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CGW3M4S03 Polysep® II Cartridge Filter 4 in. 1.0/0.2 µm Code M

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CGW3M4S03
3  Double Easy-Open bag
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      Overview

      Replacement Information
      Description
      Catalogue NumberCGW3M4S03
      Trade Name
      • Polysep®
      DescriptionPolysep® II Cartridge Filter 4 in. 1.0/0.2 µm Code M
      References
      Product Information
      FormatDouble 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 M (2-118) O-rings
      Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
      Prefilter MaterialBorosilicate Glass Fiber (BGF)
      Quality LevelMQ400
      Applications
      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 µm
      Gravimetric ExtractablesThe extractables level was equal to or less than 56 mg per 4-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 Length4 in. (10 cm)
      Diameter7.1 cm (2.8 in.)
      Filtration Area0.18 m²
      Device Size4 in.
      Nominal Pore Size1.0 / 0.2 µm
      Materials Information
      Chemistry
      • Mixed Cellulose Esters (MCE)
      Device Material
      • Polypropylene
      Seal MaterialSilicone (SI)
      Support MaterialSpun bonded polypropylene
      Toxicological Information
      Safety Information according to GHS
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      Packaging Information
      Material Size3
      Material PackageDouble Easy-Open bag
      Transport Information
      Supplemental Information
      Specifications
      Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L
      Global Trade Item Number
      Catalogue Number GTIN
      CGW3M4S03 04053252560491