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7
Plan the kit configuration
Consider what fluids you want from where and layout a Single-Use Kit identifying the reagents and any
recirculation bag links using the Define Kit screen in the Protocol Builder.
Review the layout thinking through challenges like rinsing bags, intermediate bags and concentrate
waste disposal.
Plan the protocol
Write a first draft of the protocol incorporating recommended priming steps and the various step types
available.
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Use the Rotea
1. Estimate the total run time for the protocol and the time to complete each step.
2. Estimate the bag volume at the end of each step.
3. Compare the bag volume with the bag capacity and highlight when the capacity is exceeded.
4. View each step in the protocol to see the bag volumes (numerical value and graphical
representation), fluid path, flow rate, G force, the trigger that would be activated to move to the
next step and the time to complete the step.
5. Play the Rotea
6. Simulate the impact of changes to input volumes, bag capacities and data entry values without
changing the original protocol.
Where possible for early process development work with new cells and media, the output line for
steps processing cells, e.g. loading, washing and harvesting, should be directed to separate bags. The
combined total of cells in the output bags should be equal to what was put in. If the combined total is
not equal, or the amount of cells in any bag is not what is expected, having separate bags will enable
you to pinpoint in which steps cells were lost.
It can often be helpful to separate the protocol into sections, e.g. a sequence of priming steps
followed by a block of processing steps that are performed multiple times until a large batch of cells is
processed. Where loops are ultimately required, initially create and test the protocol on a smaller batch
without loops. Add the loops once you are happy with the protocol settings.
CTS
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Rotea
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Counterflow Centrifugation System Process Design User Guide
Simulation software to:
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Simulation software in real time, 4x or 8x speed, pause and skip.
Design new protocols
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