This project consisted of the design of a leading edge Class 10,000 (ISO 7) cell therapy clean room facility for spinal cord injured patients. Included design of gown and pre-gown area, tissue/cell preparation lab, laboratory support spaces, CO2 incubators, bio-safety cabinets, centrifuges and ultra-low freezer. The cell center is a FDA validated GMP facility. SBEC performed commissioning of MEP systems for Owner FDA validation.
Scope of work included:
- Dynamic room pressure controls
- Tight humidity tolerances
- Uninterruptible Power Supply (UPS) power
- Pre-action fire protection system
- Temperature control designed and operated at 68 degree F +/- 2 degrees
- Humidity control designed and operated at 45% RH +/- 5%
- Airflow measuring for both outdoor make-up air and total airflow for clean room fan
- Gowning room and ante-room vestibule with door interlock
- Fan-powered HEPA pass-through with door interlock
- DI water and electric steam autoclave