Pall LevMixer DB-300 User manual
Pall Life Sciences. USA: Port Washington, NY, USA 1 800 717 7255 toll free (USA),+1 516 484 5400 phone,
© 2012, Pall Corporation. Pall, Allegro, Kleenpak, Stax and the Allegro Design are trademarks of Pall Corporation. ®
indicates a trademark registered in the USA and TM indicates a common law trademark.
Filtration.Separation.Solution is a service mark of Pall Corporation.
LevMixer®
Single-Use Mixing System
OPERATOR MANUAL
Models DB-300, DB-300C
USD 3184
Document #: 020-17475-00 Revision: E Page #: 2 of 63
A.SAFEGUARDS & PRECAUTIONS
1. Read and follow all instructions in this manual carefully, and
retain this manual for future reference
2. Do not use this instrument in any manner inconsistent with
these operating instructions or under any conditions that exceed
the environmental specifications stated.
3. Be sure the power supplied to this instrument matches the
specifications indicated on the control box and described on
the Copy of Equipment Nameplate page.
4. If the drive unit is transported or stored in temperatures colder
than the operating environment it is necessary to wait 1-2 hours
to equalize the internal temperatures of the drive unit before
powering on.
5. Be sure all power is disconnected before opening, assembling
or disassembling the superconductive drive unit or its control
box.
6. For full compliance with CE specifications, be sure the
appropriate ground connection is made.
7. For technical assistance contact the sales organization from
which you purchased the product or Pall Life Sciences directly
8. Each LevMixer®mixing bag contains a magnetic impeller,
which is a source of strong magnetic field within close proximity
(12 inches) of the impeller. PEOPLE USING ANY ELECTRONIC
MEDICAL DEVISES, SUCH AS PACEMAKERS, SHOULD NOT BE
INVLOVED IN THE CLOSE HANDLING OF LEVMIXER MIXING BAGS,
MAGNETIC CHARGERS, IMPELLERS OR TEST IMPELLERS.
Document #: 020-17475-00 Revision: E Page #: 3 of 63
9. Keep the supplied magnetic shields on bags, magnetic
chargers, and impellers when not in use.
DO NOT open the machine or control box while the Drive Unit is
plugged in.
DO NOT submerge the drive in water. The unit outer surfaces
may be cleaned and sanitized by wiping with a mild detergent
solution.
DO NOT cut the ground plug.
Document #: 020-17475-00 Revision: E Page #: 4 of 63
B. TABLE OF CONTENTS
A. SAFEGUARDS & PRECAUTIONS...................................................................................2
B. TABLE OF CONTENTS .....................................................................................................4
C. SPECIFICATIONS.............................................................................................................5
D. OVERVIEW .......................................................................................................................7
E. PRINCIPLE OF OPERATION...........................................................................................7
F. MIXING SYSTEM COMPONENTS AND ACCESSORIES............................................9
G. SUPERCONDUCTING DRIVE UNIT CONTROL..........................................................14
H. CHARGING THE SUPERCONDUCTORS ....................................................................17
I. DOLLY –TANK ASSEMBLY...........................................................................................21
J. BAG-INTERFACE ASSEMBLY ......................................................................................24
K. INSERTING MIXING BAG INTO CONTAINER ..........................................................25
L. COUPLING THE BAG WITH SUPERCONDUCTING DRIVE UNIT ............................26
M. MIXING...........................................................................................................................30
N. REMOVING SUPERCONDUCTING DRIVE UNIT FROM TANK ...............................30
O. MAINTENANCE & CARE OF SUPERCONDUCTING DRIVE UNIT ..........................31
P. OPERATOR CONTROL INTERFACE GUIDE ...............................................................44
Q. SPARE PARTS & STANDARD ACCESSORIES LISTS...................................................63
R. ELECTRICAL SCHEMATIC............................................................................................67
S. COMPACT MODEL.......................................................................................................58
T. LEVMIXER - SERVICE....................................................................................................61
Document #: 020-17475-00 Revision: E Page #: 5 of 63
C.SPECIFICATIONS
Table1. Specifications sheet
Footprint (in. & mm) WxLxH:
16” x 44” x 36” (compact configuration)
16” x 51.6” x 36” (expanded)
Control box, cart, & mixer
enclosure material:
304L Stainless Steel
Control box, cart, & mixer
enclosure surface finish
At least 35 µin. Ra / 0.89 µm Ra
Control box ingress rating:
IP 65
Enclosure ingress rating:
IP 23
Voltage:
100-230VAC,50/60Hz
Input Wattage:
Less than 350W
Amperage:
100V 2.8A; 110V 2.5A ; 230V 1.5A
Voltage fluctuation:
+/- 10%
Altitude rating:
1000m
Max humidity:
85%, avoid condensation
Ambient temperature:
4-40°C
Motor horsepower:
1/8hp
Power cord length:
20 ft (600 cm)
Power cord plug options:
US, Continental Europe, Swiss, Australia, Japan, UK
E-stop (present, yes/no,
location):
Yes, face of control box
Min and Max speed:
20 to 210 RPM
Connections for remote
output/control:
TURCK RSFPV61, RSFPV579
Functions available from
remote control panel:
Motor - start, stop. Speed –adjustment, indication. Alarm –
indication. Mode of control (remote/local) –indication
Signal type(s) for remote
output/control:
Impeller speed out 4-20mA, motor control
in 0-10 VDC, discrete I/O signals relay contact type
Alarms generated:
Motor failure, impeller coupling failure, speed off-range failure,
cryocooler failure, E-stop activation
Mixer charge time:
35 minutes
Operator interface type:
Touchscreen PLC
Method for RPM
measurement:
Direct measurement of impeller speed via non-contact
magnetic sensor
Noise level at operator
position:
67dB
Casters:
2X swivel (front), 2X stationary (rear)
Wheel material:
Polyurethane
Recipe storage:
Yes. Up to 10 can be stored. Up to ten instructions in each
recipe are executed sequentially. Each instruction contains
individual programmable parameters: mixing time, pause
time, and speed.
Password protection:
Operator level: access to protected function - start recipe run.
Supervisor level: access to protected functions - Recipe Editor,
Pause or Abort Recipe run, Switch of Control between Local
to Remote, adjustment of set up for reduced set of
parameters. Maintenance level: access to protected
functions –Program Setup parameters, System parameters
and includes Supervisor level of access.
Document #: 020-17475-00 Revision: E Page #: 6 of 63
D. OVERVIEW
The LevMixer®utilizes a levitating impeller in a sterile closed bag, driven and levitated by
asuperconducting drive. The LevMixer® is able to mix within sterile disposable
hermetically sealed standard or custom bags with volumes up to 2000L.
The mixing system hardware has three major components:
1. Superconducting drive unit
2. Elevated Retaining Tank (either on dolly or with integrated legs)
3. Drive Port that couples drive unit with bag
The mixing system can accommodate a variety of standard and custom-designed
single-use mix bags available from PALL LifeSciences.
E. PRINCIPLE OF OPERATION
The LevMixer®’s mixing technology is based on non-contact magnetic coupling
between conventional permanent magnets in the impeller and superconducting
material in the drive. Superconducting material has the ability to trap the magnetic
field generated by the permanent magnets and “lock the magnetic field in memory” in
an equilibrium position.
Figure 1: Noncontact magnetic coupling between the
permanent magnet and superconductors. The
superconducting material traps the magnetic field from
the magnet, resulting in stable mechanical coupling
without physical contact.
The trapped magnetic field behaves like mechanical springs; if the magnet is moved
up, down or sideways by outside forces (e.g., gravity or angular torque), it will tend to
be pulled back to an equilibrium position. The peculiar nature of magnet-
Document #: 020-17475-00 Revision: E Page #: 7 of 63
superconductor interaction ties the two bodies together resulting in a very stable
mechanical coupling with finite equilibrium separation. This peculiar stability cannot be
attained in conventional mixer designs that employ two permanent magnets.
The Cryogenic temperatures (approx. –200oC) required for the superconducting
material are achieved by an internal cryocooler (Sterling cycle refrigerator).
Document #: 020-17475-00 Revision: E Page #: 8 of 63
F. MIXING SYSTEM COMPONENTS AND ACCESSORIES
Figure 2: Main components of LevMixer system.
Document #: 020-17475-00 Revision: E Page #: 9 of 63
Figure 3: From left to right, Magnetic Charger (DBCI001), Shield for Magnetic Charger, (DBAK011)
and Magnetic Charger (DBCI001) coupled with Shield. During the charging procedure, the ball
bearing (red in far left picture) should rest on the surface of the levitation head of the drive unit.
Figure 4: From left to right, Magnetic Charger (DBCI005), Shield for Magnetic Charger, (DBAK011)
and Magnetic Charger (DBCI005) coupled with Shield. During the charging procedure, the ball
bearing (red in far left picture) should rest on the surface of the levitation head of the drive unit.
Magnetic Charger & Test Impeller Chart:
*Note: the appropriate magnetic charger must be used to set the drive machine for
use with the corresponding impeller. The machine will not properly drive an impeller
which does not have the corresponding magnet configuration.
Magnetic Charger
Corresponding Test
Impeller
Magnet Configuration
DBCI001
DBAK004
6-magnet charger &
impeller
DBCI005
DBAK007
4-magnet charger &
impeller
Document #: 020-17475-00 Revision: E Page #: 10 of 63
Figure 5: (Top) Drive-bag interface. (Bottom) Interface is installed in the
railed port of the dolly (held in place by the O-ring).
Document #: 020-17475-00 Revision: E Page #: 11 of 63
Figure 6: Magnetic clamp (left) and centering aligner (right).
Figure 7: Magnetic clamp is assembled with centering aligner prior to
attachment to the bag.
Document #: 020-17475-00 Revision: E Page #: 12 of 63
G. SUPERCONDUCTING DRIVE UNIT CONTROL
Note: the Superconducting drive unit is sealed for water/spray resistance and has a
splash resistant control box.
General Overview
Direct reading of impeller speed of rotation is provided by a sensor ring on the levitation
head. Speed of rotation is calculated based on direct reading of the impeller
magnets.
IMPORTANT! Correct reading of RPM is available only when the sensor ring is correctly
installed on the levitation head, the unit properly charged AND the correct impeller is
coupled above the levitation head. Incorrect readings may result in an alarm after
rotation is started.
External electrical connections are done with cables running along the frame.
The controls are located on the face panel of the control box (Figure 8). They are:
Touchscreen Controller, Quick adjustment keys, Power Switch, and Emergency Stop
push button. In addition, other connections including one for remote control are
available on the back panel of the control box as shown in Figure 9.
Most control functionality is provided to the user through the touchscreen interface
including activation of functions, display of system information, and alarm status.
The LevMixer can be operated in one of three modes selected by the operator from
the Main Menu: Manual mode, Automatic mode, and Remote mode. Each mode
includes a specific set of functions to support processing requirements.
Two auxiliary modes of operation can be activated by the system: Power Up mode
used to monitor the unit is properly charged, and Failure mode used to notify the
operator of detected malfunctions. Both auxiliary modes require operator interaction.
Note: mixing functionality is not available in either auxiliary mode.
When the drive unit is powered on it automatically begins in Power Up mode. At this
stage the system will determine the current levitation condition and provide directions
to the operator. Charging may be required as part of the power up procedure.
Operator access to the mixing functions via the Main Menu is only available after the
power up process is successfully completed.
Turning power off while the mixer is in charged condition should only be done through
the shutdown procedure. Otherwise it will be detected as an unscheduled power
outage and an alarm notification will be displayed upon next power on.
IMPORTANT! In case of emergency the operator can stop rotation of the motor by
pressing the E-Stop button on the face panel. This can be done during any mode of
operation. Doing so halts motor rotation and activates the system Failure mode while
Document #: 020-17475-00 Revision: E Page #: 13 of 63
leaving other functions of the drive unit in operation. To reset the unit release the E-stop
button by pulling it up until it clicks, then acknowledge the alarm on the touch screen.
IMPORTANT! If the drive unit charging phase has not been completed it is possible the
Levmixer will not levitate correctly. In order to ensure proper levitation in those cases,
turn the unit off, wait for at least 25 minutes, and then charge it following the standard
procedure as described in section H.
For details of operation see Section P Operator Control Interface Guide
Figure 8: Face panel of control box
Figure 9: Rear panel of control box.
Document #: 020-17475-00 Revision: E Page #: 14 of 63
H. CHARGING THE SUPERCONDUCTORS
NOTES:
1. To maintain levitation the superconductors in the levitation head of the LevMixer should
be properly charged. Charging is part of the Power Up mode sequence and is
monitored on the power up window on the touch screen.
