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CSPE reduces the time span between designing the system and the start of production. After numerous turnkey projects involving the use of the turbo booster, Gerhard Breu, Chairman of the Optima Pharma Division, takes stock and gives an insight into how CSPE will become even more effective in the future.
"Comprehensive Scientific Process Engineering" – the term coined at Optima Pharma in 2018 sounds rather awkward and complex. The idea behind it is no less complex. Large turnkey system construction projects would be accelerated sustainably and the associated risks minimized by using a comprehensive, scientifically based concept. Has it succeeded?
As part of CSPE 2.0, we will continue to increase the level of integration of the pharmaceutical lines.
Many of the customers who have benefited from CSPE since then think – yes, definitely. Among them are two contract manufacturers that had already started up several new systems for filling COVID-19 vaccines in early 2021. The green light for developing these lines came in the spring of 2020, just as the first lockdown was paralyzing all of Europe and vaccine development was still in its infancy. At breakneck speed, three filling lines that had been intended for other products were reconfigured. They were able to be delivered in the shortest possible time. Three more filling systems are currently being built, and once again CSPE is ensuring that the phase leading up to the start of production can be considerably accelerated.
Optima Pharma has developed the CSPE concept to do everything in its power to shorten the time-to-market for its customers' products. Optima, as a total system provider, also performs a significantly higher proportion of the services involved in constructing complex pharmaceutical systems in-house. This drastically reduces the time required between the start of installation and starting production at the customer's site.
Even the risk analysis performed before the actual project starts is shaped by CSPE. The consistency shown by all departments in identifying potential hurdles is exemplary. They draw on the workflows of similar, past projects to do this. Every work step that used to be a time-waster is now optimized. This paves the way for the current project to run smoothly. In the design phase, the developers rely on digital engineering, and do so in an extremely systematic manner. Methods like CFD (computational fluid dynamics) and strength calculations have been part of the engineering toolbox for many years.
Modeling plant components in the context of digital engineering allows errors to be eliminated at an early engineering stage.
The systems, almost in the same way as in subsequent production, are supplied with ultrapure water, steam, and coolant, etc. via the media channels in the CSPE Center.
In the context of CSPE, they are given an even higher priority throughout the entire life cycle of a system. For example, if the customer makes changes to certain process conditions at a later date, Optima Pharma can make a virtual "tweak". This makes it possible to anticipate any problems that may result from the change. Simulation and digital engineering also assist with the planning of the sterilization process. At Optima, cycle development is already taking place. Simulation is used to optimize the dispersion of VHP (vaporized hydrogen peroxide) in the isolator. Suitable positions for the bio-indicators during pre-cycle development are defined. The simulation result can be used in the subsequent performance qualification as proof of a safe decontamination process.
Digital engineering also produces a virtual preliminary mock-up. With its help, the system's designers and future operators can experience it in virtual reality. Even before the wooden mock-up is built, they can get an idea of accessibility and are able to make quite a few suggestions for improvements. However, there is still a need for the wooden mock-up, among other things to test the handling of heavy or particularly sensitive components. The virtual mock-up can be used in two ways at once because it also does a good job for training purposes.
Another extremely helpful aspect is the option of carrying out an iFAT (integrated Factory Acceptance Test) for turnkey systems comprising filling and closing machines, isolators, and freeze dryers. To this end, Optima Pharma commissioned the CSPE Center with its 4,600 square meters of space in 2019. It provides enough space for the large turnkey lines. They can operate in real conditions here, almost in the same way as in the subsequent production phase. Media channels run along the floor, and all line components can be quickly connected to them. This is how the finished pharmaceutical line for the iFAT is supplied with process heating or cooling, demineralized water, and compressed air. The tests carried out in the CSPE Center ensure that the subsequent installation and the Site Acceptance Test (SAT) at the customer's site are both significantly faster.
In the meantime, the CSPE Center is being fully utilized, and the next one is being built – and it will be 25 percent larger than the first one. It is scheduled for completion by the end of 2021 because the CSPE concept, including the pre-cycle development and iFAT, impresses Optima's customers across the board.
Gerhard Breu, Chairman of the Optima Pharma Division, is pleased to receive their very positive feedback, as well as further input. These suggestions for improvement are already having an impact. Breu announces, "Integration levels are set to become even higher in future, as part of CSPE 2.0. Work that, up to now, has typically been done on the customer's construction site will be carried out to an even greater extent in one of our CSPE centers."
Project experience shows that CSPE is successful. The scientifically validated, comprehensive approach to engineering expedites the implementation of turnkey projects. In any case, those customers who order complete lines benefit from fewer "friction losses", as any interface problems will have already been resolved on the supplier's premises. So CSPE delivers what it promises. The system is "production ready" in best time.
