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High-Containment in Mexico – coordinated operator protection

Two high-containment plants have been commissioned at the Mexican pharmaceuticals manufacturer, PiSA Farmacéutica. Specialists in solid formulations at Fette Compacting supplied two tablet presses for highly-active substances and are still acting as a central contact partner.

Containment 1090i

PiSA Farmacéutica has every reason to celebrate: in September 2020, the Mexican pharmaceuticals company commissioned two high-containment plants for the production of highly-active medication in its factory in Tlajomulco, following a successful Site Acceptance Test (SAT). Both plants were realized by Fette Compacting and its partners from the Excellence United alliance over the course of the past two years.

The heart piece of the new plants is represented by two i Series tablet presses from Fette Compacting. Highly-active immunosuppressive drugs are produced on the 1090i WiP single-rotary press while the 3090i WiP double-rotary press is used for the production of cancer medication.

Both machines feature highly-efficient containment technology, with level 5 of the Containment Guard developed by Fette Compacting ensuring maximum operator protection. In order to process highly-toxic substances efficiently, the process equipment is integrated in the isolator in wash-in-place (WIP) tablet presses. Automated cleaning of the tablet presses relieves the operator while reducing machine downtimes.

Efficient comprehensive support
Apart from the tablet presses supplied by Fette Compacting, the production lines also include components from Glatt and Uhlmann Pac-Systeme. Fette Compacting assumed the role of coordinator and contact partner for the entire project. Having one key point of contact was a decisive factor for PiSA: “We were on the lookout for a reliable partner capable of taking charge of the entire process from production through packaging as well as supplying and supporting the entire plant from a single source,” says Adriana Contreras, Engineering Director in Tlajomulco. “We found this partner in the form of Fette Compacting.”

Even after installation of the plants, PiSA continues to align any potential service issues with the specialists in solid formulations in Schwarzenbek. “If there are problems with one of the machines, PiSA always contacts us, even if the problem does not concern one of our tablet presses,” explains Andres Garcia, Managing Director Fette Compacting Mexico.

Impressive from the start
The intensive trust between PiSA and Fette Compacting has grown bit by bit over the years. “We have been collaborating with PiSA since 2011,” claims Garcia. “Back then, we supplied two 2200i tablet presses. Although we did not have our own subsidiary in Mexico at the time, this initial contact laid the foundations for cooperation in the years to follow.”

The major breakthrough came in 2014 with a presentation by Fette Compacting at the Exopack Mexico. A PiSA representative was inspired by the machine manufacturer’s product presentations and ordered two FE35 tablet presses shortly after. Presentation of fast and easy conversion of the FE35 live at the Exopack stand was particularly impressive.

Reliable machines, comprehensive service
But the technical quality of the machines is not solely decisive for this long-term collaboration. PiSA was particularly convinced by the service offered by Fette Compacting right from the start: “We were on the lookout for reliable machines offered by a supplier also offering an extensive range of services and maintenance,” reports Luis Marcos Mancera, Maintenance Manager at the PiSA tableting plant in Tlajomulco.

Supporting the machines during operation requires permanent availability and short response times. When problems arise with a tablet press, technicians are swiftly on hand to remedy the fault. The service team is available around the clock and is also on call over the weekend. What‘s more, Garcia and his team conduct training courses to ensure that PiSA employees are familiarized with new machines and always capable of operating them with maximum efficiency.

“What has made Fette Compacting such a valuable partner is not only its modern and ultra-precise technology but also its excellent service offered in the form of machine support,” sums up Luis Marcos Mancera.

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