2. Charging can only be completed when initiated on a drive unit that has remained in
power off mode for at least 25 min.
3. The system will monitor charging automatically and prevent operators from bypassing
the sequence.
4. The type of impeller (4-magnet or 6-magnet) must be selected prior to charging. It is
imperative that the charging sequence be set for the impeller type installed within the
single-use mixing bag the drive unit will operate. Pall single-use mixing bags employ the
4-magnet set-up as a standard, although the 6-magnet format is available for select
applications.
5. If the LevMixer is transported or stored in temperatures colder than the operating
environment it is necessary to wait 2 hours to equalize the internal temperature of the
drive unit prior to initiating the Power Up mode.
Figure 10: Superconductor charging sequence
CHARGING PROCEDURE:
1. Connect the superconducting drive unit to the appropriate power source (100-230
VAC 50/60Hz).
2. Select the correct charger, matching the impeller type within the mix bag to be used.
3. Remove the protective shield from the magnetic charger and place the charger,
bearing end down, on the levitation head as shown in Figure 10.
Document #: 020-17475-00 Revision: E Page #: 15 of 63
4. Press the main power button on the control box; the button will illuminate when
activated. The cryocooler and touch screen will activate. A PLACE CHARGER
IMMEDIATELY notification will be displayed on the touch screen to remind the user to
complete step 3.
5. Use the touch screen to acknowledge that the charger is in place to proceed to the
power up screen.
6. The charging procedure will start automatically. A blinking CHARGE IN PROGRESS will
display on the power up window status bar. Certain initial conditions may prevented
the system from initiating charging after power on. A notice will display on the screen if
an issue exists. See details of power up logic in Section P.3.
7. Press the blinking NONE button on the Power up screen. When the entry screen opens,
select the type of impeller: use up and down arrows to set four-magnet impeller or six-
magnet impeller type according to matching the impeller type within the mix bag to
be used. Press ENTER. The selected impeller type will now be shown on the power up
screen and a charging timer will indicate the elapsed charging time in the charging
status area (bottom row of power up screen).
8. Superconductor charging will take approximately 35 minutes. After charging is
complete a blinking READY button will appear on the screen and the CHARGED notice
will be displayed instead of charging time. Charging is complete assuming the charger
was placed on the levitation head prior to powering on the unit.
9. Proceed to Main Menu window by pressing the Main Menu button.
10. Remove the magnetic charger and replace the protective shield on the charger. IT IS
CRITICAL THAT THE CHARGER BE PLACED ON THE LEVITATION HEAD FOR THE ENTIRE 35
MINUTE CHARGING PERIOD.
Always put the protective shield back on the magnetic
charger when charging procedure is complete.
MAKE SURE charger can rotate free being installed in recess of levitated head. It should
sit loose enough to get right orientation.
DO NOT use alternative spacing/separating devices when charging the drive.
DO NOT disturb or remove the charger from levitation head until charging is completed.
Use only the magnetic charger provided in the kit.
Power off for more than 25 minutes is required to reset the superconductors.
While drive unit is charging, you can continue with Dolly –Tank Assembly
(Section 7).
Document #: 020-17475-00 Revision: E Page #: 16 of 63
Figure 11: Test impeller levitates above
the head of the super-conductive drive
unit during a levitation test.
11. Remove the protective shield from the test impeller and place the test impeller on the
levitation head. The impeller should levitate a few millimeters above the surface of the
levitation head. This will indicate that the machine is ready for operation.*
12. Select Manual Mode from Main Menu. In the Manual Mode window select the Edit
button. A Manual Setup window will appear. In the Manual Setup window press the Set
point button. When the entry window opens set the speed to 50 RPM and press ENTER.
The screen will return to Manual Setup window. Press button in the top right corner
to return to Manual mode window.
13. In the Manual mode window check that the run is set as a Permanent run with a speed
setting of 50 RPM. Press and hold START button until top bar of the window is filled (2-3
sec).
14. The levitated impeller will spin. The levitation gap should remain uniform with no
significant wobbling of the impeller*.
15. In the Manual Mode window press and hold STOP button until top bar of the window is
filled (2-3 sec).
16. When impeller stops rotating remove it from above the levitation head. Do not try to
remove the test impeller while it is spinning. Replace the protective shield on the test
impeller. The unit is now ready to be placed under the mixing tank.
