Overview of the GMP Facility
To support clinical investigation in the field of cellular therapy the ACT Laboratory is located directly adjacent to the Transfusion Medicine Division and the Clinical Blood Bank for Yale New Haven Hospital (Photo 1).
The facility (Photo 1) including storage and office areas occupies a total of 1432 sq ft of which 676 sq ft is a ISO7 GMP Clean Room Facility comprised of 4 separate areas: 1,100 sq ft ISO7 gowning area, a 206 sq ft ISO7 shared equipment area, and two fully equipped 185 sq ft ISO7 Cell Processing Laboratories (Photo 2).
In a separate area, we have a controlled rate freezer for cryopreservation of cellular products, a dedicated liquid nitrogen freezer for storage of patients’ cells, as well as additional freezers and refrigerators, all of which are monitored 24/7.
Continuous electronic monitoring of the equipment in this facility is in place. Throughout the facility, the air meets class 10,000 (ISO7) and is exchanged in excess of 15 times per hour. The facility has its own air-handling HVAC system and HEPA filters for return air.
Pass-throughs are used to segregate the flow of QA/QC released materials, human specimens, and waste.