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KVEPA05HH1 | Autoclavable Opticap® XL 5 Millipore Express® SHR single layer 0.1 µm 9/16 in. HB/HB

1  Double Easy-Open bag
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      Key Specifications Table

      Catalogue NumberKVEPA05HH1
      Trade Name
      • Millipore Express®
      DescriptionAutoclavable Opticap® XL 5 Millipore Express® SHR single layer 0.1 µm 9/16 in. HB/HB
      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: 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
      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.
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaMillipore Express® SHR
      Sterilization3 autoclave cycles of 60 min @ 126 °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.
      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 5.5 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.
      Cartridge Nominal Length5 in. (12.5 cm)
      Length21.6 cm (8.5 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area0.29 m²
      Inlet to Outlet Width21.6 cm (8.5 in.)
      Device Size5 in.
      Inlet Connection Diameter9/16 in.
      Outlet Connection Diameter9/16 in.
      Materials Information
      • Polyethersulfone (PES)
      Device Material
      • Polypropylene
      Seal MaterialSilicone (SI)
      Support MaterialPolypropylene
      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
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L


      Certificates of Quality

      Opticap XL 5 Capsule Filter with Millipore Express SHR Hydrophilic Membrane - C1EA80143
      Opticap XL 5 Capsule Millipore Express SHR Membrane
      Opticap XL 5 Capsule Millipore Express SHR Membrane - C3JA72714
      Opticap XL 5 Capsule Millipore Express SHR Membrane - C3KA83394
      Opticap XL 5 Capsule Millipore Express SHR Membrane - C4CA35856
      Opticap XL 5 Capsule Millipore Express SHR Membrane - C6DA51810
      Opticap XL 5 Capsule Millipore Express SHR Membrane - SL0618O035
      Opticap XL 5 Capsule Millipore Express SHR Membrane C6EA61363
      Opticap® XL 5 Capsule Millipore Express® SHR Membrane - C4NA25514

      Technical Info

      Demonstrating Millipore Express® SHR mycoplasma clearance capability at pilot and production scale over an extended filtration time (EMD)
      Protect Your Process from Mycoplasma Contamination
      Scalable Process Filtration with Millipore Express® SHR 0.1 μm Filters

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