Sartopore® 2 0.

1 μm
Sterilizing Grade and Mycoplasma Retentive Filter Cartridges

Specifications

Materials
Prefilter Membrane: Polyethersulfone,
asymmetric
Membrane Filter Cartridges

Endfilter Membrane: Polyethersulfone,

asymmetric
Support Fleece: Polypropylene
Core: Polypropylene
End Caps: Polypropylene
O-Rings: Silicone (optional
EPDM or Viton)

Pore Size
0.2 μm + 0.1 μm

Available sizes | Filtration Area

Description Performance Cartridges

Sartopore® 2 0.1 μm rated filter cartridges Sartopore® 2 0.1 μm cartridges provide Size 0 5” 0.3 m2 | 3.2 ft2
are especially developed for validated sterile exceptionally high flow rates, resulting Size 1 10” 0.6 m2 | 6.5 ft2
filtration and reliable mycoplasma removal in economical sizing of filtration systems. Size 2 20” 1.2 m2 | 12.9 ft2
from any media likely to contain it such as Due to the “built-in prefiltration” by a Size 3 30” 1.8 m2 | 19.4 ft2
those originating from animal sources. In 0.2 μm membrane, Sartopore® 2 0.1 μm
addition these elements are ideally suited for rated cartridges achieve outstanding Mini Cartridges
removal of unusually small microorganisms total throughputs. Size 7 0.05 m2 | 0.5 ft2
that have been shown to pass through a Size 8 0.1 m2 | 1.1 ft2
0.2 μm rated sterilizing grade filter. Wettability Size 9 0.2 m2 | 2.2 ft2
Sartopore® 2 cartridges can be easily wetted
Applications out for integrity testing even after drying Available Adapters Cartridges
Typical applications include sterilizing grade at 80 °C for 12 hours 21, 25, 27, 28
filtration and Mycoplasma removal from:
Microbiological Retention Available Adapters Mini Cartridges
– Animal Sera
Sartopore® 2 0.1 μm rated filter cartridges are 15, 18
– Cell Culture Media validated as sterilizing grade filters according
to ASTM F 838-83 standard and for Operating Parameters
– Media Components
Mycoplasma removal with a Log Reduction
Max. Allowable 5 bar |72.5 psi
– Bioprocessed Pharmaceuticals Value (LRV) of 7 for Acholeplasma laidlawii.
Differential Pressure: at 20°C
– Biological Fluids 2 bar |29 psi at 80°C
Quality Control
Each individual element is tested for integrity Max. Allowable Back 2 bar |29 psi at 20°C
Any other application requiring sub 0.2 μm Pressure:
by diffusion test prior to be released assuring
filtration for enhanced sterility assurance.
absolute reliability.
Compatibility
Documentation
Featuring a unique hydrophilic polyether-
Sartopore® 2 0.1 μm rated cartridges are
sulfone membrane, Sartopore® 2 0.1 μm
designed, developed and manufactured
cartridges are compatible from pH 1 to pH 14
in accordance with an ISO 9001 certified
and to numerous steam sterilization cycles.
Quality Management System. A Validation
Therefore they are also ideally suited for
Guide and Extractables Guide are available
filtration of solutions with high|low pH and
for compliance with regulatory requirements.
for multiple SIP|CIP cycles.
Specifications Water Flow Rates for 10″, 20″ and 30″ Cartridges

Extractables
Sartopore® 2 0.1 μm rated filter cartridges Differential pressure [bar] [psi]
1 15
meet, or exceed the requirements for WFI
quality standards set by the current USP.
10″ 20″ 30″
0.75
Regulatory Compliance
Individually integrity tested
0.5 7.5
Integrity test correlated to HIMA/ASTM
F 838-83 Bacteria Challenge Test and
Mycoplasma removal. 0.25
Non pyrogenic according to USP Bacterial
Endotoxins 0 0
0 1000 2000 3000 4000 5000
Pass USP Plastic Class VI Test
Flow Rate [l/h]
Non fiber releasing according to 21 CFR
Standardized at 20°C

Sterilization Total Throughput Comparison

In-Line Steam Sterilization:

134°C, 20 min. at max differential pressure Total Throughput [kg]
40
of 0.5 bar|7.25 psi

Autoclaving: 30
134°C, 2 bar|29 psi, 30 min

Sterilization Cycles 20
In-Line Sterilization: Min. 25
Autoclaving: Min. 25
10
Technical References
0
Validation Guide: Sartopore 2 PVDF PVDF PESU Nylon
SPK5732-e
0.2 | 0.1 μm 0.2 | 0.1 μm 0.1 μm 0.1 μm 0.1 | 0.1 μm
Extractables Guide:
SPK5731-e 10″ Cartridge format

