Pellicon® 2 Cassettes

Installation, User, and Maintenance Guide

The life science business of Merck KGaA, Darmstadt,

Germany operates as MilliporeSigma in the U.S. and Canada.
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 2

Contents
Introduction................................................................................................................ 3
Membrane Type and Area....................................................................................... 3
Nominal Molecular Weight Limit.............................................................................. 3
Intercassette Gaskets............................................................................................ 4
Water Quality....................................................................................................... 5
Feed flow Rate..................................................................................................... 5
Pump Capacity..................................................................................................... 5
Transmembrane Pressure....................................................................................... 5
Flux Excursion...................................................................................................... 6
Preparing Pellicon® 2 Cassette Filters for Use............................................................ 7
Installing Pellicon® 2 Mini Cassette................................................................................. 9
Equipment........................................................................................................... 9
Installation........................................................................................................ 10
Installing the Pellicon® 2 Cassette and Maxi Cassette in a Benchtop Holder........................ 12
Equipment......................................................................................................... 12
Installation........................................................................................................ 13
Installing the Process Scale Holder............................................................................... 17
Equipment......................................................................................................... 17
Installation........................................................................................................ 17
Tightening a Manual Holder.................................................................................. 18
Tightening a Hydraulic Process Scale Holder........................................................... 19
Pellicon® 2 Holder Assembly Maintenance..................................................................... 20
Flushing and Cleaning................................................................................................ 21
Sanitization.............................................................................................................. 26
Depyrogenation......................................................................................................... 27
Measurement of Normalized Water Permeability (NWP)................................................... 28
Integrity Testing........................................................................................................ 31
Storing Filters and Systems........................................................................................ 33
Storing the Filters in the System........................................................................... 33
Storing the Filters without the System................................................................... 33
Troubleshooting......................................................................................................... 35
Accessories and Spare Parts........................................................................................ 38
Standard Warranty.................................................................................................... 39
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 3

Introduction
This guide provides installation and operation procedures for Pellicon® 2 cassettes. Refer to the
Certificate of Quality supplied with each cassette for specifications.

Membrane Type and Filtration Area

In multiple-cassette installations, all cassettes must have the same membrane and feed
channel screen. Do not mix cassettes with membranes of different pore sizes or nominal
molecular weight limits. The area of membrane used depends on the cassette surface area
required for the application and is determined during process optimization trials.

Pellicon® 2 Filtration Area (m2)

Mini cassette 0.1
Cassette 0.5
A or C screen 2.5
Maxi cassette
V screen 2.0

Nominal Molecular Weight Limit

The retentive abilities of ultrafiltration (UF) membranes are characterized by a nominal
molecular weight limit (NMWL). NMWL does not indicate absolute retention/sieving ratings, but
can help determine what membrane rating is applicable for a particular process.
• Select a membrane that has a NMWL one-third to one-fifth the molecular weight
of the product to be retained.

• If the product must pass through the membrane to the filtrate, select a NMWL
three to five times larger than the size of the product.

• A minimum size difference of approximately five times is required between

components that are being separated.
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 4

Membrane NMWL (kDa) Membrane NMWL (kDa)

Biomax® 5 (PBCC) 5 Ultracel® 1000
1000
(PLCXK)
Biomax 8 (PBFC)
®
8 PL regenerated cellulose
1
(PLAC)
Biomax® 10 (PBGC) 10
PL regenerated cellulose
3
Biomax® 30 (PBTK) 30 (PLBC)

Biomax® 50 (PBQK) 50 PL regenerated cellulose

10
(PLGC)
Biomax® 100 (PBHK) 100

Biomax® 300 (PBMK) 300 Membrane Pore Size (µm)

Biomax® 500 (PBVK) 500 Durapore® (VVPP) 0.1

Biomax® 1000 (PBXK) 1000 Durapore® (GVPP) 0.22

Ultracel® 5 (PLCCC) 5 Durapore® (HVMP) 0.45

Ultracel® 10 (PLCGC) 10 Durapore® (DVPP) 0.65

Ultracel® 30 (PLCTK) 30

Ultracel® 100 (PLCHK) 100

Ultracel® 300 (PLCMK) 300

Effect of NMWL and Membrane Retention on Yield

A protein’s stated molecular weight can change based on pH/ionic buffer conditions, protein-
to-protein interactions, and protein-contaminant interactions. During process optimization,
characterize the feedstock solution to fully understand the potential impact on retention and
membrane selection. Product loss to the filtrate due to incomplete retention can be cumulative
for the concentration and diafiltration sections of a process. To understand retention changes
for batch ultrafiltration and constant diafiltration processes where retention remains constant,
use the following calculation:
Product Loss in Permeate = 100* {1-exp[(R-1)(ln VCF+N)]}
Where:
N = Number of diavolumes
VCF = Volumetric concentration factor
R = Product retention

Intercassette Gaskets
Pellicon® 2 mini cassettes (0.1 m2), cassettes (0.5 m2), and maxi cassettes (2.0 or 2.5 m2)
are shipped with two 0.044-inch-thick silicone gaskets for use between cassettes. Exceptions
are P2C005C25, P2C010C25, and P2C030C25 Pellicon® 2 maxi cassettes (2.5 m2) which are
shipped with two 0.088-inch-thick silicone gaskets for use between cassettes.
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 5

Water Quality
Reverse osmosis (RO) water or water for injection (WFI) is recommended.

Feed Flow Rate

The feed flow rate (L/min per m2) varies based on module and feed channel turbulence
promoter. The higher the feed flow rate, the higher the permeate flux at equal TMP.
A higher feed flow rate increases the sweeping action across the membrane, which reduces
the concentration gradient toward the membrane surface.
Higher feed flow rates cause the product to experience more passes through the pump in a
given amount of time, which can lead to product quality degradation. Also, higher feed flow
rates require larger pumps and larger-diameter piping. This increases the system holdup
volume and could increase product losses due to unrecoverable holdup.
During optimization trials, choose an appropriate combination of feed flow rate and TMP to
maximize permeate flux. This minimizes process time and/or membrane area, allowing for
optimal membrane area and pump sizing (minimal holdup due to pump sizing as well as pump
passes).

Pump Capacity
Select a pump with adequate capacity.

Cassette Recommended feed flow rates (L/min/m2)

A and C Screen 4–7
V Screen 7–10
Do not exceed 10 L/min/m2
Optimal feed flow rate and transmembrane pressure (TMP) depend on the characteristics of
the product feed stream being filtered and should be determined during optimization trials.

