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KVPVA10TT1 Opticap XL10 Viresolve NFP 1-1/2 in. TC/TC

Parvovirus removal

Opticap XL10 Viresolve NFP 1-1/2 in. TC/TC MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KVPVA10TT1
1  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberKVPVA10TT1
      Trade Name
      • Viresolve®
      DescriptionOpticap XL10 Viresolve NFP 1-1/2 in. TC/TC
      References
      Product Information
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange
      Connections, Vent/Drain1/4 in. Hose Barb with double O-ring Seal
      Maximum Differential Pressure, bar (psid)Forward: 5.5 bar (80 psid). Reverse: 3.4 bar (50 psid)
      Maximum Inlet Pressure, bar (psi)5.5 bar (80 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
      ApplicationParvovirus removal
      Key Applications
      • Protein Purification
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaViresolve® NFP
      SterilizationWater wet filter for 5 min @ 3.4 bar (50 psi); liquid cycle, slow exhaust @ 123 °C maximum 60 min
      Physicochemical Information
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Air Diffusion at 23 °C≤10 mL/min @ 3.45 bar (50 psig) in water
      Maximum Inlet Pressure (psig)80 psig
      Maximum Inlet Temperature25 °C
      Non-Fiber ReleasingThis product was manufactured with a Viresolve® 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 12 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 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
      Dimensions
      Length33 cm (13 in.)
      Filtration Area0.42 m²
      Process Volume250 L
      Device Size10 in.
      Inlet Connection Diameter1-1/2 in.
      Outlet Connection Diameter1-1/2 in.
      Materials Information
      Chemistry
      • Modified Polyvinylidene Fluoride (Modified PVDF)
      Device Material
      • Polypropylene
      Seal MaterialSilicone (SI)
      Support MaterialPolypropylene
      Vent Cap MaterialPolypropylene (PP)
      Vent O-ring MaterialSilicone (SI)
      Vent/Drain1/4 in. hose barb with double O-ring seal
      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
      Global Trade Item Number
      Catalogue Number GTIN
      KVPVA10TT1 04053252391729

      Documentation

      Certificates of Quality

      Title
      C1EB07744
      Opticap XL 10 Capsule Viresolve NFP Media C3KB43565
      Opticap XL 10 Capsule Vireseolve NFP Media C7HA29589
      Opticap XL 10 Capsule Viresolve NFP Media
      Opticap XL 10 Capsule Viresolve NFP Media C7PA78568
      Opticap XL 10 Capsule Viresolve NFP Media C8AA08888
      Opticap XL 10 Capsule Viresolve NFP Media C1AB38330
      Opticap XL 10 Capsule Viresolve NFP Media C2KB09635
      Opticap XL 10 Capsule Viresolve NFP Media C2KB14175
      Opticap XL 10 Capsule Viresolve NFP Media C7EA08999
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