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USD 2462

Total Chromatography
Pall Filter ModulesSolutions
and Capsules
with Seitz® Depth Filter Sheets
Improving choice, flexibility and costs of purification processes
The most efficient and economical way to filter every biopharmaceutical process
Pall Filter Modules and Capsules with Seitz Depth Filter Sheets
The most efficient and economical way to filter every biopharmaceutical process

• Pall® depth filter modules offer the highest filter


area volume in a single industry-standard size,
making it possible to reduce capital investment
by using fewer modules per batch.

• Pall leads the filtration industry in the shift to


disposable systems that save time and money,
reduce cleaning and cleaning validation, and
improve operator safety.

• Pall offers the widest range of filter sheet (media)


grades available.

• Pall quality control delivers the most consistent


filtration systems in the industry.

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Pall Filter Modules and Capsules with Seitz Depth Filter Sheets
The most efficient and economical way to filter every biopharmaceutical process

Pall is a technology leader for filtration,


separation, and purification and has been a
pioneer in the depth filter market by developing
a range of technologies that have an increased
efficiency and economy.

Pall depth filter modules are cost-efficient by


incorporating more filter area into a given size
than alternative depth filter formats. The extra
thickness of Seitz depth filter sheets increases SUPRAcap™ 60 depth filter capsule

their dirt-holding capacity.

In applications where Tangential Flow (TFF)


devices and Centrifuge equipment have been
traditionally used for primary separation or
clarification process steps, depth filter modules
offer a simpler, yet robust, alternative that
requires less equipment, sophistication, and
labor to operate.

Pall offers the industry’s most advanced and


SUPRAcap 100 capsule with interior depth filter
robust design, which provides superior resistance cartridge shown

to back pressure failure of the depth filter media.


Incorporating conjoined inner and outer support
layers, Pall SUPRAdisc™ II modules create a
rugged structure that both supports and protects
the Seitz depth filter sheets like no other module
or cartridge.

Pall has also led the paradigm shift towards


disposable biopharmaceutical processing
that has reduced costs, improved safety,
Cut-away of SUPRAcap 200 capsule with a
and enhanced process optimization. SUPRAdisc I module and AKS-grade, carbon
impregnated, depth filter media

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Seitz Depth Filter Sheets
Superior retention, consistency, and quality

• Superior manufacturing Pall has many years of experience in every biopharmaceutical application.

process control provides manufacturing filter sheets that meet Pall’s manufacturing capacity can make

consistent performance that the strict requirements of the it possible to deliver an entire year’s

ensures smooth scale-up. biotechnology and pharmaceutical requirements from a single production
industries. Manufacturing is performed run for ultimate process consistency.
• Pall provides unique filter using stringent in-process control
matrices that deliver methods to assure constant filtration P-Series depth filter sheets
finer retention ratings performance and high purity of the The P-Series depth filter sheets are
down to 0.1 µm. filter medium. Pall has developed filter specially designed to meet the strict
matrices specifically for the needs of requirements of the biotechnology and
• Pall provides the industry’s the biopharmaceutical industry that pharmaceutical industries. They cover
widest range of filter sheet assure nominal retention ratings down the full range of needs from bioburden
grades, making it possible to 0.1 µm for optimal filtration of reduction (typical LRV of 9.5 with EKSP
to find the perfect match for biological products and protection of grade using Brevundimonas diminuta),
virtually every application. downstream processing systems. fine filtration, clarifying filtration to coarse
filtration. Strict manufacturing controls
• Pall provides validation
All Seitz filter sheets are produced under ensure high purity of the filter medium
guides for pharmaceutical-
rigorous quality standards at an and constant filtration quality. Pall
grade sheets that reduce
ISO 9001 facility that customers may demonstrates its commitment to the
the time and cost required
inspect and audit. Finer retention ratings biopharmaceutical industry by delivering
for validation.
and consistent performance have strong endotoxin control, low level
propelled Pall into the leadership position Beta Glucan grades, and providing a
SUPRAdisc I module with
AKS grade media
in depth filter sheet media. complete validation guide Pall document
(USTR 2366 and data sheet document
Pall offers tighter grade sheets that USD 2205).
remove smaller particles as
required by the most critical HP-series depth filter sheet
biopharmaceutical processes. The HP-series depth filter sheets are
comprised of two full thickness, graded,
Pall’s superior manufacturing high-efficiency P-Series depth filter
process control ensures sheets in combination. This technology
consistent quality, performance, compresses clarification processing
and scalability of our Seitz depth steps, saving time and resources, and
filter sheets from batch to batch. reducing operation costs. High purity
Pall provides a wide range of pharmaceutical grade depth filter sheets
filter sheet classes and grades are optimized for low endotoxin and low
with different permeabilities as extractable levels and are supported with
well as materials of construction. their own unique validation guide Pall
This makes it possible to provide document (USTR 2404 and data sheet
an optimal sheet for essentially document USD 2335).

