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KTGRA04TT3 Opticap XL capsule with Aervent filter, 0.2 µm

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KTGRA04TT3
3  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberKTGRA04TT3
ReplacesKTGR04TC3
Trade Name
  • Opticap®
DescriptionOpticap XL capsule with Aervent filter, 0.2 µm
References
Product Information
HS Code8421 29 90
Device ConfigurationCapsule
Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange
Connections, Vent/Drain1/4 in. Hose Barb with double O-ring Seal
Housing MaterialPolypropylene (PP)
Maximum Differential Pressure, bar (psid)Forward: 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 4.1 bar (60 psid) @ 25 °C, intermittent
Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 23 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
European Pressure Equipment DirectiveEMD Millipore Corporation® certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.
Quality LevelMQ400
Applications
Biological Information
MediaAervent®
Sterilization30 autoclave cycles of 30 min @ 135 °C; not in-line steam sterilizable
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
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
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 15 mg after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
HydroCorr≤0.25 mL/min @ 2.6 bar (38 psig)
Nitrogen Diffusion at 23 °C≤9 mL/min @ 965 mbar (14 psig) in 70/30 % IPA/water
Maximum Inlet Pressure (psig)80 psig
Maximum Inlet Temperature25 °C
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 Length7.7 in. (19.6 cm)
Length19.6 cm (7.7 in.)
Diameter8.4 cm (3.3 in.)
Filtration Area0.21 m²
Inlet to Outlet Width19.6 cm (7.7 in.)
Device Size4 in.
Inlet Connection Diameter1-1/2 in.
Outlet Connection Diameter1-1/2 in.
Materials Information
Chemistry
  • Polytetrafluoroethylene (PTFE)
Device Material
  • Polypropylene
Seal MaterialSilicone (SI)
Support MaterialPolypropylene
Vent Cap MaterialPolypropylene (PP)
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
Global Trade Item Number
Katalogové číslo GTIN
KTGRA04TT3 04053252258329

Documentation

Certificates of Quality

Title
C3KB44278
OPTI XL 4 Capsule Aervent Membrane C2HB63521
OPTI XL 4 Capsule Aervent Membrane C2KB92323
OPTI XL 4 Capsule Aervent Membrane C2MB94168
OPTICAP XL 4 Aervent Membrane C3KB35144
OPTICAP XL 4 Capsule AERVENT Membrane C4CB01483
OPTICAP XL 4 Capsule Aervent Membrane C2SB54964
OPTICAP XL 4 Capsule Aervent Membrane C3AB75586
OPTICAP XL 4 Capsule Aervent Membrane C3AB80852
OPTICAP XL 4 Capsule Aervent Membrane C3BB80854
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Technical Info

Title
Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters
Bubble Point Test Method Using Aervent 0.2 µm Hydrophobic Membrane with 60/40 IPA

Data Sheet

Title
Sterilizing-Grade Aervent®Filters

User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules

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