Sartopore 2 XLM 0.1 μm -...
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Specifications Materials Prefilter Membrane: PES, asymmetric Endfilter Membrane: PES, asymmetric Support fleece: Polypropylene Core: Polypropylene End caps: Polypropylene O-Rings: Silicone Pore Size Combination 0.2 μm + 0.1 μm Available Sizes|Filtration Area Size 1 10” 0.8 m 2 | 8.6 ft 2 Size 2 20” 1.6 m 2 | 17.2 ft 2 Size 3 30” 2.4 m 2 | 25.8 ft 2 Available Adapters 25 Operating Parameters Max. allowable: 5 bar | 72.5 psi at 20°C Differential pressure: 2 bar | 29 psi at 80°C Max. allowable back Pressure: 2 bar | 29 psi at 20°C Sartopore ® 2 XLM 0.1 μm Sterilizing Grade and Mycoplasma Retentive Filter Cartridges Description Sartopore ® 2 XLM 0.1 μm rated filter car- tridges are especially designed for validated sterilizing grade filtration and reliable Mycoplasma removal for modern cell culture media. The unique, highly asymmetric, het- erogeneous double layer PES membranes pro- vide outstanding total throughput and flow rate performance reducing filter costs and footprint of filtration systems significantly. Applications Typical applications of Sartoproe ® 2 XLM filter cartridges include sterilizing grade filtration and Mycoplasma removal from: – Plant peptone, soy or yeast supplemented cell culture media – Serum containing cell culture media – Cell culture media components – All other cell culture media used in biotech manufacturing Any other application requiring sub 0.2 μm filtration for enhanced sterility assurance. Economy The build in prefilter layer is specifically designed to protect the final 0.1 μm mem- brane layer in cell culture media filtration applications. The optimized membrane com- bination together with the exceptionally high effective filtration of 0.8 m 2 /10" filter element allow for > 50% more performance compared to existing 0.1 μm rated filter elements, thus ensuring lowest filtration costs per liter, minimized filtration times and smallest footprint of the filtration system. Security Sartopore ® 2 XLM cartridges are validated for sterilizing grade filtration according to ASTM F 838-05 standard and for reliable Mycoplasma retention with a LRV of 7/cm 2 filtration area. They provide the highest security level to avoid unwanted microbial contamination. Compatibility The PES membrane of Sartopore ® 2 XLM cartridges provides broad chemical compati- bility from pH 1 to pH 14, low extractable levels and low unspecific binding for growth factors. They are compatible with multiple in line steam sterilization cycles up to 134°C. Scalability Sartopore ® 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. Quality Control Each individual element is tested for integrity by Diffusion-Test prior to be released assuring absolute reliability. Documentation Sartopore ® 2 XLM cartridges are designed, developed and manufactured in accordance with an ISO 9001 certified Quality Manage- ment System. A Validation Guide is available for compliance with regulatory requirements. Membrane Filter Cartridges
Transcript of Sartopore 2 XLM 0.1 μm -...
Specifications
Materials
Prefilter Membrane: PES, asymmetric
Endfilter Membrane: PES, asymmetric
Support fleece: Polypropylene
Core: Polypropylene
End caps: Polypropylene
O-Rings: Silicone
Pore Size Combination0.2 μm + 0.1 μm
Available Sizes|Filtration AreaSize 1 10” 0.8 m2|8.6 ft2
Size 2 20” 1.6 m2|17.2 ft2
Size 3 30” 2.4 m2|25.8 ft2
Available Adapters25
Operating Parameters
Max. allowable: 5 bar|72.5 psi at 20°CDifferential pressure: 2 bar|29 psi at 80°C
Max. allowable backPressure: 2 bar|29 psi at 20°C
Sartopore® 2 XLM 0.1 μmSterilizing Grade and Mycoplasma Retentive Filter Cartridges
DescriptionSartopore® 2 XLM 0.1 μm rated filter car-tridges are especially designed for validatedsterilizing grade filtration and reliableMycoplasma removal for modern cell culturemedia. The unique, highly asymmetric, het-erogeneous double layer PES membranes pro-vide outstanding total throughput and flowrate performance reducing filter costs andfootprint of filtration systems significantly.
