Even more efficient, faster and more comprehensive – Optima Pharma's CSPE approach is undergoing further optimization under the name CSPE 2.0. With the valuable experience gained from numerous projects, we are continuing to expand the successful concept for our customers and are creating the right conditions for it. The new CSPE Center II now provides 4,300 square meters more space for assembly, commissioning and qualification testing of filling and closing equipment, isolators – and now freeze dryers too. Delivering fully tested turnkey systems saves time on site and means that production can be launched more quickly and reliably.
The CSPE (Comprehensive Scientific Process Engineering) approach is a comprehensive, science-based concept that reduces the time from system design to production start-up. Optima Pharma has developed the CSPE concept to do everything in its power to reduce the time-to-market for its customers' products while maintaining the highest possible quality at delivery. As a comprehensive system provider, Optima Pharma now handles further qualification measures in-house, including significant further parts of cycle development. This significantly reduces the time needed between installation and the start of production at the customer's site, thereby cutting the overall time for customers from product development to market launch.
As of this year, Optima Pharma has considerably more space to carry out this comprehensive work. The new CSPE Center II was opened in May 2022 at Optima Pharma's headquarters in Schwaebisch Hall, Germany, in conjunction with the Optima Group's 100th anniversary celebrations. This means that 4,300 more square meters of assembly space are now available. “The CSPE Center II sends out an important signal: Despite the pandemic and the challenges associated with it, we are investing in the future, creating jobs and even more efficient processes for our customers,” says Gerhard Breu, Chairman of the Optima Pharma Division. A three-story office building complements the state-of-the-art assembly hall.
“As part of CSPE 2.0, we are increasing the integration level of the systems even further. Work that had typically been carried out at the customer's construction site will now be carried out to an even greater extent at one of our CSPE centers,” explains Breu. “More specifically, we are carrying out most of the Installation Qualification (IQ) and Operational Qualification (OQ), as well as part of the Performance Qualification (PQ) for all line components, i.e., filling line, isolator, and freeze dryer, on our site before shipment,” adds Matthias Naser, Optima Pharma's Chief Operating Officer. In the CSPE Center II, which is 14 meters high, freeze dryers can now be assembled with the other system components and tested under real-life conditions as a complete functioning unit.
Simulation und Digital Engineering unterstützen die Planung der komplexen Turnkey-Anlagen. Bereits bei der Auslegung der Anlagen optimiert Optima Pharma die Verteilung von VHP (Vapour Hydrogen Peroxide) im Isolator. Mithilfe der Simulation schaffen wir beste Ausgangsbedingungen für die Zyklusentwicklung. Zielsicher werden geeignete Positionen für die Indikatoren bei der Zyklusentwicklung bestimmt. In der späteren abschließenden Zyklusverifizierung und -validierung vor Ort (Teil der Performance Qualification) kann das Simulationsergebnis, bestätigt durch die Zyklusvalidierung, als Nachweis eines sicheren Dekontaminationsprozesses herangezogen werden. Tests vor Ort müssen in vielen Fällen nicht wiederholt werden, was wertvolle Zeit bis zum Produktionsstart einspart. Die Installations- und Qualifizierungszeit am Standort des Kunden wird um mehrere Monate reduziert. Die Anlagen sind bereits deutlich näher am „ready for production“, wenn sie das CSPE-Center verlassen.
Media troughs running in the floor make it possible to supply the completed pharmaceutical filling line for the integrated Factory Acceptance Test (iFAT) with process heating and cooling, demineralized water and compressed air. The tests carried out in the CSPE Center ensure that both the later installation and the Site Acceptance Test (SAT) conducted on the customer's premises run much more smoothly and rapidly. Alongside simulations and cycle developments, the comprehensive iFATs also include interface and safety circuit tests, leak and smoke tests, automation and software application tests, as well as SCADA integration. Optima Pharma's range of services includes extensive qualification testing for the entire production line, including isolator and freeze dryer tests. In short, Optima Pharma's customers receive a turnkey line tested to the maximum for a significantly safer and faster production launch.
Optima Pharma's worldwide service personnel, which is being tripled in the USA, for example, from 2019 to the end of 2022, will also ensure “production readiness” 24/7. A new service hub is opening in Raleigh, North Carolina in 2022 (see the report on pages 12 to 13). Here, Optima Pharma will be offering comprehensive services, sales of systems and spare parts as well as training. The aim is to be able to provide better, more rapid support to customers in the Pharma sector. “The new service hub will bring us even closer to our customers and allows us to provide faster service along with enhanced spare parts availability,” explains Ulrich Unterriker, Managing Director of Optima Machinery Corporation in Green Bay, Wisconsin.
Meanwhile, back in Schwaebisch Hall, Germany: For Optima Pharma, the new building means short distances, a pooling of strengths and efficient operating processes. The experience gained from operating CSPE Center I was incorporated into the design and led to further streamlining. It is designed to be 25% larger and provides even more space for the large turnkey lines. System modules are transported smoothly and quickly by cranes with an 8.5 meter hook height from incoming goods to the assembly hall. Along with the adjoining three-story office building, the new structure covers 7,000 square meters.
Optima Pharma inaugurated the first CSPE Center in June 2019 at its headquarters in Schwaebisch Hall. Ever since, CSPE Center I has been operating at full capacity. At Optima Pharma's Gladenbach-Mornshausen site, the existing assembly hall for freeze drying systems has been extended by 50% in the past year. An expanded building with office and assembly space is being planned at Optima's subsidiary Metall+Plastic in Radolfzell on Lake Constance. If the strong growth continues, CSPE Center II can be expanded to the south to include another CSPE Center with access to the CSPE Center II loading yard.
Project experience has shown that CSPE is successful. The scientifically validated, comprehensive approach to engineering expedites the implementation of turnkey projects. In any case, customers who order complete systems benefit from fewer “friction losses”, as any interface problems will have already been resolved on the supplier's premises. That's how CSPE delivers what it promises. The system is “production ready” in the fastest possible time.