Transcription of Sartopore 2 XLG 0.2 μm - Sartorius
1 SpecificationsMaterialsPrefilter Membrane: Polyethersulfone,asymmetricEndfilter Membrane:Polyethersulfone,asymmetricSupp ort Fleece:PolypropyleneCore:PolypropyleneEn d Caps:PolypropyleneCapsule Housing:PolypropyleneO-Rings:SiliconeFil ling Bell: PolycarbonatePore Size m + mAvailable Sizes | Filtration AreaCapsulesSize m2| ft2 MidiCaps Size 7 m2| ft2 Size m2| ft2 Size 9 m2| ft2 Size 0 m2| ft2 MaxiCaps Size 1 m2| ft2 Size m2| ft2 Size 3 m2| ft2 Available Connectors CapsulesSS, SO, OOAvailable Connectors MidiCaps SS, SO, OO, FF, FO, HH (only size 7)Available Connectors MaxiCaps SS, SO, OO, FF, BBS:11 Tri-Clamp (Sanitary)O:1 Single stepped hose barbF:3 Tri-Clamp (Sanitary)H:4 Multiple stepped hose barb (with filling bell at the outlet)B:3 1 Multiple stepped hose barbS:1 Tri-Clamp (only Capsule Size 4)O:Multiple stepped hose barb (only Capsule Size 4)Operating ParametersMax.
2 Allowable5 bar | psi at 20 CDifferential Pressure: (MidiCaps)4 bar | 58 psi at 20 C(MaxiCaps and Capsules)2 bar | 29 psi at 80 C Max. Allowable 2 bar | 29 psi at 20 CBack Pressure: Sartopore 2 XLG mSterilizing Grade MidiCaps , MaxiCaps and CapsulesDescriptionSartopore 2 XLG MidiCaps , MaxiCaps andCapsules are self contained filter units thatare especially designed for sterilizing gradefiltration in special applications of cell culture processes. The unique heterogeneousdouble layer PES membrane combination of Sartopore 2 XLG MidiCaps , MaxiCaps and Capsules is specifically developed to dealwith the broad variety of contaminants in up- and downstream processing of biotechapplications. They provide consistently hightotal throughput performance for biologicalfluid streams independent from media andprocess applications of Sartopore 2 XLG MidiCaps , MaxiCaps and Capsules includesterilizing grade filtration of: Plant peptone or yeast supplemented cellculture media Serum containing cell culture media Other cell culture media used in biotechmanufacturing Clarified cell culture harvest Downstream Intermediates (before andafter UF | DF and chromatography steps)EconomyThe combination of the built-in m pre-filter in front of a m final filter togetherwith the 30% enlarged effective filtration areaper XLG filter element provide an outstandingtotal throughput and flow rate performancein the target applications.
3 Thus ensuring highest process efficiency, minimized filtra-tion costs and short filtration cycle PES membrane of Sartopore 2 XLG MidiCaps , MaxiCaps and Capsules providebroad chemical compatibility from pH 1 to pH14 and low extractable levels. They are com-patible with multiple autoclaving cycles up to134 2 XLG filter elements are availablein a broad range of sizes and formats to provide linear scale-up from R&D to SavingThe use of the capsule design concept avoidsinvestment in stainless steel filter housingsand eliminates additional costs for cleaningof housings and cleaning RetentionSartopore 2 XLG MidiCaps , MaxiCaps andCapsules are fully validated as sterilizinggrade filters according to HIMA and ASTM F-838-05 guidelines. Quality Control Each individual element is tested for integrity by and Diffusion-Test prior tobeing released assuring absolute 2 XLG MidiCaps , MaxiCaps andCapsules are designed, developed and manufactured in accordance with an ISO9001 certified Quality Management System.
4 A Validation Guide is available for compliancewith regulatory Filter CartridgesSartorius Stedim Biotech GmbHAugust-Spindler-Strasse 1137079 Goettingen, GermanyPhone + + USA Toll-Free + + + + + + subject to change without notice. Printed and copyrighted by Sartorius Stedim Biotech GmbH. | WPublication No.: SPK2090-e11053 Order No.: 85032-535-11 Ver. 05 | 2011 SpecificationsExtractablesSartopore 2 XLG m rated MidiCaps ,MaxiCaps and Capsules meet or exceed the requirements for WFI quality standardsset by the current USP. Regulatory ComplianceIndividually integrity testedIntegrity test correlated to HIMA/ASTM F 838-05 Bacteria Challenge TestNon pyrogenic according to USP BacterialEndotoxinsPass USP Plastic Class VI TestNon fiber releasing according to 21 CFRS terilizationAutoclaving:134 C, 2 bar, 30 minSterilization Cycles (MaxiCaps and MidiCaps )Autoclaving:Min.
5 25No In-Line Steam SterilizationTechnical ReferencesValidation Guide:SPK5772-eSoy Peptone Supplemented Cell Culture MediaMonoclonal Antibody PoolAntibody Concentration: mg/mlOrder CodesPore SizePack sizeTest Max. Min.[ m](pieces)PressureDiffusionBubble Point[bar | psi][ml/min][bar | psi]XLG Capsules:5441307G4--** + | | 46 XLG MidiCaps :5445307G7--** + | | 465445307G8--** + | | 465445307G9--** + | | 465445307G0--** + | | 46 XLG MaxiCaps :5441307G1--** + | | 465441307G2--** + | | 465441307G3--** + | | 46**: Connector StyleSartopore 2 XLG | PESC ompetitor A | PESC ompetitor B | PES0500100015002000 Total Throughput per 10" MaxiCaps [l] Sartopore 2 XLG | PESC ompetitor A | PESC ompetitor B | PES020406080100120 Total Throughput per 10" MaxiCaps [l]
