Optima expands for pharma filling & freeze-drying systems

New state-of-the-art assembly and testing systems 

New Optima CSPE center
With around 46,000 square feet (4,300 square meters) of production space, Optima's new CSPE Center will provide optimal conditions for processing the large order backlog. Source Optima

The Optima Group is building another CSPE Center at its headquarters in Schwaebisch Hall for assembly and comprehensive commissioning of pharmaceutical filling lines. This will expand the production area by around 46,000 square feet (4,300 square meters) and provide new office space. At Optima Pharma’s site in Gladenbach-Mornshausen (Hesse, Germany), the existing assembly hall for freeze-drying systems is being expanded by 50%. The investment is due to the high volume of orders received and ongoing developments in the Optima Group’s Pharma Division.

The Pharma Division of the group is particularly experiencing high demand for filling and packaging solutions. There was a short-term increase in the already high order backlog caused by the Covid-19 pandemic. In light of this, production capacities are being expanded at the Schwaebisch Hall and Gladenbach-Mornshausen (Marburg-Biedenkopf County, Hesse) sites. 

EOT crane in CPSE Center Optima
In the CSPE Center, a crane system is used to place isolators on top of the filling systems. The assembly hall offers maximum safety and helps speed up process flows. Source Optima

Fast process flows and short time-to-market

Optima Pharma opened its first CSPE (Comprehensive Scientific Process Engineering) Center at its headquarters in Schwaebisch Hall, Germany, in June 2019. Since then, the CSPE Center has been fully utilized, so the new building is 25% larger, with an almost identical design. The expected completion date is late 2021. 

The CSPE expedites processes from system design to production start. One aspect is the integrated (complete) Factory Acceptance Tests of entire lines (iFATs). With a total area of around 75,000 square feet (7,000 square meters), the new building has state-of-the-art equipment, enabling joint Factory Acceptance Tests of the filling and closing systems and isolators under realistic production conditions. 

Optima first CPSE Center
Optima Pharma’s first CSPE Center (pictured on the right) was in operation by June 2019. Source Optima

In the approximately 46,000-square-foot (4,300-square-meter) assembly area, the emerging pharmaceutical lines will be supplied with process heating and cooling and demineralized water and compressed air via supply lines during commissioning, cycle development, and integrated FAT (iFAT). CSPE Center testing ensures that both the subsequent installation and the Site Acceptance Test (SAT) at the customer’s site proceed much faster. For Optima’s customers, this shortens the time from product development to market launch by several months. The building will have a separate logistics area. The employees will also enjoy optimal working conditions in the spaciously designed three-floor office building. 

The CSPE approach takes effect – CSPE 2.0 is in the wings

The successful concept will continue to grow. “Integration levels are set to become even greater in the future, as part of CSPE 2.0. Work that in the past typically took place on the customer’s site will have already been carried out to an even greater extent in one of our CSPE Centers,” says Gerhard Breu, chairman of the Optima Pharma Division. Another customer request concerns GMP-compliant cycle development, which can be handled entirely by Optima Pharma in the future. “This again significantly increases the level of integration, which, in turn, shortens the commissioning phase at the customer’s site even further,” Breu explains. 

Extension at Optima Pharma site completed in record time

An expansion of capacity was also needed at the Optima Pharma site in Gladenbach-Mornshausen. The freeze-drying systems manufactured there are used in many turnkey projects, together with filling and closing lines from Schwaebisch Hall or as a stand-alone solution. The existing multi-story assembly hall with approximately 27,000 square feet (2,500 square meters) of assembly space is being expanded by around 11,000 square feet (1,000 square meters). “This investment will enable us to further increase our production and thus create the best conditions for further growth at the Gladenbach-Mornshausen site,” explains Stephan Reuter, the managing director. The groundbreaking ceremony took place in October 2020. 

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