IMG_1966 Bambino FCL WhiteDistrict tenants can access the USD Aseptic GMP Production and Training Center at a discounted rate. The GMP Center is located in the park’s anchor facility, the Graduate Education and Applied Research (GEAR) Center.

The GMP Center provides pilot-scale aseptic cGMP services to clients manufacturing pharmaceuticals, biologics and medical devices for product development and clinical trials. The Center establishes a quality agreement with each client.

GMP Services include:

  • Process consulting at intake;
  • Full auditing of all batch records and laboratory data for accuracy, authenticity, and completeness; and
  • Post-production sanitization.

The Center offers automated sterile fill, stoppering and crimp capping. These services utilize a Capmatic Bambino monoblock system with the following features:

  • Fill volumes from 3 ml to 120ml
  • Paristaltic dosing pump
  • Nitrogen purge at fill and stoppering
  • Automatic reject station
  • Allen Bradley control system

Facilities and equipment are managed to cGMP standards including:

  • Routine balance and equipment calibration;
  • Routine environmental monitoring and controls;
  • Validation of all equipment, software, and systems;
  • Cleaning verification of any non-dedicated equipment after manufacturing; and
  • A preventative maintenance program with change control.