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KVVLA05HH1 Opticap® XL5 Durapore® 0.1 µm 9/16 in. HB/HB

KVVLA05HH1
1  Double Easy-Open bag
Purchase on Sigma-Aldrich

Overview

Replacement Information
Description
Catalogue NumberKVVLA05HH1
Trade Name
  • Opticap®
DescriptionOpticap® XL5 Durapore® 0.1 µm 9/16 in. HB/HB
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; 1.0 bar (15 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®
SterilityOther
Sterilization3 autoclave cycles of 60 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.
WettabilityHydrophilic
Physicochemical Information
Pore Size0.1 µm
Inlet ConnectionHose Barb
Outlet ConnectionHose Barb
Air Diffusion at 23 °C≤10 mL/min @ 3.9 bar (56 psig) in water
Bubble Point at 23 °C≥4830 mbar (70 psig) air with water
Gravimetric ExtractablesThe extractables level was equal to or less than 15 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 Length5 in. (12.5 cm)
Length21.3 cm (8.4 in.)
Diameter14.5 cm (5.7 in.)
Filtration Area0.35 m²
Inlet to Outlet Width21.3 cm (8.4 in.)
Device Size5 in.
Inlet Connection Diameter9/16 in.
Outlet Connection Diameter9/16 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
Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL
Global Trade Item Number
Catalogue Number GTIN
KVVLA05HH1 04053252380860

Documentation

Operational Excellence Dossier

Title

Certificates of Quality

Title
OPTICAP XL 5 Capsule Durapore Membrane C2PB42026Z
OPTICAP XL 5 Capsule Durapore Membrane C2SB57162Z
Opticap XL 4 Capsule Durapore Membrane C1CB03977Z
Opticap XL 5 Capsule Durapore Membrane C0KB03624
Opticap XL 5 Capsule Durapore Membrane C1MB64716Z
Opticap XL 5 Capsule Durapore Membrane C7EA99006
Opticap XL 5 Capsule Durapore Membrane C7HA22664
Opticap XL 5 Capsule Durapore Membrane C8HA93814
Opticap XL 5 Capsule Durapore Membrane - C8AA13307
Opticap XL 5 Capsule Durapore Membrane - C9NA04334

Technical Info

Title
Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters
Establishing Product Specific Bubble Point Specifications For Sterilizing-Grade Filters
Simplified, efficient sizing of sterilizing-grade normal flow filters for buffer solutions

Data Sheet

Title
Durapore® Family Guide

User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules

Related Products & Applications

Product Families

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Categories

Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Durapore