CSPE: Turbo Boost for Turnkey

Today, Koyuncular knows how to avoid these and similar hurdles in the complex process from planning to operating a plant. He has broken down the different stages of CSPE in detail – from predesign and mock-up construction through design, basic commissioning of the isolator, and construction and commissioning of the complete line to pre-cycle development and iFAT; almost every single step has been recorded. Thanks to these intensive tests, turnkey systems then master the stage leading up to media fi ll at the user’s site much faster than before. 
“The challenge is that some of our teams, who in the past operated more or less independently from one another, have to work hand in hand as part of the CSPE concept,” says Koyuncular. This requires discipline and restricts certain freedoms. In the future, everyone’s tasks and the exact timeframe for their completion will be defined. As process owner, Koyuncular monitors everything and ensures that everyone involved complies with the plan. The goal is to avoid unnecessary standstills and redundant overlaps of certain activities. 
Various turnkey projects are currently in one of the CSPE steps. Even if they started before the new Optima standard was adopted, they still benefit from the advantages of an integrated FAT, at least during the final stages. Methods such as digital engineering and simulation have, incidentally, been used for a long time in all Optima projects. The resulting valuable input can thus also be applied to line commissioning in these projects.

Next a mock-up is prepared, which for the first time shows the entire system including the isolator – if only as a model. Any positioning of gloves, doors, or environmental monitoring systems (EMS), for example, will later affect the isolator load and thus the VHP cycle. Here too, customers like LEO Pharma benefit from the consistently systematic approach, which minimizes time lost. 
In the meantime, LEO Pharma's turnkey plant has already gone through the engineering stage. Koyuncular’s breakdown clearly shows the customer that nothing is left to chance here. For example, detailed flow simulations or strength calculations highlight weaknesses long before the first mechanic even reaches for a wrench. The system is optimized first and foremost during this stage: through calculations based on the 3D data and simulations provided by the simulation team. If necessary, there are also second and third simulation and revision rounds. “For LEO Pharma, that wasn’t necessary. The technical engineering team had done a great job right from the outset,” says Koyuncular. In fact, however, insights obtained from simulations in comparable earlier plants were also incorporated. Koyuncular adds: “In our approach, the technical engineering and simulation teams benefit time and time again from feedback from the iFAT. This makes our models increasingly precise and reliable.” The P&ID planning and the interface concept, for example, could be finalized in no time for this project. Just as straightforward was the coordination of the security concept between Optima and M+P. Here, the fact that all plant components come from a single source has already paid off.

During commissioning, the comprehensive approach of the new method pays off once more: the quality of the basic settings for the machines are no longer dependent on the experience of the technicians. Rather, digital engineering and simulations together provide the basic parameters with high accuracy. Subsequent fine-tuning and pre-cycle development are much faster than before. The Chairman of Optima Pharma explains: “We’re seeing an essential paradigm shift here. Especially as the models are becoming more and more accurate as experiences are fed back. Simulation can even support later modifications to already delivered systems. We're switching from an experience-based model to an integral, data-driven model that leads to continuous improvement deterministically and no longer randomly,” says Breu.
After delivery to LEO Pharma, the system will be positioned in a cleanroom – unlike at Optima. “Other environmental conditions usually bring with them a certainrequalifi cation effort,” states Koyuncular, “but in the projects we have already completed, this was necessary only to a lesser extent than usual. Much of what has been qualified by us can be simply taken over, along with the relevant documentation. "This not only saves customers valuable time until the start of production, but also manpower. Anyone who has had to use expensive freelancers for requalification, for example, can now have this important task taken care of by their own employees – and thus also keep the knowledge gained in-house.