Always put the protective shield back on test impeller when
testing procedure is complete.
If at any time the drive unit is turned off or unplugged, or if
there is a power outage for more than 15 minutes, or if an outage
occurs at any period during charging the drive unit must be recharged
before use –review section H above and repeat the charging
procedure steps 1-14.
*If the test impeller does not levitate or substantial wobbling occurs (more than 1.2 mm
change in the gap) the system must be reset. Turn the system off for at least 25 minutes
and repeat the set up procedure. If the problem continues, contact a technical
representative from your distributor or Pall Life Sciences directly.
Document #: 020-17475-00 Revision: E Page #: 17 of 63
I. DOLLY –TANK ASSEMBLY
For compact drive unit model see Section S.
1. The Dolly/Tank has a pre-cut hole over the drive port. Insert the drive/bag Interface
into this hole from below and apply the O-ring to secure as shown in Figure 5. It is not
necessary to remove or replace the Interface after installation (i.e. after mixing or
between batches).
2. Position the plastic tank on the dolly. The bottom of the tank has two pre-cut holes: a
small hole for the bag drain and a larger hole for the drive head. Line up the larger hole
with the drive port on the dolly. The tank hole should fit loosely around the Interface.
3. When using PALL standard containers and dollies, tanks up to and including 350L use a
centrally located impeller and therefore use the central port dolly configuration. PALL
standard 500L bags use off-center impeller and therefore use the off-center port dolly
configuration. See procedure below for changing the dolly port configuration.
CHANGING DOLLY CONFIGURATION BETWEEN CENTER AND OFF-CENTER IMPELLER PORT
1. Determine which port configuration is required: central 15” port or off-center 8” port.
Each rail of the dual port has an adjuster attached to the rail with two screws. The right
adjuster is marked with two dots and the left adjuster is marked with one dot. The right
and left rails of the port are also marked with two and one dot respectively, see images
below.Right adjuster should always be used with the right rail and the left adjuster with
the left rail.
Figure 12: Rail port orientation –Showing left side vs. right
Document #: 020-17475-00 Revision: E Page #: 18 of 63
2. To set the rails for the central (15”) port position set the right and left adjusters so that
the side with word “CENTER” is visible on both. See figures 13 and 14. Ensure that the
two dot marks on the right adjuster are located next to the two dot marks on the rail
and single dot mark of the left adjuster is located next to the single dot mark on the left
rail. Secure the adjusters with the screws provided.
3. To set the rails for the off center (8”) port position set the right and left adjusters so that
the side with words “OFF-CENTER” is visible on both. See figures 15 and 16. Ensure that
the two dot marks on the right adjuster are located next to the two dot marks on the
rail and single dot mark of the left adjuster is located next to the single dot mark on the
left rail. Secure the adjusters with the screws provided.
Figure 13: Left Rail - Center Installation Figure 14: Right Rail –Center Installation
Figure 15: Left Rail –Off-Center Installation Figure 16: Right Rail –Off-Center Installation
Document #: 020-17475-00 Revision: E Page #: 19 of 63
J. BAG-INTERFACE ASSEMBLY
Figure 17: Assembly of dry bag with interface
Procedure:
1. Carefully open the EXTERNAL packaging of the mixing bag. A protective shield is
magnetically attached to the outside of the bag over the Impeller seat. This shield
must be removed from the bag before assembling the interface.
2. Assemble the centering aligner and magnetic clamp on the outside of the bag as
shown in Figure 17.
Document #: 020-17475-00 Revision: E Page #: 20 of 63
K. INSERTING MIXING BAG INTO CONTAINER
Figure 18: Bag-Tank Assembly
Procedure:
1. Place the mixing bag in the tank by aligning the magnetic clamp with the large pre-
cut port on the bottom. Pull the bottom drain tube through the drain port opening.
2. Insert the magnetic clamp into the port.
3. Before filling the bag, ensure that the bottom drain tube is clamped. If the bag
contains an EZ-Drain, ensure the drain is fully closed and clamp the drain in place using
the provided plastic drain clip.
4. As bag starts to fill, gently pull the bottom surface of the bag to remove any wrinkles,
especially near the impeller.
DO NOT exceed recommended bag capacity.
DO NOT alter the tube and/or impeller configuration.
This manual suits for next models
1
Table of contents
Other Pall Mixer manuals
