Millipore Sigma Pellicon 3 Cassettes User Manual

Installation and User
Guide

Pellicon® 3 Cassettes

Contents

Introduction ..................................... 2

Membrane Type ........................... 2

Pump Capacity ............................ 2

Water Quality .............................. 2

Installation ...................................... 2

Pellicon® 3 88 cm2 and 0.11 m2

Cassette Holder Installation ........... 2

Pellicon® 3 0.57 or 1.14 m2 Cassette

Benchtop Holder Installation .......... 3

Manual Process-Scale Holder

Installation ................................. 4

Hydraulic Process Scale Holder

Installation ................................. 5

Maintenance ................................... 7

Flushing and Cleaning ....................... 7

Flushing ..................................... 8

Cleaning ..................................... 8

Sanitization ..................................... 9

Depyrogenation .............................. 10

Integrity Testing ............................. 10

Measurement of Normalized Water

Permeability................................... 11

Storage ......................................... 12

Troubleshooting .............................. 14

Warranty ....................................... 15

The life science business of Merck KGaA, Darmstadt,
Germany operates as MilliporeSigma in the U.S. and Canada.

Pellicon® 3 Cassettes Installation and User Guide 2

Introduction

This guide provides installation and
maintenance procedures for Pellicon® 3
cassettes. It is not intended to provide
validation protocols or supporting data
for validation purposes. Please refer
to the cassette Validation Guide for
this information. Please refer to the
Certificate of Quality supplied with each
cassette for specifications.

Membrane Type

Install filters containing only one type
of membrane in the filter holder at one
time. Do not mix filters with different
pore sizes or nominal molecular weight
cutoffs. The area of membrane used
depends on the filter surface area
required for your particular application.

Pump Capacity

When operating Pellicon® 3 cassettes,
select a pump with adequate capacity.
Recommended feed crossflow rate for
cassettes is 4 - 6 liter/min/m2. Optimal
cross flow will depend on the actual
solution being filtered.

Water Quality

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

Installation

Pellicon® 3 88 cm2 and 0.11 m2 Cassette Holder Installation

NOTE

Pellicon® 3 88 cm2 and 0.11 m2 Cassettes must be installed in a Pellicon®
Cassette Holder, Catalog Number XX42PMINI.

Holder Installation

1. Loosen the nuts on the tie rods of the
holder and remove the nuts, washers,
tie rod spacers and end plate.

2. Inspect the tie rods and nuts for signs
of burrs or stripped threads. Replace
any damaged components. Nuts must
turn freely on the tie rods to ensure
proper tightening of the holder.

3. Slide the Pellicon® 3 Cassette onto
holder so that the tie rods pass
through the cutouts in the Pellicon®
3 Cassette. Repeat to install one or
two additional Pellicon® 3 Cassettes
if required.

4. Slide the end plate onto the tie rods
and press the end plate against the
cassette.

5. Install the tie rod spacers, washers and nuts. Hand-tighten the nuts, alternating from one
nut to the other nut.

NOTE

Uneven tightening of the nuts can damage the Pellicon® Cassette. Nonparallel
plates or compression of the filters at one end can cause leakage.

Pellicon® Cassette Holder, XX42PMINI

Pellicon® 3 Cassette

6. Tighten the nuts using the torque wrench and 9/16 in. socket supplied with the
Pellicon® Cassette Holder. If your wrench has a ratchet head, move the lever to the
right lock position to tighten the nuts or to the left lock position to loosen the nuts.

Pellicon® 3 Cassettes Installation and User Guide 3

7. Set the torque wrench at 180 to 200
in. lb. (20.3 to 22.6 Nm) by holding
the spring loaded lock collar down
and turning the handle until the 180
to 200 in. lb. (20.3 to 22.6 Nm)
mark aligns with the 0 (zero) mark
on the collar.

8. Rotate the handle slightly to spring
the lock collar back into place.

9. Attach the socket to the torque
wrench by firmly pressing the socket
onto the torque wrench drive.

10. Place the socket over one nut. With a
continuous motion, turn each nut ¼
turn, alternating between the nuts,
until the wrench clicks, which will
indicate it has reached the set force.

Pellicon® 3 0.57 or 1.14 m2 Cassette Benchtop Holder Installation

XX42P0060 Pellicon® Cassette Acrylic Filter Holder
XX42PRV60 Pellicon® Cassette Acrylic Holder Low Retentate Volume
XX42P0080 Pellicon® Cassette Stainless Steel Holder
XX42P0K80 Pellicon® Cassette Stainless Steel Holder Assembly

1. Loosen the nuts on the tie rods of the holder and remove the nuts, washers and end plate.

2. Inspect the tie rods and nuts for signs of burrs or stripped threads. Replace any
damaged components. Nuts must turn freely on the tie rods to ensure proper
tightening of the holder.

3. Clean the manifold adapter plate (XXPEL3MAP) with an alcohol wipe.

4. Slide the manifold adapter plate onto the holder against the holder’s manifold
plate, with the solid light grey side labeled “Manifold Side” towards the manifold,
and the wings resting on the tie rods. Slide the manifold adapter plate directly
up against the stainless steel manifold.

5. Slide the Pellicon® 3 cassette up against the manifold adapter plate. The dark
grey center with light grey perimeter of the manifold adapter plate should be up
against the Pellicon® 3 cassette.

6. Slide a Pellicon® 3 Cassette onto the holder.

7. Slide the end plate with the handle side up onto the tie rods.

8. Tie rod spacers (XX4200066) are available when operating the system with low
membrane area. Place enough spacers on each rod so that the length of exposed
threaded tie rod is less than the length of the hex socket. Replace the washers
and nuts. Hand tighten the nuts in a diagonal pattern.

