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KVGBA10TT1 Opticap Sterilizing Grade XL10 Durapore Hydrophobic 0.22 µm 1-1/2 in. TC/TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KVGBA10TT1
1  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberKVGBA10TT1
ReplacesSN2M027A6
Trade Name
  • Opticap®
DescriptionOpticap Sterilizing Grade XL10 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≥1240 mbar (18 psig) nitrogen with 60/40 % IPA/water
Nitrogen Diffusion at 23 °C≤10 mL/min @ 1.7 bar (25 psig) with 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 Length10 in. (25 cm)
Length33.5 cm (13.2 in.)
Diameter14.5 cm (5.7 in.)
Filtration Area0.69 m²
Inlet to Outlet Width33.5 cm (13.2 in.)
Device Size10 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
Katalogové číslo GTIN
KVGBA10TT1 04053252491047

Documentation

Certificates of Quality

Title
Opticap XL 10 Capsule Durapore Membrane C8DA65883
Opticap XL 10 Capsule Durapore Membrane C7EA12179
Opticap XL 10 Capsule Durapore Membrane C7MA60815
Opticap XL 10 Capsule Durapore Membrane C9HA34751
Opticap XL 10 Capsule Durapore Membrane C1HB07881
Opticap XL 10 Capsule Durapore Membrane C7JA44940
Opticap XL 10 Capsule Durapore Membrane C7KA52916
Opticap XL 10 Capsule Durapore Membrane C7MA70244
Opticap XL 10 Capsule Durapore Membrane C8CA40267
Opticap XL 10 Capsule Durapore Membrane C9SA80994Z
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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