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Providing the Benefits of Seitz ® High Performance Depth Filter Media in Scalable Capsule Formats Supracap Depth Filter Capsules

Supracap Depth Filter Capsules - Pall Corporationru.pall.com/pdfs/Biopharmaceuticals/10.3368_SUPRAcap8pg_BR.pdfSupracap depth filter capsules are ideal prefilters for the ... format

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Page 1: Supracap Depth Filter Capsules - Pall Corporationru.pall.com/pdfs/Biopharmaceuticals/10.3368_SUPRAcap8pg_BR.pdfSupracap depth filter capsules are ideal prefilters for the ... format

Providing the Benefits of Seitz® High Performance Depth Filter Media in Scalable Capsule Formats

Supracap™ Depth Filter Capsules

Page 2: Supracap Depth Filter Capsules - Pall Corporationru.pall.com/pdfs/Biopharmaceuticals/10.3368_SUPRAcap8pg_BR.pdfSupracap depth filter capsules are ideal prefilters for the ... format

Supracap depth filter capsules are ideal prefilters for the

removal of unwanted solids from the process stream –

protecting your more expensive membranes, safeguarding

product integrity, and accelerating throughput. By diminishing

the need for frequent filter change-outs, Supracap capsules

can significantly increase your process efficiency and reduce

your carbon footprint by decreasing waste.

These high performance depth filter capsules integrate

seamlessly into any development process, featuring versatile

configurations and a variety of sizes and filter media.

Supracap capsules are especially well-suited for process

development and pilot-scale applications. They can be

autoclaved and – depending on the filter media selected –

used for a wide range of critical applications.

Features and BenefitsComplete flexibility – Choices in filter media, effective

filtration area, capsule configuration, and connection

styles enable customized filtration solutions.

Low hold-up volume – Increased product recovery

requires low post-use rinse volumes.

Seamless linear scalability – Greater flexibility and

assurance of application success from development to

production scale. Scalable to Pall’s entire line of traditional

Supradisc® modules, as well as Stax™ capsules.

Minimized risk – Mechanically robust design provides

unobstructed process flows, consistent and scalable

filtration results, as well as high filter media integrity.

Completely disposable – Eliminates the need for cleaning

and cleaning validation.

Encapsulated design – Reduces operator exposure

to potential biohazards.

No external housing required – Easier to use and

manipulate while eliminating capital expenditures.

Supporting Unique Process Requirements

Use Supracap depth filter capsules for primary and

secondary filtration steps in a variety of applications.

Mammalian cell cultures

Yeast

E.coli lysates and refolds

Vaccines

Blood plasma proteins and serum

Media

Designed to Provide Choice and Flexibility

The Supracap range of disposable capsules comes in a

variety of options to enable you to select the correct capsule

to meet your specific process requirements, offering different

configurations for:

Filter area

Depth filter media grade

Capsule configuration

Inlet/outlet connections

Dependable, Cost-Effective Filtration Protection for Biopharmaceutical Applications

2

Supracap 100 internal cartridge

Page 3: Supracap Depth Filter Capsules - Pall Corporationru.pall.com/pdfs/Biopharmaceuticals/10.3368_SUPRAcap8pg_BR.pdfSupracap depth filter capsules are ideal prefilters for the ... format

www.pall.com/lab3

Incorporating Seitz Depth Filter MediaSupracap capsules are available in a wide range of

advanced pharmaceutical-grade Seitz depth filter media.

Supported with comprehensive validation guides, Seitz depth

filter media meet the highest pharmaceutical standards for:

Quality

Lot-to-lot consistency

Manufacturing control

Low extractable content

Low endotoxin content

Scalability�– Depth�Filter�Sheet�Media�Formats

Media Options

Pall offers an extensive portfolio of pharmaceutical-grade

depth filter sheets for use in the entire Supracap line of

disposable capsules. This flexibility of choice allows Pall

to help you meet the unique needs of your application.

Bio-series

Seitz Bio-series depth filters are specially developed from

highly purified natural and modified cellulose fibers and

contain no inorganic materials, such as diatomaceous earth

(DE), perlite or glass fibers. The lack of these inorganic

substances significantly reduces the levels of ash and heavy

metal extractables. For further information please reference

Pall data sheet USD 2201.

P-series

Seitz P-series depth filters have been specifically engineered

to meet the strict requirements of the biotechnological and

pharmaceutical industries. Stringent in-process control

methods assure consistent filtration quality, a very high

purity of filter medium, and alignment with the requirements

of the pharmaceutical industry. For further information,

please reference Pall data sheet USD 2205 or validation

guide USTR 2366.

