A Pharmaceutical Manufacturer in Indiana requested help from Performance Validation (PV) with the commissioning and qualification of a continuous manufacturing process train. The process train was the first commercial continuous manufacturing suite for the company. The continuous manufacturing process closely mimicked a process train in the development area.
The Continuous Manufacturing process is an equipment train located within a dedicated suite. For products amenable to a direct compression process, the system is designed to continuously and accurately meter raw materials to attain a specified target unit formula, uniformly blend these materials, and compress the blend into finished tablet cores without isolation, interruption, or manual intervention. This is achieved through a vertical arrangement of loss-in-weight feeders, a horizontal high-shear paddle-style mixer, and a conventional tablet press which are integrated via a distributed control system. Tablet quality is assured through real-time evaluation of feeder, mixer, and tablet press performance in combination with periodic sampling and analysis of produced tablets in an automated tablet tester equipped to evaluate tablet weight, thickness, and hardness (where tablet shape permits). Additional process analytical technology instruments and real-time process models are present in the system.
Performance Validation (PV) provided validation engineering resources to aid in the development and execution of the testing for this equipment, and to provide a lifecycle approach for documentation, including requirements, specifications, system and component criticality assessments, and summary using the company policies and procedures, to successfully release the equipment:
The Continuous Manufacturing process was qualified and released on time per project schedule. This enabled the company to use the equipment for commercial manufacturing.
The company successfully transitioned a batch manufacturing process to a continuous manufacturing process. This resulted in an increased performance and product yield from the facility and associated manufacturing equipment. This improved performance led the company to replicate this process at two other manufacturing sites. As identified by ISPE in the Facility of the Future Award the manufacturer was recognized for the progressive mass balance control scheme anchored by advanced automation and PAT technology, key to insuring consistent control, low process variability, and high quality assurance.
About Performance Validation: Performance Validation is a 100% employee-owned company has been serving the life science industries since 1988, and is a nationwide leader in providing validation, commissioning, and quality services for pharmaceutical, biotechnology, and medical device manufacturers.
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VP/ Indiana Division Director
Performance Validation, Inc
Office: (317) 248-8848
Cell: (317) 727-8495