Millipore Labscale User manual

Labscale™Tangential
Flow Filtration System
User Guide

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Notice
The information in this document is subject to change without notice and should
not be construed as a commitment by Millipore Corporation. Millipore Corporation
assumes no responsibility for any errors that may appear in this document. This manual
is believed to be complete and accurate at the time of publication. In no event shall
Millipore Corporation be liable for incidental or consequential damages in connection
with or arising from the use of this manual.

Labscale Tangential Flow Filtration System User Guide 3
Contents
Introduction 5
Operator and Equipment Safety 5
Labscale Stirbase Setup 6
Module set up 6
Operating Requirements 7
System Overview/Unpacking Lists 8
Labscale TFF System 8
Labscale 500 mL Reservoir 9
Labscale Stir Base 11
Labscale Pump Module 12
Pellicon XL 50 Device 13
User Supplied Materials 13
Labscale TFF System Setup 14
Labscale 500 mL Reservoir Setup 16
Labscale Stir Base Set Up 19
Labscale Pump Module Set Up 21
Install Cleaning Tubing 25
Install Cleaning Tubing 25
Clean System 26
Drain System 27
Flush System 29
Flushing Device 30
Install Pellicon XL Device 30
Flushing 31
Drain System 33
Integrity Testing—Pellicon XL Device on System 33
Preconditioning 34
Concentration 35
Product Recovery 37
Dialtration—Vacuum 38
Shutdown 40
Cleaning Device 40
Clean System 40
Drain System 42
Flushing Device 42
Clean Base 42
Specications 43
Specications 43
Materials of Construction 43
ECComplianceCerticate 44

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Labscale TFF SystemOrdering Information 45
Labscale TFF system kit 45
Compatible pumps and pump head 46
Pellicon XL Devices 46
Labscale TFF System Maintenance 47
Labscale Stir Base Spare Parts 47
Labscale 500 mL Reservoir Spare Parts 47
Labscale Pump Module Spare Parts 49
PumpCheckValveFlushing 50
Diaphragm Pump Maintenance 51
Electrical Schematic 53
Labscale TFF SystemTroubleshooting 54
Electrical/Control 54
Performance 55
Pressure 56
Technical Assistance 58

Labscale Tangential Flow Filtration System User Guide 5
Introduction
The Labscale TFF system is a simple, easy to use system, designed
specifically for the Pellicon®XL device. This modular system
includes a 500 mL acrylic reservoir with pressure gauges, device
docking manifold and retentate valve; system base with integral
magnetic stirrer and diaphragm pump. The design of this system
allows Millipore’s Pellicon XL device to dock directly onto the side
of the reservoir, making tubing connections short, minimizing
holdup and recirculation volumes.
Operator and Equipment Safety
Anyone operating or working near the Labscale system must be
aware of the following:
• Read and understand this Operators Manual before performing
maintenance on the system. Failure to follow instructions could
result in user injury or system damage.
• Read and understand all maintenance instructions in this operating
instruction manual before performing maintenance on the system. Failure
to follow instructions could result in user injury or system damage.
• Prior to operation, ensure the Labscale system is fully assembled
as described in Labscale TFF System Setup. Ensure all pumps and
sensors are properly conected to their connection ports on the system.
• Never operate the Labscale system in a hazardous environment or
use with flammable, combustible or solvent liquids.
• Any alteration of the Labscale system from factory specification
may cause unsafe conditions and will void the product warranty.
• Use appropriate power supply cable and fuses for the area where
the Labscale system is operated for information, see Labscale
Stirbase Setup.

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Labscale Stirbase Setup
• If you order the pump module separatly, ensure pump module
wiring connections are correctly installed, see Chapter “Labscale
Pump Module set up”.
Module set up
Risk of electric shocks
• Unplug power cord prior to opening the blank panel from system base.
• There are no user-serviceable parts inside the Labscale system.
• Service should be performed only by trained and authorized
personnel.
Risk of rupture
• Use caution when opening and closing valves. Failure to open or
close valves at the appropriate times could result in trapped high
pressure, product loss, damaged cassettes, chemical spills, and
pump damage. Carefully follow all operating instructions
• Prior to each use, carefully inspect all hoses and tubing for kinks
or restrictions that could result in pressure buildup and possible
rupture of hoses or tubing.
• Prior to each use, carefully check that tubing at pump outlet to feed
in port (FEED IN) and cleaning tubing are Sta-Pure (white) tubing.
Failure in correctly installing Sta-Pure (white) tubing can result in
overpressurized tubing and burst.
• Transfer pump tubing can rupture due to continuous contact
with moving parts. Follow tubing manufacturer’s recommended
replacement interval.
• Never move the system while there is liquid in the tank, while
system processes are running or the cassettes is in place.

