CAMO Software

Process Analytical Technology (PAT) and Quality by Design (QbD)


PAT is process analysis in real-time. At-line real-time analytical measurements can replace off-line time consuming chemical analyses. Locating information in those measurements, identifying the important process parameters and creating a model able to measure the quality instantaneously are the main stakes in PAT. MVA is the key tool.

Apply your model at-line to control in real time the behavior of your process. In term of MVA the methods used are regression models for prediction (MLR, PCR, PLSR) and PLSDA and SIMCA for classification.

Process control and optimization are iterative in nature. Directly and continuously batch measurements can monitor the evolution of a process. This way deviation can be detected and corrected at an early stage, hence reducing the number of waste and rework. Unit operations and overall process understanding will guide optimizing the production quality.

Use data collected from all production steps to provide a total view of the process and its performance. This collection of data goes through the integration and use of models to various third party process sensors. Store and use the information to provide third party a quality report.

Process centric approach to quality with multivariate data analysis
Process Analytical Technology (PAT) involves fundamental changes to working practices. It is based on the application of sophisticated and high technology process analyzers and the development of online Multi-Variate Analysis (MVA). Analysis of the process data is a key to understand the process and keep it under multivariate statistical control.

The philosophy behind the Process Analytical Technology (PAT) initiative represents a move away from traditional product centric measurements of quality to a process centric focus on quality.

This process centric approach to quality may start at the early design stages of the process (Quality by Design, QbD) so as to have the quality built in. It continues throughout the entire life-cycle of a product. The measurement of Critical Quality Attributes (CQA's) all along the entire process will ensure consistent product quality. These quality attributes define the Design Space of the process.

ICH Q10 approach of PAT

ICH Q10 approach of PAT


QbD: overarching paradigm

QbD: overarching paradigm

Services

  • Multivariate data analysis of historical data
  • Creation of models to be applied online
  • PAT & QbD implementation strategies
  • Interpretation of regulatory guidance
  • Process optimization and control

Unscrambler® X Process Pulse II

Improve process monitoring, understanding and control with Unscrambler® X Process Pulse II. It enables powerful multivariate models developed with The Unscrambler® X to be used to monitor at-line, on-line and in-line processes.

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See also

The Unscrambler® X ADI Insight Server: The first chemometric solution to implement the OPC-UA Analyzer Device Integration specification, enabling powerful multivariate models to be deployed in a vendor neutral platform.

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New The Unscrambler® X is the first multivariate software with seamless integration to Siemens SIPAT 4.0 process automation solution

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Project Examples

  • Systematic approach for process optimization, achieving process understanding using PAT and Six Sigma
  • Integration of The Unscrambler® Technology into the PAT environment
  • Chemometrics for PAT
  • Identification and verification of raw materials or final product quality by classification models
  • Identification of counterfeits from MVA models developed from spectroscopic as well as other laboratory measurements
  • Reaction monitoring, dryer monitoring and measuring tabletting and coating process
  • Spectroscopic analysis using FTIR, NIR, Raman or UV-vis technologies for real-time measurements
  • PAT and QbD project management

 

Business Partners


SIPAT is the software solution of Siemens to support Process Analytical Technology (PAT) implementation for the life sciences industry.

The Unscrambler® Xis used to build multivariate data analaysis models. It is the only chemometrics software offering seamless integration with the latest release of Siemens SIPAT 4.0.

With the integration of Unscrambler® X Prediction Engine and Unscrambler® X Classification Engine these powerful models can now be utilized for on-line prediction and classification in the SIPAT system.

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ABB xPAT

ABB’s PAT solutions, xPAT provides integration with enterprise systems & a host of analyzers for continuous process improvement, realtime product release and Quality by Design. (QbD).

The Unscrambler Predictor is integrated into ABB's FTSW products thus giving the user all of the predictive and diagnostic tools found in The Unscrambler®.

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SYMBION

Symbion-DX and RX provides standardized platforms for controlling a wide range of spectrometers and other analytical instruments.

The combination of the Symbion and CAMO software products provides a comprehensive capability for process analytical methods development and on-line deployment.

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Brochure

Seminar: Nutzen Sie leistungsstarke Multivariate Datenanalyse effektiv - durch den Einsatz innovativer Batch-Modellierung und den Einsatz der „Echtzeit-Prozessüberwachung“
13.09 München | 14.09 Frankfurt | 15.09 Düsseldorf | 16.09 Hamburg

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