USD's current Good Manufacturing Practices (cGMP) and Aseptic Processing Facility at the Graduate Education and Applied Research (GEAR) Center is a unique resource within South Dakota. It is able to support manufacturing pharmaceuticals, biologics and medical devices for product development and clinical trials while maintaining compliance with applicable regulatory and industry standards.
cGMP Facility Floor Plan
The USD cGMP lab is 835 ft. sq. and consists of: ISO Class 8 Primary and Secondary Gowning Rooms, ISO Class 7 Clean Prep Room and Aseptic Processing Room, two ISO Class 5 Laminar Flow Hoods and one ISO Class 5 Isolation Tent.
Facilities and Equipment are managed to cGMP standards including:
- Balance & Equipment calibration
- Environmental monitoring and controls
- TSI Facility Monitoring System - Continuous Particle, Pressure, Temperature and Humidity Monitoring
- Validation of all equipment, software, and systems
- Cleaning verification of any non-dedicated equipment after manufacturing
- Preventative maintenance program with change control
- FSA fully automated sterile fill system
- Fill volumes: 3mL to 120mL
- Nitrogen purge at fill and stoppering
- Automatic reject station
- Allen Bradley control system
Consolidated Sterilizer System - Double Door, Pass Thru Autoclave
- Model: PT-SR-26A-ADVPLUS
- Chamber Dimensions: 26" x 26" x 29"
- Volume: 15.25 cu. ft.
Grieve Depyrogenation Oven
- Model: Modified CLB-500
- Work Space Dimensions: 24" x 36" x 27"
- Volume: 13.5 cu. ft.