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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.
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LAGR04TP6
6  Double Easy-Open bag
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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
Catalog Number GTIN
LAGR04TP6 04053252344305

Documentation

Optiseal Aervent Cartridge Filter 0.2 µm hydrophobic SDS

Title

Safety Data Sheet (SDS) 

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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Technical Info

Title
Steam Sterilization & Integrity Testing Procedures

User Guides

Title
Visual Inspection Guide

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Categories

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