuticals. The products to be mixed are added from above; liquid products are distributed by means of a spray system.
