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Figure 1: iCELLis 500+ bioreactor
3.2 iCELLis 500+ Control System
The iCELLis 500+control system was specifically designed to operate, monitor and control the
iCELLis 500+ bioreactors. The system body is composed of grade 304/316 L stainless steel and
houses the following elements (Figure 2):
•
A bottom assembly with controller PLC, agitation motor, electrical connection, media preheater,
and the bioreactor docking station with load-cells; optionally two accessory peristaltic pumps
can be added in dedicated compartments;
•
A middle assembly with gas management block;
•
A top assembly with pumps, probe connections, probe transmitters, electrical connections,
emergency stop buttons and the touch screen panel;
•
An external TCU for bioreactor temperature control.
The bioreactor is placed on the docking station, which contains the load-cells and a magnetic
coupling for the agitation. When installed on the docking station, the bioreactor is directly under the
sensor connections.
Process control is performed through a dedicated interface (iCELLis 500+ software) and can be
accessed locally through the touch-screen panel or remotely. The iCELLis 500+ software has been
developed specifically for iCELLis 500+ platform in order to make the equipment compatible with
authorities’ standard guidelines for electronic records and signatures in biopharmaceutical processes
(21 CFR Part 11, Eudralex Annex 11).