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Seitz Depth Filter Sheets
Superior retention, consistency, and quality

BIO-series depth filter sheets a more open structure and


BIO-series depth filter sheets have been combine very high outputs
specially developed for the strict with long filtration cycles due
requirement of the biotech and to their high dirt holding
pharmaceutical industries. Manufactured capacity. For further information
from highly purified natural and modified pertaining to the T-series depth
cellulose fibers, BIO-series depth filter filter sheets please reference data
sheets have significantly reduced levels sheet USD 2202.
of ash and heavy metal extractables.
The use of selected cellulose fibers and AKS-series depth filter sheet
their arrangement result in a very low The AKS-series depth filter
protein adsorption in the filter matrix and sheets use powdered
an excellent rinsing behavior after activated carbon (PAC)
filtration. For further information immobilized within a matrix of
regarding BIO-series depth filter sheets cellulosic fibers to eliminate the
please reference data sheet USD 2201. need for handling bulk powdered
carbon. Used primarily for its
K-Series depth filter sheets adsorption properties of colors and
The K series depth filter sheets, with 13 other impurities, AKS filter sheets
different retention ratings, cover the eliminate the need to work with PAC
entire range of needs from bio-burden that can contaminate a clean room
reduction to fine and coarse filtration. and take significant time to remove and
Comprised of a balanced composition of clean. For additional information
cellulosic fibers, diatomaceous earth, concerning Seitz AKS-grade depth filter
and perlite enables the creation of a well media and SUPRAdisc modules
defined matrix. It is this matrix which incorporating these products please
specifies the retention ratings of each of reference brochure USTR 2549.
the 13 different grades of the K-series
line. For further information concerning
the K-series depth filter sheets please Top right- Validation Guides:
USTR 2404 Pall SUPRAdisc
reference data sheet USD 2200. HP depth filter media
USTR 2366 Pall P-series
depth filter media
T-Series depth filter sheets
Right - Stack of Seitz
The T-series depth filter sheets from Pall Depth Filter Sheets
include 7 different grades. Similar in
composition to the K-Series, the
T-Series depth filter sheets cover a range
of coarse filtration enabling them to be
used to remove the largest of the
contaminants. They are characterized by

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SUPRAdisc Depth Filter Modules
Formatting Seitz sheets in a new design

