A person in cleanroom gear uses a tablet in a sterile environment, with the Siemens Accelerate shape in the background.

SIMATIC SIPAT: Software for real-time quality control

The reduction of time to market is a crucial competitive factor for pharmaceutical companies. Key to achieving this reduction is right-first-time testing, an approach that prevents the production of faulty batches of medicinal products so that they are always within the required specifications.

For improved quality and flexibility in process management

With our knowledge of Process Analytical Technology (PAT) and Good Manufacturing Practice (GMP) and our SIMATIC SIPAT pharma software, we can help turn quality into an integral part of your production process and enable you to become more flexible at the same time – for production expansions, new products, and entry into new markets.

Right-first-time production via Quality by Design (QbD)

The Pharmaceutical CGMPs for the 21st Century initiative of the US Food and Drug Administration (FDA) has led to a rethinking in the pharmaceutical industry. Quality by Design (QbD), the transfer of previously downstream quality controls into the manufacturing process itself, is meant to accelerate processes and prevent the production of faulty batches of medicinal products. The introduction of Process Analytical Technology (PAT) supports a right-first-time production process that delivers the correct product quality straight away.

Faster product release with SIMATIC SIPAT

The implementation of Process Analytical Technology (PAT) in the pharmaceutical industry has begun. Siemens has developed the SIMATIC SIPAT software to support this important trend. The result is improved process quality and a reduced risk of losing products because of non-conformity. SIMATIC SIPAT provides a series of tools that support PAT in the development and production processes; for example, process analytics, and tools for process control and report generation. And it is able to interpret and link the data from these tools in an intelligent manner. SIMATIC SIPAT ensures complete data transparency starting with product development and feeds the correlated data back into the process. In addition, it allows reliable forecasts with which the quality and efficiency of the process can be continuously improved up to the level of the manufacturing execution system (MES), laboratory information management system (LIMS), and enterprise resource planning (ERP) system.

The result is a production process that operates according to the right-first-time principle. Another advantage: online monitoring ensures that the process operates within the specifications and thus lowers costs. With SIPAT, pharmaceutical manufacturers can achieve a sound understanding of their processes and can release products faster based upon process data. In short, SIPAT enables companies to develop their processes further based on quality by design (QbD) and right-first-time testing. System capacity utilization can be increased by about one-third and production costs can be by reduced by 10-20 percent after just a short time.

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Pfizer Pharma-Referenz in Freiburg, Deutschland

Multidisciplinary PAT introduction approach

1. Process analysis

Analyzing your processes to uncover potentials for better and more controlled process quality.

2. Joint strategy development

Working with you to develop a strategy for the implementation of methods and tools that will allow you to get your production ready for real-time release.

3. Implementation of the PAT system

Step-by-step implementation of your PAT solution with the appropriate technology, expertise, and software.

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