Pharmaceutical production: Switch to Konti in ATEX zone 20
3/4/2024 Production Article

Pharmaceutical production: Switch to Konti in ATEX zone 20

Continuous production promises more profitable processes and higher product quality. More and more companies in the pharmaceutical industry are also making the switch since the FDA and EMA have not only made this easier, but even encouraged it. Mixing technology is often at the centre of the equipment. Designs suitable for pharmaceutical continuous processes are available from various suppliers. Some also ensure dust explosion protection in ATEX zone 20.

Continuous Blender from Gericke – Close-Up With Gericke's ATEX 20-approved continuous mixers, continuous manufacturing of solids is also possible in the presence of combustible dusts.

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.

multi-chamber homogenising and dispersing machine With the IKA solution, the liquid phase is injected into the mixing area from the side. Solids are fed in from above; the finished mixed product is discharged at the bottom.

Crushing granulates simultaneously

IKA offers a multi-chamber homogenising and dispersing machine (MHD for short) for the continuous mixing of solid and liquid products. The MHD system achieves good dispersing results with a single passage. Among other things, it is suitable when up to 80 % solids are to be introduced, even if the liquid phase is already highly viscous. Granular solids can also be mechanically comminuted at the same time. IKA also offers a laboratory machine to simplify scale-up. The machine supports production in accordance with the EHEDG guidelines (European Hygienic Engineering and Design Group) and is CIP/SIP-capable. Explosion-proof versions in accordance with the ATEX 95 directive are also available.

CoriMix The CoriMix ring-pan mixer can be customised to the product requirements by selecting different mixing tools.

Horizontal mixing of pasty components

Lödige offers ring-pan mixers for continuous operation. The CoriMix is a horizontal mixer that has been specially developed for the homogeneous mixing of liquid or pasty components into powdery bulk materials. It is also suitable for a wide range of applications, including pharmaceuticals and food. The mixer rotates at a high speed. This results in a centrifugal force that forces the product against the mixing wall. There it is pushed through the mixing chamber. Liquids can be added through the drum wall or inside via a hollow shaft. This continuous mixer is also ATEX-compliant.

Flexible use as a batch or continuous mixer

The AMK mixing systems from amixon can be integrated into continuous production processes or operated as batch mixers. They are suitable for dry, moist, and suspended goods. Products can be both gently homogenised and intensively deagglomerated. The highest hygiene standards are achieved, and the interior of the vessel is certified as ATEX zone 20. With the AMK design, which utilises the boiler flow, the mixer drive only starts at half the filling level. From a filling level of approx. 80% of the useful content, the discharge unit opens. The filling level is then maintained until the end of production. The mixer empties continuously until the last residue remains.

Coperion ZSK MEGAlab extruder in pharmaceutical design New design, new functions: The laboratory extruder from Coperion benefits from shorter downtimes for screw changes and maintenance, among other things.

Optimised pharmaceutical laboratory extruder

Coperion also offers continuous and semi-continuous production processes, including the Coperion ZSK MEGAlab extruder in pharmaceutical design. It can be designed for different safety levels, cleaning methods and access options. Pharmaceutical extruders are available for laboratory scale and product development applications as well as for continuous production systems. In the GMP-compliant system design, all parts in contact with the product are made of stainless steel (3.1). The supplier uses FDA-compliant oils/lubricants. An optimised version of the ZSK 18 MEGAlab laboratory extruder was presented in January 2024. New features include plug-in heating cartridges for fast housing conversion and an electrically lockable maintenance door. A dosing rack for up to four dosing units enables the variable addition of ingredients. The associated control cabinet is also available in various versions, including stainless steel or as a terminal box - for ATEX requirements.


Ulla Reutner

Dr. Ulla Reutner

Chemist and freelance specialised journalist