PAT and QbD solutions

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

Process centric approach to quality with multivariate data analysis

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.

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

News

CAMO Software announces integration of its multivariate analytical software, 'Unscrambler Predictor & Unscrambler Classifier' with SIPAT

Brochure

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	QbD: overarching paradigm

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 PAT implementation.

The Unscrambler® is used to build multivariate models. With the integration of Unscrambler Predictor and Unscrambler Classifier these models can now be utilized for online prediction and classification in the SIPAT system.

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