Millipore Pellicon Single Pass TFF User manual

The life science business of Merck
KGaA, Darmstadt, Germany
operates as MilliporeSigma in the
U.S. and Canada.
Installation and User
Guide
Pellicon®Single-Pass TFF Accessories
®

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Pellicon®Single Pass TFF Accessories Installation and User Guide 3
Contents
Introduction...........................................................................5
Catalog Numbers ............................................................5
Pellicon®Single-Pass TFF Installation.........................................6
Pellicon®2 Mini Cassette Installation..................................6
Pellicon®2 Cassette Installation ........................................9
Pellicon®3 88 cm2or 0.11 m2Cassette Installation ............ 12
Pellicon®3 0.57 m2or 1.14 m2Cassette Installation........... 15
Flushing and Cleaning ........................................................... 18
Flushing....................................................................... 18
Cleaning ...................................................................... 19
Sanitization ......................................................................... 20
Depyrogenation.................................................................... 21
Integrity Testing................................................................... 22
Measurement of Normalized Water Permeability (NWP).............. 24
Storage............................................................................... 27
Storing the Filters in the System ..................................... 27
Storing the Filters without the System ............................. 27
Standard Product Warranty.................................................... 28

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Pellicon®Single Pass TFF Accessories Installation and User Guide 5
Introduction
This guide provides installation and maintenance procedures
for the Pellicon®Cassette Single-Pass TFF Accessories. It is not
intended to provide validation protocols or supporting data for
validation purposes. Refer to the appropriate Pellicon®Cassette
Validation Guide for this information. Refer to the Certificate of
Quality supplied with each Pellicon®cassette or hardware for
specifications. Refer to the appropriate cassette user guide for
additional information on installation and use.
The Pellicon®Cassette Single-Pass TFF Accessories must be
installed in the appropriate Pellicon®Cassette holder.
For supporting information on cassette installations, refer to the
following:
• Pellicon®2 Cassettes Maintenance, Installation and User Guide
• Pellicon®3 Cassettes Installation and User Guide
• Torque and Compression Force of Pellicon®2 and 3 Cassettes
Catalog Numbers
This user guide supports the following catalog numbers.
Catalog
Number Description Cassette Size
XXSPTFF01
Pellicon®Single-Pass TFF
Mini Kit
Includes four diverter
plates and two silicone
gaskets
Pellicon® 3 88 cm2
and 0.11 m2
Pellicon®2 0.1 m2
XXSPTFF02 Pellicon®Single-Pass TFF
cassette diverter plate
Pellicon® 3 0.57 m2and
1.14 m2
Pellicon®2 0.5 m2
XXSPTFF03
Pellicon®Single-Pass
TFF cassette retentate
collection plate
Pellicon® 3 0.57 m2and
1.14 m2
Pellicon®2 0.5 m2

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Pellicon®Single-Pass TFF
Installation
Pellicon®2 Mini Cassette Installation
Required Equipment
Items listed in this table are required for a three-section single-
pass TFF installation with Pellicon®2 Mini Cassettes. Sections may
be added or removed as needed for each specific application.
Item Description Quantity
Pellicon®Single-Pass TFF Mini Kit
(includes four diverter plates and two silicone gaskets) 1
Pellicon®2 Mini Cassette (includes two silicone gaskets) 3
Pellicon®Mini holder with extended tie rods 1
NOTES
Refer to the Pellicon®2 Cassette Installation Guide for cassette
installation instructions.
Install only identical cassettes in the filter holder. Do not mix
cassettes with different screens, membrane types, filtration
areas, or nominal molecular weight cutoffs.
Installation of Pellicon®2 Mini Cassettes requires inter-
cassette gaskets. Each cassette is provided with two gaskets.
The Pellicon®Single-Pass TFF Mini Kit provides two additional
gaskets, all of which are required for installation.
The diverter plates must be installed between individual
cassettes with the port locations alternating position as
shown in the following illustration.

Pellicon®Single Pass TFF Accessories Installation and User Guide 7
Installation
9
1
1
2
2
2
2
2
2
2
2
3
3
3
3
4
4
4
5
6
6
6
7
7
7
8
Components
Key Description
1 Holder end plate
2 Gasket
3 Pellicon®Single-Pass TFF Mini diverter plate
4 Pellicon®2 Mini Cassette
5 Tie rod spacer
Port Descriptions
Key Description User Supplied Connections
6 Feed/retentate ports Cap or pressure gauge with cap
7 Permeate ports Hose barb for tubing connection
and optional valve
8 Retentate port
Pressure gauge with hose barb
and pinch clamp, for retentate
outlet tubing
9 Blind permeate port Cap

