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CGW671S03 Polysep® II Cartridge Filter 10 in. 0.5 µm Code 7

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CGW671S03
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberCGW671S03
Trade Name
  • Polysep®
DescriptionPolysep® II Cartridge Filter 10 in. 0.5 µm Code 7
References
Product Information
FormatDouble Layer
HS Code8421 29 90
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
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 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 Area0.46 m²
Device Size10 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 ≥5 L
Global Trade Item Number
Catalog Number GTIN
CGW671S03 04053252258978

Documentation

Polysep® II Cartridge Filter 10 in. 0.5 µm Code 7 SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
Certificate of Quality CGW671S03-BM4EB9012
Certificate of Quality CGW671S03-BM4HB8781
Certificate of Quality CGW671S03-BM4NB4959
Polysep II Cartridge C0EB65923
Polysep II Cartridge C0NB36998
Polysep II Cartridge C0SB77719
Polysep II Cartridge C1JB27087
Polysep II Cartridge C0AB89307
Polysep II Cartridge C0BB35781
Polysep II Cartridge C0CB42313

Technical Info

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

Data Sheet

Title
Milligard®Sanitary Cartridge Housings