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KTGRA02FF3 Opticap Sterilizing Grade XL2 Aervent 0.2 µm 3/4 in. TC/TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KTGRA02FF3
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKTGRA02FF3
ReplacesKTGR04FF3
Trade Name
  • Opticap®
DescriptionOpticap Sterilizing Grade XL2 Aervent 0.2 µm 3/4 in. TC/TC
References
Product Information
HS Code8421 29 90
Device ConfigurationCapsule
Connections, Inlet/Outlet19 mm (3/4 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≤0.12 mL/min @ 2.6 bar (38 psig)
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 Length5.3 in. (13.5 cm)
Length13.5 cm (5.3 in.)
Diameter8.4 cm (3.3 in.)
Filtration Area0.1 m²
Inlet to Outlet Width13.5 cm (5.3 in.)
Device Size2 in.
Inlet Connection Diameter3/4 in.
Outlet Connection Diameter3/4 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
Catalog Number GTIN
KTGRA02FF3 04053252303371

Documentation

Opticap Sterilizing Grade XL2 Aervent 0.2 µm 3/4 in. TC/TC SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
OPTICAP XL 2 Capsule Aervent Membrane C2SB55387
OPTICAP XL 2 Capsule Aervent Membrane C3KB38395
OPTICAP XL 2 Capsule Aervent Membrane C3KB42239
OPTICAP XL 2 Capsule Aervent Membrane C3KB45433
OPTICAP XL 2 Capsule Aervent Membrane C4AB86430
OPTICAP XL 2 Capsule Aervent Membrane C4MB93139
OPTICAP XL 2 Capsule Aervent Membrane C4NB99653
Opticap XL 2 Capsule Aervent Membrane C0KB04880
Opticap XL 2 Capsule Aervent Membrane C1HB27749
Opticap XL 2 Capsule Aervent Membrane C3AB82427
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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
Steam Sterilization & Integrity Testing Procedures

Data Sheet

Title
Sterilizing-Grade Aervent®Filters

User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules
Visual Inspection Guide