HP-series

Seitz HP-series depth filter sheets are comprised of two

distinct layers of Seitz P-series depth filter sheets – a coarser

layer upstream followed by a finer layer downstream.

These performance-enhanced depth filter sheets have

been designed for use in low viability, high solids containing

applications. As small shifts in process conditions can cause

dramatic differences in filtration requirements, the flexibility

of combining any combination of P-series media in an HP

format allows for improved process optimization. For further

information, please reference Pall data sheet USD 2335 or

validation guide USTR 2404.

P-series HP-seriesBio-series

(1 grades) (Double layer w/4+ grades)(1 grades)

Supracap 60 capsules Supracap 100 capsules

AdvancedPharmaceutical

Grade Depth Filter Media

Biopharm

Product

Filtration

HighPerformanceCell CultureClarification

100% OrganicFilter Matrix –Low Product

Binding

< 1-3 liters 3-100 liters*

* For larger production volumes, please visit www.pall.com/biopharm for more information.

Flexibility of Design

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4

Tested and Certified Batch tested in order to meet all quality requirements.

Manufactured under a Quality Management System

certified to ISO 9000 and ISO 9001 and an Environmental

Management System certified to ISO 14001.

All plastic components used in construction meet the

specifications for Biological Reactivity Tests in vivo for

Class VI Plastics (121 °C) as described in the current

United States Pharmacopeia (USP).

Supracap Capsules Meet Industry Requirements

Supracap capsules have been designed to meet industry

requirements including autoclaving and low extractables.

They offer high flow rates and throughputs and are

designed to have minimal hold-up volumes. The translucent

shell makes venting and draining easier as liquid levels are

now visible.

Technical Service

For the best possible results and maximum reliability,

Pall recommends performing filter evaluations utilizing your

process and process conditions. Pall specialists can provide

valuable assistance, either at your facility or in our Scientific

and Laboratory Services laboratories. Pall offers hands-on

assistance and places its extensive technical resources at

your disposal in the form of worldwide technical advice,

including cost-reduction programs, process review, and

problem solving.

Pall UpScaleSM Program

From drug discovery and basic research,

through process development and production,

Pall Corporation is the single source for all

your filtration and separation needs. Our UpScale program

provides you with the scalable products and support you

need to bring new products to market faster.

Designed to Meet High Quality Standards

Page 5: Supracap Depth Filter Capsules - Pall Corporationru.pall.com/pdfs/Biopharmaceuticals/10.3368_SUPRAcap8pg_BR.pdfSupracap depth filter capsules are ideal prefilters for the ... format

www.pall.com/lab5

The range of Supracap capsules provides a scalable and

reliable depth filter platform for rapid process development,

utilizing the same design, flow path, and filter media as

larger scale Pall Supradisc depth filter modules and

Stax™ capsules.

Scalable both linearly in performance and seamlessly

through product format transitions, Supracap capsules will

save time and costs during critical screening, development

and process operations. The fully disposable design

eliminates any cleaning or handling concerns typically

associated with housings, especially when dealing with

biological and hazardous products.

The Supracap range of capsules has been designed

to provide cost effectiveness, flexibility and ease-of-use,

while minimizing the exposure risks to operators.

Supracap 60 Capsules

Ideal for developing and optimizing processes during

scale-up and scale-down studies, the Supracap 60

capsules [26 cm2 effective filtration area (EFA)] can be

used to quickly and accurately determine the exact Seitz

depth filter media necessary for process filtration success.

Supracap 60 and Supracap 100 capsules share a similar

design, filter media and flow path construction, allowing for

simplified scale-up and scale-down initiatives.

Supracap 100 Capsules

Benefitting from the proven Pall Supradisc II mechanically

robust module design, Supracap 100 capsules enable

consistent, reliable filtration results from batch to batch.

Through the use of dual drainage plates, the Supradisc II

module design imparts the structural integrity necessary for:

Unobstructed process flow

Consistent filtration results

Minimized risk to filter media rupture in the event

of reverse pressure

Scalability

Supracap 100 capsules are available in two sizes, ranging

from 0.025 m2 to 0.1 m2 (0.27 ft2 to 1.08 ft2) EFA.* To meet

your growing process requirements, these capsules can be

manifolded together to create larger systems and are ideal

for scale up when transitioning from development to

commercial phase manufacturing.

* Larger sizes available online. Please visit www.pall.com/biopharm for more information.

