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LAGRM1S02 Optiseal-M Aervent Cartridge Filter 0.2 µm hydrophobic

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
LAGRM1S02
2  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberLAGRM1S02
Trade Name
  • Optiseal®
DescriptionOptiseal-M Aervent Cartridge Filter 0.2 µm hydrophobic
References
Product Information
HS Code8421 99 99
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
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.
Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
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 Length1 in. (2.5 cm)
Filtration Area0.05 m²
Device Size1 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 Size2
Material PackageDouble Easy-Open bag
Transport Information
Supplemental Information
Specifications
Global Trade Item Number
Katalogové číslo GTIN
LAGRM1S02 04053252249112

Documentation

Certificates of Quality

Title
Opticap 1 Cartridge Aervent Membrane C7EA10631
Optiseal 1 Cartidge Aervent Membrane C8AA07958
Optiseal 1 Cartriddge Aervent Membrane C1CB42861
Optiseal 1 Cartridge Aervent C9MA7@$!)R
Optiseal 1 Cartridge Aervent Membane C9MA72411R
Optiseal 1 Cartridge Aervent Membrane C1CB42858
Optiseal 1 Cartridge Aervent Membrane C1DB94855
Optiseal 1 Cartridge Aervent Membrane C1EB00536
Optiseal 1 Cartridge Aervent Membrane C2EB75259
Optiseal 1 Cartridge Aervent Membrane C9CA03033
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Kategorie

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