Sartopore 2 0.45 μm - Sartorius€“ Designed, developed and manufactured in accordance with an...
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Product Information Sartopore ® 2 0.45 µm Applications – Therapeutics – Buffers – Injectables – Ophthalmics – Large volume parenterals – Antibiotics – Biological Fluids – Tissue Culture Media – Bulk pharmaceutical products – Acetic and basic solutions No. 1 choice for bioburden reduction & particle removal Due to the “built-in prefiltration” by a 0.8 μm membrane, Sartopore ® 2 0.45 μm rated filter systems are ideally suited for bioburden reduction and particle removal of highly viscous and difficult to filter pharmaceutical solutions. Due to its hydro- philic Polyethersulfone membrane Sartopore ® 2 0.45 μm filter elements offer outstanding total throughputs and flow rate performances. Thus ensuring highest process efficiency, minimized filtration costs and short filtration cycle times. Broad compatibility and highest reliability The unique Polyethersulfone membrane gives Sartopore ® 2 0.45 μm broad chemical compatibility, including a pH-range from pH 1 to pH 14, and a high thermal resistance, making it suitable for a broad range of filtration liquids. To assure absolute reliability, each individual Sartopore ® 2 0.45 μm filter element is integrity testes by Diffusion Point and Bubble Point Test prior to release. Scalability Sartopore ® 2 0.45 μm filter elements are available in a broad range of sizes and formats to provide linear scale-up from R&D to process scale. The wide range of membrane areas from 300 cm 2 to 1.8 m 2 per filter element guarantees greatest flexibility and most economic filter sizing. Sartopore ® 2 0.45 μm Bioburden & Particle Retentive Filter Elements – Extremely high flow rates and total throughputs – Number one choice for bioburden reduction & particle removal – Broad compatibility and easy scalability – Outstanding filtration performance of aqueous solutions that are highly viscous & difficult to filter
Transcript of Sartopore 2 0.45 μm - Sartorius€“ Designed, developed and manufactured in accordance with an...
Product Information
Sartopore® 2 0.45 µm
Applications– Therapeutics
– Buffers
– Injectables
– Ophthalmics
– Large volume parenterals
– Antibiotics
– Biological Fluids
– Tissue Culture Media
– Bulk pharmaceutical products
– Acetic and basic solutions
No. 1 choice for bioburden reduction & particle removalDue to the “built-in prefiltration” by a 0.8 μm membrane, Sartopore® 2 0.45 μm rated filter systems are ideally suited for bioburden reduction and particle removal of highly viscous and difficult to filter pharmaceutical solutions. Due to its hydro-philic Polyethersulfone membrane Sartopore® 2 0.45 μm filter elements offer outstanding total throughputs and flow rate performances. Thus ensuring highest process efficiency, minimized filtration costs and short filtration cycle times.
Broad compatibility and highest reliabilityThe unique Polyethersulfone membrane gives Sartopore® 2 0.45 μm broad chemical compatibility, including a pH-range from pH 1 to pH 14, and a high thermal resistance, making it suitable for a broad range of filtration liquids. To assure absolute reliability, each individual Sartopore® 2 0.45 μm filter element is integrity testes by Diffusion Point and Bubble Point Test prior to release.
ScalabilitySartopore® 2 0.45 μm filter elements are available in a broad range of sizes and formats to provide linear scale-up from R&D to process scale. The wide range of membrane areas from 300 cm2 to 1.8 m2 per filter element guarantees greatest flexibility and most economic filter sizing.
