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KVGBA05TT1 Opticap Sterilizing Grade XL5 Durapore Hydrophobic 0.22 µm 1-1/2 in. TC/TC

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KVGBA05TT1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKVGBA05TT1
Trade Name
  • Opticap®
DescriptionOpticap Sterilizing Grade XL5 Durapore Hydrophobic 0.22 µm 1-1/2 in. TC/TC
References
Product Information
HS Code8421 22 00
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: 3.4 bar (50 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.
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
MediaDurapore®
Sterilization20 autoclave cycles of 30 min @ 126 °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 Size0.22 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Bubble Point at 23 °C≥1170 mbar (17 psig) nitrogen with 60/40 % IPA/water
Nitrogen Diffusion at 23 °C≤5 mL/min @ 1.7 bar (25 psig) in 60/40 % IPA/water
Indirect Food AdditiveAll component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
Maximum Inlet Pressure (psig)80 psig
Maximum Inlet Temperature25 °C
Non-Fiber ReleasingThis product was manufactured with a Durapore® 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 in. (12.5 cm)
Length21.6 cm (8.5 in.)
Diameter14.5 cm (5.7 in.)
Filtration Area0.35 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
  • Polyvinylidene Fluoride (PVDF)
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
KVGBA05TT1 04053252446139

Documentation

Certificates of Quality

Title
OPTICAP XL 5 Capsule Durapore Membrane C3AB77787
Opticap XL 5 Capsule Durapore Membrane C7HA24903
Opticap XL 5 Capsule Durapore Membrane C7MA59710
Opticap XL 5 Capsule Durapore Membrane C0BB30506
Opticap XL 5 Capsule Durapore Membrane C1CB07762Z
Opticap XL 5 Capsule Durapore Membrane C1HB07880Z
Opticap XL 5 Capsule Durapore Membrane C3AB47319Z
Opticap XL 5 Capsule Durapore Membrane C7KA37021
Opticap XL 5 Capsule Durapore Membrane C7SA05528
Opticap XL 5 Capsule Durapore Membrane C9DA09273
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Technical Info

Title
Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters
Vent Filter Sizing for Mobius®Single-use Mixing Solution

User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules