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

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
CGW3M4S03
3  Double Easy-Open bag
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Description
Catalogue NumberCGW3M4S03
Trade Name
  • Polysep®
DescriptionPolysep® II Cartridge Filter 4 in. 1.0/0.2 µm Code M
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
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
Packaging Information
Material Size3
Material PackageDouble Easy-Open bag
Specifications
Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L
Global Trade Item Number
Katalogové číslo GTIN
CGW3M4S03 04053252560491