Millipore Sigma Vibrant Logo
Attention: We have moved. Merck Millipore products are no longer available for purchase on MerckMillipore.com.Learn More

KVVLG10HH1 Opticap® Gamma Compatible Sterilizing Grade XL10 Durapore® 0.1 µm Gamma Compatible 9/16 in. HB/HB

Opticap® Gamma Compatible Sterilizing Grade XL10 Durapore® 0.1 µm Gamma Compatible 9/16 in. HB/HB MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KVVLG10HH1
1  Double Easy-Open bag
Purchase on Sigma-Aldrich

Przegląd

Replacement Information
Description
Catalogue NumberKVVLG10HH1
ReplacesKVVL01HB1
Trade Name
  • Opticap®
DescriptionOpticap® Gamma Compatible Sterilizing Grade XL10 Durapore® 0.1 µm Gamma Compatible 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; 1.7 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®
SterilityNon-sterile, Gamma compatible
Sterilization3 autoclave cycles of 60 min @ 126 °C; capable of 45 kilogray (4.5 Megarad) gamma exposure; 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≤21.1 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 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
Numer katalogowy GTIN
KVVLG10HH1 04053252716331

Documentation

Emprove Dossier

TitleVersion
2.0

Operational Excellence Dossier

Title

Certificates of Quality

Title
OPTICAP XL 10 Capsule Durapore Membrane C3HB19688
OPTICAP XL 10 Capsule Durapore Membrane C3SB66691
OPTICAP XL 10 Capsule Durapore Membrane C4KB82963
Optical XL 10 Capsule Durapore Membrane - C9PA22652
Opticap XL 10 Capsule Durapore Membrane C0DB56006Z
Opticap XL 10 Capsule Durapore Membrane C1HB08008Z
Opticap XL 10 Capsule Durapore Membrane C2NB08924Z
Opticap XL 10 Capsule Durapore Membrane C7DA86438
Opticap XL 10 Capsule Durapore Membrane C7NA68392
Opticap XL 10 Capsule Durapore Membrane C0BB88546
Show more

Technical Info

Title
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

Powiązane produkty i zastosowania

Product Families

Durapore® 0.1 µm and 0.22 µm Gamma Compatible Capsule Filters

Enhanced process efficiency and cost-effectiveness from reduced cleaning and validation requirements
Dowiedz się więcej >>

Durapore® 0.1 µm and 0.22 µm Capsule Filters

0.1 µm and 0.22 µm hydrophilic polyvinylidene fluoride (PVDF) membranes for sterile liquid filtration
Dowiedz się więcej >>

Związane produkty według: Brand Facete

Opticap®

Kategorie

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