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1. Loosen the nuts on the tie rods of the holder and remove the
nuts, washers, tie rod spacers, and end plate.
2. Slide the Pellicon®2 Mini Cassette gasket onto the holder so
that the tie rods pass through the cutouts in the gasket.
3. Slide the Pellicon®Single-Pass TFF mini diverter plate onto
the holder so that the tie rods pass through the cutouts in the
diverter plate. Note the location of the fittings on the diverter
plate.
4. Slide a gasket onto the holder.
5. Slide a Pellicon®2 Mini Cassette onto the holder.
6. Slide a gasket onto the holder.
7. Slide a diverter plate onto the holder so that the fittings on
the diverter plate are in the opposite location of the previous
diverter plate.
8. Slide a gasket onto the holder.
9. Install the next Pellicon®2 Mini Cassette.
10. Slide a gasket onto the holder.
11. Complete the installation with the required number of diverter
plates, alternating the location of the ports on the diverter
plates.
12. Slide a gasket onto the holder.
13. Install the end plate of the holder and torque the holder
using the specifications described in the Pellicon®2 Cassette
Installation Guide.
14. To nalize the serial ow path, cap or connect tubing to
the diverter plates ports (female luer lock) according to the
descriptions listed in the table in this section.
NOTE
For details on installation and torque specification, please
refer to the Pellicon®2 Cassette Installation Guide.

Pellicon®Single Pass TFF Accessories Installation and User Guide 9
Pellicon®2 Cassette Installation
Required Equipment
Items listed in this table are required for a three-section single-
pass TFF installation with Pellicon®2 Cassettes. Sections may be
added or removed as needed for each specific application.
Item Description Quantity
Pellicon®Single-Pass TFF Cassette diverter plate 3
Pellicon®Single-Pass TFF Cassette retentate
collection plate 1
Pellicon®2 Cassette (includes two silicone gaskets) 3
Pellicon®2 gasket (spare) 1
Pellicon®stainless steel holder 1
NOTES
Refer to the Pellicon®2 Cassette Installation Guide for cassette
installation instructions.
Install only identical cassettes in the filter holder. Do not mix
cassettes with different screens, membrane types, filtration
areas, or nominal molecular weight cutoffs.
Installation of Pellicon®2 Cassettes requires inter-cassette
gaskets. Each cassette is provided with two gaskets.
Installation with diverter plates requires one additional
gasket, which must be ordered separately.
The Pellicon®Single-Pass TFF Cassette retentate collection
plate is required to collect the retentate from the single-
pass TFF cassette installation.
The diverter plates must be installed between individual
cassettes with the tab locations alternating as shown in the
following illustration.

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Installation
1
2
3
5
1
2
2
2
2
2
3
2
3
4
4
4
Key Description
1 Holder end plate
2 Gasket
3 Pellicon®Single-Pass TFF Cassette diverter plate
4 Pellicon®2 Cassette
5 Pellicon®Single-Pass TFF Cassette retentate collection plate
1. Loosen the nuts on the tie rods of the holder and remove the
nuts, washers, tie rod spacers and end plate.
2. Slide the Pellicon®2 Cassette gasket onto the holder.
3. Slide the Pellicon®Single-Pass TFF cassette diverter plate onto
the holder so the tab on diverter plate is on the feed flow side
of the holder.
4. Slide a gasket onto the holder.
5. Slide a Pellicon®2 Cassette onto the holder.
6. Slide a gasket onto the holder.
7. Slide a diverter plate onto the holder so the tab on diverter
plate is on the opposite side of the previous diverter plate.

Pellicon®Single Pass TFF Accessories Installation and User Guide 11
8. Slide a gasket onto the holder.
9. Install the next Pellicon®2 Cassette.
10. Complete the installation with the required number of diverter
plates, alternating the location of the tabs on the diverter
plates.
11. Slide a gasket onto the holder.
12. To finalize the serial flow path, install the Pellicon®Single-
Pass TFF Cassette retentate collection plate onto the holder
by aligning the retentate collection openings of the retentate
plate so they are on the opposite side of the feed tab of the last
diverter plate installed.
NOTES
The handle of the retentate plate may be removed to allow
stacking of multiple process scale holders.
The retentate collection plate has two retentate outlet ports
(3/4-inch TC) for installation flexibility. Use one to collect
concentrated retentate and cap the unused port.
The permeate is collected through the Pellicon®holder
permeate ports.
Retentate Collection Plate
13. Install the end plate of the holder and torque the holder
using the specifications described in the Pellicon®2 Cassette
Installation Guide.
Retentate port
Retentate port