Depth filter sheets have been The individual filter cells, making up each
• More filter area per module.
successfully used for a vast range of SUPRAdisc module, are constructed by
• Up to 5 m (54 ft ), the
2 2 applications using an array of equipment joining two or more depth filter sheets
industry’s highest level of primarily based on filter presses. separated by a single polypropylene
filter area per industry With their excellent mechanical strength, drainage plate and edge-sealed in an
standard size module. Seitz depth filter sheets can be readily injection molding process. The drainage
incorporated into SUPRAdisc modules plate aids with the flow distribution as
• Enables reduction in capital
and installed into enclosed filter well as provides downstream support
equipment costs by reducing
housings. This arrangement reduces to the filter sheets to guarantee an
number of modules.
cleaning and cleaning validation, excellent flow distribution throughout
• More rigid design allows up simplifies installation, and reduces time the entire module and to increase
to four (4) filters to be between batches. filter cell stability.
stacked vertically for
unparalleled density — SUPRAdisc depth filter modules provide SUPRAdisc depth filter modules
up to 20 m2 (215 ft2) of more filter area than competitors are built around a polypropylene
available surface area. modules within the same industry tubular center core that supports the
standard dimensions. The largest 16 in. individual filter cells and adapters.
• Wide range of module styles
SUPRAdisc modules offer 5 m2 (54 ft2) of
and sizes and filter media
filter area — the highest level of any The rigid center core carries the load
enable SUPRAdisc modules
to be applied to nearly any module in the industry. This may help in when the modules are stacked vertically.

application. reducing capital equipment expenditure Up to four modules can be stacked


by filtering the same volume of product without concern over deformation of the
with fewer modules. modules due to weight and stress that
12 in. diameter SUPRAdisc
module with a double O-ring
might otherwise impact the integrity of
and bayonet lock adapter the filters.

The SUPRAdisc module adapter has


two O-rings and a bayonet lock, a
configuration successfully used in the
pharmaceutical industry for filter
cartridges. As a result, SUPRAdisc
modules can be installed easily and
quickly into filter housings. A flat gasket
adapter is also available enabling
installation into housings that only allow
flat gasket sealing arrangements. In the
flat gasket adapter version, an integrated
gripping groove permits the use of a
module-lifting device.

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SUPRAdisc Depth Filter Modules
Formatting Seitz sheets in a new design

All grades of Seitz depth filter media


available in flat sheet formats may be
incorporated into SUPRAdisc modules,
so the change from an open sheet filter
system to a modular system is
straightforward, requiring only a minimal
amount of re-validation.

A range of module types with different


permeabilities, filter media, and diameters -
12 in. modules (284 style) and 16 in. modules
(410 and 413 style) - permits precise optimization
of the filter system to specific filtration tasks.
For further information regarding SUPRAdisc I
depth filter modules please reference data sheet
USD 2204.

Flat gasket adapter

Double O-ring adapter

413 mm (16 in.) module with double O-ring adapter

Family of SUPRAdisc modules - 12 in. x 16 cell modules with both flat gasket and double O-ring adapters,
12 in. x 5 cell module with double O-ring adapter and 16 in. x 20 cell module with flat gasket adapter

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SUPRAdisc II Depth Filter Modules
An evolutionary change

The SUPRAdisc II depth


• Dual separator plate design
filter module provides a
provides support layers that
protect filter sheets from unique design that locks

pressure surges, avoiding together and supports


lost product batches caused every component of the
by pressure blowouts. filter in a unitized body for
substantial improvements I n s i d e Outside
• All components locked in robustness and
together in unitized body integrity. Through direct
that increases robustness
support of the filter sheets both on the The enclosed design of the
and integrity.
up-stream and down-stream sides, the SUPRAdisc II depth filter also guards

• Efficient use of available filter SUPRAdisc II design guards against against damage by eliminating direct
surface area. ruptures caused by over-pressurization. operator handling of the discs.
This eliminates a common problem that
• Eliminates need for direct can cause bypass in other module The new depth filter module can be used
operator handling of filter designs. The use of both an inner and with either a double O-ring or flat gasket
cells to prevent damage and outer separator plate enables more filter housing. The ability to fit either type
ensure uniform performance. efficient use of housing makes it possible to use
of the these modules with a wide range of
• The largest 16 in.
size modules available existing equipment. The molded filter

provide 5 m2 (54 ft2) filter surface components are made of polypropylene


of filter area, more area by eliminating while the O-rings are either made of
than any sheet-to-sheet contact. silicone (standard) or other gasket
competitive module. This contact can contribute to loss of materials (optional).
available filter area and a reduction in
overall expected filter performance. As with our SUPRAdisc Modules, the
SUPRAdisc II design can be stacked
up to 4 modules high without concern
of deformation or loss of module
integrity. This is due to the design of the
inner tubular core. This center core is
capable of carrying the load of the
saturated wet weight of the modules,
minimizing the compressive forces on
individual filter cells, and subsequently
the filter sheets, to eliminate possible
bypass conditions. For further
information regarding SUPRAdisc II
depth filter modules please reference
data sheet USD 2304.
SUPRAdisc II - 16 in. diameter modules with flat gasket end fittings