Transmembrane Pressure
The average applied pressure from the feed to the filtrate side of the membrane.
TMP = [(PF + PR)/2] - Pf
Where:
TMP = Transmembrane pressure
PF = Feed pressure
PR = Retentate pressure
Pf = Filtrate pressure
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 6

Flux Excursion
The relationship between flux and transmembrane pressure can be understood by generating
a flux excursion curve, which is a plot of the permeate flux versus transmembrane pressure at
constant feed flow rate:
• The first part of the curve is where the flux increases with increasing pressure
(TMP). This is the pressure-dependent regime.

• The level part of the curve (knee of the curve) is the pressure-independent
regime. At this point, there is no gain in flux made by increasing pressure.

• When flux starts to plateau at the knee of the curve, the optimum process TMP
operating point has been identified.

If the process is run with a TMP setpoint in the pressure-independent regime, maximum flux
can be achieved, and the required membrane area can be minimized. However, at this point,
the protein wall concentration is high and could exceed a solubility limitation, leading to yield
losses. Additionally, running under these conditions could cause fouling and eventual decrease
in flux. However, if a TMP setpoint in the pressure-dependent regime is used, fluxes are lower
and more membrane area is required.
Ideally, for a standard ultrafiltration/diafiltration process, the optimum TMP to run a process is
at the knee of the curve. This is the point where nearly the highest flux is achieved without
exerting excessive pressure or reaching exceedingly high protein wall concentrations
(polarization) or fouling.
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 7

Preparing Pellicon® 2 Cassette Filters for Use

This flow chart shows the recommended prep, cleaning and testing steps, which are detailed in
this guide, for Pellicon® 2 cassettes.

Set up system. Concentrate

Install membranes. diafilter.

Clean, sanitize, and Remove product

depyrogenate. from system.

Test integrity and Clean membranes

permeability. and system.

Equilibrate with Test integrity and

process buffer. permeability.

Flush. Store.

Handling the Cassettes

The cassettes are fragile. Avoid touching the cassette membrane surface. If a cassette is
dropped or the membrane surface impacted, replace the cassette.

Flush and Cleaning

Flush, clean, and fully wet Pellicon® 2 cassettes before processing product to prevent
contamination with storage solutions or manufacturing residues (see Flushing and Cleaning).
Normalized Water Permeability Test
Perform a normalized water permeability (NWP) test to monitor cleaning effectiveness (see
Measurement of Normalized Water Permeability (NWP)).

Integrity Testing
Perform an integrity test before and after using Pellicon® 2 cassettes. This test can detect
gross device or membrane defects and installation issues (see Integrity Testing).
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 8

Preconditioning
To optimize performance, precondition the membrane by circulating a buffer or medium that
closely matches the product to be filtered through the system, including fluid temperature, pH,
and osmolarity. Preconditioning the cassettes improves product solubility, prevents product
precipitation and absorption during startup, and maximizes product recovery.

Inspecting Tie Rods and Nuts

Inspect the tie rods and bronze nuts for burrs or stripped threads. Nuts should turn freely on
the tie rods for proper tightening of the holder.

Replacing Intercassette Gaskets

Two silicone intercassette gaskets are supplied with each cassette, refer to table below for
replacement information. For catalog numbers refer to Accessories and Spare Parts.
Pellicon® 2 Cassette Gasket Options

Gasket
Description Thickness Device
mm (in.)
No alignment tabs
1.1
(wings) for mini holders Pellicon® 2 mini 0.1 m2 cassettes
(0.044)
only
No alignment tabs
1.1
(wings) for benchtop All Pellicon® 2 0.5 m2 cassettes
(0.044)
holders only
All Pellicon® 2 Biomax®, Ultracel® and regenerated
1.1 cellulose membrane, A and C screen, 2.5 m2 devices
With alignment tabs
(0.044) except for Ultracel® 5, 10, 30 kD C screen 2.5 m2
devices
Double thick, with 2.2 Ultracel® 5, 10, 30 kD C Screen 2.5 m2 devices:
alignment tabs (0.088) P2C005C25, P2C010C25, P2C030C25
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 9

Installing Pellicon® 2 Mini Cassette

Install Pellicon® 2 mini cassettes only in a Pellicon® 2 mini cassette holder.

Equipment
• Pellicon® 2 mini holder, shipped with standard tie rods

• Torque wrench

• Hex-type socket, 9/16 inch deep, supplied with the Pellicon® 2 mini holder

• Gaskets, supplied with the Pellicon® 2 mini cassette (For replacements, refer to
Replacing Intercassette Gaskets.)

• Spacers, supplied with the Pellicon® 2 mini holder

NOTE
The number of spacers needed depends on the number of cassettes
installed. Use additional spacers with long tie rods when installing minimum
membrane area.
Pellicon® 2 Mini Holder Tie Rod Options

Number of Pellicon® 2
Length 0.1 m2 Cassettes
Description
(mm)
A and C screen V screen

Pellicon® 2 mini holder standard tie rods 103 1 to 3

Pellicon® 2 mini holder long tie rods 141.6 1 to 5

Cogent® M1 mini holder long tie rods 200 1 to 8

Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 10

Installation

Tie rod
Tie rod
Filter gasket tab
End plate
Filter gasket
Tie rod spacers
Filter Washer
Nut

Installing the intercassette gasket Attaching the end plate

1. Remove the clear protective film from both sides of the silicone gasket. Wet the gasket with
water if required.
2. Slide the gasket tabs over the tie rods and press the gasket against the base plate, as
shown in the illustration.
3. Ensure that the large feed and retentate holes on the silicone gasket align to the large feed
and retentate holes on the holder base plate.
4. Carefully remove the cassette from the packaging. Handle the cassette by the jacket sides
to prevent damage to the exterior screen and membrane. Align the cassette with the tie
rods. Install the cassette so it is parallel with the base plate.
NOTE
The cassette will extend beyond the edges of the holder end plate if the
cassette is not properly aligned to the feed, retentate, and permeate holes.
5. Repeat step 1 and slide the silicone gasket tabs over the tie rods. Gently align the gasket
against the cassette.
6. Repeat steps 4 and 5 for additional cassettes.
7. Slide the end plate onto the tie rods and press the end plate against the gasket.
8. Place an equal number of spacers on each tie rod. Use tie rod spacers when operating the
system with low membrane area. Place enough spacers on each tie rod so the nuts are
screwed less than the length of the hex socket on the tie rods to tighten the holder.
9. Place one washer and one nut on each tie rod. Hand tighten the nuts evenly by alternating
from one to another.
10. Tighten the holder with the torque wrench set between 20.3 and 22.6 Newton-meters (180
and 200 inch-pounds).
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 11

11. Turn each nut ¼ turn with the torque wrench, alternating from one nut to the other until
the torque wrench clicks when it reaches the set point.
12. Wait 5–10 minutes to allow the compression to stabilize. Retorque to 20.3 and 22.6
Newton-meters (180 and 200 inch-pounds).
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 12

Installing the Pellicon® 2 Cassette and

Maxi Cassette in a Benchtop Holder
Equipment
• Stainless steel holder, shipped standard with long tie rod
or
Acrylic holder, shipped standard with short tie rod

• Torque wrench

• Hex-type socket, /16 inch deep, supplied with the holder

15

• Stainless steel support plate, 2 pack, one per holder base

• Gaskets, supplied with the Pellicon® 2 cassette (For replacements, refer to

Replacing Intercassette Gaskets.)

