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CGW653S03 Polysep® II Cartridge Filter 30 in. 0.5 µm Code 5

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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CGW653S03
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberCGW653S03
Trade Name
  • Polysep®
DescriptionPolysep® II Cartridge Filter 30 in. 0.5 µm Code 5
References
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 5 (2-222) O-rings 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 Length30 in. (75 cm)
Diameter7.1 cm (2.8 in.)
Filtration Area1.38 m²
Device Size30 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 ≥15 L
Global Trade Item Number
Catalog Number GTIN
CGW653S03 04053252388927

Documentation

Polysep® II Cartridge Filter 30 in. 0.5 µm Code 5 SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
Certificate of Quality CGW653S03-BM3PB0704
Polysep II Cartridge C0AB89306
Polysep II Cartridge C7EA12738
Polysep II Cartridge - C9HA47557
Polysep II Cartridge C1NB71271
Polysep II Cartridge- C9SA85539

Technical Info

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

Data Sheet

Title
Milligard®Sanitary Cartridge Housings