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SUPRAdisc HP Depth Filter Modules
High performance cell clarification depth filter modules

Frequently, single-layer depth filter As a result, multiple stages of filtration


modules are unable, as a single stage, or capital intensive equipment are
to remove the large variety and quantity used to each remove a specific
of impurities found in today's range of particles. SUPRAdisc
biopharmaceutical applications. HP depth filter modules
provide a substantial
• Combines pre-clarification and improvement by incorporating
clarification within a single two full-thickness depth filter sheet
module.
layers, making it possible, for
• Increases filtration efficiency example, to combine cell harvesting
up to 30% more than single- and final clarification into
layer formats. a single step. The SUPRAdisc HP
modules offer enhanced clarification
• SUPRAdisc HP depth filter
modules incorporate two layers abilities for process steps with high
of Seitz filter media into a single solids content, wide particle distributions
module to remove widely and low cell viability. A key advantage to
varying particle sizes and
using the SUPRAdisc HP depth filter
concentrations.
modules is the wide variety of Seitz
• The downstream layer enables depth filter sheets that can be
increased efficiency of the combined together to create a unique 12 in. diameter SUPRAdisc I HP module
upstream layer.
and optimized filter for each specific
• Each 16 in. diameter module process need.
provides up to 2.5 m2 (27 ft2) of For further information regarding
available filter area per module -
The availability of 12 in. and 16 in. SUPRAdisc HP depth filter modules
the highest level of any 16 in.
diameter module in the industry. diameter SUPRAdisc I HP modules and please reference data sheet USD 2335.
16 in. diameter SUPRAdisc II HP
modules, enables the selection of
the best module format to meet
process parameters.

Filter cell design of Pall SUPRAdisc HP module

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SUPRAcap 60 Depth Filter Capsules
Helps get new products to market faster and more efficiently

SUPRAcap™ 60 capsules are designed


• Helps process developers
for developing and optimizing a
get to market faster and
process during scale-up and
more efficiently.
scale-down studies. They can be
used to quickly and accurately • Ready-to-use format makes
determine what grade of Seitz it easier for researchers to
depth filter sheet media will evaluate filter sheet
provide the best performance performance.
in a particular process
• Uses the same filter sheets
application and also help to
as production scale filter
estimate the filter area
modules and capsules.
required to meet specific
SUPRAcap 60 with AKS grade filter media
process volume • Filter sheet manufacturing
requirements. SUPRAcap process controls enable
60 capsules are readily The SUPRAcap 60 capsule offers broad more accurate scale-up.
scalable to Pall SUPRAcap 100 chemical compatibility with a wide range of
• For further information
capsule, SUPRAdisc I and SUPRAdisc II solutions found in the biopharmaceutical
reference data sheet
depth filter modules. SUPRAcap 60 industry. The SUPRAcap 60 capsule is
USD 2208.
capsules are also available with Seitz HP completely disposable, which saves time
sheet media (double-layer) that scales to during manufacturing and improves safety
SUPRAcap 60
Pall SUPRAcap 100 HP capsules and by eliminating the need for cleaning capsules
SUPRAdisc HP Filter modules. operations. Instead of having to put
together filtration products into appropriate
SUPRAcap 60 capsules are available with assemblies, SUPRAcap 60 capsules are
a wide range of Seitz depth filter sheet supplied in a ready-to-use format.
media for optimal grade selection. With SUPRAcap 60 depth filter capsules feature
26 cm (4.0 in. ) of available filter area of the
2 2
a connection that is compatible with
same Seitz filter sheets used in all Luer-Lok* access devices for ease of use.
SUPRAdisc modules, SUPRAcap 60 An upstream vent valve on the SUPRAcap
capsules provide an optimal product scale 60 capsule makes it easier to
for initial process development projects. remove air from the
The hold-up volume of SUPRAcap 60 capsules prior to use.
capsules is very low, which saves the time
and expense of introducing additional
flushing fluids at the beginning and the end
of the process. The product adds
substantial value to applications such as
cell harvesting, antibiotics production,
serum processing, and clarification of
fermenter broth.