• Spacers, supplied with the Pellicon® 2 benchtop holder

NOTE
The number of spacers needed depends on the number of cassettes installed.
Use additional spacers with long tie rods when installing minimum membrane
area.
Pellicon® 2 Cassette and Maxi Cassette Tie Rod Options

Length Number of Pellicon® 2 Cassettes

Description
(inches) A and C screen V screen
Long tie rods 5 to 10 x 0.5 m2 5 to 10 x 0.5 m2
10.50
for stainless steel holder 1 to 2 x 2.5 m2 1 to 2 x 2.0 m2
Short tie rods 1 to 5 x 0.5 m 2
1 to 5 x 0.5 m2
7.00
for stainless steel holder 1 x 2.5 m2 1 x 2.0 m2
Long tie rods 5 to 10 x 0.5 m2 5 to 10 x 0.5 m2
12.50
for acrylic holder 1 to 2 x 2.5 m2 1 to 2 x 2.0 m2
Short tie rods 1 to 5 x 0.5 m2 1 to 5 x 0.5 m2
8.75
for acrylic holder 1 x 2.5 m2 1 x 2.0 m2
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 13

Installation
Stainless steel Pellicon® 2 Cassette holder

Hex nut

Lock washer

Washer

Stainless steel spacer

Handle
Top plate
manifold

Pellicon®
cassette

Threaded
tie rod

PERMEATE

Permeate
outlet port Gasket plate

Threaded holes 3/4 inch

for inserting sanitary
the tie rods Tri-Clover®
connection
Retentate
Bottom plate port
RETENTATE
manifold
Feed inlet port

1 inch sanitary
Tri-Clover®
connection FEED
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 14

Acrylic Pellicon® 2 Cassette holder

Nut

Washer

Stainless steel
bushing
Top acrylic
pressure plate
Top pressure plate

Even numbered holes Tie rod

(filtrate)

Intercassette gasket
for Pellicon® 2 cassettes
Pellicon® cassette only

Odd numbered holes

(retentate)

Intercassette gasket

Permeate manifolds
Bottom (four holes)
manifold plate

FEED

PERMEATE Pressure gauge

RETENTATE
Bottom pressure plate
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 15

1. For acrylic holder installation only, place the bottom acrylic manifold onto the aluminum
base. The manifold is part of the base in the stainless steel holder.
2. Remove the protective clear polyethylene film from both sides of the silicone gasket. Place
the silicone gasket on the bottom manifold plate. Optional: Use highly purified water to wet
the gasket.
3. Install one stainless steel support plate onto the holder base. This plate will ensure a good
seal between the holder and cassette ports.
4. Remove the protective clear polyethylene film from both sides of the silicone gasket. Place
the silicone gasket on top of the stainless steel plate. Optional: Use highly purified water to
wet the gasket.
5. Carefully cut the vacuum sealed bag and remove the cassette. Handle the cassette by the
jacket sides to prevent accidental damage on the exterior screen and membrane. Place the
cassette on top of the silicone gasket. The notches on the sides of the cassette align with
the tie rods on the holder.
NOTE
Orient the cassette so that the label is at the front of the holder, right side up,
for easier reading.
6. When using more than one cassette in the holder, repeat steps 4 and 5. End with a silicone
gasket on top of the final cassette.
7. For acrylic holders only, install the top acrylic plate on top of the last gasket.
8. Place the top aluminum pressure plate (acrylic holders) or the top stainless steel plate
(stainless steel holders) with the slotted or handle side facing up.
9. Place onto the tie rods, in this sequence, the tie rod spacers (as needed), washers, and
bronze hex nuts.
NOTE
Tie rod spacers are required when operating the system with low membrane
area. Place enough spacers evenly on each tie rod so that, when the holder is
tightened, the nuts are screwed less than the length of the hex socket on the
tie rods. The number of spacers needed depends on the number of cassettes
installed.
10. Hand tighten the nuts in a diagonal pattern as evenly as possible, in the sequence shown in
the illustration.

4 1/8 Turn 1

2
3
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 16

11. Set the torque wrench to 40 to 45 Nm (350–400 in-lb).

12. Initially turn each nut to a ½ or ¾ turn, in the sequence shown in the illustration.
13. As it becomes more difficult to tighten each nut, use ⅛ to ¼ turns in the same sequence.
14. After each nut reaches set point of 40 to 45 Nm (350–400 in-lb), the wrench will click.
15. Wait 5–10 minutes to allow system compression to stabilize. Retorque to 40 to 45 Nm (350
–400 in-lb).
16. The system can be retorqued up to a maximum of 62 Nm (550 in-lb) as needed to ensure a
liquid tight seal or if the installation fails its integrity test.
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 17

Installing the Process Scale Holder

Intercassette gasket

Intercassette gasket

Equipment
• Manual or hydraulic enclosure holder

• Torque wrench

• Socket (manual holder only)

• Stainless steel support plate

• Gaskets, supplied with the Pellicon® 2 maxi cassette (For replacements, refer to
Replacing Intercassette Gaskets.)

Up to four Pellicon® 2 maxi cassettes (2.5 m2 or 2.0 m2 for V screen) can be installed on each
side of the holder (eight maxi cassettes per level).

Installation
1. Loosen the nuts on the tie rods of the holder and remove the nuts, washers, and end plate.
2. Remove the protective clear polyethylene film from both sides of a silicone gasket.
Optional: Wet the gasket with highly purified water. Install the gasket on one side of the
center manifold block by slipping the wings over the tie rods (manual holder) or alignment
rods (hydraulic holder). Ensure the gasket is flat and align the holes in the gasket with
those on the manifold.
3. Install one stainless steel support plate on top of the gasket.
4. Carefully remove the protective clear polyethylene film from both sides of a silicone gasket.
Optional: Wet the gasket with purified water. Install the gasket on top of the stainless steel
support plate by slipping the wings over the tie rods (manual holder) or alignment rods
(hydraulic holder). Ensure the gasket is flat. Align the holes in the gasket with the holes on
the manifold.
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 18

5. Remove the Pellicon® 2 cassette from the vacuum sealed bag. Handle the cassette by the
jacket sides to prevent accidental damage on the exterior screen and internal membrane.
Place the cassette against the silicone gasket. The notches on the sides of the cassette align
with the tie rods on the holder. When using more than one cassette in the holder, place one
silicone gasket between every single cassette, ending with a silicone gasket against the
final cassette.
6. Slide the stainless steel end plate against the final gasket.
7. Place tie rod spacers as needed. Place a washer and a nut onto each tie rod.
8. Hand tighten the nuts in a diagonal fashion as evenly as possible, in the same sequence
as for torquing (see step 10 in Installing the Pellicon® 2 cassette and maxi cassette in a
Benchtop Holder, Installation).

