KEGBG003HH3 Gamma Phobic Opticap® XL 300 Express SPG 0.2 hose barb

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KEGBG003HH3
3  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKEGBG003HH3
      Trade Name
      • Opticap®
      DescriptionGamma Phobic Opticap® XL 300 Express SPG 0.2 hose barb
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet14 mm (9/16 in.) Hose Barb
      Connections, Vent/Drain1/4 in. Hose Barb with double O-ring seal
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)Forward: 4.2 bar (60 psid) @ 25 °C; Reverse: 2.1 bar (30 psid) @ 25 °C, intermittent
      Maximum Inlet Pressure, bar (psi)4.1 bar (60 psi) @ 23 °C
      European Pressure Equipment DirectiveEMD Millipore Corporation® certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      Quality LevelMQ400
      Applications
      Key Applications
      • Small scale single-use applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaMillipore Express® SPG
      SterilityGamma
      SterilizationGamma compatible to 45 kGy; 3 autoclave 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.
      WettabilityHydrophobic
      Physicochemical Information
      Pore Size0.2 µm
      Inlet ConnectionHose Barb
      Outlet ConnectionHose Barb
      Bubble Point at 23 °C≥1210 mbar (17.5 psig) air with 70/30 % IPA/water
      Gravimetric ExtractablesThe extractables level was equal to or less than 3 mg after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
      HydroCorr≤0.16 mL/min @ 2.6 bar (38 psig)
      Maximum Inlet Pressure (psig)60 psig
      Maximum Differential Pressure60 psi (4.1 bar) continuous
      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 gamma irradiation and three autoclave cycles, the TOC was measured to be equal to or less than 3367 µg/device.
      USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
      Dimensions
      Length11.9 cm (4.7 in.)
      Diameter5.6 cm (2.2 in.)
      Filtration Area0.048 m²
      Inlet to Outlet Width11.9 cm (4.7 in.)
      Inlet Connection Diameter9/16 in.
      Outlet Connection Diameter9/16 in.
      Materials Information
      Chemistry
      • Polyethersulfone (PES)
      Device Material
      • Gamma stable polypropylene/Polysulfone
      Seal MaterialSilicone (SI)
      Support MaterialPolyethylene
      Vent Cap MaterialPolypropylene (PP)
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size3
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications

      Documentation

      Certificates of Quality

      Title
      Opticap XL 300 Capsule Millipore Express SPG Membr
      Opticap XL 300 Capsule Millipore Express SPG Membrane C7CA62092
      Opticap XL 300 Capsule Millipore Express SPG Membrane C7EA95901
      Opticap XL 300 Capsule Millipore Express SPG Membrane C7SA01135
      Opticap XL 300 Capsule Millipore Express SPG Membrane C8BA29415
      Opticap XL 300 Capsule Millipore Express SPG Membrane C0BB84984
      Opticap XL 300 Capsule Millipore Express SPG Membrane C0CB38546
      Opticap XL 300 Capsule Millipore Express SPG Membrane C5DA00293
      Opticap XL 300 Capsule Millipore Express SPG Membrane C6HA58118
      Opticap XL 300 Capsule Millipore Express SPG Membrane C6PA17956

      Technical Info

      Title
      Application Note: Vent Filter Sizing for Mobius® Single-use Mixing Solution
      Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters
      Filter Integrity Test Methods
      Pharmacological Profiling in Human Embryonic Progenitor Cells Using High Content Analysis

      Data Sheet

      Title
      Gamma Stable Opticap® XL Capsule Filters with Millipore Express® SPG Hydrophobic Membrane (EMD)

      User Guides

      Title
      Opticap® XL Capsules and Opticap® XLT Capsules