37091/04 – ch20 (Issued: 2020-06)
CliniMACS® Plus System User Manual (Canadian edition)
4 – STEP
1: CliniMACS® CD19 Reagent
IV. Preparation of leukapheresis product
The following sections describe the recommended procedure
for the preparation of the leukapheresis product using the
Terumo Sterile Connection Device (TSCD).
- The operator must be familiar with the operation and use of
the TSCD.
- Before starting the cell labeling and separation procedure
ensure that all needed supplies and equipment are available.
Analysis
Before starting the preparation of the leukapheresis product the
following parameters should be determined:
- Total number of leukocytes
- Percentage of CD19 positive cells
- Total number of CD19 positive cells
- Viability
Recheck the parameters after the labeling procedure. This is
necessary because the following three sample parameters
have to be entered in the software during the setup of the
CliniMACS Plus Instrument prior to loading the tubing set onto
the instrument:
- Concentration of leukocytes per mL
- Percentage of CD19 positive cells
- Final volume of the cell sample (sample loading volume)
Other tests might be required depending on the intended use
of the cells. Record all data.
Important
■
All bag handling should be done in
a sterile environment (e.g. laminar
flow hood) using aseptic techniques.
The connection of tubing using the
TSCD may be performed outside the
laminar flow hood.
■
Perform sample preparation and
cell separation at room temperature
(+19 °C to +25 °C [+66 °F to +77 °F]).
Lower or higher ambient temperature
will result in less purity and yield of
the target cells.
