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.
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.
- 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.