NOTE

Uneven tightening of the nuts can damage the Pellicon® Cassette. Nonparallel
plates or compression of the filters at one end can cause leakage.

9. Tighten the nuts using the torque wrench and 15/16 in. deep hex socket supplied
with the Pellicon® Cassette Holder.

10. Set the torque wrench by turning the knurled locking collar clockwise or by pulling
the handle out to unlock. Turn the torque setting scale clockwise until the 350 in-lb
(40 Nm) mark on the torque scale is opposite the zero mark on the smooth collar.
Turn the knurled locking collar counterclockwise to lock.

Pellicon® 3 Cassettes Installation and User Guide 4

of tie rods

pressure plate

11. Using the torque wrench and 15/16 in.
deep hex socket, turn each nut 1/8 turn
in the sequence shown here. When the
wrench clicks, this indicates that the set
force has been reached. DO NOT OVER
TORQUE. Evenness of torque is critical
to system performance.

top

plate

manifold

threaded

tie rod

Pellicon
Cassette

®

hex nut

washer

stainless steel
bushing

handle

top acrylic

Pellicon

Filter

MILLIPORE

®

nut

washer

stainless steel
bushing

top

pressure plate

tie rod

manifold adapter

Gasket Plate

plate

Pellicon® Holder Tightening Sequence

NOTE

Depending on the results of the
Integrity Test, the torque may need
to be increased at intervals of 50
in-lb (5.6 Nm) up to a maximum of
550 in-lb (62 Nm).

12. Recheck the torque prior to use.

NOTE

If the filter holder is tightened in a
cold area and moved to a warmer
area, loosen the nuts entirely, let
the filter holder warm up, and then
retighten to prevent warping of the
end plates.

PERMEATE

threaded

holes for

insertion

bottom

plate

manifold

permeate
outlet port

1in. sanitary
Tri-Clover®
connection

retentate
outlet port

feed inlet
port

FEED

manifold adapter

Gasket Plate

plate

3/4 in. sanitary
Tri-Clover

®

connection

RETENTATE

bottom

manifold plate

FEED

PERMEATE

RETENTATE

pressure plate

Exploded View of Acrylic Pellicon®

Cassette Filter Holder.

bottom

permeate
manifolds

(four holes)

pressure

gauge

Exploded View of Stainless Steel Pellicon®

Cassette Filter Holder.

Manual Process-Scale Holder Installation

1. Loosen the nuts on the tie rods of the holder and remove the nuts, washers and
end plate.

2. Inspect the tie rods and nuts for signs of burrs or stripped threads. Replace any
damaged components. Nuts must turn freely on the tie rods to ensure proper
tightening of the holder.

3. Clean the manifold adapter plate (XXPEL3MAP) with an alcohol wipe.

4. Slide the manifold adapter plate onto the holder against the holder’s manifold plate,
with the solid light grey side labeled “Manifold Side” towards the manifold, and the
wings resting on the tie rods. Slide the manifold adapter plate directly up against the
stainless steel manifold.

Pellicon® 3 Cassettes Installation and User Guide 5

5. Slide the Pellicon® 3 cassette up against the manifold adapter plate. The dark
grey center with light grey perimeter of the manifold adapter plate should be up
against the Pellicon® 3 cassette.

6. Replace the spacers, washers and nuts as shown in Figure 5. Hand-tighten the
nuts in a diagonal fashion (see Figure 4). Use a few drops of suitable lubricant on
the tie-rods and between the nuts and the washers if required.

Note Uneven tightening of the nuts can damage the Pellicon® 3 Cassette.

Nonparallel plates or compression of the filters at one end can cause leakage.

7. Tighten the nuts using the torque wrench and 15/16 in. deep hex socket supplied
with the Pellicon® 3 Cassette Holder.

8. Set the torque wrench by turning the knurled locking collar clockwise or by pulling
the handle out to unlock. Turn the torque setting scale clockwise until the 350 in-lb
(40 Nm) mark on the torque scale is opposite the zero mark on the smooth collar.
Turn the knurled locking collar counterclockwise to lock.

9. Using the torque wrench and 15/16
in. deep hex socket, turn each nut
1/8 turn in the sequence shown in
Figure 4. When the wrench clicks,
this indicates that the set force
has been reached. DO NOT OVER
TORQUE. Evenness of torque is
critical to system performance.

Hydraulic Process Scale Holder Installation

The Hydraulic Closure with Manual
Controls is intended for use with the
Millipore Process Scale Filter Holder. It
will maintain appropriate pressure on
the holder during processing or during
storage of installed filter cassettes.

RUN mode is required for process
operations. The system hydraulic pressure
is maintained at 1800 psig ± 100 psig.

In STORE mode, the system may be
stored with the Pellicon® 3 cassettes
installed. The system hydraulic pressure
is maintained at 1200 psig ± 100 psig.

Note Depending on the results of the

Integrity Test, the torque may need
to be increased at intervals of 50
in-lb (5.6 Nm) up to a maximum of
550 in-lb (62 Nm).

10. Recheck the torque prior to use.

Process Scale Holder

Hydraulic Process Scale Holder

1. Set the System Mode switch to DUMP.

Note

Check the Hydraulic Pressure Gauge
on the hydraulic power unit panel to be
sure the pressure is relieved. Do not
proceed until the hydraulic pressure
reaches 0 psig as read on gauge PI-2.