Terumo BCT Quantum Cell Expansion System, Operator'S Manual

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Quantum System Overview
The Quantum Cell Expansion System is an automated system for growing adherent and suspension cells
in a functionally closed environment. The term “functionally closed” is often used in the FDA
‑
regulated
blood and blood component industry to describe systems that are closed at the point of manufacture
except for tubing with pre
‑
connected sterile barrier filters on spike and port connections, and/or
openings that only allow flow out of the system. Under this definition, the Quantum system is
functionally closed, as it contains a sterile barrier between the Cell Expansion Set and any external
openings. The system also has mechanisms in place for adding media, loading cells, harvesting cells, and
taking samples without opening the system.
The Quantum system includes an incubator and a cell expansion set used for expanding different cell
types. The cell expansion set has a hollow-fiber bioreactor, an intracapillary (IC) circulation loop, an
extracapillary (EC) circulation loop, bags, and other components necessary for the cell expansion
process. The system also includes a touch screen that enables the operator to communicate with the
system. The operator follows the instructions on the touch screen to perform the following:
•
Load, prime, and unload the cell expansion set.
• Select and perform tasks during the cell expansion process, such as feeding and waste removal.
• Troubleshoot alarms.
Introduction
2-2 Quantum
®
Cell Expansion System • Operator's Manual for Software Version 2.1