Ordering Information Sartorius Stedim Biotech GmbH

August-Spindler-Strasse 11
Order Code Pore size Pack size Test Max. 37079 Goettingen, Germany
[μm] [Pieces] Pressure Diffusion Phone +49.551.308.0
[bar|psi] [ml/min] Fax +49.551.308.3289
Standard Cartridges www.sartorius-stedim.com
544**58K0 0.1 1 4.0 | 58
USA Toll-Free +1.800.368.7178
544**58K1 0.1 1 4.0 | 58 24
UK +44.1372.737159
544**58K2 0.1 1 4.0 | 58 48
France +33.442.845600
544**58K3 0.1 1 4.0 | 58 72
Italy +39.055.63.40.41
Spain +34.90.2110935
Mini Cartridges
Japan +81.3.3740.5407
544**58K7------B 0.1 5 4.0 | 58 4
544**58K8------B 0.1 5 4.0 | 58 6 Specifications subject to change
544**58K9------B 0.1 5 4.0 | 58 9 without notice. Printed and copyrighted
by Sartorius Stedim Biotech GmbH. | W
Publication No.: SPK2035-e11055
**: Adapter Type Order No.: 85030-512-64
Ver. 05 | 2011
 Sartopore® 2 0.2 μm
Sterilizing Grade Filter Cartridges

Specifications

Materials of Construction
Prefilter Membrane: Polyethersulfone,
asymmetric
Membrane Filter Cartridges

Endfilter Membrane: Polyethersulfone,

asymmetric
Support Fleece: Polypropylene
Core: Polypropylene
End Caps: Polypropylene
O-Rings: Silicone (optional
EPDM or Viton)

Pore Size
0.45 μm + 0.2 μm

Available sizes | Filtration Area

Description Performance Cartridges

Sartopore® 2 0.2 μm rated sterilizing grade Sartopore® 2 cartridges provide an exception- Size 0 5” 0.3 m2 | 3.2 ft2
filter cartridges are designed for filtration ally high total throughput by fractionated Size 1 10” 0.6 m2 | 6.5 ft2
of a broad range of pharmaceutical products filtration due to the “built-in prefiltration” of Size 2 20” 1.2 m2 | 12.9 ft2
where compliance with cGMP requirements the 0.45 μm membrane. The asymmetric pore Size 3 30” 1.8 m2 | 19.4 ft2
has to be fulfilled. Sartopore® 2 cartridges structure of the polyethersulfone membrane
feature a unique hydrophilic heterogeneous provides high flow rates at low pressure Mini Cartridges
double layer Polyethersulfone membrane drops. Size 7 0.05 m2 | 0.5 ft2
with broad chemical compatibility, high Size 8 0.1 m2 | 1.1 ft2
thermal resistance and higher throughput Wettability Size 9 0.2 m2 | 2.2 ft2
and flow-rate than any other sterilizing Sartopore® 2 cartridges can be easily wetted
grade filter cartridge. out for integrity testing even after drying Available Adapters Cartridges
at 80 °C for 12 hours. 21, 25, 27, 28
Applications
Typical applications include sterilizing Microbiological Retention Available Adapters Mini Cartridges
grade filtration of: Sartopore® 2 filter cartridges are fully 15, 18
– Therapeutics validated as sterilizing grade filter elements
– Biological Fluids according to HIMA and ASTM F-838-83 Operating Parameters
– Opthalmics guidelines.
Max. Allowable 5 bar |72.5 psi
– SVPs, LVPs
Differential Pressure: at 20°C
– Antibiotics Quality Control
2 bar |29 psi at 80°C
– WFI Each individual element is integrity tested
– Chemicals by diffusion and bubble point test prior Max. Allowable Back 2 bar |29 psi at 20°C
– Cleaning and sanitizing agents to release, assuring absolute reliability. Pressure:
– Bulk pharmaceutical products
Documentation
Compatibility Sartopore® 2 cartridges are designed, devel-
The polyethersulfone membrane is compatible oped and manufactured in accordance with
with a pH range from pH 1 to pH 14 and an ISO 9001 certified Quality Management
unaffected by steam sterilization cycles System. A Validation Guide and Extractables
making Sartopore® 2 cartridges ideal for Guide are available for compliance with
filtration of solutions with high|low pH and regulatory requirements.
for SIP|CIP-cycles.
Specifications Water Flow Rates for 10″, 20″ and 30″ Cartridges

