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KR05A10TT1 Opticap® XL10 Polygard®-CR 5.0 µm 1-1/2 in. TC/TC

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KR05A10TT1
1  Double Easy-Open bag
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      Replacement Information
      Description
      Catalogue NumberKR05A10TT1
      ReplacesKR0501TC1
      Trade Name
      • Opticap®
      DescriptionOpticap® XL10 Polygard®-CR 5.0 µm 1-1/2 in. TC/TC
      References
      Product Information
      FormatSingle Layer
      HS Code8421 29 90
      Device ConfigurationCapsule
      Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange
      Housing MaterialPolypropylene (PP)
      Maximum Differential Pressure, bar (psid)4.8 bar (70 psid) @ 20 °C
      Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 25 °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.
      Quality LevelMQ400
      Applications
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaPolygard®-CR
      Sterilization3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable
      Physicochemical Information
      Pore Size5.0 µm
      Inlet ConnectionSanitary Flange
      Outlet ConnectionSanitary Flange
      Gravimetric ExtractablesThe extractables level was equal to or less than 55 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
      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)
      Length33.5 cm (13.2 in.)
      Diameter10.7 cm (4.2 in.)
      Inlet to Outlet Width33.5 cm (13.2 in.)
      Device Size10 in.
      Inlet Connection Diameter1-1/2 in.
      Nominal Pore Size5.0 µm
      Outlet Connection Diameter1-1/2 in.
      Materials Information
      Chemistry
      • Polypropylene (PP)
      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 ≥5 L
      Global Trade Item Number
      Número de catálogo GTIN
      KR05A10TT1 04053252485367

      Documentation

      Certificados de qualidade

      Título
      Opticap XL 10 Capsue Polygard-CR Media - C7DA92116
      Opticap XL 10 Capsule Polygard - CR Media - C9PA84964
      Opticap XL 10 Capsule Polygard -CR Media C0AB17861
      Opticap XL 10 Capsule Polygard -CR Media C0DB61786
      Opticap XL 10 Capsule Polygard -CR Media C0JB01057
      Opticap XL 10 Capsule Polygard -CR Media C0SB83231
      Opticap XL 10 Capsule Polygard -CR Media C9MA89570
      Opticap XL 10 Capsule Polygard -CR Media C7SA05058
      Opticap XL 10 Capsule Polygard -CR Media C8AA16338
      Opticap XL 10 Capsule Polygard -CR Media C8CA35677
      Show more

      Manuais do usuário

      Título
      Opticap® XL Capsules and Opticap® XLT Capsules

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      Categorias

      Biopharmaceutical Manufacturing > Downstream Processing > Bioburden Reduction/Particulate Control > Depth Filter based > Polygard CR
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