The use of systematic methods and tools for design of process monitoring and analysis system for product quality control can be very useful in the manufacturing industry, particularly the pharmaceutical industry. The design of process monitoring and analysis system involves the identification of the critical quality parameters, selection of economical & reliable data measurement methods and integration with the control system.

A model and data (knowledge) based computer-aided framework including the methods and tools through which the design of a process monitoring and analysis system for product quality control can be generated, analyzed and/or validated, has been developed. The developed framework consists of three main parts: a knowledge base of methods and tools for monitoring/analysis, a model library to supplement the gaps in the knowledge base and an algorithm for design and analysis of process-product specific monitoring and analysis systems. The knowledge base provides the necessary information/data during the design of the process monitoring & analysis system. It contains information for typical unit processes in terms of the type of operation they perform, the process variables involved with those operations, the corresponding actuator candidates, and the equipments used for on-line measurement of data (type of equipment, accuracy, precision, operating range, response time, drift, resolution, cost etc.). The model library contains a set of mathematical models for different types of unit processes, sensors and controllers. They are used to generate data (when measured data are not available) as well as for verification of the performance of the closed-loop controlled process. The design-analysis algorithm identifies the optimal monitoring & analysis system in terms of cost and/or time subject to the product-process constraints. It consists of mainly four analysis steps: process analysis to identify the process points and process variables, sensitivity analysis to identify the critical process points and critical process variables, interdependency analysis to couple the critical process variables with the actuators and performance analysis of monitoring tools to select the measuring equipments. A software prototype for design of process monitoring and analysis systems, based on the mentioned framework has been developed.

The objective of this presentation is two-fold, first to highlight the design software together with the design methodology and then to demonstrate the application of the developed software. The developed software is able to design new process monitoring & analysis systems as well as to analyze existing process monitoring & analysis systems. The application of the software for design of process monitoring & analysis systems will be illustrated through two practical case studies involving pharmaceutical products