* Luer-Lok is a trademark of Becton, Dickinson and Company.


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SUPRAcap 100 Depth Filter Capsule
Flexible format filters bring the benefits of disposables to a wide application range

New SUPRAcap 100 depth filter


capsules offer a unique format that can
be scaled to higher volumes than
previously achievable. The fully
disposable design eliminates the time
required to assemble and clean filter
• SUPRAdisc II module concept in an
encapsulated cartridge format. components, thus saving labor and
downtime. The elimination of the need
• Scales from just a few liters to full to clean these filters and ancillary
process volumes.
equipment reduces operator exposure
• Disposable format capsules eliminate to hazardous process flows and
need for cleaning operations and cleaning solutions.
protect operators from hazardous
substances.
The internal depth filter cartridge
• Choice of in-line or T-styles to fit assembly draws upon the design of
different foot prints and process the larger SUPRAdisc II modules.
needs.
By fully supporting both the upstream
• Can be manifolded together or and downstream layers of the depth
with other Kleenpak™ Nova filter sheets, this design avoids lost
capsule filters to create product batches due to back pressure
disposable systems.
failure of the filter sheets. The use of
For further infomation dual supporting layers enables full
please reference data sheet utilization of available filter area as
USD 2463. blinding because of filter sheet-to-filter
sheet contact is eliminated.

SUPRAcap 100,
in line capsule with depth SUPRAcap 100 depth filters are offered
filter cartridge shown in a flexible format that enables them to
scale to match your requirements at
every stage of your product's lifecycle.
They are available in both in-line and
T-styles, so they fit different footprints
and needs and multiple filters can be
manifolded together to scale up
production volumes and meet specific
application requirements. The T-style is
ideal for constructing disposable
systems of multiple capsules in series
or in parallel configuration.

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SUPRAcap 100 Depth Filter Capsule
Flexible format filters bring the benefits of disposables to a wide application range

The filters can even be purchased as HP Version (double layer)


pre-assembled manifold components. Surface Area

As a fully disposable unit, the installed 10 in. 0.05 m2 (0.54 ft2)

cost of a SUPRAcap 100 capsule is 20 in. 0.1 m2 (1.08 ft2)


30 in. 0.15 m2 (1.61 ft2)
typically lower than a similarly sized
stainless steel housing and module
arrangement. As a result, they offer an These different configurations can
extremely cost effective alternative. process liquids in batch sizes ranging
from 3 to 100+ liters with a single filter.
SUPRAcap 100 filters come in Of course, by manifolding filters, virtually
10, 20, and 30 in. lengths, providing any batch size can be accommodated.
the industry's widest range of filter area. The SUPRAcap 100 capsules are
available in either single layer format (SL)
Single Layer Capsule or HP- double layer format (DL), and
Surface Area scale directly to Pall SUPRAdisc and
10 in. 0.09 m (0.97 ft )
2 2
SUPRAdisc II formats. SUPRAcap 100
20 in. 0.18 m (1.9 ft )
2 2
capsule filters are available with a wide
30 in. 0.27 m2 (2.9 ft2) range of Seitz depth filter sheet grades
for optimal grade selection. Close-up of depth filter cartridge internal of the
SUPRAcap 100 capsules

Comparison of Scalability
1.80

1.60

1.40

1.20

1.00
∆p [bar]

