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CGW6M4S03 Polysep® II Cartridge Filter 4 in. 0.5 µm Code M

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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CGW6M4S03
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberCGW6M4S03
Trade Name
  • Polysep®
DescriptionPolysep® II Cartridge Filter 4 in. 0.5 µm Code M
References
Product Information
FormatDouble Layer
HS Code8421 99 99
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 / 0.5 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 / 0.5 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
Catalog Number GTIN
CGW6M4S03 04053252389979

Documentation

Polysep® II Cartridge Filter 4 in. 0.5 µm Code M SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
Certificate of Quality CGW6M4S03-BM4BB1212
Certificate of Quality CGW6M4S03-BM4HB7763
Certificate of Quality CGW6M4S03-BM4NB8542
Polysep II Cartridge C0NB32364
Polysep II Cartridge C2NB33320
Polysep II Cartridge C0CB49983
Polysep II Cartridge C0JB88600
Polysep II Cartridge C0JB99262
Polysep II Cartridge C1JB22045
Polysep II Cartridge C8NA31403
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Technical Info

Title
Safe Handling and Storage of Filtration Devices Containing Mixed Cellulose Ester Membranes

Data Sheet

Title
Milligard®Sanitary Cartridge Housings