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KVVLS04FH3 Opticap® Sterile Sterilizing Grade XL4 Durapore® 0.1 µm 3/4 in. TC-9/16 in. HB

Opticap® Sterile Sterilizing Grade XL4 Durapore® 0.1 µm 3/4 in. TC-9/16 in. HB MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KVVLS04FH3
3  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberKVVLS04FH3
Trade Name
  • Opticap®
DescriptionOpticap® Sterile Sterilizing Grade XL4 Durapore® 0.1 µm 3/4 in. TC-9/16 in. HB
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet19 mm (3/4 in.) Sanitary Flange/14 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; 1.0 bar (15 psid) @ 80 °C. Reverse: 2.8 bar (40 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 ConnectionSanitary Flange
Outlet ConnectionHose Barb
Air Diffusion at 23 °C≤5.7 mL/min @ 3.9 bar (56 psig) in water
Bubble Point at 23 °C≥4830 mbar (70 psig) air with 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).
TOC/ConductivityAfter sterilization and a controlled water flush, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 ºC.
USP Bacterial EndotoxinsA sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Dimensions
Cartridge Nominal Length4 in. (10 cm)
Length17.0 cm (6.7 in.)
Diameter6.1 cm (2.4 in.)
Filtration Area0.18 m²
Device Size4 in.
Inlet Connection Diameter3/4 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 Size3
Material PackageDouble Easy-Open bag
Transport Information
Supplemental Information
Specifications
Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL
Global Trade Item Number
Numer katalogowy GTIN
KVVLS04FH3 04053252376948

Documentation

Emprove Dossier

TitleVersion
2.0

Operational Excellence Dossier

Title

Certificates of Quality

Title
Opticap XL 4 Capsule Durapore Membrane C8DA63015
Opticap XL 4 Capsule Durapore Membrane C1EB03914Z
Opticap XL 4 Capsule Durapore Membrane C3CB97496
Opticap XL 4 Capsule Durapore Membrane C7EA01387
Opticap XL 4 Capsule Durapore Membrane C8AA09727
Opticap XL 4 Capsule Durapore Membrane C8CA42614
Opticap XL 4 Capsule Durapore Membrane C8NA13989
Opticap XL 4 Capsule Durapore Membrane C9CA09260
Opticap XL 4 Capsule Durapore Membrane C3CB99866
Opticap XL 4 Capsule Durapore Membrane C3MB60946
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Data Sheet

Title
Durapore® Family Guide

User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules