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CGW171S03 Polysep® II Cartridge Filter 10 in. 1.0/0.2/0.1 µm Code 7

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CGW171S03
3  Double Easy-Open bag
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      Overview

      Description
      Catalogue NumberCGW171S03
      Trade Name
      • Polysep®
      DescriptionPolysep® II Cartridge Filter 10 in. 1.0/0.2/0.1 µm Code 7
      Product Information
      FormatTriple Layer
      Device ConfigurationCartridge
      Maximum Differential Pressure, bar (psid)3.5 bar (50 psid) @ 25 °C
      Maximum Inlet Pressure, bar (psi)3.5 bar (50 psi) @ 25 °C
      Cartridge CodeCode 7 (2-226) O-ring and spear
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      Prefilter MaterialBorosilicate Glass Fiber (BGF)
      Quality LevelMQ400
      Biological Information
      Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
      MediaPolysep™ II
      Sanitization30 min with hot water @ 80 °C
      Sterilization10 autoclave cycles or SIP @ 121 °C for 30 min
      Physicochemical Information
      Pore Size1.0 / 0.2 / 0.1 µm
      Gravimetric ExtractablesThe extractables level was equal to or less than 140 mg per 10-inch cartridge 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. All component materials meet the requirements of the EU framework regulation [1935/2004/EC] regarding materials and articles intended to contact food.
      Non-Fiber ReleasingThis product was manufactured with a media combination 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)
      Diameter7.1 cm (2.8 in.)
      Filtration Area0.42 m²
      Device Size10 in.
      Nominal Pore Size1.0 / 0.2 / 0.1 µm
      Materials Information
      Chemistry
      • Mixed Cellulose Esters (MCE)
      Device Material
      • Polypropylene
      Seal MaterialSilicone (SI)
      Support MaterialSpun bonded polypropylene
      Packaging Information
      Material Size3
      Material PackageDouble Easy-Open bag
      Specifications
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L
      Global Trade Item Number
      Catalogue Number GTIN
      CGW171S03 04053252604195