Sartopore® 2 0.45 μmBioburden & Particle Retentive Filter Elements
– Extremely high flow rates and total throughputs– Number one choice for bioburden reduction &
particle removal– Broad compatibility and easy scalability – Outstanding filtration performance of aqueous
solutions that are highly viscous & difficult to filter
Technical Data
Available Sizes Filtration Area Max. Diffusion at 2.5 bar | 36 psi[ml/min]
Min. Bubble Point [bar | psi]
Cartridges | MaxiCaps®
Size 0.5 (Only Cartridge) 0.3 m2 | 3.2 ft2 7 2.2 | 32
Size 1 0.6 m2 | 6.5 ft2 12 2.2 | 32
Size 2 1.2 m2 | 12.9 ft2 24 2.2 | 32
Size 3 1.8 m2 | 19.4 ft2 36 2.2 | 32
MidiCaps® | Mini Cartridges
Size 7 0.05 m2 | 0.5 ft2 3 2.2 | 32
Size 8 0.1 m2 | 1.1 ft2 4 2.2 | 32
Size 9 0.2 m2 | 2.2 ft2 6 2.2 | 32
Size 0 (Only MidiCaps®) 0.45 m2 | 4.8 ft2 12 2.2 | 32
Capsules
Size 5 0.03 m2 | 0.32 ft2 2 2.2 | 32
Materials
Prefilter Membrane Polyethersulfone, asymmetric
Endfilter Membrane Polyethersulfone, asymmetric
Support Fleece Polypropylene (In-Line Steam sterilizable & autoclavable)
CorePolypropylene
Pore Size Combination
0.8 μm + 0.45 μm
Max. Allowable Differential Pressure
Cartridges | Mini Cartridges5 bar | 72.5 psi at 20°C2 bar | 29 psi at 80°C
MaxiCaps® 5 bar | 72.5 psi at 20°C3 bar | 43.5 psi at 50°C
MidiCaps® 5 bar | 72.5 psi at 20°C2 bar | 29 psi at 80°C
Capsules4 bar | 58 psi at 20°C2 bar | 29 psi at 50°C
Max. Allowable Back Pressure
2 bar | 29 psi at 20°C (for all elements)
End CapsPolypropylene
Capsule HousingPolypropylene
O-RingSilicone(other materials on request)
Filling BellPolycarbonate
Sartopore® 2 0.45 µm 3
Regulatory Compliance
– Each individual element is tested for integrity by Bubble Point and Diffusion test
– Fully validated as sterilizing grade filters according to ASTM current F-838 guidelines
– Designed, developed and manufactured in accordance with an ISO 9001 certified Quality Management System
– Meet or exceed the requirements for WFI quality standards set by the current USP
– Non pyrogenic according to USP Bacterial Endotoxins
– USP Plastic Class VI Test
– Non fiber releasing according to 21 CFR
Sterilization
Cartridges, Mini CartridgesIn-Line Steam Sterilization134 °C, 0.5 bar, 20 min. Min. 25 Sterilization Cycles
or
Autoclaving134°C, 2 bar, 30 minMin. 25 Sterilization Cycles
MaxiCaps®, MidiCaps® & CapsulesAutoclaving134°C, 2 bar, 30 minMin. 25 Sterilization Cycles (MidiCaps® & MaxiCaps®)
Technical References
Validation Guide SPK5732-eExtractables Guide SPK5731-e
Performance
Total Throughput Comparison
10” Cartridges
* Cellulose Ester prefilter
0 2500 5000 7500 10000
Flow Rate [l/h]
0
0.1
0.2
0.3
0.4
0.5Differential Pressure [bar]
0
1.5
3
4.5
6
7.5[psi]
10" 20" 30"
Water Flow Rate for MaxiCaps® and Standard Cartridges
Standardized at 20°C
Total Throughput at 95% blockage [kg]140
120
100
80
60
40
20
0Sartopore® 2 0.8 | 0.45 µm
PVDF CE* | 0.45 µm
PVDF 0.65 | 0.45 µm
PESU 0.45 | 0.45 µm
Nylon 0.45 µm
Ordering Information
544 06 G
Mini Cartridge
Filter Size7: 0.05 m2 | 0.5 ft2 8: 0.1 m2 | 1.1 ft2
9: 0.2 m2 | 2.2 ft2
Adapter15: Bayonet adapter with o-ring18: Plug Adapter with double o-ring
-- - - -- B--
Packing SizeB: box of 5
544 25 06 G
Cartridge
Filter Size0: 0.3 m2 | 3.2 ft2 (5“)1: 0.6 m2 | 6.5 ft2 (10“)2: 1.2 m2 | 12.9 ft2 (20“)3: 1.8 m2 | 19.4 ft2 (30“)
