Synopsis of Parenteral Facility Capping Line Commissioning, Qualification, and Computer System Validation (CSV) Project

Situation: A leading pharmaceutical manufacturing company purchased a complete automated Capping Line for installation at one of their parenteral facilities as part of a Diversified Hospital Care (DHC) Upgrade initiative. Issues: Before putting the Capping Line to use, the capping line's various equipment components and process operations had to be validated and qualified to meet FDA regulatory compliance mandates. Requirement: Complete Validation/Qualification and Computer System Validation (CSV) activities on the equipment and associated process operations.

Brock Solutions' Role: Providing a team consisting of a variety of specialized roles, including a CQ/CSV Coordinator, an Automation Lead, a Quality Control Specialist, and Process Engineers to perform Validation/Qualification and CSV exercises for each component and associated component system of the Capping Line, which consisted of UAP Hoods, Capping Machine, Accumulation Tables, Raised Stopper Detector, Nude Vial Identification, External Vial Washer, Inspection Machines, Trayloaders, Tray Washer, and Conveyors. Technology: Allen-Bradley ControlLogix PLC platform, RSViewSE Human Machine Interfaces (HMIs), Oracle database, RSTestStand.

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