(438f) Integrated Control and Data Management System for Continuous Pharmaceutical Manufacturing Process
- Conference: AIChE Annual Meeting
- Year: 2017
- Proceeding: 2017 Annual Meeting
- Group: Pharmaceutical Discovery, Development and Manufacturing Forum
- Time: Tuesday, October 31, 2017 - 5:05pm-5:27pm
In this work, different control strategies for direct compaction continuous tablet manufacturing process has been developed and implemented into our pilot-plant facility using industry standard control platform. The critical control variables are drug concertation, powder level, main compression force, tablet weight and hardness. Both, feedback (FB) as well as feedforward (FF) control strategies have been implemented into the pilot-plant. Feedback (FB) control strategy has been compared with a combined feedforward/feedback (FF/FB) control strategy. A novel method for real time monitoring of powder density has been developed and integrated with feedforward control loop. The feedforward control loop takes the powder bulk density signal as an input and mitigate the effect of variations in powder bulk density on CQAâs proactively and thereby reduces the rejections significantly in compare to only feedback control strategy. Three control algorithms (PID, MPC, hybrid MPC-PID) have been also implemented and compared for feedback loops. The flexible control system is designed in such a way that any control scheme can be easily selected. The control system is also modular in nature that can be easily transferred to any other control platform and manufacturing plant. The continuous tablet manufacturing pilot-plant runs under each control scheme and their performance are evaluated and thereby a best control system has been identified. A systematic methodology for material traceability has been also developed and coupled with integrated control system. The methodology starts with material and process specifications followed by scanning the powder drums and transmitting the material and time information to the control platform. The control platform then utilizes the information stored in the database, generated through residence time distribution model and information collected through real time monitoring to track the material during continuous manufacturing. All the relevant data generated during continuous manufacturing has been systematically collected, stored and organized in a data hub (OSI PI). The PAT data has been collected through PAT data management tool (synTQ) and then transferred to the PI system while the other operational data has been collected in control platform (DeltaV) and send to PI system via OPC communication. Finally, the data has been transferred to the cloud system for enterprise wise efficient sharing and applications.
The objective of this presentation is two-fold: first to evaluate the performance of integrated control system of continuous pharmaceutical tablet manufacturing process and then to highlight the material traceability and data management framework.
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