Adapter21: double open end with flat gaskets25: 2 Flange Bayonet adapter with 226 double o-ring27: Bayonet adapter with 222 double o-ring28: 3 Flange Bayonet adapter with 222 double o-ring
(Standard with silicone o-ring optional with EPDM o-ring. Example: 5442506G1---E)
(Standard with silicone o-ring optional with EPDM o-ring. Example: 5441506G1---E--B)
544 73 06 G
MaxiCaps®
Filter Size1: 0.6 m2 | 6.5 ft2 (10“)2: 1.2 m2 | 12.9 ft2 (20“)3: 1.8 m2 | 19.4 ft2 (30“)
Connector InletS: 1½“ Tri-Clamp 50 mm O: ½“ single stepped hose barbF: ¾“ Tri-Clamp 25 mm
Sterilization--: autoclavable
(Optional with vent valve design for connection of integrity tester. Example: 5447307H1--SSIT)
Connector OutletS: 1½“ Tri-Clamp 50 mm O: ½“ single stepped hose barbF: ¾“ Tri-Clamp 25 mm
B544 13 06 G
Capsules
Filter Size5: 0.03 m2 | 0.32 ft2
Connector InletS: ¾“ Tri-Clamp 25 mmO: ¼“ multiple stepped
hose barb
Packing SizeB: box of 5
Sterilization--: autoclavable
Connector OutletS: ¾“ Tri-Clamp 25 mmO: ¼“ multiple stepped
hose barb
--
544 53 06 G
MidiCaps®
Filter Size7: 0.05 m2 | 0.5 ft2 8: 0.1 m2 | 1.1 ft2
9: 0.2 m2 | 2.2 ft2
0: 0.45 m2 | 4.8 ft2
Connector InletS: 1½“ Tri-Clamp 50 mm O: ½“ single stepped hose barbF: ¾“ Tri-Clamp 25 mm H: ¼“ multiple stepped hose barb
(only size 7 with filling bell)
Sterilization--: autoclavable
Packing SizeA: box of 4 (size 7,8,9)V: box of 2 (size 0)
Connector OutletS: 1½“ Tri-Clamp 50 mm O: ½“ single stepped hose barbF: ¾“ Tri-Clamp 25 mm H: ¼“ multiple stepped hose barb
(only size 7 with filling bell)
--
Sartorius Stedim Biotech GmbHAugust-Spindler-Strasse 1137079 Goettingen, GermanyPhone +49.551.308.0Fax +49.551.308.3289www.sartorius-stedim.com
USA Toll-Free +1.800.368.7178Argentina +54.11.4721.0505Brazil +55.11.4362.8900Mexico +52.55.5562.1102UK +44.1372.737159France +33.442.845600Italy +39.055.63.40.41Spain +34.913.586.098Russian Federation +7.812.327.53.27Japan +81.3.4331.4300China +86.21.6878.2300
Specifications subject to change without notice. Printed and copyrighted by Sartorius Stedim Biotech GmbH. | WPublication No.: Order No.: Ver. 01 | 2012
Sales and Service ContactsFor further contacts, visit www.sartorius-stedim.com
EuropeGermanySartorius Stedim Biotech GmbHAugust-Spindler-Strasse 1137079 Goettingen
Phone +49.551.308.0Fax +49.551.308.3289
Sartorius Stedim Systems GmbHRobert-Bosch-Strasse 5 – 7 34302 Guxhagen
Phone +49.5665.407.0Fax +49.5665.407.2200
FranceSartorius Stedim FMT S.A.S.ZI des PaludsAvenue de Jouques – CS 9105113781 Aubagne Cedex
Phone +33.442.845600Fax +33.442.845619
Sartorius Stedim France SASZI des PaludsAvenue de Jouques – CS 7105813781 Aubagne Cedex
Phone +33.442.845600Fax +33.442.846545
AustriaSartorius Stedim Austria GmbHModecenterstrasse 221030 Vienna
Phone +43.1.7965763.18Fax +43.1.796576344
BelgiumSartorius Stedim Belgium N.V.Rue Colonel Bourg 1051030 Bruxelles
Phone +32.2.756.06.80Fax +32.2.756.06.81
HungarySartorius Stedim Hungária Kft.Kagyló u. 52092 Budakeszi
Phone +36.23.457.227Fax +36.23.457.147
ItalySartorius Stedim Italy S.r.l.Via dell’Antella, 76/A50012 Antella-Bagno a Ripoli (FI)
Phone +39.055.63.40.41Fax +39.055.63.40.526
NetherlandsSartorius Stedim Netherlands B.V.
