Flexel 3D System 1000L Instructions For Use; Preparation Of The Palletank; Flexel ® 3D Bag 1000L Installation; Filling Of 1000L Flexel ® 3D Bags - Sartorius Stedim Biotech FLEXEL 3D-Beutel Benutzerhandbuch

3. Flexel ® 3D System 1000L Instructions for use

3.1. Preparation of the Palletank

a) Open the hinged front doors by removing
the four locking systems (See Fig. 3)
b) Before proceeding to Flexel
installation in the Palletank
the internal surfaces of the Palletank
SMOOTH, FREE OF ANY PARTICLES that
might damage the bag surface and DRY.
c) Open the 2 bottom gates (See Fig. 4):
- Check that the Palletank
contain 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 1000L Installation
a) Obtain a packaged Flexel ®
the appropriate size and position it
on a smooth table with no sharp angular
corners. Bag size matches Palletank
b) On a table, position the bag in such a
way that the label is visible. The 4-port
system is uppermost and should be posi-
tioned on the back. This correct position-
ing will ensure a proper insertion of the
Flexel ® 3D Bag in the Palletank
c) 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. 5)
d) To open and remove the secondary
(external) packaging (See Fig. 6):
- cut one of its corner just under the
closure weld with a pair of rounded
scissors and open completely by
tearing along the weld.
- remove the secondary packaging by
sliding it away from the Flexel
(See Fig. 6)
e) Check that the Flexel ® 3D bag secondary
packaging is free from any damage that
could compromise the sterility.
f) Repeat the d), e) steps for the primary
(internal) packaging.
g) Remove the two adhesive tapes from the
®
Flexel 3D Bag without unfolding the bag
(See Fig. 7).
4
®
h) To position the bag inside the Palletank
- Hold the folded bag on both arms with
the 4-port system uppermost and on
the back, and the two (bottom) ports
® 3D Bag underneath. (See Fig. 8)
®
, check that - Position yourself on the side of the
® are Palletank
- Introduce the folded bag in the
Palletank
such a way that the bottom ports
face the bottom gates.
®
does not
i) Remove the bottom port tubes from the
Flexel ®
j) Insertion of the bottom port tubes in the
bottom gates:
- 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
3D Bag of inside the groove of the bottom port.
(See Fig. 9)
- Slightly pull down the bottom port and
® at the same time close the mobile jaw
size.
inside the groove of the bottom port.
(See Fig. 10)
- 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
® . trying to pull the bottom port out
from the bottom gate. The bottom port
must remain in place. If it not the case,
repeat the j) step.
- Repeat the j) step for the second
bottom port
k) Position the clamps on the bottom tubes
as close as possible to the bottom port
and close them (See Fig B).
l) Unfold the bag and fold down the 4-port
system and the tubing onto the front
wall. (See Fig. 11)
® 3D Bag.
m) Check the correct positioning of the
K-seal of the Flexel
of the Palletank
and back of the container (see Fig. 11)
n) Remove the protective foam
o) Close all clamps on the 4-port system
tubing. (See Fig. B)
® closest to the bottom gates
®
by the front opening in
3D Bag folds.
® 3D Bag in the middle
®
and parallel to the front
®
: 3.3. Filling of 1000L Flexel
You may fill either through the top or the
bottom. (See Fig. 12)
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 filling through the top, be
particularly careful not to connect
through the front opening.
c) Open the clamps only on the tubing
line that the bag will be filled from.
(See Fig. A)
d) Start to fill the Flexel
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. 13)
e) After having filled the bag with a few
liters of fluid (representing 5—6 % of the
bag nominal volume), stop the filling
and:
- Manually adjust each bag corner to its
appropriate position. (See Fig. 14)
- Close the hinged front doors and secure
the four locking systems.
f) Fill the bag to its nominal volume
(See Fig. 15).
g) 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. 16)
h) Close the clamps (See Fig B) and discon-
nect the filling line.
®
3D Bags
® 3D Bag - Sartorius
®
.