Robertson GMP Lab

Researchers in the GMP Lab

The Robertson cGMP Laboratory is a FACT accredited, FDA registered, multi-purpose facility that includes 13 individual rooms and 3 manufacturing rooms, covering 3150 GSF. This facility is dedicated to the manufacturing of biologics and processing of tissues for human clinical use.

The facility’s mechanical systems, architectural features and finishes meet US Food and Drug Administration as well as relevant international requirements for controlled clean room manufacturing environments and aseptic processing. Some of its attributes include:

  • Ultra low particulate air (ULPA) filters and air-handling units are configured to deliver particulate-free air at a positive air pressure respective to surrounding rooms and spaces.
  • All critical parameters (temperature, pressure, and humidity) are monitored.
  • Periodic environment monitoring is performed to assure microbiological control.
  • All manufacturing equipment and utilities are validated in accordance with biopharmaceutical standards.
  • Standard operating procedures assure that all systems are properly maintained and functional.
  • Access to the facility is controlled.

The facility includes manufacturing and support operations on one floor consisting of CNC, ISO 8, and ISO 7 areas.

Robertson cGMP Laboratory Suite Floor Plan

For more information about the facility, please contact the Robertson GMP Laboratory Director at norin.meadows@duke.edu.