Phone +31.30.60.25.080Fax +31.30.60.25.099
PolandSartorius Stedim Poland Sp. z o.o.ul. Wrzesinska 7062-025 Kostrzyn
Phone +48.61.647.38.40Fax +48.61.879.25.04
Russian FederationLLC “Sartorius Stedim RUS”Uralskaya str. 4, Lit. B199155 St. Petersburg
Phone +7.812.327.53.27Fax +7.812.327.53.23
SpainSartorius Stedim Spain, S.A.U.Avda. de la Industria, 32Edificio PAYMA28108 Alcobendas (Madrid)
Phone +34.913.586.098Fax +34.913.589.623
SwitzerlandSartorius Stedim Switzerland AGRingstrasse 24 a8317 Tagelswangen
Phone +41.52.354.36.36Fax +41.52.354.36.46
U.K.Sartorius Stedim UK Ltd.Longmead Business CentreBlenheim Road, EpsomSurrey KT19 9 QQ
Phone +44.1372.737159Fax +44.1372.726171
UkraineLLC “Sartorius Stedim RUS”Post Box 440 “B”01001 Kiev, Ukraine
Phone +380.44.411.4918Fax +380.50.623.3162
AmericasUSASartorius Stedim North America Inc.5 Orville Drive, Suite 200Bohemia, NY 11716
Toll-Free +1.800.368.7178Fax +1.631.254.4253
ArgentinaSartorius Argentina S.A. Int. A. Ávalos 4251 B1605ECS Munro Buenos Aires
Phone +54.11.4721.0505 Fax +54.11.4762.2333
BrazilSartorius do Brasil Ltda Avenida Senador Vergueiro 2962 São Bernardo do Campo CEP 09600-000 - SP- Brasil
Phone +55.11.4362.8900Fax +55.11.4362.8901
MexicoSartorius de México, S.A. de C.V.Libramiento Norte de Tepotzotlan s/n,Colonia Barrio Tlacateco,Municipio de Tepotzotlan,Estado de México,C.P. 54605
Phone +52.55.5562.1102Fax +52.55.5562.2942
PeruSartorius Peru S.A.C.Avenue Alberto del Campo 411 Floor 12 – The Office15076 – San Isidro, Lima
Phone +51.1.441 0158 Fax +51.1.422 6100
Asia|PacificAustraliaSartorius Stedim Australia Pty. Ltd.Unit 5, 7-11 Rodeo DriveDandenong South Vic 3175
Phone +61.3.8762.1800Fax +61.3.8762.1828
ChinaSartorius Stedim Biotech (Beijing) Co. Ltd.No. 33 Yu’an RoadAirport Industrial Park Zone BShunyi District, Beijing 101300
Phone +86.10.80426516Fax +86.10.80426580
Sartorius Stedim (Shanghai) Trading Co., Ltd.3rd Floor, North Wing, Tower 1No. 4560 Jinke RoadZhangjiang Hi-Tech Park Pudong DistrictShanghai 201210, P.R. China
Phone +86.21.6878.2300Fax +86.21.6878.2882
Sartorius Stedim Biotech (Beijing) Co. Ltd.Guangzhou Representative OfficeUnit K, Building 23Huihua Commerce & Trade BuildingNo. 80 Xianlie Middle RoadGuangzhou 510070
Phone +86.20.37618687 | 37618651Fax +86.20.37619051
IndiaSartorius Stedim India Pvt. Ltd.#69/2-69/3, NH 48, JakkasandraNelamangala Tq562 123 Bangalore, India
