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CWL3M4S03 Milligard® Low Protein Binding Cartridge Filter 4 in. Code M 0.2 µm

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
CWL3M4S03
3  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberCWL3M4S03
Trade Name
  • Milligard®
DescriptionMilligard® Low Protein Binding Cartridge Filter 4 in. Code M 0.2 µm
References
Product Information
FormatSingle Layer
Device ConfigurationCartridge
Filter GradeLow Protein Binding Milligard® Media
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.
Quality LevelMQ400
Applications
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaMilligard® LPB
Sterilization10 autoclave cycles or SIP @ 121 °C for 30 min
Physicochemical Information
Pore Size0.2 µm
Gravimetric ExtractablesThe extractables level was equal to or less than 40 mg per 4-inch cartridge after a 2 L flush and 24 hours in water at controlled room temperature.
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 Area0.32 m²
Device Size4 in.
Nominal Pore Size0.2 µm
Materials Information
Chemistry
  • Low Protein-Binding Mixed Cellulose Esters (MCE)
Device Material
  • Polypropylene
Seal MaterialSilicone (SI)
Support MaterialPolyester
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 ≥9 L
Global Trade Item Number
Katalogové číslo GTIN
CWL3M4S03 04053252344749

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Kategorie

Biopharmaceutical Manufacturing > Harvest > Bioburden Reduction / Particulate Control > Membrane based > Milligard & Milligard LPB > Milligard Cartridge
Biopharmaceutical Manufacturing > Downstream Processing > Bioburden Reduction/Particulate Control > Membrane based > Milligard
Biopharmaceutical Manufacturing > Upstream Processing > Bioburden Reduction / Particulate Control > Membrane based > Milligard & Milligard LPB > Milligard Cartridge