Tightening a Manual Holder

1. Set the torque wrench to 40 to 45 Nm (350–400 in-lb).
2. Turn each nut ½ or ¾ turn in the sequence shown in the illustration.

4 1/8 Turn 1

2
3

3. As it becomes harder to tighten each nut, use ⅛ to ¼ turns, in the same sequence.
4. After each nut reaches set point of 40 to 45 Nm (350–400 in-lb), the wrench will click.
5. Wait five to ten minutes to allow system compression to stabilize. Retorque to 40 to 45 Nm
(350–400 in-lb).
6. The system can be retorqued up to a maximum of 62 Nm (550 in-lb) as needed to ensure a
liquid-tight seal or if the installation fails the integrity test.
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 19

Tightening a Hydraulic Process Scale Holder

The hydraulic closure with manual controls is intended for use with the Pellicon® 2 process
scale cassette holder. It maintains appropriate pressure on the holder during processing or
during storage of installed cassettes.
Use run mode for process operations. The appropriate hydraulic compression for process and
cleaning operations is 134 + 6.7 bar (1950 ± 100 psig).
1. Install the grooved tie rods, Triclover clamps, clamp inserts, and the hand tightening
wheels.
NOTE
Only hand tighten the hand wheels. Do not use a wrench. Ensure that each
end plate is flush against the cassette assembly and both hand wheels are
snug against the end plate. At least one inch of excess thread on the clamp
rod exiting the hand wheel should be exposed.
2. Repeat the procedure for any other holder levels.
3. Set the system to run mode to compress the cassettes.
NOTE:
The hydraulic compression range of 134 + 6.7 bar (1950 ± 100 psig) is
specific to Pellicon® 2 installation with our hydraulic piston design. A different
set point will be needed if installing Pellicon® 2 cassettes into other holders.
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 20

Pellicon® 2 Holder Assembly

Maintenance
Pellicon® 2 cassettes must be operated while under compression from the holder assembly
to ensure that the cassettes seal properly. Compression is supplied by applying torque to the
nuts on the threaded tie rods of the holder assembly.
Proper holder maintenance will prevent the necessity for higher torque values to achieve
proper sealing.
1. Clean nuts, washers, and tie rods before every use to ensure that they are free of particles.
Use a mild solvent such as IPA and water.
2. Apply a few drops of suitable lubricant on the tie rods and between the nuts and the
washers whenever permitted at specified intervals per standard operating procedures. Use
food-grade vegetable oil or glycerin.
NOTE
Check quality assurance protocols before introducing a new lubricant.
3. Protect the tie rods from receiving any blows that could damage their threads, which can
lead to galling. Do not damage tie rods when using a torque wrench.
4. Replace any component that is visibly worn or does not spin freely.
5. Replace nuts and washers after every ten installations to maintain high sealing force in the
holder.
6. When new nuts do not spin freely, refurbish the threaded rods with a ⅝ in.–18 die.
7. Keep a set of spare on hand at all times.
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 21

Flushing and Cleaning

These flushing and cleaning procedures are recommended guidelines. Evaluate flushing and
effective cleaning procedures for each process.
Flush and clean all cassettes before first use.
Flush Pellicon® 2 cassettes before and after filtration processes and cleaning to remove
the chemical agents in that step. When multiple solutions are required for cleaning and
sanitization, flush each cleaning agent completely from the system before introducing the next
cleaning agent.
Use a cleaning agent that is compatible with the membrane and device.
1. Fill the recycle tank with highly purified water, water for injection (WFI), or reverse
osmosis (RO) water. Extremely pure flush water prevents fouling the membranes and the
introduction of contaminants into the system.
2. Open the retentate valve completely and direct the retentate line to drain.
3. Direct the permeate line to drain.
4. Turn on the feed pump and pump water into the feed port of the Pellicon® 2 holder.
Recommended feed flows for flushing, cleaning, storing, and all process steps are detailed
in the following table. Determine actual process flow rates during optimization trials.

Feed Screen Feed Flow (L/min/m2)

A 4.0-6.0

C 4.0-7.0

V 7.0-10.0

NOTE These flow rates are appropriate for most typical applications; however, some
processes may require flow rates outside of these ranges. Do not exceed
10 L/min/m2.
5. Membrane flushing and cleaning is detailed in the following table:

Volume per m2
Operation Step Solution
(L)
Initial preservative or Single pass with
≥20 WFI, RO, or HPW
storage solution flush permeate open*
Single pass with
10 See Recommended
Cleaning and/or permeate open*
Cleaning Agents and
sanitization Total recirculation**
5 to 10 Conditions for Pellicon® 2
(30-60 min)
Post cleaning and/or Single pass with
10 to 20
sanitization Flush permeate open*
Final flush and Single pass with
≥10
NWP measurement permeate open* WFI, RO, or HPW
Flush until user conductivity Total recirculation**
specification is met (10-15 min) with NWP 10
(if applicable) measurements
*Single pass with permeate open: Permeate and retentate valves are open. Flows are directed to drain. Adjust
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 22

the retentate valve so that 30–50% of the feed flow is converted to filtrate. This ratio of filtrate to feed is defined as
the conversion ratio.

**Total recirculation: Permeate and retentate flow paths are directed to the recycle tank. After first 12 L/m2 have
flowed through retentate side, partially close the retentate valve to achieve 30–50% conversion.

Additional flush volumes, recirculation, and hold steps can be performed to ensure that specific
flush requirements are met.
If the system is complex and has other associated manifolds, ensure that all wetted surfaces
in the manifolds are exposed to the solution. All valves exposed to process fluids should also
be exposed to the cleaning and flushing solutions. Cycle (partially open and then partially
close) valves at least twice over the course of the cycle to ensure that all wetted internal
surfaces of the valve body are exposed to the solutions.
Take samples from the retentate and permeate after the final flush to determine the level of
storage solution and/or cleaning solution removed from the cassette.
For proper cleaning of cassettes, sodium hydroxide is the most common cleaning agent. It is
effective for removing proteins and nucleic acids and for inactivating most viruses, bacteria,
yeast, fungi, and endotoxins. It can be easily detected, removed, and disposed of.