Phone +91.80.4350.5250Fax +91.80.4350.5253
JapanSartorius Stedim Japan K.K.4th Fl., Daiwa Shinagawa North Bldg.8-11, Kita-Shinagawa 1-chomeShinagawa-ku, Tokyo, 140-0001 Japan
Phone +81.3.4331.4300Fax +81.3.4331.4301
MalaysiaSartorius Stedim Malaysia Sdn. Bhd.Lot L3-E-3B, Enterprise 4Technology Park MalaysiaBukit Jalil57000 Kuala Lumpur, Malaysia
Phone +60.3.8996.0622Fax +60.3.8996.0755
SingaporeSartorius Stedim Singapore Pte. Ltd.10 Science Park Rd The Alpha #02-13/14Singapore Science Park IISingapore 117684
Phone +65.6872.3966Fax +65.6778.2494
South KoreaSartorius Korea Biotech Co., Ltd.8th Floor, Solid Space B/D, PanGyoYeok-Ro 220, BunDang-GuSeongNam-Si, GyeongGi-Do, 463-400
Phone +82.31.622.5700Fax +82.31.622.5799
www.sartorius-stedim.com
Sartorius Stedim Biotech GmbHAugust-Spindler-Strasse 1137079 Goettingen, GermanyPhone +49.551.308.0Fax +49.551.308.3289www.sartorius-stedim.com
USA Toll-Free +1.800.368.7178Argentina +54.11.4721.0505Brazil +55.11.4362.8900Mexico +52.55.5562.1102UK +44.1372.737159France +33.442.845600Italy +39.055.63.40.41Spain +34.913.586.098Russian Federation +7.812.327.53.27Japan +81.3.4331.4300China +86.21.6878.2300
Specifications subject to change without notice. Printed and copyrighted by Sartorius Stedim Biotech GmbH. | WPublication No.: Order No.: Ver. 01 | 2012
Sales and Service ContactsFor further contacts, visit www.sartorius-stedim.com
EuropeGermanySartorius Stedim Biotech GmbHAugust-Spindler-Strasse 1137079 Goettingen
Phone +49.551.308.0Fax +49.551.308.3289
Sartorius Stedim Systems GmbHRobert-Bosch-Strasse 5 – 7 34302 Guxhagen
Phone +49.5665.407.0Fax +49.5665.407.2200
FranceSartorius Stedim FMT S.A.S.ZI des PaludsAvenue de Jouques – CS 9105113781 Aubagne Cedex
Phone +33.442.845600Fax +33.442.845619
Sartorius Stedim France SASZI des PaludsAvenue de Jouques – CS 7105813781 Aubagne Cedex
Phone +33.442.845600Fax +33.442.846545
AustriaSartorius Stedim Austria GmbHModecenterstrasse 221030 Vienna
Phone +43.1.7965763.18Fax +43.1.796576344
BelgiumSartorius Stedim Belgium N.V.Rue Colonel Bourg 1051030 Bruxelles
Phone +32.2.756.06.80Fax +32.2.756.06.81
HungarySartorius Stedim Hungária Kft.Kagyló u. 52092 Budakeszi
Phone +36.23.457.227Fax +36.23.457.147
ItalySartorius Stedim Italy S.r.l.Via dell’Antella, 76/A50012 Antella-Bagno a Ripoli (FI)
Phone +39.055.63.40.41Fax +39.055.63.40.526
NetherlandsSartorius Stedim Netherlands B.V.
