Important functions of SIMATIC SIPAT:

Data acquisition

Recording of process analysis data

SIMATIC SIPAT can be used together with various analyzers to record product and process data. Depending on the device-specific functions and the software support provided by the manufacturer, SIMATIC SIPAT can not only be used for data acquisition, but also for configuration of the analyzer, including calibration and system suitability testing.

Receipt/reading of data and data distribution

SIMATIC SIPAT uses open technologies based on industrial standards for data exchange with external systems, for example, with the SIMATIC PCS 7 process control system. SIMATIC SIPAT can read in process parameters such as temperature, pressure or pH value for application in a PAT procedure via an OPC interface. OPC communication can also be used to inform SIMATIC SIPAT about the beginning or end of a batch, procedure or phase.

In addition to the online data of analyzers and the SIMATIC PCS 7 process control system, SIMATIC SIPAT can also use quality parameters from ERP systems, LIMS systems such as SIMATIC IT Unilab, or MES systems such as SIMATIC IT Production Suite, such as the results of a raw material analysis.

Device calibration and system performance test

The performance of analyzers is usually checked before they are put into use. SIMATIC SIPAT takes this workflow into account, and triggers a calibration or a system performance test on the basis of internal or external standards. For tracking purposes, SIMATIC SIPAT saves the results as well as other data recorded with this device.

Data mining

The Data Miner is used to preprocess the product and process data recorded with SIMATIC SIPAT. It can be used to evaluate data and to design and validate models.

SIMATIC SIPAT records data during runtime, preprocesses it and, if necessary, can use models in the background to provide predictions. The results can be visualized and/or distributed with SIMATIC SIPAT. SIMATIC SIPAT can work together with different types of data mining or MVDA software packages. Chemometric functions from Umetrics are already integrated as standard in SIMATIC SIPAT.

The models are saved with version and status data in the SIMATIC SIPAT archive. It is unnecessary to combine all predictions for a specific PAT procedure in one single model. A procedure can include several models which can be arranged hierarchically or in parallel. The data required for this purpose can be used repeatedly.

In contrast to other PAT systems which are usually limited to one model of an analyzer or perhaps to an additional model of a single procedure, a general process model can be developed with SIMATIC SIPAT that allows prediction of the end product quality parameters.

Model types

• Model of a single analyzer
  Model on the basis of the recorded data of a particular analyzer, for example, through creation of a near infrared procedure (NIR), the prediction of specific parameters, principal component analysis (PCA) or a partial least squares procedure (PLS)
• Model of a single procedure
  Model on the basis of the recorded data of a particular single procedure (data from sensors, analyzers etc.), for example, a combination of pH value, temperature, pressure, dissolved oxygen and NIR data during operation of a single bioreactor
• Host process/product (range) model
  Model on the basis of the recorded data of various single procedures of the total process range from the raw materials up to the end product. This model is a special feature of SIMATIC SIPAT.

Monitoring and open-loop control

Integration in the batch

The model of a single procedure or of the process is used as the basis for development of a model for process control (feedback and feedforward control/correction).

SIMATIC SIPAT is responsible for the quality aspects of the process, and provides the corresponding information for the SCADA/process control system. The SCADA/process control system implements the control measures required to guarantee the quality. To implement the feedforward/feedback control, the two systems are connected in real-time via an OPC interface.

The close connection to a batch system for batch process automation permits synchronization of the recipe-based procedures with SIMATIC SIPAT. SIMATIC SIPAT can then define the end conditions for a particular procedure or phase, for example.

Visualization of data

The graphic user interface (GUI) of SIMATIC SIPAT permits you to record data interactively, to create new PAT procedures, or to view additional information on current or historical production batches. All critical quality parameters can be monitored online.

The process can be monitored by comparing plotter parameters with the golden batch series. Visualization takes place either using the SCADA/process control system or the graphic user interface of SIMATIC SIPAT.

Feedback for SCADA/process control system

SIMATIC SIPAT can be configured so that predicted parameters critical to the quality can be returned to the SCADA/process control system. These can then be used by the SCADA/process control system for control using traditional PID controllers or Advanced Process Control (APC) technologies.

SIMATIC SIPAT can send prediction values or principal components online to the SCADA/process control system and to any OPC servers. ERP and MES systems can also be integrated as outputs. A typical application example is the transfer of information concerning one or more critical quality parameters to an MES or ERP system to approve a batch following a particular single procedure.

Logging

SIMATIC SIPAT saves all data measured and calculated during the operative execution of a PAT procedure together with the available batch information in a database. This data is available for evaluation using any logging tools.

SIMATIC SIPAT supports logging with:

• Predefined or user-specific reports
• Logging module for creation of CSV files using universal database queries

The logs present in CSV format can be imported into statistics programs or Microsoft Office applications.

Audit functionality

SIMATIC SIPAT is provided with a comprehensive audit functionality which supports quality assurance of the production sequences in accordance with the guidelines for Good Manufacturing Practice (GMP) in the pharmaceutical industry and in the food and fodder industry. This guideline conforms with the corresponding statutory directives, in particular the Food and Drug Administration (FDA) guidelines anchored in 21 CFR Part 11. The most important audit function blocks include:

• System security and authorization checks
• Electronic signatures
• Recording of all changes to data sets (including information on who, what, and why)
• Storage of documents and repeatability in the online database as well as in the archived data
• Version check for objects such as PAT procedures, models, device settings, etc.

Customized adjustments

The standard functionality provided with SIMATIC SIPAT for design, analysis, optimization and control of product development and production on the basis of up-to-date measurements of critical quality and performance attributes of raw materials, process materials and procedures is extremely comprehensive and versatile. It can be easily configured by trained users via the SIMATIC SIPAT graphic user interface (GUI).

The sequences which can be implemented with the SIMATIC SIPAT standard functions can be adapted and expanded by means of user-specific functions and workflows.