Extractables [psi]
Differential pressure [bar]
Sartopore® 2 0.2 μm rated filter cartridges 1 15
meet, or exceed the requirements for WFI
quality standards set by the current USP. 10″ 20″ 30″
0.75
Regulatory Compliance
100% Individually integrity tested
0.5 7.5
Integrity test correlated to HIMA/ASTM
F 838-83 Bacteria Challenge Test
0.25
Non-pyrogenic according to USP Bacterial
Endotoxins
0 0
Passes USP Plastics Class VI Test 0 2,000 4,000 6,000 8,000 10,000 12,000 14,000
Flow [l/h]
Non-fiber releasing according to 21 CFR

Standardized at 20°C
Sterilization
Total Throughput Comparison
In-Line Steam Sterilization:
134°C, 20 min. at max differential pressure
of 0.5 bar|7.25 psi Total throughput [kg at 95 % blockage]
100
Autoclaving:
134°C, 2 bar|29 psi, 30 min 80

Sterilization Cycles
In-Line Sterilization: Min. 25 60
Autoclaving: Min. 25
40
Technical References
20
Validation Guide:
SPK 5732-e
0
Sartopore 2 PESU PVDF PVDF Nylon
Extractables Guide: 0.45 | 0.2 μm 0.8 | 0.2 μm 0.2 μm 0.22 μm 0.2 | 0.2 μm
SPK5731-e
10″ Cartridge format

Ordering Information Sartorius Stedim Biotech GmbH

August-Spindler-Strasse 11
Order Code Pore size Pack size Test Max. Min. 37079 Goettingen, Germany
[μm] [Pieces] Pressure Diffusion Bubble Point Phone +49.551.308.0
[bar|psi] [ml/min] [bar|psi] Fax +49.551.308.3289
Standard Cartridges www.sartorius-stedim.com
544**07H0 0.2 1 2.5 | 36 10 3.2 | 46
USA Toll-Free +1.800.368.7178
544**07H1 0.2 1 2.5 | 36 18 3.2 | 46
UK +44.1372.737159
544**07H2 0.2 1 2.5 | 36 36 3.2 | 46
France +33.442.845600
544**07H3 0.2 1 2.5 | 36 54 3.2 | 46
Italy +39.055.63.40.41
Spain +34.90.2110935
Mini Cartridges
Japan +81.3.3740.5407
544**07H7------B 0.2 5 2.5 | 36 4 3.2 | 46
544**07H8------B 0.2 5 2.5 | 36 5 3.2 | 46 Specifications subject to change
544**07H9------B 0.2 5 2.5 | 36 7 3.2 | 46 without notice. Printed and copyrighted
by Sartorius Stedim Biotech GmbH. | W
Publication No.: SPK2030-e11057
**: Adapter Type Order No.: 85030-511-67
Ver. 05 | 2011
 Sartopore® 2 0.45 μm
Bioburden & Particle Reductive Filter Cartridges

Specifications

Materials
Prefilter Membrane: Polyethersulfone,
asymmetric
Membrane Filter Cartridges

Endfilter Membrane: Polyethersulfone,

asymmetric
Support Fleece: Polypropylene
Core: Polypropylene
End Caps: Polypropylene
O-Rings: Silicone (optional
EPDM or Viton)