Labscale Tangential Flow Filtration System User Guide 7
• Never operate the system without the tank cover in place. Never
operate the system if any moving parts are exposed. Never operate
the system with the pump housing open.
• Use appropriate personal protective equipment, including eye
protection, when operating the system.
This equipment can potentially be used with biohazardous
products.
Operating Requirements
The system needs to be connected to electrical power and have
fuses installed to operate.
The Labscale system must only be uesd with the Millipore wall
transfomer provided and Millipore accessories.
Location Power Supply Reference
North America
Japan
115 VAC 50/60Hz, 1-phase XX42LSS11
Europe,
China
230 VAC 50/60Hz, 1-phase XX42LSS12
United Kingdom 230 VAC 50/60Hz, 1-phase XX42LSS13
Operating Conditions
The maximum operating altitude 2000 m
The over voltage category 2
The temperature operating range 40 to 25 °C (39 to 77 °F)
in a non-condensing
environment
Storage Conditions
The temperature storage range -10 C to 55 °C (14 to 131
°F) in a non-condensing
environment

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System Overview/Unpacking Lists
Labscale TFF System
The Labscale TFF System is shipped in an overpack carton that
contains three separate cartons. One carton contains the Labscale
500 mL Reservoir, one contains the Labscale Stir Base with the
Labscale pump module installed, one contains the AC Adapter.
Figure 1: The Labscale TFF System, Catalog No. XX42LSS11(115V),
XX42LSS12(230V), XXL425513(230V GB).

Labscale Tangential Flow Filtration System User Guide 9
Labscale 500 mL Reservoir
The reservoir manifold and instruments are an integrated system.
The feed pressure gauge indicates the pressure of the fluid being
pumped into the Pellicon XL device. The retentate pressure gauge
indicates the pressure of the fluid exiting the Pellicon XL device.
The upper manifold includes a retentate back pressure valve. The
fittings used are polypropylene and stainless steel.
1 shut-o
valve
10 ttings
10 ttings
10 clamps
1 syringe
1 Millex
Vent
1 Operating
Manual
1 stir bar
Retentate Pressure Gauge
Retentate Back
Pressure Valve
Feed Pressure Gauge
3 Rotating
Lock Rings
6 feet (1.8m) of Silicone
(translucent) tubing
1/8" (3mm) ID
Figure 2: Labscale 500 mL Reservoir, Catalog No. XX42RES01

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The following items are also packed with your Labscale 500 mL
Reservoir:
1 Shut-o Valve
10 Fittings
10 Fittings 10 Clamps
1 Syringe
1 Stir Bar
1 Millex
®
Vent
1 Operating Manual
3 Rotating
Lock Rings
6 feet (1.8 m) of Silicone
(translucent) tubing
1/8 in. (3 mm) ID
2 x 1 ft (0.3m) of Sta-Pure®
peristaltic pump tubing
1/8 in. (3 mm) ID.
Figure 3: Labscale 500 mL Reservoir Accessories

Labscale Tangential Flow Filtration System User Guide 11
Labscale Stir Base
A magnetic stirrer is installed inside the base housing. A stir bar is
packed with the Labscale Stir Base unit. The speed control knob
for the stirrer is located on the front of the stir base.
1 Stir Bar
120 V
230V GB
230V
2 Thumbscrews
1 Operating
Manual
1 Stir Bar
120 V
230V GB
230V
2 Thumbscrews
1 Operating
Manual
Figure 4: Labscale Stir Base
Assembly No. 29755
1 Stir Bar
120 V
230V GB
230V
2 Thumbscrews
1 Operating
Manual
Figure 4b:Labscale Stir
Base Accessories
Figure 4c:AC Adapter Assembly No.
29209, (120V), 29781 (230V), 29913
(230V GB)

