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KVEPG3THH1 Opticap® Gamma Compatible XLT 30 Millipore Express® SHR single layer 0.1 µm 5/8 in. HB/HB without gauge port

Opticap® Gamma Compatible XLT 30 Millipore Express® SHR single layer 0.1 µm 5/8 in. HB/HB without gauge port: のSDS（安全データシート）、CoA（試験成績書）およびCoQ（品質証明書）、カタログなど製品関連の技術資料を入手いただけます。
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KVEPG3THH1
1  Double Easy-Open bag
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      概要

      Replacement Information
      Description
      Catalogue NumberKVEPG3THH1
      Trade Name
      • Millipore Express®
      DescriptionOpticap® Gamma Compatible XLT 30 Millipore Express® SHR single layer 0.1 µm 5/8 in. HB/HB without gauge port
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet16 mm (5/8 in.) Hose Barb
      Connections, Vent/Drain1/4 in. Hose Barb with double O-ring Seal
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)Forward: 6.9 bar (100 psid) intermittent @ 25 °C; 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 2.1 bar (30 psid) @ 25 °C, intermittent
      Maximum Inlet Pressure, bar (psi)6.9 bar (100 psi) intermittent @ 23 °C; 5.5 bar (80 psi) @ 23 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      T-line/Gauge PortT-line
      Quality LevelMQ400
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaMillipore Express® SHR
      SterilityNon-sterile, Gamma compatible
      SterilizationGamma Compatible to 45 kGy. May be autoclaved for 3 cycles of 60 min @ 123 °C; not in-line steam sterilizable
      Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.1 µm
      Inlet ConnectionHose Barb
      Outlet ConnectionHose Barb
      Bubble Point at 23 °C≥2586 mbar (37.5 psig) nitrogen with 70/30 % IPA/water
      Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
      Maximum Inlet Pressure (psig)80 psig
      Maximum Differential Pressure80 psi (5.5 bar) continuous
      100 psi (6.9 bar) intermittent
      Maximum Inlet Temperature25 °C
      Non-Fiber ReleasingThis product was manufactured with a Millipore Express® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
      TOC/ConductivityAfter sterilization and a controlled water flush of 33 L, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 °C.
      USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
      Dimensions
      Cartridge Nominal Length30 in. (75 cm)
      Length87.2 cm (34.3 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area2.06 m²
      Inlet to Outlet Width19.8 cm (7.4 in.)
      Device Size30 in.
      Inlet Connection Diameter5/8 in.
      Outlet Connection Diameter5/8 in.
      Materials Information
      Chemistry
      • Polyethersulfone (PES)
      Device Material
      • Polypropylene
      Seal MaterialSilicone (SI)
      Support MaterialPolyester
      Vent Cap MaterialPolypropylene (PP)
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size1
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥4.5 L
      Global Trade Item Number
      カタログ番号 GTIN
      KVEPG3THH1 04053252312045

      Documentation

      Material Qualification Dossier

      タイトルバージョン
      6.0

      Operational Excellence Dossier

      Title

      品質証明書

      タイトル
      Opticap XLT 30 Capsule Durapore Millipore Express SHR Membrane C1KB22762
      Opticap XLT 30 Capsule Millipore Express SHR Membrane C0MB26702

      技術情報

      タイトル
      Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters
      Cell Culture Media Microfiltration and Mixing: Reducing Risk with Single-use Technology
      Mycoplasma clearance by Millipore Express SHR filters at pilot and production scales
      Scalable Process Filtration with Millipore Express® SHR 0.1 μm Filters

      データシート

      タイトル
      Millipore Express®SHR Hydrophilic Filters

      ユーザーガイド

      タイトル
      Opticap® XL Capsules and Opticap® XLT Capsules
      User Guide - Filters with Millipore Express®Membrane

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      カテゴリー

      Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Millipore Express® > Millipore Express® SHR