Fette Compacting has teamed up with Lechler and Merck to develop an innovative, washable air management system for tablet presses. The system enables fully automatic, validatable cleaning of exhaust air pipes under containment conditions, setting new standards in terms of safety and efficiency.

Containment, meaning the safe confinement of substances, is essential in pharmaceutical production. The protection of personnel and the environment is crucial, especially when dealing with highly active ingredients. “Today's containment solutions must do more than just seal off the production area,” explains Marcel Issmer, Group Manager Platform Management at Fette Compacting. “Modern concepts consider the entire process of a plant – from production to cleaning to maintenance.”

For highly active substances, Fette Compacting relies on proven high-containment systems with fully automatic cleaning of all components exposed to active ingredients. Sophisticated air management ensures safe air flow and reliable dust extraction. However, cleaning the complex air duct systems used to be a time-consuming task. “Methods such as flooding the pipes consume a lot of water, may not completely remove residues, or require manual reworking,” says Issmer. “That's why we wanted to create a better solution.”

Joining forces
The solution was developed in close cooperation between the three partners. Fette Compacting initiated the project as a containment expert. Lechler, an established supplier of washing jets, contributed its expertise in jet and flow technology. Boris Schmidt, team leader for computer-aided engineering at Lechler, explains: “Our task was to develop the jet concept for the complete cleaning of the branched air ducts. To do this, we carried out complex CFD simulations.”

Merck was one of several test customers providing the application environment at the new Launch and Technology Center (LTC) in Darmstadt, where highly active pharmaceuticals will be manufactured under the strictest containment conditions in the future.

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CFD simulation was used to determine the appropriate arrangement of the jets along the pipe.

Simulations showed the angle at which the rotating pop-up jets must be positioned to achieve optimal cleaning.

Digital test run
The CFD simulations carried out by Lechler played a decisive role in the development. “We mapped the entire pipe system in 3D and simulated the washing process in counterflow,” explains Schmidt. “This means we analyzed how the spray water behaves while an air flow is simultaneously present in the opposite direction. This enabled us to ensure that the containment conditions are maintained even during washing.” The simulations examined the complete wetting of all surfaces and the drainage of the washing water. This enabled Lechler to determine the optimal arrangement and positioning of rotating pop-up jets, which ensure uniform, dead space-free, and resource-saving cleaning. “These virtual tests enabled us to verify the concept at an early stage and significantly shorten the development time,” emphasizes Issmer.

From theory to practice
At Merck's LTC, the washable air management system was integrated into a high-containment facility with a 2090i WiP tablet press. The challenge was to extend the washing process to the inlet of the filter unit. This meant that a pipe length of approximately 30 meters had to be washed – other test customers had previously only had to wash around ten meters. To make this possible, a larger control cabinet was required to control more washing nozzles, among other things.

Thin tubes were attached to the air ducts at test customer Merck in Darmstadt to enable them to be cleaned.

Complex technology, simple operation
A key goal during development was to make operation as simple and safe as possible. That is why the control system is fully integrated into the tablet press's human-machine interface. The operator selects the appropriate washing program, and the entire cleaning process runs fully automatically. “Dust and highly active particles are reliably bound and removed during the washing process without any manual intervention,” emphasizes Issmer.

This not only ensures easy handling but also reduces the susceptibility to errors and significantly increases operator safety. In addition, all process parameters are documented seamlessly in the cleaning log.

Fourfold benefits at a glance

• Increased operator safety: No manual cleaning required and minimized exposure risk.

• Improved system integrity: Clean pipes increase component service life and prevent cross-contamination.

• Resource conservation: Lower water consumption compared to flooding.

• Validatability: The automated process is reproducible and GMP-compliant.
   

Tomorrow's industry standard
The washable air management system stands for innovation through cooperation. It combines maximum safety with efficiency and sustainability in a technology that is new to tablet presses. “Other customers are already interested in implementing the system,” reports Issmer. “This shows once again how important interdisciplinary cooperation is in the pharmaceutical industry.”