(642i) Condition Based Maintenance for Sensor Network Reliability in Continuous Oral Solid Dose Manufacturing
- Conference: AIChE Annual Meeting
- Year: 2019
- Proceeding: 2019 AIChE Annual Meeting
- Group: Pharmaceutical Discovery, Development and Manufacturing Forum
Thursday, November 14, 2019 - 10:14am-10:29am
Continuous manufacturing of drug product is the outcome of targeted process intensification with systematic integration of product and process knowledge, instrumentation and automation systems, quality control protocols and real-time process management for a solids processing system handling pharmaceutical materials. Success in the technology necessitates appropriate infrastructure for Information and Operations Technology integration.
At the core of such integrated systems is sensor network analytics, consisting of reliable and accurate measurements from field devices combined with mature process understanding to provide good quality estimates of unmeasured process variables . In continuous tablet manufacturing, four leading causes of instrumentation faults are observed, which affect monitoring robustness. These include communication failure, instrument configuration, calibration and instrument age. Such instrumentation failures could potentially cause a systemic failure of the CM process.
This work focuses on leveraging systems engineering methods for real-time operations management, in particular, condition-based maintenance to improve operational reliability by mitigating sensor network failures in drug product CM. We discuss the following: (i) an integrated data-driven and model-based framework for systematic sensor network fault monitoring, (ii) the configuration and implementation of condition-based maintenance in a tablet processing pilot plant at Purdue University .
The proposed maintenance management approach is comprised of three workflows which are linked in an integrated data-driven and model-based framework. First, sensor network analytics methods of statistical process monitoring, data reconciliation, and gross error detection are leveraged for real-time process data validation, ensuring measurement accuracy, detecting sensor faults, and estimating unmeasured variables. Proof of concept of these approaches have recently been demonstrated by the research group [3,4]. Second, gross errors are identified for their root cause for appropriate maintenance activities, such as corrective, preventive and predictive maintenance. Third, to reconnect a maintained sensor, guidelines such as ASTM D6122, E2968 are leveraged and customized for the process.
The integrated framework is implemented at Purdue University in a pilot scale continuous direct compression facility. An analytically redundant sensor network using process equipment sensors, inline and at-line sensors are networked with automation systems such as Emerson DeltaV, OSIsoft PI System and Applied Materials Smart Factory Rx. A hierarchical systems integration architecture closely following ISA-95 is set up to advance the practice of Quality-by-Design in continuous manufacturing towards Quality-by-Control and Industry 4.0 .
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 M. Moreno, S. Ganesh, Y. Shah, Q. Su, M. Gonzalez, Z. Nagy, G. Reklaitis. Sensor Network Robustness using Model-based Data Reconciliation for Continuous Tablet Manufacturing. J Pharm Sci (2019).
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