Life Science Quality Assurance, Process Analytical Technology

What is Process Analytical Technology (PAT)?

The FDA considers PAT to be a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality.

An aspect of the FDA's CGMP initiative to help pharmaceutical manufacturers gain more flexibility has been the use of PAT to apply multivariate modeling and real-time analytical methods to predict and control product quality during the manufacturing process.

_{Reference: Guidance for Industry, October 2004: PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance}

Seamless PAT Integration

Deploying PAT as a strategy to increase quality and improve financial performance of drug product and drug substance manufacturing is proven. Emerson’s solutions for PAT-based manufacturing help streamline your manufacturing processes while increasing final product quality. We accomplish this by integrating multivariate data and real-time chemometric process models to predict CQAs from spectral data measured by specialized PAT analytical instruments. The predicted CQAs are uploaded to our DeltaV™ control system in real time to execute control actions based on the CQA measurement.

Our Process Analytical Technology (PAT) solutions enable new ways to design, analyze and control manufacturing processes that enable you to become more efficient while reducing over-processing enhances efficiency and minimizes waste, ultimately ensuring final product quality.

Increased quality - Reduction of off-spec material and better yield.
Faster product release - PAT measurements can eliminate some post production testing and allow material to flow through the process faster.
Reduced cycle time - In many cases, materials are over processed. Using PAT to detect the processing end point can reduce the cycle time.
Energy savings - When PAT measurements enable reduction of cycle time, the cost of energy to run equipment will also be reduced.
Reduced labor costs - PAT can reduce the number of samples submitted to the QC lab and reduce lab costs.