Feature article: Smart Engineering Meets Digitalization

The pharmaceutical industry is currently facing many challenges, of which coming to terms with the Covid-19 pandemic is only one. However, the development of vaccines, the associated production processes and the establishment of a functioning supply chain have shown, as under the magnifying glass, what is really important in the industry: bringing new active ingredients onto the market as quickly as possible and being faster than the competition. "Time-to-market, cost efficiency and competitiveness - this trio drives the pharmaceutical industry today," says Martin Mayer, Head of Business Development Smart Engineering at ZETA.

New business area for new challenges

The academically-accomplished mechanical engineer with 20 years of CAD experience has been developing a completely new business area since 2019: Smart Engineering Services "We repeatedly encounter similar challenges in investment projects faced by biotechnology companies," explains Mayer. Globalization has also shrunk the pharmaceutical world: International competitors are developing a new dynamic and driving the top dogs in front of them.

Markets are shifting, the trend towards personalized medicine calls for new system concepts and makes business with blockbusters more difficult. Overall, the entire business is becoming faster, more volatile and more difficult to assess. The times from approval to the clearance of a plant project are now significantly shorter than a few years ago. All of this has consequences for the control of engineering projects and the entire life cycle of the plant - a broad field of activity for the new business area whose tasks are already a part of Smart Engineering Services.

"In recent years, we have developed a digital tool and method box to help our customers overcome their challenges," says Mayer. But it's not just about tools and methods. A tool alone does not solve a problem. It is only as good as the specialists who work with it, he emphasizes and adds: "We know how a project works, how investment projects are handled, what role the project partners play and who has to take on which tasks, at what time."

Today it is no longer possible without integration

Over the years, the system provider specializing in biotechnology has developed into a one-stop-shop solution provider that offers planning, engineering, development, manufacturing, automation, digitalization and maintenance from a single source. The company sees itself as an innovation driver in the industry and the new business area within which Mayer is pursuing an integrated approach also fits in with this. “From our own experience and numerous complex projects, we know what an ideal engineering environment should look like today,” he explains.

ZETA originally comes from manufacturing and has developed into a general planner in recent years. It was only two years ago that a masterpiece was delivered for a leading biopharmaceutical company with a biotechnological launch factory, the largest project in the company's history. The Liebochers still manufacture a lot in-house and have acquired a great deal of knowledge regarding how the chain ideally meshes from the concept to the detailed design to the isometrics, the ordering process and construction.

One Toolchain for all Engineering Tasks

Like many of its customer companies, ZETA has accumulated a software zoo in engineering over many years: Excel, a lot of self-made, isolated solutions that made manual transfers necessary and at some point no longer matched the requirements that the more complex projects and decision-making structures of the customers placed on the planning department.

As a result, the decision was made in 2018 to create an integrated digital workflow for process engineering projects in addition to the commercial processes that are mapped in an ERP. This started a development process from which end customers can also benefit today. “Our goal was to reproduce all engineering tasks in a single toolchain,” explains Mayer.

For the digitalization of the engineering processes, ZETA relies on a software environment, at the center of which is the COMOS software from SIEMENS. COMOS is a database-centered, object-based engineering tool that follows the "single point of truth" principle: Maintain data in one place - use it multiple times. This avoids inconsistencies in data management over the system life cycle and simplifies documentation - a real added value, especially for the document-heavy pharmaceutical and biotech industries.

"We have developed many pharmaceutical-specific modules since its introduction in 2018," explains Mayer. In plain language this means: There is now a pharmaceutical-specific object catalog that contains the components required for the work of engineering partners. The topics of validation and qualification for GMP are also reproduced, taking into account the requirements of GAMP5 and CFR Part 11.

“With our solution, we can cover all phases via COMOS, from the feasibility study, concept, basic and detail engineering to production and qualification, and thus digitally across all disciplines of process engineering, 2D and 3D systems planning, electrical planning and automation process in one environment,” emphasizes Mayer. All releases are digitally traceable, all specifications and certificates are managed centrally. This means that there is complete, comprehensible documentation as required for pharmaceutical projects.

In terms of openness, our experts are now working on modules with which the technical building equipment and HVAC systems can be integrated - an aspect that is often neglected, but is inseparable for ZETA. "We guarantee perfect coordination between the process system and the technical building equipment in this way," says Mayer.

After all, it's about the big picture - namely, digitalization over the entire life cycle of the system: starting with planning, through the digital twin for training and commissioning, to as-built documentation during the system's runtime. The building is part of this. The integrated approach of ZETA's engineers is a great starting point for all those who are aiming for Pharma 4.0 projects.

The Digital Twin: a Multi-Talent

The digital twin, the basis of all digitalization activities, is delivered virtually free of charge. “Our 3D planning data are the basis for the 3D representation of the system. The digital twin already exists before the physical twin,” explains Mayer. This has far-reaching consequences, because the digital twin is multi-talented: If you combine the data of the twin of the biological process steps (fermentation, cell culture, harvest, filtration, etc.) with those of the technical twin, it is possible to simulate manufacturing processes in order to develop the most commercially attractive production process on an industrial scale through optimization loops.