PAT Solutions

Process Analytical Technology (PAT) is a system for designing, analyzing and controlling manufacturing through timely measurements of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.

The goal of PAT is to understand and control the manufacturing process, which is consistent with our current drug quality system: quality cannot be tested into products; it should be built-in or should be by design.

Process Analytical Technology tools:

PAT tools are used within a system to provide effective and efficient means for acquiring information to facilitate process understanding, develop risk-mitigation strategies, achieve continuous improvement, and share information and knowledge. In the PAT framework, these tools can be categorized as:

bullets Multivariate data acquisition and analysis tools
bullets Modern process analyzers or process analytical chemistry tools
Process and endpoint monitoring and control tools
bullets Continuous improvement and knowledge management tools

An appropriate combination of some, or all, of these tools may be applicable to a single-unit operation, or to an entire manufacturing process and its quality assurance.

Benefits of PAT:

bullets Reducing production cycle times by using on-, in-, and/or at-line measurements and controls.
bullets Preventing rejects, scrap and re-processing
bullets Considering the possibility of real time release.
bullets Increasing automation to improve operator safety and reduce human error.
bullets Facilitating continuous processing to improve efficiency and manage variability
bullets Using small-scale equipment (to eliminate certain scale-up issues) and dedicated manufacturing facilities.
bullets Improving energy and material use
bullets Increasing capacity