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CGW601S03 Polysep® II Cartridge Filter 10 in. 0.5 µm Code 0

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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CGW601S03
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberCGW601S03
Trade Name
  • Polysep®
DescriptionPolysep® II Cartridge Filter 10 in. 0.5 µm Code 0
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 0 (2-222) 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 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
Catalogue Number GTIN
CGW601S03 04053252340284

Documentation

Polysep® II Cartridge Filter 10 in. 0.5 µm Code 0 SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
Polysep II Cartridge C0BB00235
Polysep II Cartridge C0JB95586
Polysep II Cartridge C0SB43420
Polysep II Cartridge C1HB12027
Polysep II Cartridge C1HB13173
Polysep II Cartridge C7DA02603
Polysep II Cartridge C7DA99302
Polysep II Cartridge C7EA06210
Polysep II Cartridge C8SA72885
Polysep II Cartridge C9JA68329
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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