Comparison�of�Scalability�– CHO�Clarification�

(Post�Fermenter)�Filter�Grade�– PDK5�at��150�LMH

Culture harvest conditionsTotal cells 9.68 x 106/mL Viable cells 1.99 x 106/mLViability 20.6, Turbidity > 1000 NTU

Scalable Single-Use Depth Filtration

1.6

1.4

1.2

1.0

0.8

0.6

0.4

0.2

00 50 100 150 200 250 300

Volumetric Throughput (L/m²)

∆p (

bar)

Supracap 100 5 in. capsuleSupracap 100 10 in. capsuleStax capsule

Supracap 60 capsule Supracap 60 capsule Supracap 60 capsule

Page 6: Supracap Depth Filter Capsules - Pall Corporationru.pall.com/pdfs/Biopharmaceuticals/10.3368_SUPRAcap8pg_BR.pdfSupracap depth filter capsules are ideal prefilters for the ... format

From Benchtop Through Pilot to Process Scale

A well integrated suite of single-use devices is critical when

scaling up or down a process for further analysis. Apart

from the ease-of-use aspect of these disposable products,

designing them with similar flow resistance, flow paths and

filter area utilization will produce results that more accurately

predict what will be demonstrated at larger scales.

Supported by these complimentary technologies, Pall has

extended this seamless approach to products to their larger

Stax capsule system (50 to 20,000+ liters). Building upon

the same criteria for design, flow path and filter media,

Pall has established a comprehensive portfolio of single-use

technologies. These products provide seamless, linear

scalability in filtration performance from benchtop to process.

Scalability�– EFA

Supracap 60 Capsules (< 1 to 3 liters)

Capsule 26 cm² (0.028 ft²) of EFA

Supracap 100 Capsules (3 to 100 liters)1

5 in. capsules 0.05 m² (0.54 ft²) SL2 EFA

0.025 m² (0.27 ft²) DL3 EFA

10 in. capsules 0.1 m² (1.08 ft²) SL EFA0.05 m² (0.54 ft²) DL EFA

1 For larger production volumes, please visit www.pall.com/biopharm for more information.2 SL = Single layer Seitz depth filter media such as P-series and BIO-series3 DL = Double layer Seitz depth filter media such as HP-series

Complete Single-Use Systems

With the additional benefit of being able to manifold

the Supracap 100 capsules together, or with other Pall

Kleenpak™ Nova capsule filters, the Supracap 100

capsules can be easily incorporated into Pall Allegro™

disposable systems.

These disposable systems can combine depth filters,

final sterile filters and biocontainers – making a complete

filter train. This convenient, single-use system can be easily

designed to your specifications and is ready to use straight

out of the box.

Simple, scalable and disposable, Pall Supracap capsules

provide high performance filtration and flexibility in a

convenient single-use format.

6

Proven High Performance Depth Filter Media

Permeability�of�Seitz�P-series,�HP-series�and�

Bio-series�Depth�Filter�Sheet�Media����

2,000

100

50

0

Bio 20 K 900 P PDD1 PDE2 PDH4 PDK5

1,000

200

500

150

Typi

cal P

erm

eabi

lity

(L/m

²/m

in a

t 1 b

ar)

25

20

15

10

5

1

0.5

0

Mic

rons

Bio 20 K 900 P PDD1 PDE2 PDH4 PDK5

Nominal�Retention�Rating�of�Seitz�P-series,�HP-series

and�Bio-series�Depth�Filter�Sheet�Media�

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www.pall.com/lab7

Materials�of�Construction�

Supracap 60 CapsulesCapsule Polycarbonate

Vent Polypropylene

Supracap 100 CapsulesHousing Bowl Polypropylene

Housing Head1 Polypropylene

O-rings Silicone elastomers1 Formulated with TiO² whitener, which does not contribute to organic extractables.

Maximum Operating Pressure2

Supracap 60 and 100 Capsules 3 bar (44 psi) @ 40 ºC 2 In compatible fluids which do not soften, swell, or adversely affect the filter or itsmaterials of construction.

Maximum Differential PressureSupracap 60 Capsules 1.5 bar (22 psi)

Supracap 100 Capsules 2.4 bar (35 psi)

Sterilization - AutoclavingSupracap 60 Capsules 1 cycle: 125 ºC at 30 minutes

Supracap 100 Capsules 1 cycle: 125 ºC at 60 minutes

Supracap 60 and Supracap 100 Capsule Filter AreaSC060 NP5L NP6

Single layer 26 cm² 0.05 m2 0.1 m2

(0.028 ft²) (0.54 ft2) (1.08 ft2)

HP-version 26 cm² 0.025 m2 0.05 m2

(0.028 ft²) (0.27 ft2) (0.54 ft2)

Supracap 100 Capsules Void Volumes3

Capsule Length NP (mL)127 mm (5 in.) 652

254 mm (10 in.) 11253 Void volume is defined as amount of liquid required to fill entire capsule with cartridge installed inside.

