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The integrated, service-friendly system aids work processes and speeds up the implementation of software changes

Industry Software

Virtualization on the march

On a new-build project at the B. Braun AG facility in Berlin, ZETA Automation opted for a virtualized platform featuring the Simatic PCS 7 process control system with Simatic Batch. The service-friendly automation and IT system enabled the production plant to be put into operation more rapidly and efficiently than with alternative systems. The solution has shortened plant shutdown times and reduced lifecycle costs.

Leading medical technology and pharmaceutical manufacturer B. Braun AG, based in Melsungen, Germany, has commissioned a new production plant at its Berlin site. Following the initial development phase, the 4,600-square-meter facility now produces sterile injection solutions and packages them in plastic ampules. The project was completed rapidly – just 18 months from award of contract to final acceptance. That short time window also posed a major challenge for ZETA Automation, which handled the complete automation package for the formulation plant. The contract covered plant design, selection and installation of the hardware and software components, equipping the control cabinets, hardware and software engineering, electrical installation, and commissioning and qualification.

Integrated recipe control

To automate injection solution production, ZETA chose the Simatic Batch V8.0 software package for the Simatic PCS 7 process control system, safe in the knowledge that it would deliver consistent batch quality. The process control system conforms to the requirements of FDA 21 CFR Part 11. The integrated recipe control means that the automation system does not need to be modified in the event of changes to the recipe – the control recipes run in Simatic Batch. User-specific production reports are implemented by the standard report designer of the Simatic Batch system. Authorized users are able to export individual recipes, trend data, and audit trail and alarm data, and the batch recipes created by the user can be saved, copied, and reused for new batch recipes.

In terms of hardware, the plant was equipped with a central main control cabinet for the automation systems and high-performance Siemens frequency converters, with server racks for the Simatic PCS 7 infrastructure, virtualized on two hosts, as well as with on-site enclosures for the distributed I/O system. Simatic Batch is operated via multiple thin clients with touch functionality housed in a stainless steel cabinet in the clean room ­process area.

Fast and efficient project execution

The process control system is based on a virtualized computer system, which not only offers sufficient reserves for later plant expansions but, thanks to its performance, also represents a future-proof investment. For this virtualized system platform, ZETA recommended that the B. Braun project team use Simatic Virtualization as a Service (SiVaaS).

ZETA was able to complete the project smoothly and successfully, thanks to the state-of-the-art virtualized computer platform, which enabled the key elements to be executed on schedule and within budget. Those key elements included, in particular, the drafting of function specifications based on process descriptions and piping and instrumentation diagrams developed by ZETA, writing of the Simatic PCS 7 application software in conformance to GAMP 5 and S88, installation of a batch management system with formulation mode, and development of custom trend and production reports. For Björn Stolle, project manager at ZETA ­Automation, the outstanding teamwork with the customer was key: “The collaboration with B. Braun was handled optimally, with successful solutions being developed on a joint basis. B. Braun operators were available to us at all times during the commissioning phase, enabling us to complete the project efficiently and successfully.” A major benefit for B. Braun in terms of the project execution was that ZETA offers both process know-how and expertise in automation. This meant that process sequences could be incorporated quickly and, above all, safely into the Simatic Batch PCS 7 software project.

Decreased plant shutdown time

ZETA consciously chose SiVaaS because it meant the benefits of Siemens support were available right from the project phase. And  B. Braun also benefited, because SiVaaS assures customers of professional service and fast supply of replacement parts. All the members of the project team, from both B. Braun and ZETA, agreed that  ZETA’s choice of hardware and software systems was exactly right. The continuity and service-friendliness it offered, combined with a significant easing of the workload and shorter plant shutdown times, were key factors in the success of the new production plant. The ­continuous function chart (CFC) / sequential function chart (SFC) structures configured within the Simatic PCS 7 system mean that any software changes can be implemented more rapidly than with conventional Supervisory Control and Data Acquisition (SCADA) systems, resulting in roughly 30% less shutdown time.

The certified Siemens Automation Drives Solution Partner is well respected in the production plant automation market for the pharmaceutical, biotech, and food industries

Picture credits: Thomas Rosenthal