ApplicationsTypical applications of Sartoproe® 2 XLM filtercartridges include sterilizing grade filtrationand Mycoplasma removal from: – Plant peptone, soy or yeast supplemented
cell culture media– Serum containing cell culture media– Cell culture media components– All other cell culture media used in biotech
manufacturingAny other application requiring sub 0.2 μmfiltration for enhanced sterility assurance.
EconomyThe build in prefilter layer is specificallydesigned to protect the final 0.1 μm mem-brane layer in cell culture media filtrationapplications. The optimized membrane com-bination together with the exceptionally high effective filtration of 0.8 m2/10" filterelement allow for > 50% more performancecompared to existing 0.1 μm rated filter elements, thus ensuring lowest filtration costsper liter, minimized filtration times andsmallest footprint of the filtration system.
SecuritySartopore® 2 XLM cartridges are validated for sterilizing grade filtration according toASTM F 838-05 standard and for reliableMycoplasma retention with a LRV of 7/cm2
filtration area. They provide the highest security level to avoid unwanted microbialcontamination.
CompatibilityThe PES membrane of Sartopore® 2 XLM cartridges provides broad chemical compati-bility from pH 1 to pH 14, low extractable levels and low unspecific binding for growthfactors. They are compatible with multiple in line steam sterilization cycles up to 134°C.
ScalabilitySartopore® 2 XLM filter elements are availablein a broad range of sizes and formats to provide linear scale-up from R&D to processscale.
Quality ControlEach individual element is tested for integrityby Diffusion-Test prior to be released assuringabsolute reliability.
DocumentationSartopore® 2 XLM cartridges are designed,developed and manufactured in accordancewith an ISO 9001 certified Quality Manage-ment System. A Validation Guide is availablefor compliance with regulatory requirements.
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Sartorius Stedim Biotech GmbHAugust-Spindler-Strasse 1137079 Goettingen, Germany
Phone +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 +34.90.2110935Japan +81.3.3740.5407
Specifications subject to change without notice. Printed and copyrighted by Sartorius Stedim Biotech GmbHW · GPublication No.: SPK2110-e10091Order No.: 85032-537-88Ver. 09 | 2010
Specifications
ExtractablesSartopore® 2 XLM 0.1 μm rated filter car-tridges meet, or exceed the requirements forWFI quality standards set by the current USP.
Regulatory ComplianceIndividually integrity tested
Integrity test correlated to HIMA/ASTM F 838-05 Bacteria Challenge Test
Non pyrogenic according to USP BacterialEndotoxins
Pass USP Plastic Class VI Test
Non fiber releasing according to 21 CFR
Sterilization
In-Line Steam Sterilization:134°C, 20 min. at max differential pressure of 0.5 bar
Autoclaving:134°C, 2 bar, 30 min
Sterilization CyclesIn-Line Sterilization: Min. 25Autoclaving: Min. 25
Technical References
Validation Guide:SPK5787-e
Order Codes
Cartridges Pore Size Test Max. [μm] Pressure Diffusion
[bar|psi] [ml/min]
5442558M1 0.2 + 0.1 4.0|58 395442558M2 0.2 + 0.1 4.0|58 785442558M3 0.2 + 0.1 4.0|58 117
Plant Peptone Supplemented Cell Culture Media
Soy Supplemented Cell Culture Media
Sartopore® 2 0.1 µm XLM
Competitor A 0.1 µm PES/PVDF
Competitor B 0.5 + 0.1 µm PES
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Sartopore® 2 0.1 µm XLM
Competitor A 0.1 µm PES/PVDF
Competitor B 0.5 + 0.1 µm PES
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Total Throughput per 10" Cartridge [l]
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