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Labscale Pump Module
The Labscale Pump Module consists of a panel mounted electronic
diaphragm pump and a panel mounted speed controller that can
be installed in the Labscale Stir Base. The Labscale Pump Module
is mounted inside the base if a complete system was purchased. If
the pump unit was purchased separately, it is packed as shown in
figure 5.
Note: This Labscale Pump Module can only be used with the
Millipore Labscale Stir Base.
4 clamps 4 ttings
1 Installation
Instructions
3 feet of Silicone
(translucent) tubing
1/8" (3mm) ID
1 x 1 ft (0.3m) of
Sta-Pure® peristaltic
pump tubing
1/8 in. (3 mm) ID.
Figure 5: Labscale Pump Module Catalog No. XX42PMP01
4 clamps 4 ttings
1 Installation
Instructions
3 feet of Silicone
(translucent) tubing
1/8" (3mm) ID
1 x 1 ft (0.3m) of
Sta-Pure® peristaltic
pump tubing
1/8 in. (3 mm) ID.
4 clamps 4 ttings
1 Installation
Instructions
3 feet of Silicone
(translucent) tubing
1/8" (3mm) ID
1 x 1 ft (0.3m) of
Sta-Pure® peristaltic
pump tubing
1/8 in. (3 mm) ID.
Figure 6: Labscale Pump Module Accessories

Labscale Tangential Flow Filtration System User Guide 13
Pellicon XL 50 Device
The Pellicon XL device is not included with the Labscale TFF
System. It must be purchased separately. The Pellicon XL device
includes an Accessories Kit that is packed in the Pellicon XL box
below the device. The parts in the accessory kit are not required
for this system installation.
User Supplied Materials
You will need to supply the following items for system setup:
suitable containers for retentate, permeate and waste collection,
scissors, a Pellicon XL Device.

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Labscale TFF System Setup
See “Labscale 500mL Reservoir Setup” section for detailed setup
instructions.
COVER
MILLEX VENT
FILTER
VENT PORT
FEED PRESSURE GAUGE
RETENTATE
PRESSURE
GAUGE
RESERVOIR
SHUT-OFF VALVE
TANK OUT PORT
FEED IN PORT
RET OUT PORT
PERM 2 OUT
PERM 1 OUT
RET IN PORT
RETENTATE TUBING
PERMEATE TUBIN
G
RETENTATE
BACK PRESSURE
VALVE
DIA RECIRC
Figure 7: Labscale 500 mL Reservoir set up.

Labscale Tangential Flow Filtration System User Guide 15
COVER
MILLEX VENT
FILTER
VENT PORT
FEED PRESSURE GAUGE
RETENTATE
PRESSURE
GAUGE
RESERVOIR
SHUT-OFF VALVE
TANK OUT PORT
FEED IN PORT
RET OUT PORT
PERM 2 OUT
PERM 1 OUT
RET IN PORT
RETENTATE TUBING
PERMEATE TUBIN
G
RETENTATE
BACK PRESSURE
VALVE
DIA RECIRC
Figure 8: Labscale 500 mL Reservoir set up with Labscale TFF System.
COVER
MILLEX VENT
FILTER
VENT PORT
FEED PRESSURE GAUGE
RETENTATE
PRESSURE
GAUGE
RESERVOIR
SHUT-OFF VALVE
TANK OUT PORT
FEED IN PORT
RET OUT PORT
PERM 2 OUT
PERM 1 OUT
RET IN PORT
RETENTATE TUBING
PERMEATE TUBIN
G
RETENTATE
BACK PRESSURE
VALVE
DIA RECIRC
Figure 9: Labscale 500 mL Reservoir set up with user supplied peristaltic
pump.
Install the Sta-Pure (white) tubing on the pump outlet and feed in
port of the reservoir.