Recommended Cleaning Agents and Conditions for Pellicon® 2

Cleaning Temperature Time
Membrane Concentration pH
Agent (°C) (minutes)
PLAC, PLBC* NaOH 0.05 N 12.7 Ambient 15–30

PLGC NaOH 0.1 N 13 20–50 30

Ultracel® NaOH 0.1 N 13 20–50 30

Biomax® NaOH 0.1–1.0 N 13–14 20–50 30–60

Ultracel®, Biomax®, Peracetic
100–200 ppm 3.5 20–50 15–30
Durapore® Acid
50–250 ppm
Biomax®, Durapore® NaOCl 7–8 20–50 15–30
(active chlorine)
*Milder cleaning conditions can extend the life of regenerated cellulose membranes with a nominal molecular
weight limit of 1, 3, or 5 kDa. Use ambient temperatures and the lowest NaOH concentration possible. Better
membrane life has been observed at 20–25 °C for PLAC and PLBC membranes and 25–40°C for PLGC, etc.

Alternate Cleaning Conditions and Agents for Pellicon® 2 Filters

Time
Membrane Cleaning Agent Concentration pH Temperature
(min)
0.1N/250 ppm to
Biomax® NaOH/NaOCl 13 20–50 °C 30
0.5N/600 ppm
NaOCl – This step
100–500 ppm
must be followed by a
Durapore® followed by 0.1N 10-11 20–50 °C 30
water flush and an acid
phosphoric acid
recirculation.
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 23

Cleaning Agents Based on Application

Cleaning Agent
Process Fluid Probable Foulants
Recommended Alternate

Pellicon® 2 with ultrafiltration membranes

Protein solutions
Blood and serum products, NaOH
bacterial and mammalian Adsorbed protein
NaOCl*
products, enzymes, vaccines,
viruses
NaOH followed
Bacterial cell whole broths Adsorbed protein, antifoams, cell by
E Coli, bacillus, other debris, lipids, polysaccharides
NaOCl*
NaOH followed
by H3PO4
Protein, lipopolysaccharides, cell
Bacterial lysates NaOCl*
debris
followed by
H2PO4
Nucleic acids N/A H3PO4
Polysaccharides
N/A
lipopolysaccharides, NaOH, NaOCl*
Adsorbed polysaccharide
dextrins, pectins, starches, Tergazyme®
mucopolysaccharides
Depyrogenation
radio opaque imaging agents, Residual organic colloids,
NaOH
antibiotics, low-molecular- lipopolysaccharides
weight solutions
NaOH followed
Food and beverage streams by NaOCl*
Protein, tannins, phenolics,
Food, wine, proteins, vinegar, organic colloids, humic acids Tergazyme®
juice followed by
NaOCl*
Citric acid
Iron complexes
HNO3
Water treatment
HNO3 citric
Mineral scale, inorganic deposits
acid H3PO4
Pellicon® 2 Cassette Filters with microporous Durapore® membranes
Protein clarification
Triton® X-1OO,
Recombinant proteins, blood Precipitated protein, lipoproteins NaOCl,
Tergazyme,
and serum products, pre- and lipids Tween® 80
Urea
column clarification
Mammalian cell culture Cell debris NaOCl H3PO4
Cell wall debris, precipitated NaOCl,
Red blood cell ghosts N/A
protein Tergazyme®
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 24

Cleaning Agent
Process Fluid Probable Foulants
Recommended Alternate
NaOCl, Triton® X-1OO
Bacterial cell broths Absorbed protein, antifoams, cell
Tergazyme® or SDS
mycelial, fungal debris, lipids, polysaccharides,
followed by followed by
fermentation broths media ingredients
NaOCl NaOCl
Tween® 80,
Triton® X-1OO
Protein, lipopolysaccharides, cell NaOCI followed
Bacterial lysate clarification or SDS
debris by H3PO4
followed by
NaOCl
NaOCl
Pre-chromatographic Tween® 80
lnsoluble denatured protein Triton® X-1OO
clarification followed by
NaOCl
Polysaccharides Triton® X-1OO
Lipopolysaccharides, NaOCl or or SDS
Adsorbed polysaccharide
Dextrins, Pectins, Starches, Tergazyme® followed by
Mucopolysaccharides NaOCl
Juice and beverage Pectin, starches, polyphenolics,
NaOCl* N/A
clarification protein complexes, colloids
Water treatment Iron complexes, mineral scale Citric acid HNO3
Clarification of inorganic
Mineral scale inorganic deposits HNO3, H3PO4 Citric acid
precipitates
*Not for use with any cellulose membranes.

Cleaning Conditions
Cleaning Temperature Time
Foulants Membrane Concentration pH
Agents °C (minutes)
13–
Organics, biofilms, Biomax® 0.1–0.5N 40–50
13.7
biopolymer,
PLAC, PLBC NaOH 30–60
proteins
polyphenolic 0.1N 20–25 13
Ultracel®
Proteins,
Biomax® 250 ppm active
biopolymers NaOCl 40-50 10–11 30–60
Durapore® chlorine
polysaccharides
Biopolymers
proteins, colloidal
deposits,
All Tergazyme® 0.2% 40-50 9–10 30–60
polyphenolic
fats, oils, grease,
antifoams, scale
Triton®-X
Proteins, lipids, 100
lipopolysaccarides, All 0.1% 40–50 5–8 30-60
SDS
oils, antifoams
Tween® 80
Proteins,
All Urea 7M 40–50 8 60
protein precipitates
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 25

Cleaning Temperature Time

Foulants Membrane Concentration pH
Agents °C (minutes)
Mineral scale,
All HNO3 0.1N 40–50 1.0 30
nucleic acids
Citric acid
Iron, manganese, (adjust to
All 1% 40–50 3.0 60
scale pH 3 with
NH4OH)
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 26

Sanitization
Always sanitize after the system has been thoroughly cleaned and flushed before processing.
Sanitization pressures, flow rates, and volumes are identical to those used for cleaning (see
Flushing and Cleaning).
Select a sanitization agent based on membrane compatibility.

Membrane Temperature
Sanitization Agent Concentration pH
Type °C
Biomax® NaOCl 100–500 ppm 10–11 20–50
NaOCl
Durapore® NOTE: This step must be 100–500 ppm 10–11 20–50
followed by a water flush and
an acid recirculation.
All
Peracetic acid 50–200 ppm — 20–25
Membranes
Biomax® 0.5–1.0 N 13.7–14
NaOH 20–50
Ultracel® 0.1 N 13

NOTES
Use sanitization agents and conditions that are suitable for the process
requirements. Sanitization agents must comply with applicable local
regulations.

