Design of condition-based maintenance framework for process operations management in pharmaceutical continuous...

Area of Science:

• Pharmaceutical Manufacturing
• Process Engineering
• Maintenance Strategies

Background:

• Continuous manufacturing offers increased efficiency and agility in pharmaceutical production.
• Effective management of materials, equipment, analyzers, and data is crucial for continuous operations.
• Limited research exists on managing abnormal conditions and ensuring infrastructure reliability in continuous manufacturing.

Purpose of the Study:

• To introduce Condition-Based Maintenance (CBM) as a strategy for verifying and sustaining pharmaceutical manufacturing systems.
• To focus on the application of CBM in the continuous manufacturing of oral solid dosage products (OSD-CM).
• To outline a systems architecture and infrastructure for CBM implementation in OSD-CM.

Main Methods:

• Introduced CBM as a general strategy leveraging process knowledge and real-time data.
• Outlined a systems architecture design for CBM in OSD-CM.
• Described infrastructure implementation on an OSD-CM testbed using commercial automation systems and enterprise architecture standards.

Main Results:

• Presented sample fault scenarios involving equipment and process analyzers within the CBM framework.
• Demonstrated the practical implementation of CBM infrastructure on a testbed.
• Highlighted the relevance of CBM for both single unit operations and integrated systems in digitalized manufacturing.

Conclusions:

• Condition-based maintenance (CBM) is a viable strategy for ensuring the reliability and operational excellence of continuous pharmaceutical manufacturing.
• A well-defined systems architecture and enabling infrastructure are vital for successful CBM implementation.
• Proactive use of process data through CBM modernizes maintenance practices in the increasingly digitalized pharmaceutical industry.