Pore Size
0.8 μm + 0.45 μm

Available sizes | Filtration Area

Description Performance Cartridges

Sartopore® 2 0.45 μm rated filter cartridges Sartopore® 2 0.45 μm cartridges provide Size 0 5” 0.3 m2 | 3.2 ft2
are designed for bioburden reduction and exceptional high flow rates, resulting in Size 1 10” 0.6 m2 | 6.5 ft2
particle removal from a broad range of economical sizing of filtration systems. Size 2 20” 1.2 m2 | 12.9 ft2
pharmaceutical products. They offer extreme- Due to the “built-in prefiltration” by a 0.8 μm Size 3 30” 1.8 m2 | 19.4 ft2
ly high flow rates and total throughputs and membrane, Sartopore® 2 0.45 μm rated car-
are therefore ideally suited for membrane tridges offer outstanding total throughputs. Mini Cartridges
prefiltration of aqueous solutions and highly Size 7 0.05 m2 | 0.5 ft2
viscous, difficult to filter pharmaceutical Wettability Size 8 0.1 m2 | 1.1 ft2
products. Sartopore® 2 cartridges can be easily wetted Size 9 0.2 m2 | 2.2 ft2
out for integrity testing even after drying
Applications at 80 °C for 12 hours. Available Adapters Cartridges
Typical applications include bioburden 21, 25, 27, 28
reduction and particle removal from: Microbiological Retention
Sartopore® 2 0.45 μm rated filter cartridges Available Adapters Mini Cartridges
– Buffers
are validated for removal of Serratia 15, 18
– Biological Fluids marcessens with a Log Reduction Value (LRV)
of 7 according to HIMA and ASTM F-838-83 Operating Parameters
– Opthalmics
guidelines.
Max. Allowable 5 bar |72.5 psi
– LVP
Differential Pressure: at 20°C
Quality Control
– Antibiotics 2 bar |29 psi at 80°C
Each individual element is integrity tested
– Bulk pharmaceutical products by diffusion and bubble point test prior Max. Allowable Back 2 bar |29 psi at 20°C
to release, assuring absolute reliability. Pressure:
Compatibility
Featuring a unique hydrophilic polyether- Documentation
sulfone membrane, Sartopore® 2 0.45 μm Sartopore® 2 cartridges are designed, devel-
cartridges are compatible with solutions oped and manufactured in accordance with
from pH 1 to pH 14 and are unaffected by an ISO 9001 certified Quality Management
numerous steam sterilization cycles. They are System. A Validation Guide and Extractables
ideally suited for filtration of solutions with Guide are available for compliance with
high|low pH and for multiple SIP |CIP cycles. regulatory requirements.
Specifications Water Flow Rates for Standard Cartridges

Extractables Differential Pressure [bar] [psi]

Sartopore® 2 0.45 μm rated filter cartridges
meet, or exceed the requirements for WFI 0,5
quality standards set by the current USP.
10″ 20″ 30″
0,4
Regulatory Compliance
100% Individually integrity tested 0,3
Integrity test correlated to HIMA/ASTM
F 838-83 Bacteria Challenge Test using 0,2
Serratia marcescens
0,1
Non-pyrogenic according to USP Bacterial
Endotoxins
0
Meets USP Plastics Class VI biological 0 2500 5000 7500 10000
reactivity test, in vivo Flow Rate [l/h]

Non-fiber releasing according to 21 CFR Standardized at 20 °C

Sterilization Total Throughput Comparison

In-Line Steam Sterilization:

134°C, 20 min. at max differential pressure Total Throughput at 95% blockage [kg]
of 0.5 bar|7.25 psi 140
120
Autoclaving:
134 °C, 2 bar|29 psi, 30 min 100

Sterilization Cycles 80
In-Line Sterilization: Min. 25
Autoclaving: Min. 25 60
40
Technical References 20

Validation Guide: 0
SPK 5732-e Sartopore® 2 PVDF PVDF PESU Nylon
0.8 |0.45 μm CE*|0.45 μm 0.65|0.45 μm 0.45|0.45 μm 0.45 μm
Extractables Guide:
SPK5731-e 10″ Cartridges
* Cellulose Ester prefilter
Ordering Information Sartorius Stedim Biotech GmbH
August-Spindler-Strasse 11
Order Code Pore size Pack size Test Max. Min. 37079 Goettingen, Germany
[μm] [Pieces] Pressure Diffusion Bubble Point Phone +49.551.308.0
[bar|psi] [ml/min] [bar|psi] Fax +49.551.308.3289
Standard Cartridges www.sartorius-stedim.com
544**06G0 0.45 1 1.7 | 25
USA Toll-Free +1.800.368.7178
544**06G1 0.45 1 1.7 | 25 12 2.2 | 32
UK +44.1372.737159
544**06G2 0.45 1 1.7 | 25 24 2.2 | 32
France +33.442.845600
544**06G3 0.45 1 1.7 | 25 36 2.2 | 32
Italy +39.055.63.40.41
Spain +34.90.2110935
Mini Cartridges
Japan +81.3.3740.5407
544**06G7------B 0.45 5 1.7 | 25 3 2.2 | 32
544**06G8------B 0.45 5 1.7 | 25 4 2.2 | 32 Specifications subject to change
544**06G9------B 0.45 5 1.7 | 25 6 2.2 | 32 without notice. Printed and copyrighted
by Sartorius Stedim Biotech GmbH. | W
Publication No.: SPK2039-e11055
**: Adapter Type Order No.: 85030-513-44
Ver. 05 | 2011