SIMATIC SIPAT, overview

Process Analytical Technology (PAT) was initiated by the Food & Drug Administration. With this technology you can design, analyze, optimize and control product development processes and production processes so that the quality required for the end product can be absolutely guaranteed. The basis is up-to-date measurements of critical quality and performance attributes of raw materials, process materials and procedures.

Intended uses for PAT:

• Gaining comprehensive knowledge concerning the product and its development process
• Determination of relevant factors influencing the quality of the end product from the recorded product and process data
• Estimation of the end product quality through continuous analysis of the influencing factors
• Early introduction of closed-loop control measures for safeguarding the quality of the end product
• Safeguarding of consistent product quality when upscaling the process from laboratory operation to production and when changing production quantities
• Validation of process in accordance with statutory directives
• Improvement of total performance of process

Real-time tracking of parameters relevant to product quality not only helps you to understand and control the total process better, it also helps to reduce or even completely eliminate final inspections. The preparation of samples for quality control at the end of the process (which can sometimes be extremely time-consuming) or for follow-up checks can thus be omitted.

The results obtained with PAT during product development in the laboratory can be easily upscaled to production mode. The production quantities can be rapidly and flexibly adapted to changing market requirements while maintaining the same level of quality.

All these features result in very short product development and launch times with significant cost advantages.

SIMATIC SIPAT from Siemens is the appropriate software platform for integration of PAT in the process industry. PAT can then be integrated into existing or new infrastructures. These can feature SCADA/process control systems (optionally with batch automation), Manufacturing Execution Systems (MES), Enterprise Resource Planning Systems (ERP), Laboratory Information Management Systems (LIMS), data portals, knowledge management systems, etc. Linking to the SIMATIC PCS 7 process control system by means of OPC.

Important features of SIMATIC SIPAT:

• Modular, scalable architecture with uniform interfaces for process analyzers and data mining applications
• Can be integrated into existing or new infrastructures
• Data recording: recording of product and process data using standard analyzers
• Data mining: data evaluation and determination of relevant quality parameters, for example, through modeling and validation with multivariate data analysis (MVDA)
• Real-time prediction of quality parameters
• Continuous monitoring and control of product quality
• Online visualization, report functions, and analysis of historical data
• Support for simple and fast process validation
• Audit functionality for compliance with statutory directives
• Conformity with the directives defined in 21 CFR Part 11 with regard to version management, saving of raw data, and access privileges

Note:

The current software SIMATIC SIPAT V5.0 can be used in combination with SIMATIC PCS 7 V8.1+SP1.