Milder cleaning conditions can extend the life of regenerated cellulose

membranes with a nominal molecular weight limit of 1, 3, or 5 kDa. Use
ambient temperatures and the lowest NaOH concentration possible.
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 27

Depyrogenation
If depyrogenation is required, perform only after the system has been cleaned, sanitized, and
flushed. Depyrogenation pressures, flow rates, and volumes are identical to those used during
cleaning (see Flushing and Cleaning). Use water for injection or reverse osmosis water. Based
on membrane compatibility, select a depyrogenation agent from the table below.

Depyrogenation Conditions and Agents

Sanitization Temperature
Membrane Concentration pH Time (minutes)
Agent °C
Biomax® NaOH 0.1-1.0N 30-50 13-13.7 30
Ultracel® NaOH 0.1N 30-40 13 30
300 ppm active
Biomax®,
NaOCl chlorine 30-50 10-11 30
Durapore®
(600 ppm NaOCl)
All H3PO4 0.1N 30-40 1.0 30
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 28

Measurement of Normalized Water

Permeability (NWP)
Normalized water permeability (NWP) is the measurement of clean water through a membrane
at certain pressure and temperature conditions. Determine the reference measured NWP for
Pellicon® 2 membranes prior to the first use of each cassette after exposure to the cleaning
solution. Clean and flush new membranes before measuring NWP. Initial NWP is used as a
benchmark against which subsequent water permeability measurements can be compared.
A permeability measurement can be taken in a different solution such as storage solution
or equilibration buffer (this is typically more convenient at large scale). Consistently take
permeability measurements in the same solution and under the same feed flow and pressure
conditions so that each subsequent value can be compared to the initial measurement.
1. Take the NWP measurement during the last total recirculation step of membrane flushing
and cleaning.
2. Fill the tank with clean water, preferably at 25 °C, or the storage solution or buffer. Take
the permeability measurement in the same solution and under the same process conditions
every time.
3. Set the feed pump to the feed flow rate used during processing.
4. Partially close the retentate valve to achieve the retentate pressure listed. Higher pressures
are necessary for lower molecular weight limit membranes. For more open membranes >
50 kDa adjust the retentate value to generate 5 psi retentate pressure and then control the
permeate flow to the target 100–150 L/hr/m2 (LMH) or approximately 30% conversion of
the feed flow into permeate flow.

Membrane NMWL Retentate Pressure (psi)

1, 3, 5 kDa 20–30

10 kDa 5–15

30 kDa 1–5
> 50 kDa 5, then use permeate control to restrict filtrate flux to
(open UF and MF membranes) 100–150 LMH or 30% conversion of feed to permeate flow

5. Recirculate the fluid for 5–10 minutes. Ensure that the flow, pressure, and temperature
conditions are stable.
6. Record the feed and permeate flow rates, feed, retentate and permeate pressures, and the
temperature of the fluid.
7. Use the following equation to calculate the NWP:
R●F
NWP =
A●
{[ ] }
Pin + Pout
2
-PP
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 29

This yields LMH/psi [liters/m2/hours/psi]

Where:
R = Permeate flow rate in L/hour Pin = Feed pressure in psi
Pout = Retentate pressure in psi Pp = Permeate pressure
(if non-zero) in psi
A = Total filter area in m2
F = Temperature correction factor from the NWP temperature correction factor
(F)* table.
8. After the first use of the cassette, the NWP should be 60–120% of the original NWP. The NWP
should then stabilize for future runs or slowly decrease in a reproducible, stable fashion. It is
recommended that the cassette be discarded before 50% of the reference NWP is reached.
NOTE
Cleaning effectiveness, cleaning optimization, and the fouling potential of
the product stream all impact on how rapidly the NWP falls upon cassette
reuse. Unstable or irreproducible NWP measurements between membrane
sets is a sign that the cleaning procedure is not effective.

NWP Temperature Correction Factor (F)*

T (°F) T (°C) F T (°F) T (°C) F T (°F) T (°C) F

125.6 52 0.595 96.8 36 0.793 68.0 20 1.125

123.8 51 0.605 95.0 35 0.808 66.2 19 1.152

122.0 50 0.615 93.2 34 0.825 64.4 18 1.181

120.2 49 0.625 91.4 33 0.842 62.6 17 1.212

118.4 48 0.636 89.6 32 0.859 60.8 16 1.243

116.6 47 0.647 87.8 31 0.877 59.0 15 1.276

114.8 46 0.658 86.0 30 0.896 57.2 14 1.310

113.0 45 0.670 84.2 29 0.915 55.4 13 1.346

111.2 44 0.682 82.4 28 0.935 53.6 12 1.383

109.4 43 0.694 80.6 27 0.956 51.8 11 1.422

107.6 42 0.707 78.8 26 0.978 50.0 10 1.463

105.8 41 0.720 77.0 25 1.000 48.2 9 1.506

104.0 40 0.734 75.2 24 1.023 46.4 8 1.551

102.2 39 0.748 73.4 23 1.047 44.6 7 1.598

100.4 38 0.762 71.6 22 1.072 42.8 6 1.648

98.6 37 0.777 69.8 21 1.098 41.0 5 1.699

*Based on water fluidity relative to 25 ºC (77 ºF) fluidity value F= (μT ºC/μ25 ºC) or (μT ºF/μ77 ºF).
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 30

Average Water Permeability at Room Temperature for Pellicon® 2 Cassette

Filters
These water permeability values are based on a membrane coupon tested under controlled
conditions. System and device variables can modify the water permeability values greatly;
these values are for guidance only.

Average Water Permeability

Membrane and NMWL
(LMH/psi) (LMH/Bar)