Nominal�Dimensions

Supracap 60 Capsules

Maximum Height (A) Maximum Diameter (B)

Single layer media 32.5 mm (1.28 in.) 75 mm (2.95 in.)

HP media 36 mm (1.42 in.) 75 mm (2.95 in.)

Supracap 100 Capsules

In-line NP5 NP6Maximum diameter 154 mm (6.1 in.) 154 mm (6.1 in.) (B) including valves

Height (A) with hose 263 mm (10.4 in.) 397 mm (15.6 in.) barb inlet/outlet

Height (A) with 213 mm (8.4 in.) 335 mm (13.2 in.) sanitary inlet/outlet

A

B

A

B

A

B

Supracap�100�NP�Style�Capsules

Supracap�60�Capsules

Technical Specifications

Page 8: Supracap Depth Filter Capsules - Pall Corporationru.pall.com/pdfs/Biopharmaceuticals/10.3368_SUPRAcap8pg_BR.pdfSupracap depth filter capsules are ideal prefilters for the ... format

Ordering Information

Supracap�100�Capsules*

*Staübli vent and stepped hose barb drain fitted as standard.

Supracap�60�Capsules

Pall Part Number: SC060

Code Media GradeB020 BIO 20P900 K900PPDD1 PDD1PDE2 PDE2PDH4 PDH4PDK5 PDK5XAK7 AKS7

(activated carbon)

Visit�us�on�the�Web�at�www.pall.com/lab

E-mail�us�at�[email protected]

© 2010, Pall Corporation. Pall, , Allegro, Kleenpak, Seitz, Stax, Supracap, and Supradisc are trademarks ofPall Corporation. ® indicates a trademark registered in the USA. Filtration. Separation. Solution.SM and UpScale areservice marks of Pall Corporation. Stäubli is a service mark of Stäubli AG.

07/10, PDF, GN10.3368 PN33573

Pall�Life�Sciences600 South Wagner Road

Ann Arbor, MI 48103-9019 USA

800.521.1520 USA and Canada

(+)800.PALL.LIFE Outside USA and Canada

734.665.0651 phone

734.913.6114 fax

Australia – Cheltenham, VICTel: 03 9584 81001800 635 082 (in Australia)Fax: 1800 228 825Austria – WienTel: 00 1 49 192 0Fax: 00 1 49 192 400Brasil – São Paulo, SPTel: +55 11 5501 6000Fax: +55 11 5501 6025Canada – OntarioTel: 905-542-0330800-263-5910 (in Canada)Fax: 905-542-0331Canada – QuébecTel: 514-332-7255800-435-6268 (in Canada)Fax: 514-332-0996800-808-6268 (in Canada)China – P. R., BeijingTel: 86-10-6780 2288Fax: 86-10-6780 2238France – St. Germain-en-LayeTel: 01 30 61 32 32Fax: 01 30 61 58 [email protected]

Germany – DreieichTel: 06103-307 333Fax: 06103-307 [email protected] – MumbaiTel: 91 (0) 22 67995555Fax: 91(0) 22 67995556Italy – BuccinascoTel: +3902488870.1Fax: +39024880014Japan – Tokyo Tel: 03-6901-5800Fax: 03-5322-2134Korea – SeoulTel: 82-2-560-8711Fax: 82-2-569-9095Malaysia – SelangorTel: +60 3 5569 4892Fax: +60 3 5569 4896Poland – WarszawaTel: 22 510 2100Fax: 22 510 2101Russia – MoscowTel: 5 01 787 76 14Fax: 5 01 787 76 15

SingaporeTel: 65 6 389-6500Fax: 65 6 389-6501South�Africa –JohannesburgTel: +27-11-2662300Fax: +27-11-3253243Spain – MadridTel: 91-657-9876Fax: 91-657-9836Sweden – LundTel: (0)46 158400Fax: (0)46 320781Switzerland – BaselTel: 061-638 39 00Fax: 061-638 39 40Taiwan – TaipeiTel: 886 2 2545 5991Fax: 886 2 2545 5990Thailand – BangkokTel: 66 2937 1055Fax: 66 2937 1066United�Kingdom – FarlingtonTel: 02392 302600Fax: 02392 [email protected]

Pall Part Number: NP

Code5L6

Nominal Length5 in. (127 mm)10 in. (254 mm)

Media GradeBIO 20

K900P

PDD1

PDE2

PDH4

PDK5

CodeBO20

K900

PDD1

PDE2

PDH4

PDK5

Code1

6

Connection Options1 - 1.5 in. sanitary flangeinlet and outlet

13 mm ( in.) single barbhose barb inlet and outlet