The digital factory, which in this context refers to the convergence of process and facilities infrastructure planning in an integrated 3D model, is not exactly a new issue for the big players in the process industry. However, many small and medium-size companies do not yet have seamless data management. A comprehensive 3D model can be extremely useful during the design of pharmaceutical production lines.
A comprehensive 3D model can be extremely useful during the design of pharmaceutical production lines, because engineers can look at cleanroom equipment and pure media from several different perspectives. Facilities infrastructure is closely linked to production, making the advantages of integrated planning readily apparent. The advantages are obvious: engineers can try out different variations before construction gets underway.
The goal of the “digital factory” is to create a 3D model of the entire factory including the buildings and production areas. The digital factory is also a valuable tool during expansion and modernization projects. The buildings and production systems including all of the pipelines are represented in a digital model.
A trial expansion scenario can be run through the model. A centralized digital model also helps the service team to draw up the maintenance plan. The advantages are so compelling that 3D models have now become indispensable at large companies. “Digital SD models which include the buildings are now standard in the process industry. BASF simply does not build any more plants without a digital 3D model,” explained Ronald-Alexander Klein, Senior IT Manager at BASF. The planners at Bayer Technology Services (BTS) even have their own tool.
The Process and Engineering Data Warehouse (PEDW) links process information to plant data, flow charts, equipment, special components, documentation and reports to create a coherent information base. This approach, which has many advantages during the planning phase in the chemical industry, also has a lot to offer in the pharmaceutical industry. However, companies are more reluctant to embrace the digital factory philosophy. One of the reasons cited is the small size of the production systems, and many people believe that it is not always worth making the investment in an all-inclusive 3D model.
Pharmaceutical systems present a special set of challenges
There is also another reason. Horst Jetter, who runs his own engineering agency, says that there are special issues which have to be taken in consideration. “More than in any other industry, all of the different disciplines have to be linked together. There is also a need to comply with national and international regulations as well as internal company standards. The list includes:
Compliance with and documentation of specified temperature, moisture and room pressure limits
Compliance with applicable GMP guidelines and a concerted effort to achieve quick, problem-free FDA approval for the entire production process and the associated environmental conditions and systems design
Minimization of energy costs and optimization of operational safety and reliability throughout the entire production process
Monitoring of quality during the deployment of industrial equipment
Exact specifications relating to the functionality and commissioning criteria of industrial equipment
According to Jetter, all of the planners on these projects usually start to work at the same time. Process engineering initially defines the space requirements. The architect uses this information to design the building, and preliminary investigations on the major industrial equipment run in parallel.
Simulations are run to determine the thermal behavior of the building on an hourly basis throughout an entire year
Plant simulation is used to analyze and compare the cost and functional performance of the best systems and to define the optimal solution
Flow simulation is run to model conditions in the room, identify possible particle distributions, etc. The results of the simulation are used to make sure that the solution meets the customer requirements.
LSMW, a subsidiary of M+W Zander, emphasizes the importance of facilities planning. Layout development is not the domain of the architect. The layout of the process areas must be undertaken by persons who have detailed knowledge of process requirements and GMP regulations, namely the process engineers. This is the only way to be sure that the layout is optimized for the process and meets GMP requirements. However, that is not the whole story. Defining the best layout helps minimize investment and operating costs and maximize operational reliability. Taking cleanrooms as an example, cleanroom equipment plays an important role during the design of new buildings or renovation work. Defined hygiene zones and air locks and functional pressure cascades which meet the needs of the process are just as important as optimal air management in critical areas (e.g. where the product is handled in the open).
A process issue rather than a software issue
The Fraunhofer IPA takes the view that the digital factory must always be firmly focused on the avoidance of planning errors which can be very costly and significantly increase time to market if they are discovered too late. In the study entitled “Erfolgsfaktoren bei der Einführung der Digitalen Fabrik” (Success Factors During the Introduction of the Digital Factory), Sabine Bierschenk and Tom-David Graupner argue that the digital factory is a process issue rather than a software issue and believe that it lays the foundation for the future integrated partnership between development, production and the supplier base. Software and digital methodologies merely create the basis for the digital factory. However, long-term opportunities and tangible benefits can only be expected from the digital factory if the tools are firmly anchored in the process and organizations. The digital factory is a long-term issue for manufacturing companies, and in that sense it is comparable to the introduction of CAD technology.
In summary, the digital factory is very common in the automotive industry. Should this be a model for the pharmaceutical planning team? The international benchmarking study “Operative Excellence in the European Pharmaceutical Industry” (APV Arbeitsgemeinschaft Pharmazeutischer Verfahrenstechnik) indicates that this may well be the case. Viewed at a higher level, the study indicates that transferring proven cost-reduction strategies from the automotive industry to pharmaceutical production could be very beneficial.
Excellent IT tools are the key
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