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KPHLA10FF1 | Opticap® XL10 Durapore® 0.45 µm without prefilter 3/4 in. TC/TC

KPHLA10FF1
1  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKPHLA10FF1
      Trade Name
      • Opticap®
      DescriptionOpticap® XL10 Durapore® 0.45 µm without prefilter 3/4 in. TC/TC
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet19 mm (3/4 in.) Sanitary Flange
      Connections, Vent/Drain1/4 in. Hose Barb with double O-ring Seal
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)Forward: 3.4 bar (50 psid) @ 25 °C. Reverse: 3.4 bar (50 psid) @ 25 °C, intermittent
      Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 23 °C; 2.8 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.
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaDurapore®
      Sterilization3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
      WettabilityHydrophilic
      Physicochemical Information
      Pore Size0.45 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Air Diffusion at 23 °C≤15 mL/min @ 1.5 bar (22 psig) in water
      Bubble Point at 23 °C≥1930 mbar (28 psig) air with water
      Gravimetric ExtractablesThe extractables level was equal to or less than 25 mg per capsule after 24 hours in water at controlled room temperature.
      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 Inlet Temperature25 °C
      Non-Fiber ReleasingThis product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
      USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
      Dimensions
      Cartridge Nominal Length10 in. (25 cm)
      Length33.0 cm (13.0 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area0.69 m²
      Inlet to Outlet Width33.0 cm (13.0 in.)
      Device Size10 in.
      Inlet Connection Diameter3/4 in.
      Outlet Connection Diameter3/4 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      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
      Specifications
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

      Documentation

      Certificates of Quality

      Title
      KPHLA10FF1 - C3DA96214
      Opticap XL 10 Capsule Durapore M<embrane C6EA61387
      Opticap XL 10 Capsule Durapore Membrane C6MA13988
      Opticap XL 10 Capsule Durapore Membrane - C2NA71275
      Opticap XL 10 Capsule Durapore Membrane - C3CA86241
      Opticap XL 10 Capsule Durapore Membrane - C3EA27075
      Opticap XL 10 Capsule Durapore Membrane - C3HA39077
      Opticap XL 10 Capsule Durapore Membrane - C3JA77672
      Opticap XL 10 Capsule Durapore Membrane - C3NA18995
      Opticap XL 10 Capsule Durapore Membrane - C3PA69494
      Opticap XL 10 Capsule Durapore Membrane - C4AA22439
      Opticap XL 10 Capsule Durapore Membrane - C4CA40844
      Opticap XL 10 Capsule Durapore Membrane - C4DA48072
      Opticap XL 10 Capsule Durapore Membrane - C4DA54491
      Opticap XL 10 Capsule Durapore Membrane C4KA07197
      Opticap XL 10 Capsule Durapore Membrane C4KA90427
      Opticap XL 10 Capsule Durapore Membrane C4NA24807
      Opticap XL 10 Capsule Durapore Membrane C5CA75866
      Opticap XL 10 Capsule Durapore Membrane C5DA93302
      Opticap XL 10 Capsule Durapore Membrane C5NA67546
      Opticap XL 10 Capsule Durapore Membrane C5SA00567
      Opticap XL 10 Capsule Durapore Membrane C6AA09016
      Opticap XL 10 Capsule Durapore Membrane C6CA32959
      Opticap XL 10 Capsule Durapore Membrane C6EA65339
      Opticap XL 10 Capsule Durapore Membrane C6JA93230
      Opticap XL 10 Capsule Durapore Membrane C6NA27275
      Opticap XL 10 Capsule Durapore membrane C5MA53745
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0AA83407
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0CA13210
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0CA97602
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0DA17136
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0DA24421
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0JA61437K
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0KA65134K
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0MA78582K
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0MA80477
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0NA03621K
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0NA93697K
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C1CA61496K
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C1EA85881
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C1HA93384
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C1KA13501
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C2AA70042
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C2CA96507
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C2EA15330
      Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C2EA21719
      Opticap® XL 10 Capsule Durapore® Membrane - C5CA86932
      Opticap® XL Capsule Filter with Hydrophilic Durapore® Membrane - C1JA95438
      Opticap® XL Capsule Filter with Hydrophilic Durapore® Membrane - C2AA73288
      Opticap® XL Capsule Filter with Hydrophilic Durapore® Membrane - C2PA67917
      Opticap® XL Capsule Filter withHydrophilic Durapore® Membrane - C0PA08653K

      Data Sheet

      Title
      Durapore® 0.45 μmH ydrophilic Filters