Product Information

Sartopore 2 XLM 0.1 m

Highest Safety Best Bacterial Retention Fully validated as sterilizing-grade filter (LRV>7/cm2 filter area

for Brevundimonas diminuta according to current ASTM F-838 guideline)

Validated for retaining Acholeplasma laidlawii with an LRV7/cm filter area using the filtration method published by the PDA Mycoplasma Task Force (PDA J Pharm Sci and Tech 2014, 68 281-296)

This filter has also successfully been tested for Mycoplasma orale and Mycoplasma fermentans

Sartopore 2 XLM also retains Leptospira licerasiae (LRV 50% more performance compared to existing 0.1 m rated filter elements, thus ensuring lowest filtration costs per liter, minimized filtration times and smallest footprint of the filtration system.

ScalabilitySartopore 2 XLM 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 210 cm2 to 2.4 m2 per filter element guarantees greatest flexibility and most economic filter sizing.

Sartopore 2 XLM 0.1 mSterilizing Grade & Mycoplasma RetentiveFilter Elements

Lowest filter consumption by high filtration capacity

Lowest risk of Mycoplasma contamination for your fermentation process

Unmet combination of highest safety and performance for any 0.1 m Mycoplasma retentive filter in the market

Fully validated as sterilizing grade filter (according to current ASTM F-838 guideline)

Materials

Prefilter Membrane Polyethersulfone, asymmetric

Endfilter MembranePolyethersulfone, asymmetric

Support FleecePolypropylene (In-Line Steam sterilizable & autoclavable)Polyester (-irradiatable or -irradiatable | autoclavable)

Technical Data

Available Sizes Filtration Area Max. Diffusion at 4.0 bar | 58 psi [ml/min]

Cartridges, T-Style MaxiCaps, MaxiCaps

Size 0.5 0.4 m2 | 4.3 ft2 19

Size 1 0.8 m2 | 8.6 ft2 39

Size 2 1.6 m2 | 17.2 ft2 78

Size 3 2.4 m2 | 25.8 ft2 117

MidiCaps | Gamma MidiCaps

Size 7 0.065 m2 | 0.7 ft2 5

Size 8 0.13 m2 | 1.4 ft2 7

Size 9 0.26 m2 | 2.8 ft2 12

Size 0 0.52 m2 | 5.6 ft2 24

Capsules | Gamma Capsules

Size 4 0.021 m2 | 0.22 ft2 1.5

Pore Size Combination

0.2 m + 0.1 mCorePolypropylene

End CapsPolypropylene

Capsule HousingPolypropylene

O-RingSilicone (other materials on request)

Filling BellPolycarbonate

Max. Allowable Differential Pressure

Cartridges 5 bar | 72.5 psi at 20C 2 bar | 29 psi at 80C

T-Style MaxiCaps, MaxiCaps, MidiCaps | Gamma MidiCaps

5 bar | 72.5 psi at 20C 3 bar | 43.5 psi at 50C

Capsules | Gamma Capsules Size 44 bar | 58 psi at 20C 2 bar | 29 psi at 50C

Max. Allowable Back Pressure

2 bar | 29 psi at 20C (for all elements)

Sartopore 2 XLM 0.1 m 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

CartridgesIn-Line Steam Sterilization134 C, 0.3 bar, 20 min. Min. 25 Sterilization Cycles

or

Autoclaving134C, 2 bar, 30 minMin. 25 Sterilization Cycles

MidiCaps & CapsulesAutoclaving134C, 2 bar, 30 minMin. 25 Sterilization Cycles (MidiCaps)Min. 5 Sterilization Cycles (Capsules)

Gamma MidiCaps & Gamma CapsulesGamma Irradiation< 50 kGy1 Sterilization Cycle

T-Style MaxiCaps & MaxiCaps

Autoclaving134C, 2 bar, 30 minMin. 5 Sterilization Cycles

or

Gamma Irradiation< 50 kGy1 Sterilization Cycle

Technical References

Validation Guide SPK5809-e

Performance

Plant Peptone Supplemented Cell Culture Media

Sartopore 2 0.2|0.1 m XLM

Competitor A 0.1 m PES/PVDF

Competitor B 0.5 + 0.1 m PES

0

500

1000

1500Total Throughput per 10" Cartridge [L]

Sartopore 2 0.2|0.1 m XLM

Competitor A 0.1 m PES/PVDF

Competitor B 0.5 + 0.1 m PES

0

500

1000

1500

2000Total Throughput per 10" Cartridge [L]

Soy Supplemented Cell Culture Media

Sartorius Stedim Biotech GmbHAugust-Spindler-Strasse 1137079 Goettingen, GermanyPhone +49.551.308.0Fax +49.551.308.3289www.sartorius-stedim.com

USA Toll-Free +1.800.368.7178UK +44.1372.737159France +33.442.845600Italy +39.055.63.40.41Spain +34.90.2110935Russian Federation +7.812.327.5.327Japan +81.3.4331.4300China +86.21.68782300

Specifications subject to change without notice. Printed and copyrighted by Sartorius Stedim Biotech GmbH. | WPublication No.: Order No.: Ver. 01 | 2013

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

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Phone +33.442.845600Fax +33.442.845619

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Phone +32.2.756.06.80Fax +32.2.756.06.81

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Phone +36.23.457.227Fax +36.23.457.147

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Phone +39.055.63.40.41Fax +39.055.63.40.526

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Phone +31.30.60.25.080Fax +31.30.60.25.099

filtratie.nederland@sartorius-stedim.com

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Phone +48.61.647.38.40Fax +48.61.879.25.04

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Phone +7.812.327.53.27Fax +7.812.327.53.23

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Phone +34.902.110.935Fax +34.91.358.96.23

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Phone +41.52.354.36.36Fax +41.52.354.36.46

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Phone +44.1372.737159Fax +44.1372.726171

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Phone +380.44.411.4918Fax +380.50.623.3162

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Toll-Free +1.800.368.7178Fax +1.631.254.4253

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Phone +54.11.4721.0505 Fax +54.11.4762.2333

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Phone +55.11.4362.8900Fax +55.11.4362.8901

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Phone +52.55.5562.1102Fax +52.55.5562.2942

leadsmex@sartorius.com

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Phone +51.1.441 0158 Fax +51.1.422 6100

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Phone +61.3.8762.1800Fax +61.3.8762.1828

ChinaSartorius Stedim Biotech (Beijing) Co. Ltd.No. 33 Yuan 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

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Phone +81.3.4331.4300Fax +81.3.4331.4301

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Phone +60.3.8996.0622Fax +60.3.8996.0755

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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