Phone +31.30.60.25.080Fax +31.30.60.25.099
PolandSartorius Stedim Poland Sp. z o.o.ul. Wrzesinska 7062-025 Kostrzyn
Phone +48.61.647.38.40Fax +48.61.879.25.04
Russian FederationLLC “Sartorius Stedim RUS”Uralskaya str. 4, Lit. B199155 St. Petersburg
Phone +7.812.327.53.27Fax +7.812.327.53.23
SpainSartorius Stedim Spain, S.A.U.Avda. de la Industria, 32Edificio PAYMA28108 Alcobendas (Madrid)
Phone +34.913.586.098Fax +34.913.589.623
SwitzerlandSartorius Stedim Switzerland AGRingstrasse 24 a8317 Tagelswangen
Phone +41.52.354.36.36Fax +41.52.354.36.46
U.K.Sartorius Stedim UK Ltd.Longmead Business CentreBlenheim Road, EpsomSurrey KT19 9 QQ
Phone +44.1372.737159Fax +44.1372.726171
UkraineLLC “Sartorius Stedim RUS”Post Box 440 “B”01001 Kiev, Ukraine
Phone +380.44.411.4918Fax +380.50.623.3162
AmericasUSASartorius Stedim North America Inc.5 Orville Drive, Suite 200Bohemia, NY 11716
Toll-Free +1.800.368.7178Fax +1.631.254.4253
ArgentinaSartorius Argentina S.A. Int. A. Ávalos 4251 B1605ECS Munro Buenos Aires
Phone +54.11.4721.0505 Fax +54.11.4762.2333
BrazilSartorius do Brasil Ltda Avenida Senador Vergueiro 2962 São Bernardo do Campo CEP 09600-000 - SP- Brasil
Phone +55.11.4362.8900Fax +55.11.4362.8901
MexicoSartorius de México, S.A. de C.V.Libramiento Norte de Tepotzotlan s/n,Colonia Barrio Tlacateco,Municipio de Tepotzotlan,Estado de México,C.P. 54605
Phone +52.55.5562.1102Fax +52.55.5562.2942
PeruSartorius Peru S.A.C.Avenue Alberto del Campo 411 Floor 12 – The Office15076 – San Isidro, Lima
Phone +51.1.441 0158 Fax +51.1.422 6100
Asia|PacificAustraliaSartorius Stedim Australia Pty. Ltd.Unit 5, 7-11 Rodeo DriveDandenong South Vic 3175
Phone +61.3.8762.1800Fax +61.3.8762.1828
ChinaSartorius Stedim Biotech (Beijing) Co. Ltd.No. 33 Yu’an RoadAirport Industrial Park Zone BShunyi District, Beijing 101300
Phone +86.10.80426516Fax +86.10.80426580
Sartorius Stedim (Shanghai) Trading Co., Ltd.3rd Floor, North Wing, Tower 1No. 4560 Jinke RoadZhangjiang Hi-Tech Park Pudong DistrictShanghai 201210, P.R. China
Phone +86.21.6878.2300Fax +86.21.6878.2882
Sartorius Stedim Biotech (Beijing) Co. Ltd.Guangzhou Representative OfficeUnit K, Building 23Huihua Commerce & Trade BuildingNo. 80 Xianlie Middle RoadGuangzhou 510070
Phone +86.20.37618687 | 37618651Fax +86.20.37619051
IndiaSartorius Stedim India Pvt. Ltd.#69/2-69/3, NH 48, JakkasandraNelamangala Tq562 123 Bangalore, India
Phone +91.80.4350.5250Fax +91.80.4350.5253
JapanSartorius Stedim Japan K.K.4th Fl., Daiwa Shinagawa North Bldg.8-11, Kita-Shinagawa 1-chomeShinagawa-ku, Tokyo, 140-0001 Japan
Phone +81.3.4331.4300Fax +81.3.4331.4301
MalaysiaSartorius Stedim Malaysia Sdn. Bhd.Lot L3-E-3B, Enterprise 4Technology Park MalaysiaBukit Jalil57000 Kuala Lumpur, Malaysia
Phone +60.3.8996.0622Fax +60.3.8996.0755
SingaporeSartorius Stedim Singapore Pte. Ltd.10 Science Park Rd The Alpha #02-13/14Singapore Science Park IISingapore 117684
Phone +65.6872.3966Fax +65.6778.2494
South KoreaSartorius Korea Biotech Co., Ltd.8th Floor, Solid Space B/D, PanGyoYeok-Ro 220, BunDang-GuSeongNam-Si, GyeongGi-Do, 463-400
Phone +82.31.622.5700Fax +82.31.622.5799
www.sartorius-stedim.com
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Check the availability of your desired configuration with your Sartorius sales representative or online at:
