(657f) Development, Implementation, and Use of an On-line Laser Diffraction Particle Size Method in a Spray Drying Manufacturing Process

Too often the performance of a PAT method is described in terms of PAT prediction model performance (the error found when predicting a validation data set), or even PAT method validation (carried out against a protocol to validate the method in terms of characteristics found in ICH Q2 (R1) or ASTM E2829 - A Risk based Guidance for Verification of Process Analytical Methods), when these activities are only part of the challenge around generating a PAT method which is expected to remain in place during the life time of the commercial process.

The purpose of this paper is to take the audience on a journey from initial justification, hardware development, implementation, hardware qualification, model and method validation and use as an IPC that is part of a commercial control strategy. The use will be demonstrated with reference to the control strategy complexity pyramid, but also suggests how the same data could be used as part of a level 3, level 2, or even level 3 control strategy as described by the control strategy complexity pyramid. This includes the challenges of representative sampling, robust process interfaces, and interconnection to plant automation systems for feedback and feed forward control, but also covers strategy for long-term maintenance.