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Pellicon®3 88 cm2or 0.11 m2Cassette
Installation
Required Equipment
Items listed in this table are required for a three-section single-
pass TFF installation with Pellicon®3 88 cm2or 0.11 m2Cassettes.
Sections may be added or removed as needed for each specific
application.
Item Description Quantity
Pellicon®Single-Pass TFF Mini Kit (includes four
diverter plates and two silicone gaskets) 1
Pellicon®3 88 cm2and 0.11 m2Cassette 3
Pellicon®Mini holder with extended tie rods 1
NOTES
Refer to the Pellicon®3 Cassette Installation Guide for cassette
installation instructions.
Install only identical cassettes in the filter holder. Do not mix
cassettes with different screens, membrane types, filtration
areas, or nominal molecular weight cutoffs.
The diverter plates must be installed between individual
cassettes with the ports in alternating positions as shown in
the following illustration.

Pellicon®Single Pass TFF Accessories Installation and User Guide 13
Installation
Components
Key Description
1 Holder end plate
2 Gasket
3 Pellicon®Single-Pass TFF Mini diverter plate
4 Pellicon®3 88 cm2or 0.11 m2Cassette
5 Tie rod spacer
Port Descriptions
Key Description User Supplied Connections
6 Feed/retentate ports Cap or pressure gauge with cap
7 Permeate ports Hose barb for tubing connection
and optional valve
8 Retentate port
Pressure gauge with hose barb
and pinch clamp, for retentate
outlet tubing
9 Blind permeate port Cap
1
2
3
4
5
6
1
2
7
7
7
3
3
3
4
4
6
6
8
9

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1. Loosen the nuts on the tie rods of the holder and remove the
nuts, washers, tie rod spacers and end plate.
2. Slide a gasket onto the holder.
3. Slide the Pellicon®Single-Pass TFF mini diverter plate onto
the holder so that the tie rods pass through the cutouts in the
diverter plate. Note the location of the fittings on the diverter
plate.
4. Slide a Pellicon®3 Cassette onto the holder.
5. Slide a diverter plate onto the holder so that the fittings on
the diverter plate are in the opposite location of the previous
diverter plate.
6. Install the next Pellicon®3 Cassette.
7. Complete the installation with the required number of diverter
plates, alternating the location of the ports on the diverter
plates.
8. Slide a gasket onto the holder.
9. Install the end plate of the holder and torque the holder
using the specifications described in the Pellicon®3 Cassette
Installation Guide.
10. To finalize the serial flow path, cap or connect tubing to
the diverter plates ports (female luer lock) according to the
descriptions listed in the table in this section.

Pellicon®Single Pass TFF Accessories Installation and User Guide 15
Pellicon®3 0.57 m2or 1.14 m2Cassette
Installation
Required Equipment
Items listed in this table are required for a three-section single-
pass TFF installation with Pellicon®3 0.57 m2or 1.14 m2Cassettes.
Sections may be added or removed as needed for each specific
application.
Item Description Quantity
Pellicon®Single-Pass TFF Cassette diverter plate 3
Pellicon®Single-Pass TFF Cassette retentate
collection plate 1
Pellicon®3 0.57 m2or 1.14 m2Cassette 3
Pellicon®3 manifold adapter plate 1
Pellicon®stainless steel holder 1
NOTES
Refer to the Pellicon®3 Cassette Installation Guide for
cassette installation instructions.
Install only identical cassettes in the filter holder. Do not
mix cassettes with different screens, pore sizes or nominal
molecular weight cutoffs.
The single-pass TFF installation with Pellicon®3 0.57 m2or
1.14 m2cassettes requires one Pellicon®2 inter-cassette
gasket or one Pellicon®3 Manifold adapter plate, which must
be ordered separately.
The Pellicon®Single-Pass TFF Cassette retentate collection
plate is required to collect the retentate from the single-pass
TFF cassette installation.
The diverter plates must be installed between individual
cassettes with the tab locations alternating as shown in the
following illustration.

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Installation
Key Description
1 Holder end plate
2 Pellicon®Single-Pass TFF Cassette diverter plate
3 Pellicon®3 0.57 m2or 1.14 m2Cassette
4 Pellicon®Single-Pass TFF retentate collection plate
5 Pellicon®3 manifold adapter plate
1. Loosen the nuts on the tie rods of the holder and remove the
nuts, washers, tie rod spacers and end plate.
2. Slide the Pellicon®2 inter-cassette gasket or Pellicon®3 Manifold
Adapter Plate onto the holder.
3. Slide the Pellicon®Single-Pass TFF cassette diverter plate onto
the holder so the tab on diverter plate is on the feed flow side
of the holder.
4. Slide a Pellicon®3 Cassette onto the holder.
5. Slide a diverter plate onto the holder so that the tab on the
diverter plate is on the opposite side of the previous diverter
plate.
6. Install the next Pellicon®3 Cassette.
31
3
4
5
1
2
2
2
3

