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CCGL02TP1 Charged Durapore® Cartridge 20 in. 0.22 µm Code 0

Charged Durapore® Cartridge 20 in. 0.22 µm Code 0 MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
CCGL02TP1
1  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberCCGL02TP1
Trade Name
  • Durapore®
DescriptionCharged Durapore® Cartridge 20 in. 0.22 µm Code 0
References
Product Information
Device ConfigurationCartridge
Maximum Differential Pressure, bar (psid)Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 135 °C. Reverse: 3.5 bar (50 psid) @ 25 °C
Maximum Inlet Pressure, bar (psi)Forward - 5.5 bar (80 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 135 °C; Reverse - 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.
Quality LevelMQ400
Applications
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaCharged Durapore®
SterilityOther
Sterilization10 SIP cycles of 30 min @ 135 °C
Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
WettabilityHydrophilic
Physicochemical Information
Pore Size0.22 µm
Air Diffusion at 23 °C≤20 mL/min @ 2.1 bar (30 psig) in water
Bubble Point at 23 °C≥3100 mbar (45 psig) air with water
Flow Rate45 L/min @ 600 mbar ΔP
Gravimetric ExtractablesThe extractables level was equal to or less than 20 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.
Non-Fiber ReleasingThis product was manufactured with a Durapore® membrane 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 Length20 in. (50 cm)
Diameter6.9 cm (2.7 in.)
Filtration Area1.38 m²
Device Size20 in.
Materials Information
Chemistry
  • Polyvinylidene Fluoride (PVDF)
Device Material
  • Polypropylene
Seal MaterialSilicone (SI)
Support MaterialPolypropylene
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Storage and Shipping Information
Packaging Information
Material Size1
Material PackageDouble Easy-Open bag
Transport Information
Supplemental Information
Specifications
Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL
Global Trade Item Number
Numer katalogowy GTIN
CCGL02TP1 04053252306570

Documentation

Certificates of Quality

Title
CHARGED DURAPORE CARTRIDGE C3CB84696
Cahrged Durapore Cartridge C8MA07154
Charged Durapore Cartridge C0CB36147
Charged Durapore Cartridge C3KB51030
Charged Durapore Cartridge C8NA32918
Charged Durapore Cartridge - C7EA88949
Charged Durapore Cartridge - C8SA70408
Charged Durapore Cartridge C0KB00962
Charged Durapore Cartridge C0KB14933
Charged Durapore Cartridge C0NB37528
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Technical Info

Title
Bubble Point Test Method Using Durapore® 0.22 µm Hydrophilic Membrane with 60/40 IPA
Integrity Test Troubleshooting - Beyond Rewet and Retest

Data Sheet

Title
Charged Durapore® Hydrophilic 0.22 μm Cartridge Filters
Durapore® Family Guide

User Guides

Title
Hydrophilic Durapore® Cartridges and Capsules User Guide
Wetting Instructions for Filter Units with Durapore Membrane

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Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Durapore