Ø 60mm flat sheet

0.80 SUPRAcap 100

SD I module
0.60

0.40

0.20

0.00
0 50 100 150 200 250 300 350
Throughput [L/m2]

Example of scalability of the SUPRAcap 100 capsules in comparison to 60 mm flat sheet (generally small scale process
development) and Supradisc I modules (generally large scale clinical of commercial scale manufacturing)

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SUPRAcap 200 Depth Filter Capsules
High area production filters in a disposable format

SUPRAcap 200 depth filter capsules provide • Disposable format capsules


the same high process volume capabilities as eliminate the need for cleaning
operations and protect operators
the 12 in. SUPRAdisc I and SUPRAdisc II
from hazardous substances.
depth filter modules in a disposable,
encapsulated format. The SUPRAcap 200 • Ideally suited for fine chemical
disposable capsule saves time and money filtration operations.

because the filtration system is supplied in a


• Available with carbon sheets to
ready-to-use format. Minimal time and cost eliminate the need for handling
are required for assembly, sterilizing, and powdered carbon.
cleaning of this filtration system so turn-around
time between process runs is minimized.
SUPRAcap 200 depth filter capsules are
The disposable capsules do not require offered with a wide range of Seitz filter
cleaning, so the cost of cleaning chemicals sheets, including sheets with powdered
and water for injection is eliminated. Cleaning activated carbon immobilized in a matrix of
validation of the housing is eliminated or cellulose fibers. Carbon sheets provide the
substantially reduced since only a few small ability to utilize carbon for decolorization
parts come into contact with your process and the removal of trace contaminants
fluid. These parts can be easily placed into a without having to handle powdered carbon,
parts washer and cleaned. The capsules are which tends to be dispersed by the air and
used once and then discarded. Operator may contaminate critical process
safety is increased since operator exposure to equipment. Carbon sheets provide superior
process fluids and chemicals required for contaminant removal since the impurities in
cleaning operations is greatly reduced. the liquid stream are forced to contact
carbon-impregnated filter material as
SUPRAcap 200 depth filter capsules feature a opposed to a bulk carbon process that
unique design in which a metal housing relies upon diffusion of contaminants to
supports the soft sided, polypropylene reach the active sites in the carbon.
capsules. The use of the housing and a soft- For further information please
sided encapsulation technique minimizes the reference data sheet
cost and weight of the disposable capsules. USD 2295.
The distance between the outside diameter of
the capsule and the inside diameter of the
housing ensures capsule integrity during use.
The use of the capsule inside of the housing
reduces the overall void volume of the system,
minimizing the volume of rinse fluid necessary
Cut-away of a TUV rated Pall pre- and post-use compared to conventional
Advanta™ for SUPRAcap housing
showing 3 SUPRAcap capsules. module and housing arrangements. SUPRAcap 200
Each capsule has a SUPRAdisc I with carbon
module inside sheets shown

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TUV rated Pall Advanta for
SUPRAcap housing with the
dome removed and SUPRAcap
capsules exposed.

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New York - USA
+1 516 484 5400 phone Visit us on the web at www.pall.com/biopharmaceutical
+1 516 801 9548 fax
pharmafilter@pall.com e-mail Pall Corporation has offices and plants throughout the world in locations including:
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany,
Portsmouth - Europe India, Indonesia, Ireland, Italy, Japan, Korea, Malaysia, Mexico, New Zealand, Norway,
Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland,
+44 (0)23 9230 3303 phone
Taiwan, Thailand, United Kingdom, the United States and Venezuela.
+44 (0)23 9230 2506 fax Distributors are located in all major industrial areas of the world.
BioPharmUK@europe.pall.com e-mail
, Pall, Kleenpak, Pall Advanta, Seitz, SUPRAcap and SUPRAdisc are trade marks of Pall Corporation.
Filtration. Separation. Solution. and UpScale are service marks of Pall Corporation.
Part Numbers quoted above are protected by the Copyright of Pall Corporation.

® indicates a trademark registered in the USA.


© 2007, Pall Corporation.
PELEH/MG/04.2007

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