The Upstate stem Cell cGMP Facility is a multi-use facility, with high flexibility and versatility designed specifically with the goal of eliminating or minimizing contamination and/or cross-contamination of manufactured materials to ensure product safety.
In addition to multiple segregated HEPA-filtered manufacturing labs, the facility also contains process development, testing, and support space. Controlled environment design features include the following:
- Redundant air handling systems providing clean-room air classification and quality from Class 100,00 (ISO 8) to Class 100 (ISO 5)
- Pressure differentials of 0.05” w.c. between adjacent rooms with up to 60 air changes/ hour
- Rigorous control of room temperature, pressure and relative humidity
- Unidirectional flow of personnel, raw materials product, and waste
- Engineered for easy and effective cleaning, utilizing stainless steel surfaces, gel-coated polymer walls and ceilings, epoxy coated floors, minimal seams and ledges; and movable equipment and work surfaces
The USCGF has successfully completed a type C meeting with the FDA in which the facility design, intent of use, operational flow, and quality management system were reviewed in detail.