Flexel Bag For Levmixer ® Filling; Mixing - Sartorius stedim Flexel Palletank 50L Manual De Usuario

Figure 36.
Cautions:
– Do not move the Palletank
or Palletank ® Jacketed for LevMixer
®
the LevMixer drive unit Handle when
assembled.
– Ensure that electrical power remains
connected to the machine when coupling.
If the power is shut off, it is necessary to
wait 25 minutes prior charging the drive
again (Refer to 5.2.).
5.7. Flexel Bag for LevMixer
A. Check that all the clamps are closed.
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. 37)
Figure 37.
14
C. Open the clamps only on the filling line.
Start to fill the Flexel
Sartorius Stedim Biotech recommends the
use of peristaltic pumps for filling and
dispensing from the bag (See Fig. 38).
® for LevMixer ® Figure 38.
® with
D. After 30% filling:
D.1. You may manually adjust the bag to its
appropriate position to maintain a horizon-
tal surface and the bag corners positioned in
the appropriate corners of the Palletank
D.2. If you want to start mixing at this stage,
refer to Section 6.
®
Filling
D.3. If the process allows for bag opening
(non sterile process):
- Make sure the bag is filled to 30% of its
nominal volume (minimum)
- Make sure the clamp holder is opened,
- Remove the 8" plug of the bag protection
cap and the gasket by removing the union
clamp,
- Manually lift the bag and position the
bag protection cap in its dedicated clamp
holder
- If you want to start mixing or add powder
at this stage, refer to Section 6.
- Fill the bag to its nominal volume accord-
ing to your process requirements
D3. If bag opening is not possible (sterile
process), the protection cap will be posi-
tioned in the dedicated clamp holder once
the bag is filled to its nominal volume
- Fill the bag to nominal volume,
- Make sure the clamp holder is opened,
- Position the bag protection cap in its
dedicated clamp holder
Caution:
– Do not attempt to mix in dry bags. It may
result in damage of the film. The bag must
be filled to 30% of its nominal volume
prior to starting the mixing – Please refer
to Section 6 for mixing instructions.
– Powder addition can take place only when
the bag protection cap is positioned in its
dedicated clamp holder - Please refer to
Section 6 C for detailed instructions.
E. When filling is complete, close the clamps
and disconnect the filling line (if needed).

6. Mixing

Caution:
® ®
Bag for LevMixer - – Do not attempt to mix in dry bags. It may
A. Turn the speed drive switch to the
ON position and adjust the RPM with the
RPM Regulator Knob to desired speed
(See Fig. 39).
B. Mix according to application specifica-
tions.
® .
Figure 39.
C. For powder addition:
Caution:
– Powder addition can take place only
C.1. Remove the 8" plug of the bag protec-
tion cap and the gasket by removing the
union clamp,
C.2. Add the powder according to your
internal procedures
C.3. Once powder addition is complete,
we recommend closing the protection cap.
result in damage of the film. The bag must
be filled to 30% of its nominal volume
prior to starting the mixing
when the bag protection cap is positioned
in the dedicated clamp holder (refer to
5.6 section, paragraph D.3.)