Pellicon®Single Pass TFF Accessories Installation and User Guide 17
7. Complete the installation with the required number of diverter
plates, alternating the location of the ports on the diverter
plates.
8. To finalize the serial flow path, install the Pellicon®Single-
Pass TFF Cassette retentate collection plate onto the holder by
aligning the retentate collection openings of the retentate plate
to be on the opposite side of the feed tab of the last diverter
plate installed.
NOTE
The handle of the retentate plate may be removed to allow
stacking of multiple process scale holders.
The retentate collection plate has two retentate outlet ports
(3/4-inch TC) for installation flexibility. Use one to collect
concentrated retentate and cap the unused port.
The permeate is collected through the Pellicon®holder
permeate ports.
Retentate Collection Plate
9. Install the end plate of the holder and torque the holder
using the specifications described in the Pellicon®3 Cassette
Installation Guide.
Retentate port
Retentate port

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Flushing and Cleaning
NOTE
The following flushing and cleaning recommendations are
based on three cassettes in series. These recommendations
are guidelines. Actual flushing and cleaning volumes and
operating conditions depend on the membrane type, cutoff,
and screen used, as well as the applied flow rate and retentate
pressure. Evaluate flushing and effective cleaning procedures
for each process to reach optimized conditions for each specific
application.
Flushing
An initial flush is required to remove storage solution from the
membrane in new cassettes. Flushing should also be performed
after each cleaning, depyrogenation, and sanitization step to
remove residual solutions. Flushing is primarily done with purified
water but may be performed with cleaning or buffer solutions.
1. Fill the tank with flushing solution.
2. Fully open the retentate valve and direct the retentate and
permeate lines to drain.
3. Turn on the feed pump and pump flushing solution into the feed
port of the Pellicon®holder at a feed flow rate of 1–4 L/min/m2.
4. When flow is established, partially close the retentate valve, if
necessary, to achieve a conversion of 30–90%.
(Conversion = permeate flow rate/feed flow rate).
NOTE
A high conversion will result in faster overall flushing, but
will require high trans-membrane pressure. Membranes
with low permeability (low cutoff) will generally not achieve
conversion at the high end of the range.
5. Flush until a total of approximately 150-300 liters of flushing
solution per m² of installed filter area have been pumped
through the system to drain. Achieving a minimum of
approximately 100 L/m2through the permeate and 30 L/m2
through the retentate is recommended. Depending on individual
removal criteria, the total flush volume can be optimized.
6. At the end of the flush, continue pumping until the flow path
lines are drained.

Pellicon®Single Pass TFF Accessories Installation and User Guide 19
Cleaning
To select a cleaning method, identify the application or suspected
foulant from the Cleaning Conditions section of the appropriate
cassette user guide. Select the cleaning agent or agents compatible
with the membrane type and application requirements.
Sanitization, depyrogenation and storage agents are chosen
similarly. In many instances, sanitization and depyrogenation may
be accomplished in the same step. Some applications require a
two-step cleaning procedure. In these cases, it is imperative that
the primary cleaning agent be flushed completely from the system
to avoid potentially harmful chemical reactions between cleaning
agents.
The cleaning step should be run at a feed flow rate of 1–4 L/min/m2
with the retentate valve partially closed to achieve a conversion of
30–90%. The retentate and permeate lines should be directed to
drain.
1. Flush until a total of approximately 15-30 liters of cleaning
solution per m² of installed filter area have been pumped
through the system and out to drain. Alternatively, the flush
can continue until the retentate and permeate conductivities
approach the conductivity of the feed solution.
2. Turn off the pump, close the retentate and permeate valves,
and allow the system to soak in the cleaning solution for
the duration noted in the Cleaning Conditions section of the
appropriate user guide. At the end of the final soak, pump the
cleaning solution to drain to empty the flow path piping.
NOTE
All surfaces exposed to process fluids should also be
exposed to the cleaning solution. It is good practice to cycle
(partially open and partially close) the valves at least twice
during the cleaning cycle to ensure that all wetted internal
surfaces of the valve body are exposed to the cleaning
solution.
3. Flush the filter with water using the same feed flow rate and
conversion conditions. Flush a total of approximately 15-30
liters of water per square meter of installed filter area through
the system to drain. Alternatively, the flush can continue until
retentate and permeate conductivity reaches an acceptable
target.

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Sanitization
Sanitization should always be performed after the membrane has
been thoroughly cleaned and flushed to reduce bioburden.
Sanitization pressures, feed flow rates and volumes are identical to
those used for cleaning. See the Cleaning procedure.
Select a sanitization agent from the appropriate user guide.