ADVERTORIAL
Innovation in process analytical technology:
The evolution of the SIPAT data management platform
Process analytical technology (PAT) is steadily gaining hold in pharmaceutical manufacturing. It is delivering improvements in process understanding and product quality and making real-time release possible. Within a few years of the US Food and Drug Administration’s regulatory encouragement of PAT, Siemens introduced its SIPAT data management platform to the industry. It has since become the global PAT system standard for GSK and Merck and is a familiar part of many other companies’ manufacturing.
Runtime data and historical data can be visualised in the same graphs, allowing real-time batch overlay reporting. SIPAT has new advanced calculation
capabilities, including evaluation rules and conditional modelling. Snippet files make it possible to add advanced calculation routines in an easy and validated way. Evaluation rules can be run on data, so that unrealistic or non-plausible results can be filtered in real-time. This ensures that the process is not disturbed by irrelevant results. Conditional modelling makes it possible to add several models at the same time, defining rules for when and how the appropriate model can be selected. Chart configuration has also been simplified and made more intuitive. There is now no limit to the amounts of charts that can be generated. Looking ahead, Siemens is developing an
SIPAT is used in many different areas, including bio-production and bio-manufacturing as well as chemical API and oral solid dose (OSD) environments. Projects have been executed at several top ten pharmaceutical companies, as well as with well respected research institutes.. Recent research projects include the use of SIPAT to deploy advanced control strategies for hot melt extrusion production technologies. Siemens is working on this with the PAT group from the University of Gent in Belgium and the Research Center for Pharmaceutical Engineering in Graz, Austria. Building on its use on batch-type settings,
SIPAT is also playing a central role in the development of continuous manufacturing in the industry. In a continuous manufacturing
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context, SIPAT collects and aggregates data, provides online calculation of critical quality attributes based on multivariate data, links into system control units and enables feedback and feed forward control strategies. The functionality of SIPAT is evolving fast as a
result of close collaboration with pharmaceutical manufacturers and research institutes. The most recent 3.1 generation of the software is more robust, easier to configure and more powerful. The model builder has evolved to become an extensive data miner. Data retrieval from the SIPAT database is now faster and more intuitive. An outlook panel allows quick filtering while new ‘drag and drop’ functionality permits datasheets and graphs to be generated in seconds.
OPC Unified Architecture (OPC UA) platform giving users universal connectivity. This will bring a more generic interface, increasing the number of SIPAT-compatible instruments and make connections easier, faster and more robust. SIPAT is one element of a complete PAT/QbD offering from Siemens that includes services in IT software validation and implementation, assistance in the design of experiment (DoE) and model generation, process control strategy and process validation. In addition, we can also offer a complete solution in automation, DCS, SCADA and control.
Siemens AG, Industry Sector, Industry Automation Division IA AS VMM PHARM Siemens allee 84
76187 Karlsruhe, Germany
European Pharmaceutical Review 09 Volume 16 | Issue 3 | 2011
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