Biomax® 5 5.0 73

Biomax® 8 11.5 167

Biomax® 10 20.0 290

Biomax® 30 24.0 348

Biomax® 50 28.0 406

Biomax® 100 39.0 566

Biomax® 300 50.0 725

Biomax® 500 56.0 819

Biomax® 100 63.0 914

PL Regenerated Cellulose (PLAC) 0.3 4.4

PL Regenerated Cellulose (PLBC) 0.6 8.7

PL Regenerated Cellulose (PLGC) 4.0 58

Ultracel® 5 0.9 13.1

Ultracel® 10 6.4 93

Ultracel® 30 10.5 152

Ultracel® 100 30.0 435

Ultracel® 300 50.0 725

Ultracel® 1,000 60.0 870

Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 31

Integrity Testing
Test cassette integrity on a cleaned and thoroughly flushed system. The presence of residual
cleaning agents and/or process residues can significantly alter integrity test results. Integrity
test pressure and air diffusion specifications for each membrane can be found on the
Certificate of Quality supplied with the cassette or in the table in this section.
1. Ensure that the system is thoroughly cleaned and that the membrane is thoroughly wetted.
Ensure thorough wetting by recirculating water for 5–10 minutes at the conditions specified
in Measurement of Normalized Water Permeability (NWP).
2. Drain the system. Drain the feed/retentate side of the system as thoroughly as possible. If
possible, manually drain the permeate line. Do not blow down.
3. Attach a regulated and filtered air supply to the feed or retentate side of the holder,
preferably to the more elevated end.
4. Isolate either the feed or the retentate manifold (the port not connected to the air supply)
by closing a valve or capping the manifold if there is no valve on it. The permeate line
should be open at all times.
5. Slowly raise the air pressure to the specified test value and wait 5 minutes or as long as
needed to purge residual water in the permeate line and stabilize air pressure.
NOTE
Do not exceed the specified test air pressure. This could displace water from
the wetted pores. This would result in excessively high air flow. Rewet the
membrane if this occurs.
6. Measure and record the air pressure, ambient temperature, and the air flow rate exiting the
permeate line. Measure the air flow rate with an air flowmeter or by measuring the air
displaced into a submerged and inverted volumetric cylinder as shown in the following
illustration.
Graduated cylinder Air displacing water
full of water

Air

Tubing from
permeate line
Container of water

7. Compare the measured air flow rate to the specified flow value in the following table. If
the measured air flow rate exceeds the specified flow value, confirm that the Pellicon® 2
cassette has been installed and torqued correctly. Rewet and retest. If problem persists,
refer to Troubleshooting.
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 32

The following table lists air flow rates through a fully water wetted membrane tested with air
at ambient temperature.
NOTE
If different test temperature or test gas is used, the air integrity specification
must be converted to the conditions. For example, if nitrogen is used as the
test gas, the diffusional flow will be 80% of the air test gas values provided
below.

Membrane Air Flow Rates (cc/min) Test

Catalog Pressure
NMWL (kDa) or 0.1 m² 0.5 m² 2.0 m² 2.5 m²
Number Pore Size (µm) (1 ft²) (5 ft²) (20 ft²) (25 ft²) psi (bar)
Biomax® membranes
P2B005--- 5 ≤4 ≤ 18 ≤ 72 ≤ 90 10 (0.69)
P2B008--- 8 ≤4 ≤ 18 ≤ 72 ≤ 90 10 (0.69)
P2B010--- 10 ≤4 ≤ 18 ≤ 72 ≤ 90 30 (2.1)
P2B030--- 30 ≤4 ≤ 18 ≤ 72 ≤ 90 10 (0.69)
P2B050--- 50 ≤4 ≤ 18 ≤ 72 ≤ 90 10 (0.69)
P2B100--- 100 ≤4 ≤ 18 ≤ 72 ≤ 90 10 (0.69)
P2B300--- 300 ≤ 12 ≤ 60 ≤ 240 ≤ 300 10 (0.69)
P2B500--- 500 ≤ 12 ≤ 60 ≤ 240 ≤ 300 10 (0.69)
P2B01M--- 1,000 ≤ 12 ≤ 60 ≤ 240 ≤ 300 10 (0.69)

Regenerated cellulose membrane

P2PLAC--- 1 (PLAC) ≤ 10 ≤ 48 ≤ 192 ≤ 240 30 (2.1)
P2PLBC--- 3 (PLBC) ≤ 10 ≤ 48 ≤ 192 ≤ 240 30 (2.1)
P2PLGC--- 10 (PLGC) ≤6 ≤ 30 n/a ≤ 150 5 (0.34)

Ultracel® membrane
P2C005--- 5 ≤7 ≤ 35 ≤ 145 ≤ 175 30 (2.1)
P2C010--- 10 ≤7 ≤ 35 ≤ 145 ≤ 175 30 (2.1)
P2C030--- 30 ≤4 ≤ 18 ≤ 72 ≤ 90 10 (0.69)
P2C100--- 100 ≤4 ≤ 18 ≤ 72 ≤ 90 10 (0.69)
P2C300--- 300 ≤4 ≤ 18 ≤ 72 ≤ 90 10 (0.69)
P2C01M--- 1,000 ≤4 ≤ 18 ≤ 72 ≤ 90 10 (0.69)

Durapore® membranes
P2VVPP--- 0.1 µm ≤3 ≤ 12 ≤ 48 ≤ 60 10 (0.69)
P2GVPP--- 0.22 µm ≤3 ≤ 12 ≤ 48 ≤ 60 10 (0.69)
P2HVMP--- 0.45 µm ≤3 ≤ 12 ≤ 48 ≤ 60 10 (0.69)
P2DVPP--- 0.65 µm ≤3 ≤ 12 ≤ 48 n/a 10 (0.69)
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 33

Storing Filters and Systems

Storing the Filters in the System
After the system has been thoroughly cleaned, flushed, and tested, it can be stored until
needed for further processing.
• Do not store an uncrated system outdoors or lean or stack the system.

• Protect the fragile parts of the system, such as the instruments and electrical
enclosure front panel, with bubble-pack or cardboard.

• Protect open pipe inlets and outlets with plastic or stainless steel caps.

• Storage pressures, flow rates and volumes are identical to those used for cleaning
(see Flushing and Cleaning).

1. Shut off the recirculation pump and clamp the lines to or from the holder or shut the feed,
retentate and permeate valves to keep the holder and cassettes full of storage solution.
2. Store the holder and cassettes at either ambient temperature or 2–8° C.
To store cassettes on the skid in the holder, shut off the recirculation pump and clamp the lines
to/from the holder or close the feed, retentate, and permeate valves to keep the holder and
cassettes full of storage solution. It is recommended that storage is performed at 2-8 °C, but if
this is impractical on the skid, ambient temperature is acceptable if correctly validated.

Storing the Filters without the System

Filters can be removed from the holder for storage. Wear appropriate protective equipment
(rubber gloves, safety glasses) when handling the storage solution.
1. Ensure that the cassettes are fully wetted with storage solution.
2. Shut off the recirculation pump and drain the system.
3. Untorque the holder and remove the cassettes.
4. Place the cassettes in a liquid tight container and fill the container with excess storage
solution to fully immerse the cassette.
5. Seal the container and store at 2 to 8°C. Do not freeze.
Suitable storage containers include plastic freezer bags with zipper seals, molded polyethylene
or polypropylene freezer containers, or plastic pails with locking and sealing lids.
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 34

Recommended Storage Solutions and Conditions for Pellicon® 2 Filters

Time Period
Storage Solution Membrane Type Concentration pH
Recommended
Biomax® 0.1N 13 6 months
PLAC, PLBC, and
0.05N 12.7 6 months
PLCCC
0.1N 13 4 months
NaOH PLGC
0.05N 12.7 8 months

0.1N 13 6 months
Ultracel®
0.05N 12.7 1 year
Benzalkonium
All 0.1% 7 1 year
chloride
H3P04 All 0.1N 2 6 months

NOTES
Use sanitization agents and conditions that are suitable for the process
requirements. Sanitization agents must comply with applicable local
regulations.

