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KVGLG10FH1 | Opticap® Gamma Compatible XL10 Durapore® 0.22 µm TC/HB

KVGLG10FH1
1  Double Easy-Open bag
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      Overview

      Replacement Information

      Key Specifications Table

      Description
      Catalogue NumberKVGLG10FH1
      Trade Name
      • Opticap®
      DescriptionOpticap® Gamma Compatible XL10 Durapore® 0.22 µm TC/HB
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet19 mm (3/4 in.) Sanitary Flange/14 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: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C. Reverse: 3.5 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®
      SterilityGamma
      Sterilization3 autoclave cycles of 60 min @ 126 °C; capable of 45 kilogray (4.5 Megarad) gamma exposure; 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 Size0.22 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionHose Barb
      Air Diffusion at 23 °C≤14 mL/min @ 2.75 bar (40 psig) in water
      Bubble Point at 23 °C≥3450 mbar (50 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)
      Length33.3 cm (13.1 in.)
      Diameter10.7 cm (4.2 in.)
      Filtration Area0.73 m²
      Device Size10 in.
      Inlet Connection Diameter3/4 in.
      Outlet Connection Diameter9/16 in.
      Materials Information
      Chemistry
      • Polyvinylidene Fluoride (PVDF)
      Device Material
      • Gamma-stable 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 ≥1 L

      Documentation

      SDS

      Title

      Safety Data Sheet (SDS) 

      Certificates of Quality

      Title
      Gamma Optcap® XL Capsule Filter with Hydrophilic Durapore® Membrane - C1KA12889
      Gamma Opticap XL Capsule Filter with Hydrophilic Dura[ore Membrane - C9MN31021
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapor Membrane - C0CA98601
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0CA10983
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0CA98602
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0EA31991
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0EA41309
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0HA47613
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0JA59277
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0JA62012
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0KA66203
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0KA71442
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0MA78504
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0NA98079
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0PA09530
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C0SA24703
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C1AA29731
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C1AA32482
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C1AA33191
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C1CA56906
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C1CA58315
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C1EA76181
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C1HA91201
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C1JA00012
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C1PA53759
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C1SA58370
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C2BA87128
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C2CA88773
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C2DA08899
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C2EA15062
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C2EA16359
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C2HA15063
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C2JA39709
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C2JA46395
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C2JA48593
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C2KA50891
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C2NA69415
      Gamma Opticap XL Capsule Filter with Hydrophilic Durapore Membrane - C9NN47612
      Gamma Opticap XL Capsule Filter with Hydrophilic Membrane - C2HA33909
      Gamma Opticap XL Caspsule Filter with Hydrophilic Durapore Membrane - C0NA87528
      Gamma Opticap XL Filter with Hydrophilic Durapore Membrane - C1KA04012
      Gamma Opticap® XL Capsule Filter with Hydrophilic Durapore® Membrane - C1CA61995
      Gamma Opticap® XL Capsule Filter with Hydrophilic Durapore® Membrane - C1SA66125
      Gamma Opticap® XL Capsule Filter with Hydrophilic Durapore® Membrane - C1SA66140
      Gamma Opticap® XL Capsule Filter with Hydrophilic Durapore® Membrane - C2DA08901
      Opticap XL 10 Capsule Durapore Meembrane - C4AA96226
      Opticap XL 10 Capsule Durapore Membrane
      Opticap XL 10 Capsule Durapore Membrane - C2PA73790
      Opticap XL 10 Capsule Durapore Membrane - C2PA81620
      Opticap XL 10 Capsule Durapore Membrane - C2PA91416
      Opticap XL 10 Capsule Durapore Membrane - C3AA22074
      Opticap XL 10 Capsule Durapore Membrane - C3AA26556
      Opticap XL 10 Capsule Durapore Membrane - C3CA50037
      Opticap XL 10 Capsule Durapore Membrane - C3CA90524
      Opticap XL 10 Capsule Durapore Membrane - C3DA94336
      Opticap XL 10 Capsule Durapore Membrane - C3EA08374
      Opticap XL 10 Capsule Durapore Membrane - C3EA09032
      Opticap XL 10 Capsule Durapore Membrane - C3EA11046
      Opticap XL 10 Capsule Durapore Membrane - C3JA62809
      Opticap XL 10 Capsule Durapore Membrane - C3JA80446
      Opticap XL 10 Capsule Durapore Membrane - C3KA82802
      Opticap XL 10 Capsule Durapore Membrane - C3KA92826
      Opticap XL 10 Capsule Durapore Membrane - C3MA00303
      Opticap XL 10 Capsule Durapore Membrane - C3NA52378
      Opticap XL 10 Capsule Durapore Membrane - C3NA60637
      Opticap XL 10 Capsule Durapore Membrane - C3SA91255
      Opticap XL 10 Capsule Durapore Membrane - C4AA95913
      Opticap XL 10 Capsule Durapore Membrane - C4BA26628
      Opticap XL 10 Capsule Durapore Membrane - C4DA44300
      Opticap XL 10 Capsule Durapore Membrane - C6CA25796
      Opticap XL 10 Capsule Durapore Membrane - C6DA50661
      Opticap XL 10 Capsule Durapore Membrane - C6JA87383
      Opticap XL 10 Capsule Durapore Membrane - C6KA89230
      Opticap XL 10 Capsule Durapore Membrane C4MA19465
      Opticap XL 10 Capsule Durapore Membrane C4NA29602
      Opticap XL 10 Capsule Durapore Membrane C5BA70867
      Opticap XL 10 Capsule Durapore Membrane C5CA81483
      Opticap XL 10 Capsule Durapore Membrane C5DA83055
      Opticap XL 10 Capsule Durapore Membrane C5EA08694
      Opticap XL 10 Capsule Durapore Membrane C5HA17891
      Opticap XL 10 Capsule Durapore Membrane C5KA47568
      Opticap XL 10 Capsule Durapore Membrane C5MA54255
      Opticap XL 10 Capsule Durapore Membrane C5PA83017
      Opticap XL 10 Capsule Durapore Membrane C6EA56074
      Opticap XL 10 Capsule Durapore Membrane C6KA92716
      Opticap XL 10 Capsule Durapore Membrane C6MA12436
      Opticap XL 10 Capsule Durapore Membrane C6MA14973
      Opticap XL 10 Capsule durapore Membrane - C3NA14953
      Opticap XL Capsule Durapore Membrane - C3EA24795
      Opticap XL10 Capsule Durapore Membrane - C2PA10865
      Opticpa XL 10 Capsule Durapore Membrane
      Opticpap 10 Capsule Durapore Membrane - C3JA77735

      Data Sheet

      Title
      Sterile and Gamma Compatible Sterilizing-grade Durapore® 0.1 μm and 0.22 μm Filters
      Sterilizing-grade Durapore® 0.1 μm and 0.22 μm Hydrophilic Filters