Intermediate Entry Rooms
These rooms are designed as material storage rooms within the GMP area. Staff will enter this room from the gowning room. The room will contain refrigerators, freezers and ultra-low freezers designated for each processing room and will allow storage of consumable items previously inspected and released for use by the Quality Assurance department.
The Intermediate Entry Rooms will be validated and maintained as Class C rooms.
Intermediate Exit Rooms
The facilty will have 2 different intermediate exit rooms, one for the human cell and tissue processing area and one for the xenotransplantation area.
This room is entered through the airlocks located between the processing room and the exit room. Staff enter the degowning room from this room.
The Intermediate Exit Rooms will be validated and maintained as Class D rooms.
Waste Processing Room
Waste will be passed from the Intermediate Exit Rooms to the Waste Processing Room through a cart pass-through. The Waste Processing Room will be equipped with a validated autoclave that will be used to decontaminate all waste generated in the facility.
A large central supply room equipped with refrigerators and freezers as well as a separate quarantine area will be used to store all supplies and materials for the facility. Access to the supply room will be controlled using card readers.
Dedicated file room to store all GMP records generated.
Material Preparatory Room
This room will be used to sterilize materials and apparatus and will be equipped with the following equipment: GMP autoclave, plasma sterilization unit, glassware washer, depyrogenation oven.