3.1. Preparation of the Palletank
®
a) If you use:
> the Palletank
®
for In-process Fluid Han-
dling, open the hinged front doors by
removing the four locking systems (see
Fig. 6)
> the Palletank
®
for Shipping, please refer
to the Palletank
®
for Shipping Instruc-
tions for Use delivered with the Palletank
®
b) Before proceeding to Flexel
®
3D bag
installation in the Palletank
®
, check that
the internal surfaces of the Palletank
®
are
smooth and free of any particles that
might damage the bag surface and DRY
c) Open the bottom gate(s) (See Fig. 7):
- Check that the Palletank
®
does not con-
tain a filled Flexel
®
3D bag (failure to
follow this instruction may result in
product loss).
- Remove the retaining clip from the
retaining clip fastening point.
- Grasp the retaining clip fastening point
and swing the bottom gate completely
open.
3.2. Flexel
®
3D Bag Installation,
100L | 200L | 500L
a) Obtain a packaged Flexel
®
3D bag of the
appropriate size and position it on a
smooth table with no sharp angular
corners.
Caution:
> If you are using a Palletank
®
for Storage,
Palletank
®
for Storage (stackable), Pal-
letank
®
for In-Process Fluid Handling or
Palletank for Weighing, the bag size
matches Palletank
®
size except for the
100L bag which is to be used with the
200L Palletank
®
> If you are using a Palletank
®
for Shipping,
the bag size matches Palletank
®
size
b) Check that the irradiation indicator on
the label is red. Record the batch number
of the bag (as seen on the product label)
(see Fig. 8).
c) On a table, position the bag so that both
the bottom port and the 4-port system
are facing you with the bottom port
underneath. This correct positioning will
ensure a proper insertion of the Flexel
®
3D Bag in the Palletank
®
d) To open and remove the secondary
(external) packaging (see Fig. 9):
- Cut one of its corner just under the clo-
sure weld with a pair of rounded scis-
sors and open completely by tearing
along the weld.
- Remove the secondary packaging by
sliding it away from the Flexel
®
3D bag
(see Fig. 9).
e) Check that the Flexel
®
3D bag secondary
packaging is free from any damage that
could compromise the sterility.
f) Repeat the d) and e) steps for the primary
(internal) packaging.
g) Remove the adhesive tape from the
Flexel
®
3D bag without unfolding the bag
(see Fig. 10).
h) To position the bag inside the Palletank
®
:
- Hold the folded bag on both arms with
the 4-port system uppermost, facing
the user and the single (bottom) port
underneath (see Fig. 11)
- Position yourself on the side of the
Palletank
®
closest to the bottom gate
> If you are using the Palletank
®
for
In-Process Fluid Handling
- Insert the folded bag in the Palletank
®
by the front opening in such a way that
the bottom port faces the bottom gate.
> If you are using the Palletank
®
for Stor-
age, Palletank
®
For Shipping or Palletank
®
for Weighing
- Insert the folded bag in the Palletank
®
in such a way that the bottom port
faces the bottom gate.
i) Insertion of the bottom port tube in the
bottom gate:
> If you are using a 100L or 200L Flexel
®
3D bag: Flip the bottom of the bag so
that the bottom port faces the bottom
gate.
> If you are using a 500L Flexel
®
3D bag:
the bottom port faces the bottom gate
- Insert the bottom port tube and pull it
through the jaw.
- Place the bottom port in contact with
the fixed jaw of the bottom gate. The
edge of the fixed jaw must be inserted
inside the groove of the bottom port
(see Fig. 12).
- Slightly pull down the bottom port and
close the mobile jaw inside the groove
of the bottom port (see Fig. 13).
- Lock the latch of the bottom gate to
secure the bottom port.
- Check the correct positioning of the
bottom port in the bottom gate by try-
ing to pull the bottom port out from
the bottom gate. The bottom port must
remain in place. If it not the case,
repeat the g) step.
j) Unfold the bag and fold down the 4-port
system and the tubing onto the front wall
(see Fig. 14).
k) Check the correct positioning of the K-
seal of the Flexel
®
3D bag in the middle
of the Palletank
®
and parallel to the front
and back of the container (see Fig. 14).
l) Remove the protective foam.
m) Position the clamp on the bottom tube as
close as possible to the bottom port and
close it (see Fig B).
n) Close all other clamps on bag tubing
(see Fig. B).
3.3. Filling of 100L | 200L and 500L
Flexel
®
3D Bags
You may fill either through the top or the
bottom (see Fig. 15).
a) Check that all the clamps are closed
(see Fig. B).
b) Open the connector protective outer-
wrap using the reversible cable tie on the
filling line and connect the bag to the
supply tank in accordance with the aseptic
procedures used on your site (see Fig. C).
Caution:
If you are using the Palletank
®
for In-
Process Fluid Handling and filling
through the top, be particularly careful
not to connect through the front open-
ing.
c) Open the clamps only on the tubing
line from which the bag will be filled
(see Fig. A).
d) Start to fill the Flexel
®
3D bag - Sartorius
Stedim Biotech recommends the use of
peristaltic pumps for filling and dispens-
ing from the bag.
Caution:
As the bag fills, it will pull on the tubes;
be careful that the tubes do not get
caught on the side of the Palletank
®
(see Fig. 16).
e) After having filled the bag with a few
liters of fluid (representing 10 % of the
bag’s nominal capacity), stop the filling
and perform the following steps:
- Manually adjust each bag corner to its
appropriate position (see Fig. 17).
- If you use the Palletank
®
for In-Process
Fluid Handling, close the hinged front
doors and secure the four locking sys-
tems.
g) Fill the bag to its nominal capacity
(see Fig. 18).
h) If you have chosen to fill through the
top, empty the liquid contained in the
filling line into the bag by raising the
tube vertically over the bag (see Fig. 19).
i) Close the clamps (see Fig B) and discon-
nect the filling line.
4
3. Flexel
®
3D System 100L | 200L | 500L Instructions for use
