37091/04 – ch20 (Issued: 2020-06)
Alternative installation of CliniMACS® Tubing Sets – 1
Alternative installation of CliniMACS® Tubing Sets
Alternative installation of
CliniMACS® Tubing Sets
The instructions in STEP 3 and the screens displayed by the
CliniMACS® Plus Instrument describe the installation of the
CliniMACS Tubing Sets under sterile conditions (clean room).
The CliniMACS Plus System itself is a closed system which does
not necessarily need to be operated in a clean room. However,
if operated outside a clean room, the installation procedure of
the tubing set needs to be adapted in order to ensure that the
sterility of the cell separation process is guaranteed.
The sterility of the cell separation process may be compromised
during the attachment of the Cell Collection Bag, the CliniMACS
PBS/EDTA Bu
ff
er, the pre-system filter, and the Cell Preparation
Bag. To ensure that the system remains sterile, these components
must be attached to the tubing set under sterile conditions (e.g.
laminar flow hood). When the components are attached to the
tubing set before installation onto the CliniMACS Plus Instrument,
the order of the instructions provided by the instrument and
the instructions in STEP 3 must be changed and further actions
taken.
When operating the CliniMACS Plus Instrument outside a clean
room, follow the following additional instructions, altering the
instructions in STEP 3.