Milder cleaning conditions can extend the life of regenerated cellulose

membranes with a nominal molecular weight limit of 1, 3, or 5 kDa. Use
ambient temperatures and the lowest NaOH concentration possible.
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 35

Troubleshooting
Problem Possible Causes Suggestions
Areas of membrane are Reflush with water and
incompletely wetted. retest (see Measurement of
Filter compression is Normalized Water Permeability
inadequate. (NWP) and Integrity Testing).
Ensure that intercassette
gaskets and adapter plates or
permeate plate are installed
correctly. Ensure threads, nuts,
Installation is improper.
and tie rods are undamaged
and installed correctly as
described in the holder user
guide.
Integrity test failure Temperature has changed since
Torque unit again and retest.
last torque of holder.
Gasket has become deformed. Replace the gasket.
Rerun the test. Follow the
procedure in Integrity Testing.
A procedural error has Ensure that system is fully
occurred. drained and air pressure
has stabilized prior to taking
measurements.
Replace any damaged cassette.
The membrane or cassette is
Replace any cassette that has
damaged.
been dropped.
If the holder is ours, ensure
torque and hydraulic set point
are correct.
Filter compression is
External liquid leak from inadequate (torque or
installed devices hydraulic pressure), causing an If the holder is from a third-
installation error. party supplier, contact
Technical Service for guidance
on the appropriate torque
settings.
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 36

Problem Possible Causes Suggestions

If the holder is ours, ensure
torque and hydraulic set point
are correct.
Filter compression is
inadequate (torque or hydraulic If the holder is from a third-
pressure). party supplier, contact
Technical Service for guidance
Yield loss on the appropriate torque
settings.
Ensure the correct membrane
is used.
Membrane retention. Ensure there is no chemical
incompatibility with membrane
during process or cleaning.
Run cleaning in reverse
direction (retentate to feed).
Feed channel is blocked.
Prefilter the feed stock and
keep environment clean.
There is an abnormally high Ensure that the appropriate
High pressure drop
pressure drop late in the membrane screen and feed
process. flow rate are selected.
Ensure devices are torqued
Devices are overtorqued. to specifications. Loosen and
retorque if necessary.
Verify procedure and rerun test
ensuring flows, temperature
A procedural error has and pressures are stable prior
occurred. to taking measurements (see
Measurement of Normalized
Water Permeability (NWP)).
NWP issue
The system and device are not
Reflush system and device.
completely flushed.
Reclean system and device.
The system and device are not Reevaluate cleaning procedure
completely cleaned. and solution (see Flushing and
Cleaning).
Lines are visible through a The interface is misinterpreted
Contact Technical Support.
maxi cassette jacket as cracks.
The color change is due to the
Pellicon® 2 jacket becomes
oxidization of the urethane Contact Technical Support.
discolored
jacket.
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 37

Accessories and Spare Parts

Description Quantity Catalog Number
Holders
Pellicon® 2 mini cassette holder (shipped with standard tie rod) 1 XX42PMINI
Pellicon® 2 holder, acrylic (shipped with short tie rod) 1 XX42P0060
Pellicon® 2 holder, stainless steel (shipped with long tie rod) 1 XX42P0080
Tie Rods
Tie rod kit, standard, stainless steel, for mini holders 2 XX42PMIST
Tie rod kit, long, stainless steel, for mini holders 2 XX42PMILG
Tie rod kit, short, stainless steel, for acrylic holders 4 XX42P60TS
Tie rod kit, long, stainless steel, for acrylic holders 4 XX42P60TL
Tie rod kit, short, stainless steel, for stainless steel holders 4 XX42TIEST
Tie rod kit, long, stainless steel, for stainless steel holders 4 XX42TIELG
Cogent M1 mini holder long tie rods 2 CMP1423
Spacers and Support Plate
Spacers for mini cassette holder, stainless steel 4 XX42PMSP
Spacers for benchtop holders, stainless steel 4 XX4200066
Support plate, stainless steel 2 PEH0TP2P1
Gaskets
Gasket, silicone, no alignment tabs (for mini holders only) 5 FTP60056
Gasket with alignment tabs (for benchtop holders only) 10 PSSP00C10
Gasket with alignment tabs 10 XX42PEG10
Gasket with alignment tabs, double thick 10 PSSP2XC10
Torque Wrenches
Torque wrench for Pellicon® 2 mini holder 1 XX42PMITW
Torque wrench for Pellicon® 2 benchtop holder installation 1 YY2029336
Sockets
Socket, 9/16 inch for Pellicon® 2 mini holder 1 XX42PMISR
Socket, /16 inch for Pellicon® 2 benchtop holders
15
1 XX4200061
Nuts and Washers
Nuts and washers (⅝ inch Nitronic® hex nuts and stainless steel
4 XX42P0069
washers) for benchtop holders
Nuts and washers (⅝ inch silicone bronze hex nuts and stainless
4 XX4200079
steel washers) for benchtop holders
Nuts and washers (hex silicone bronze nuts and washers) 4 XX42MT073
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 38

Standard Warranty
The applicable warranty for the products listed in this publication may be found at: www.
millipore.com/terms (within the “Terms and Conditions of Sale” applicable to your purchase
transaction).
Pellicon® 2 Cassettes Installation, User, and Maintenance Guide 39
We provide information and advice to our customers on application technologies and regulatory matters to the best
of our knowledge and ability, but without obligation or liability. Existing laws and regulations are to be observed in
all cases by our customers. This also applies in respect to any rights of third parties. Our information and advice do
not relieve our customers of their own responsibility for checking the suitability of our products for the envisaged
purpose.

For worldwide contact information and

technical assistance please visit:
www.sigmaaldrich.com

For additional information and

documentation please contact:
Merck KGaA, Darmstadt, Germany
Corporation with General Partners
Frankfurter Str. 250
64293 Darmstadt, Germany
Phone: + 49 6151-72 0

The vibrant M, Pellicon, Millipore, Durapore, Ultracel, and

Biomax are registered trademarks of Merck KGaA, Darm-
stardt, Germany. All other trademarks are the property of
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available via publicly accessible resources.
MK_UG2996EN Rev 3 01/2022 Replaces document number
P35430
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