(233d) Multivariate Statistical Process Control for the Continuous Manufacturing of Solid Oral Dosage Forms
- Conference: AIChE Annual Meeting
- Year: 2016
- Proceeding: 2016 AIChE Annual Meeting
- Group: Pharmaceutical Discovery, Development and Manufacturing Forum
Monday, November 14, 2016 - 3:15pm-5:45pm
The approach presented is based on the assumption that, regardless of the target set point for the main operating conditions (e.g. mass rate), the common cause variability in the process will remain the same. Hence the covariance structure for the variables in the system can be identified by a PCA model on a matrix resulting from the concatenation of data from multiple â??trial runsâ? that were pre-centered around their mean values. An analysis of the loadings vectors reveals variable correlations that matches the expectations from a process engineering standpoint; and the corresponding movement in the scores space reveals directions of expected normal (and tolerated) variability, as well as patterns that can be matched with the startup and the shutdown of the system.
Our case study presents the analysis of a model built with the data collected from the system of screw feeders that dispense material to the unit, as well as the analysis of the model obtained with data collected from the tablet press. Furthermore, a method is presented to determine the lag time between a measurement vector from the feeders, and a measurement vector from the tablet press; such that a combined lagged model can be built. The combined model eases the holistic identification of contributions in the case of a disturbance, and the use of the three models (one per system and the combined) in tandem provides a complete monitoring approach for the system as a whole.