High Potency GMP Manufacturing

Take advantage of our state-of-the-art Containment Manufacturing Area for handling high-potent products. Our High-Potent Compound Handling Area features isolator technology and state-of-the-art engineered controls. Our containment classification is based on the industry standard Performance-Based Level of Exposure Classification (PBLEC). We can handle a PBLEC Level 5 (or down to 0.1ug/cu.meter) dependent upon the type of compound/dosage form and batch size. With four containment suites, product development and commercial manufacturing can take place right in our facility.

High-Potent batch sizes can range from <1 kg - 500 kg. Additional containment support includes:

  • Staffed Industrial Hygienist
  • Medical Monitoring of workers
  • Single-pass air flow
  • Separate HVAC systems
  • Designated staging area
  • Special gowning requirements
  • Document control