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Labscale 500 mL Reservoir Setup
Note: All tubing lengths are recommended to minimize
recirculation volume. Longer lengths may be used.
After prolonged storage, the tubing may absorb a small
volume of water. As a result, the tubing color may
change from translucent to opaque, which is normal.
Air or oven drying will return the color to translucent.
Install Retentate Tubing
1. Cut silicone (translucent) tubing and install fittings as shown in
figure 10.
L = 15 cm (6 inches)
Fittings: 1 male, 1 female
MALE
FEMALE
L
L = Appropriate length to reach
collection vessel.
Fittings: 2 male
MALE
MALE
L
RET OUT PORT
RET IN PORT
RETENTATE TUBING
Figure 10: Set-up of retentate tubing, ttings and clamps.
2. Remove plugs from retentate outlet (RET OUT) and retentate
inlet (RET IN) ports.
3. Insert the male luer end of the retentate tubing into the RET
OUT port and the female luer end of the retentate tubing into
the RET IN port. Turn fittings until snug.

Labscale Tangential Flow Filtration System User Guide 17
L = 15 cm (6 inches)
Fittings: 1 male, 1 female
MALE
FEMALE
L
L = Appropriate length to reach
collection vessel.
Fittings: 2 male
MALE
MALE
L
RET OUT PORT
RET IN PORT
RETENTATE TUBING
Figure 11: Install retentate tubing.
Install Permeate Tubing
1. Cut silicone (translucent) tubing and install fittings as shown in
figure 12.
L = 15 cm (6 inches)
Fittings: 1 male, 1 female
MALE
FEMALE
L
L = Appropriate length to reach
collection vessel.
Fittings: 2 male
MALE
MALE
L
RET OUT PORT
RET IN PORT
RETENTATE TUBING
Figure 12: Set-up of permeate tubing, ttings and clamps.
2. Remove the plug from the permeate outlet port (PERM 2) and
insert the male luer end of the permeate silicone (translucent)
tubing into the PERM 2 port. Turn fitting until snug.

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TANK OUTLET
VALVE
TANK OUT PORT
MILLEX VENT
FILTER
VENT PORT
PERM 2 OUT
PERMEATE TUBIN G
Figure 13: Install permeate tubing.
InstallTankOutletValve
Remove plug from the tank outlet port (TANK OUT) and insert
the female luer end of the tank outlet valve over the TANK OUT
port. Turn the lock nut until snug.
TANK OUTLET
VALVE
TANK OUT PORT
MILLEX VENT
FILTER
VENT PORT
PERM 2 OUT
PERMEATE TUBIN
G
Figure 14: Install tank outlet valve.
InstallVentFilter
If a sterile vent is required, remove plug from the vent (VENT) port
and insert male luer end of MILLEX filter into the VENT port.

Labscale Tangential Flow Filtration System User Guide 19
Install Stir Bar
If mixing is required, open reservoir cover and drop stir bar to the
bottom of the reservoir.
TANK OUTLET
VALVE
TANK OUT PORT
MILLEX VENT
FILTER
VENT PORT
PERM 2 OUT
PERMEATE TUBIN
G
Figure 15: Install Millex vent.
Labscale Stir Base Set Up
Power Connection
1. Turn stirrer and pump (if equipped) speed controls to the off
position.
2. Connect power cord to power cord receptacle located at the
rear of the system base.
3. Align detent on connector with receptacle.
4. Press connector into receptacle and turn lock ring to secure.
5. Inspect transformer label, checking for proper voltage. The
wall transformer serves as a means of cutting the power to the
system.
Note: The system should not be located in a place that may
allow liquid to be splashed under the enclosure.

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PUMP SPEED
CONTROL KNOB
STIRRER SPEED
CONTROL KNOB
PUMP INLET PORT
PUMP OUTLET PORT
Figure 16: ower Connection
Check Operation
1. Remove the plugs from the pump inlet and pump outlet ports.
2. Turn on the pump speed control, set to 2, and listen for pump
motor.
3. Turn off the pump speed control.
4. Turn on the stirrer speed control, listen for the stirrer motor.
5. Turn off the stirrer speed control.
PUMP SPEED
CONTROL KNOB
STIRRER SPEED
CONTROL KNOB
PUMP INLET PORT
PUMP OUTLET PORT
]
Figure 17: Check operation.