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KTGRA05TT1 Aervent KTGR Opticap XL5 Capsule

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KTGRA05TT1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKTGRA05TT1
Trade Name
  • Aervent®
DescriptionAervent KTGR Opticap XL5 Capsule
References
Product Information
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), intermittent
Maximum Inlet Pressure, bar (psi)Forward - 5.5 bar (80 psi) @ 25 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C; Reverse - 4.1 bar (60 psi), Intermittent
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
Bacterial Grow-ThroughRetains Brevundimonas diminuta liquid aerosol for 21 days at a minimum challenge of 10⁷ CFU/cm²
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 28 mg per 10-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
HydroCorr≤0.38 mL/min @ 2.6 bar (38 psig) per sample
Nitrogen Diffusion at 23 °C≤12 mL/min @ 970 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).
Virus Aerosol RetentionRated for aerosol retention of a total challenge of 108–1010 plaque forming units of ΦX-174 virus particles at 85 Nm3/h (50 SCFM) per cartridge.
USP Bacterial EndotoxinsAqueous extraction contains <0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Dimensions
Cartridge Nominal Length5 in. (13 cm)
Length21.6 cm (8.5 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area0.32 m²
Inlet to Outlet Width21.6 cm (8.5 in.)
Device Size5 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 Size1
Material PackageDouble Easy-Open bag
Transport Information
Supplemental Information
Specifications
Global Trade Item Number
Catalog Number GTIN
KTGRA05TT1 04053252566288

Documentation

Aervent KTGR Opticap XL5 Capsule SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
OPTI XL 5 Capsule Aervent Membrane C2PB40758
OPTICAP XL 5 Capsule Aervent C3AB58883
Opticap XL 5 Aervent Membrane C0SB44200
Opticap XL 5 Caosule Aervent Membrane C8CA13071
Opticap XL 5 Capsule Aervent Membrane C1HB07849
Opticap XL 5 Capsule Aervent Membrane C0NB12683
Opticap XL 5 Capsule Aervent Membrane C1NB71358
Opticap XL 5 Capsule Aervent Membrane C2SB51496
Opticap XL 5 Capsule Aervent Membrane C7HA11627
Opticap XL 5 Capsule Aervent Membrane C7JA48365

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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Categories

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