Process Analytical Technology - PAT, Process development, SIPAT, Process Analytical Technologies

What is PAT?
According to the FDA (Food and Drug Administration) PAT (Process Analytical Technology) is a system for designing, analyzing and controlling manufacturing processes based on timely measurements (e.g. during processing) of critical quality and performance attributes of raw materials, in-process materials and processes with the goal of ensuring final product quality. PAT allows real time follow-up of the product quality and enhances increased process understanding.

What is SIPAT?
SIPAT is the Siemens' software solution to support PAT implementation efforts and use of PAT tools in development and manufacturing:

• SIPAT enables the increase of process understanding and allows continuous process improvement during manufacturing operations and process development.
• SIPAT enables monitoring and consolidation of product quality information, allowing real-time quality decision making
• SIPAT enables (advanced) process control whereby it can either focus on specific Unit operations or it can cover total batch quality to enable Real-time Product Release.
• SIPAT serves as the common interface for all PAT tools.

• Data collection : capture process analytical and process data
• Data mining : like MVDA (Multivariate Data Analysis) model creation and validation
• Real-time prediction of quality parameters
• Allows the application of PAT in the broad sense : monitoring and control
• A common interface for all PAT tools (process analyzers, data mining tools…) reducing complexity, allowing standardization and assuring ease of operation
• Can be used in manufacturing and development
• Allows a modular & scalable architecture (allowing a scalable PAT roll-out)
• Supports easy and fast process validation
• 21 CFR 11 ready, version management, raw data storage, user access rights
• Online visualization as well as reporting and analysis of historical data
• Integration to both existing and new infrastructures like PCS, Batch Engine, MES, LIMS, data portals, knowledge management systems.

What's New in SIPAT?
In general, the process infrastructure for PAT integration with SIMATIC SIPAT V3.0 is characterized by SCADA / process control systems (optionally with Batch automation), Manufacturing Execution Systeme (MES), Enterprise Resource Planning systems (ERP), Laboratory Information Management Systems (LIMS), data portals, knowledge-management systems, etc. ia OPC.

The salient features of SIMATIC SIPAT V3.0 are:

• Multi plant
  Sharing data between different departments / plants is now fully supported on a single SIPAT database. Depending on the access given to your log in account you have access to the departments you are interested in. Having data from different departments in one database helps knowledge sharing, data analysis, continuous improvements, faster roll outs etc.

• Operator screen
  User friendly interface for operating SIPAT and embeddable in 3rd party control systems and SIMATIC PCS 7. The content and look and feel of the user interface is off line configurable for each unit operation or user needs and thus improves the usability and lowers the training costs.
• High level next steps
  You have now the possibility to execute aggregations / calculations over all dataset in SIPAT method (i.e. typically one unit operation). This makes it possible for example to calculate the evolution of the average weight of tablet during the tabletizing process in order to include this data in the data monitoring. Besides this it's also possible to add initial conditions as an extra input for your calculations like raw material data or results from the previous processing step.
• Model builder improvements
  The Model Builder has been completely reviewed and allows you now to align data not only based upon time but for example also based on batch id. In this version it's also possible to browse for data from other databases on a more interactive way.