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Particle Monitoring System for Sterile Filling Operation

Particle monitoring system integrated with supervisory control and data acquisition system maintains product quality. 
  • Particle monitoring system assures product quality for sterile filling operation-Gannett Fleming

    To protect products from contamination, the particle content of the air must be monitored.


Grifols Therapeutics, formerly known as Talecris Biotherapeutics

Johnston County, North Carolina

Our Role
Programming, Design, Installation, Integration, Start-up, Commissioning, Qualification, Validation.

Construction Cost
  • Particle monitors linked to the SCADA system lead to improved air quality.

To maintain product quality and compliance with federal good manufacturing practice regulations such as 21 CFR parts 210 and 211, the environmental conditions in a sterile filling operation must be monitored to minimize the possibility of foreign particles. Particle monitors sample the air in proximity to the exposed product and detect deviations in air cleanliness, such as dust and microbes. The supervisory control and data acquisition (SCADA) system triggers and records a warning or an alarm depending on the size and number of particulates. This data is used for batch release.

What We Did

Gannett Fleming oversaw the design and installation of the particle monitoring system, which reports 0.5 and 5.0 micron particle counts via onboard OPC servers to a GE iFIX SCADA system. Reporting is built into the SCADA systems for product release documentation and user-generated ad-hoc reports. The off-the-shelf solution allows the company to monitor a key factor in product quality with real-time data and alerts. 

Work included developing electrical and control panel drawings, preparing system documentation, and providing programming services, installation, start-up, and technical and operations training. Gannett Fleming also provided commissioning, qualification, and computer system validation services.

Key Features

  • Technologies used include GE iFIX SCADA, GE Historian, Microsoft SQL Server, Informetrics InfoBatch reporting software, Particle Measuring Systems particle counters, and Allen Bradly ControlLogix PLC.

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