Bringing Engineering to a New Level: ZETA’s Integrated Approach – Pharmaceutical Technology

ZETA provides the best-in-class services and customised solutions to specific problems of its customers. Relying on efficient concepts and with a strong emphasis on sustainability, ZETA manages projects of various size and complexity as supplier of process technology, engineering, or as general planner.

In the following interview, Johannes Koch, Associate Director Business Line Engineering & Services, gives some valuable insights into ZETA’s integrated approach and reveals what he considers the key success factors in engineering and project delivery.

Integrated engineering

One of ZETA’s outstanding characteristics is the way the company combines its engineering force with its powers as project delivery partner. What is ZETA’s key to success in providing design and build solutions?

“The pharma or biotech process plant has always been ZETA’s backbone and original focus. When we speak about integrated delivery, we tackle all aspects of such a plant across all project phases. Having vast experience in a variety of delivery models, ZETA consults and supports as early as a CAPEX project may need to be set up, looking at various options with or without a feasibility study followed by the canonical engineering phases.

“Importantly, ZETA can then also fully deliver the process plant with all procurement activities, manufacturing in our in-house shop floors, providing outstanding dynamic testing possibilities, transferring the plant to site, performing the installation works followed by SAT or CQV activities. Here, ZETA does not separate between an engineering team and a delivery team but stands for true end-to-end delivery with a one-team approach.”

End-to-end across a wide range of activities certainly involves a vast variety of people in terms of experience and skillsets. This bears enormous potential but also poses challenges. How is ZETA dealing with those issues?

“At ZETA, we do not just put specialists together, but we also clearly follow an integrated approach team-wise with the one-team strategy. We allocate the experts required to tackle the respective problem. The core team is carefully selected for each individual project or task at hand to remain constant for the whole project. Specifically, this translates to one core team ensuring project delivery throughout all phases of the project, from earliest development to operations.”

End-to-end solutions

ZETA attaches great emphasis to the fact that its approach as a solution provider is an integrated approach. Could you describe what this implies for the customer?

“On a global picture, we define integrated support of projects totally end to end. In fact, we are able to offer integrated development far before a CAPEX project has been picturised, and after delivery of a capex project to continuously support in operations. Thereby, we are spanning the arc from laboratory, via the CAPEX project delivery, into operations – the full lifecycle of a plant.”

Operational support is not something you would expect at first glance from experts in project delivery. Please give some examples of the support you provide in operations!

“Be it with support in PQ/PPQ or ramp up or maintenance/service or smaller modifications, automation support or our smart engineering services with having applications out of the digital twin of our engineering data, debottlenecking with process simulations, batch optimisations, and so on. If necessary, our specialists even accompany the customer’s production staff during the first months of production.”

Digital strategies

Leveraging digital strategies holds significant promise in addressing many of the difficulties the pharma industry is facing nowadays, like high development costs, an enormous market competition and pressing time-to-market requirements. ZETA has a very appealing approach toward digitalisation. What is digital integrated engineering and why is it crucial for the delivery of full CAPEX projects?

“We employ a centralised, digital platform, covering all disciplines. We call it SES – Smart Engineering Services. Since it is database-driven, the specific objects exist only once, providing true actual information to all engineers involved, backed up by a huge catalogue of real devices for a targeted engineering approach.

“Integrated workflows define the tasks and their timing. Changes are visualised real-time, and ensure coherent engineering, drastically reducing the failure rate, improving the time requirements, and enabling the digital twin, which is useful for various applications, like integrated digital testing, just to mention one application that allows to execute all FAT/SAT activities based on the digitally available data in a fully digital mobile environment, minimising errors and reducing work.

“As the system is hosted in the cloud, following GDRP guidelines, a real time access is globally available. By linking our planning tool directly to our ERP system, we are exceptionally fast, reliable, and cost-efficient also in our supply chain.”

Recently, two digital products have complemented the portfolio and were integrated into ZETA’s digital tool landscape: the modelling and simulation software suite INOSIM Insight, and the INOSIM Foresight platform for predictive decision support in operation. How does this bring engineering to a new level?

Process simulations are key to map complex production scenarios, and we can derive a lot of information regarding media and utility requirements, facility robustness, bottlenecks and much more out of it. Our simulations are based on process recipes. By mapping the equipment units, the baseline for the simulations is created, which can then be used to calculate potential capacities, shift schedules, equipment requirements, and evaluate and optimise production scenarios.

“This approach allows to create a digital twin of the production processes, which includes all relevant features and behaviours of the real plant and comprehensively covers its whole lifecycle – from feasibility study throughout all the engineering phases to operations.”

The Golden Batch

Achieving the ideal version of a product and its production process, optimized in terms of quality, cost and efficiency – the “Golden Batch” – is the ultimate goal of any manufacturer. How do ZETA and INOSIM contribute to their customers attaining the “Golden Batch”?

“The golden batch is the ideal version of manufacturing and is typically used as a quality standard to monitor and maintain consistency in the manufacturing process. It is also used as a techno-economic tool to evaluate how efficiently the facility or plant is being operated. Some companies set the golden batch based on the ideal manufacturing process so that the entire plant is operating at or very close to its technical capacity, taking planned downtime into account. In real life, a lot happens during operation and many small hiccups occur that derail the golden batch, making it a theoretical goal in terms of economics. In fact, the golden batch is often not known, but simply set arbitrarily or derived from past performance, in order to achieve an operational goal.

“Imagine that today it is possible to identify the golden batch and set it as the design baseline, rather than making it an arbitrary selection. Further, it is now possible to tune an existing plant to achieve a specific golden batch based on business requirements. This is a key element that ZETA and INOSIM provide for all types of plants and facilities. By creating a fully functional digital twin of the plant, we understand the bottlenecks and align the plant and its design with the business goals, resulting in the definition of a golden batch – not by educated guesses, but by modelling the plant and its operations in a high-end plant simulation! This enables our clients to make informed decisions on whether or not additional equipment will add value or how to operate a new or even an existing older facility. At ZETA and INOSIM, we validate the business objectives by defining a golden batch together with our customers and make it the baseline for the project to be delivered.

“And we empower our customers to run the plant according to the definitions set during the design or evaluation phase, and to handle any hiccup in daily operations with maximum efficiency related to the golden batch – both for new installation as well as for existing brownfields! With FORESIGHT, we provide a predictive, dynamic production management tool that monitors and directs all tasks related to the operation of a plant. It shows the actual state of a plant and predicts its behaviour based on the previously simulated digital twin. Every deviation, every hiccup is detected, marked, and its impact on the path simulated, providing support and guidance on how best to overcome that hiccup – similar to Google Maps showing the best route and jumping to the next best scenario when a roadblock is detected!

“This is not a vision of the future – this is up and running at our customers’ production sites and shows how ZETA fully implements a digital engineering approach not only for project delivery but for the entire lifecycle of a plant, making our customers successful also in operations.”

Contact

Johannes Koch
Associate Director Business Line Engineering & Services
ZETA
johannes.koch@zeta.com