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KVVLS10HH1 Sterile Opticap® XL 10 w/Phil Dur - 10" 0.1 µm HB/HB 1pk

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KVVLS10HH1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKVVLS10HH1
Trade Name
  • Opticap®
DescriptionSterile Opticap® XL 10 w/Phil Dur - 10" 0.1 µm HB/HB 1pk
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet14 mm (9/16 in.) Hose Barb
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; 1.7 bar (25 psid) @ 80 °C. Reverse: 3.5 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®
SterilitySterile
SterilizationShipped sterile by gamma irradiation @ >25 kGray gamma exposure
Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
WettabilityHydrophilic
Physicochemical Information
Pore Size0.1 µm
Inlet ConnectionHose Barb
Outlet ConnectionHose Barb
Bubble Point at 23 °C≥4830 mbar (70 psig) air with water
Gravimetric ExtractablesThe extractables level was equal to or less than 25 mg per capsule after 24 hours in water at controlled room temperature.
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.)
Diameter10.7 cm (4.2 in.)
Filtration Area0.73 m²
Inlet to Outlet Width33.5 cm (13.2 in.)
Device Size10 in.
Inlet Connection Diameter9/16 in.
Outlet Connection Diameter9/16 in.
Materials Information
Chemistry
  • Polyvinylidene Fluoride (PVDF)
Device Material
  • Gamma-stable polypropylene
Seal MaterialLead O-ring: Silicone-coated EPDM, Outer O-ring: Silicone
Support MaterialPolyester
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
Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L
Global Trade Item Number
Catalogue Number GTIN
KVVLS10HH1 04053252488849

Documentation

Material Qualification Dossier

TitleVersion
2.0

Operational Excellence Dossier

Title

Certificates of Quality

Title
Durapore XL 10 Capsule C0SB38324Z
OPTICAP XL 10 Capsule Durapore Membrane C3PB66693
OPTICAP XL 10 Capsule Durapore Membrane C4AB79203
Opticap XL 10 Capsule Durapore Membrane C0CB37623Z
Opticap XL 10 Capsule Durapore Membrane C0EB57038Z
Opticap XL 10 Capsule Durapore Membrane C0MB24975Z
Opticap XL 10 Capsule Durapore Membrane C1HB08010Z
Opticap XL 10 Capsule Durapore Membrane C1SB03092Z
Opticap XL 10 Capsule Durapore Membrane C1SB07674Z
Opticap XL 10 Capsule Durapore Membrane C3EB05139
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Data Sheet

Title
Durapore® Family Guide

User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules