Excellence United – Bundled competence in Mexico

Excellence United and PiSA Bundled competence in Mexico

Three partners in the Excellence United alliance have realized two comprehensive high-containment plants for the Mexican pharmaceuticals manufacturer PiSA Farmacéutica. Fette Compacting, Glatt and Uhlmann impressed with all-inclusive support and tight project organization.

In September 2020, the time had come: following successful completion of the Site Acceptance Test (SAT), the Mexican pharmaceutical company PiSA Farmacéutica was able to commission two high-containment plants for the production of highly-effective medication in its factory in Tlajomulco. One with protection class OEB3 for the production of immuno-suppressants, one with protection class OEB5 for cancer drugs.

The two plants were realized by the partner companies Fette Compacting, Glatt and Uhlmann. “PiSA presented us with an exciting challenge in the form of this project,” reports Andres Garcia, Managing Director of Fette Compacting Mexico, who is responsible for coordinating the major order. “Implementation was made possible by a strong partnership in a powerful competence network, combined with a tight project organization.”

The right components

The two production lines contain several Glatt components, including the VG Pro 400 high shear granulation system, the WSG PRO 60 fluid bed system, the GCC 350 drum coater, the CWM 800 container washing machine, and the KCM 1200 container blender – all in complete containment design.

Glatt also assumed the role of system integrator. The scope of supply, from weighing in the isolator to feeding the tablet presses, tablet coaters and packaging equipment, included comprehensive material handling for all process steps.

With its 3090i WiP and the smaller 1090i WiP, Fette Compacting contributed two tablet presses for different production volumes. The immuno-suppressants are produced on the 1090i WiP single-rotary tablet press, while the 3090i WiP double-rotary tablet press is used for the production of oncological preparations. Both tablet presses are equipped with highly-efficient containment technology that ensures maximum operator protection with Level 5 of the Containment Guard developed by Fette Compacting.

Uhlmann, the expert in digital packaging solutions, supplies both the BEC 300 blister line for small and medium batches of 10,000 to 70,000 packs and the Pexcite digital solution. The state-of-the-art packaging line is capable of processing all common solid formats and offers particularly high flexibility thanks to fast format changes in less than 30 minutes. Pexcite ensures digital integration of all production machines – Glatt, Fette and Uhlmann. This software solution incorporates all the data of a production and packaging line on a single platform and makes it usable in a variety of ways. This opens up entirely new possibilities in terms of optimization, performance, quality, efficiency and safety. Batch handling, production handling, OEE monitoring, audit trail, and supervisory control become visible and can be accessed at any time, even remotely.

Reliable partners

In close collaboration, the alliance partners implemented all of the requirements on the plant’s high tightness standards at a maximum technical level. They were also particularly convincing in terms of their ability to bundle the many complex stages of the project and optimally coordinate all of the processes.

“We wanted to have these two major projects managed from a single source,” recalls Gustavo Mezzalira, Manufacturing Director at PiSA. “That's why we attached great importance to our partners being able to supply all the machines, oversee full project handling, and channel all the services for us. This is exactly what the Excellence United alliance partners were able to offer us.”

“We attached great importance to our partners being able to supply all the machines, oversee full project handling, and channel all services. This is exactly what the Excellence United alliance partners were able to offer us.”
Gustavo Mezzalira, Manufacturing Director at PiSA

The function of project coordinator and central contact person was assumed by Fette Compacting in Mexico in order to ensure customer proximity during the project. Even after the installation of the equipment, PiSA addresses all service requests to the local solid formula specialists in Mexico. “If there are any difficulties with one of the machines, PiSA always turns to the local partners, where qualified service technicians can help immediately,” explains Andres Garcia.

Major order for the alliance

Trust between PiSA and the Excellence United partners has continued to grow over the years. Experts at Glatt have been working with the company since 1986 and have repeatedly delivered precisely tailored process solutions for complex tasks.

Fette Compacting and PiSA have also known each other for a long time. In 2011, the tableting specialists supplied the company with two 2200i tablet presses for the first time. The major breakthrough in cooperation came three years later at the Exopack Mexico trade show, where Fette Compacting impressed with its FE35 tablet press.

And when it came to realizing two complete manufacturing lines at the highest containment level, the solid formula specialists in Mexico were the first points of contact. Through intensive meetings and workshops, the Excellence United partners succeeded in convincing those responsible at PiSA of the huge synergy effects associated with collaborative project management.

“It took eight months for PiSA to finally reach the decision to award the order to Excellence United”, adds Garcia. “Everyone involved at Fette Compacting, Glatt and Uhlmann invested a great deal of effort in the entire process and were all very convincing. This effort paid off in the end – for both the client and the alliance.”

PiSA Farmacéutica

Mexican pharmaceutical company PiSA Farmacéutica has been developing products and services for public and private healthcare providers in Mexico, the United States, Latin America and the Caribbean for more than 75 years. PiSA manufactures more than 90 different pharmaceutical preparations, including products from the area of anesthesiology and intensive medicine as well as prescription drugs.

Andrés Garcia
Managing Director, Fette Compacting Mexiko