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LAGR04TP6 Optiseal Aervent Cartridge Filter 0.2 µm hydrophobic

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
LAGR04TP6
6  Double Easy-Open bag
Purchase on Sigma-Aldrich

Overview

Replacement Information
Description
Catalogue NumberLAGR04TP6
Trade Name
  • Optiseal®
DescriptionOptiseal Aervent Cartridge Filter 0.2 µm hydrophobic
References
Product Information
HS Code8421 39 90
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: 4.1 bar (60 psid)
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 - 4.1 bar (60 psi)
Cartridge CodeNot Applicable
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
MediaAervent®
Sterilization80 (40 forward/40 reverse) SIP cycles of 30 min @ 135 °C; 80 autoclave 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.
WettabilityHydrophobic
Physicochemical Information
Pore Size0.2 µm
Bubble Point at 23 °C≥1100 mbar (16 psig) nitrogen with 70/30 % IPA/water
Gravimetric ExtractablesThe extractables level was equal to or less than 10 mg per 4-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
HydroCorr≤0.20 mL/min with water @ 2.6 bar (38 psig)
Nitrogen Diffusion at 23 °C≤6 mL/min @ 965 mbar (14 psig) in 70/30 % IPA/water
Non-Fiber ReleasingThis product was manufactured with a PTFE 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 Length4 in. (10 cm)
Filtration Area0.18 m²
Device Size4 in.
Materials Information
Chemistry
  • Polytetrafluoroethylene (PTFE)
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 Size6
Material PackageDouble Easy-Open bag
Transport Information
Supplemental Information
Specifications
Global Trade Item Number
Catalogue Number GTIN
LAGR04TP6 04053252344305

Documentation

Certificates of Quality

Title
OPTISEAL 4 CARTRIDGE AERVENT MEMBRANE C1CB71709
Opticap 4 Cartridge Aervent Membrane C8EA61361
Opticap 4 Cartridge Aervent Membrane C8PA55949
Optiseal 4 Cartidge Aervent Membrane C0JB00125
Optiseal 4 Cartridge Aervent Meembrane C2SB57893
Optiseal 4 Cartridge Aervent Membrane C0CB21116R
Optiseal 4 Cartridge Aervent Membrane C0EB61711
Optiseal 4 Cartridge Aervent Membrane C0NB26518
Optiseal 4 Cartridge Aervent Membrane C1BB97621
Optiseal 4 Cartridge Aervent Membrane C1CB71710
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Categories

Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Gas > Aervent