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KVGLG04TT3 Opticap® Gamma Compatible XL4 Durapore® 0.22 µm 1-1/2 in. TC/TC

Opticap® Gamma Compatible XL4 Durapore® 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.
KVGLG04TT3
3  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberKVGLG04TT3
Trade Name
  • Opticap®
DescriptionOpticap® Gamma Compatible XL4 Durapore® 0.22 µm 1-1/2 in. TC/TC
References
Product Information
HS Code8421 99 99
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: 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®
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 Size0.22 µm
Inlet ConnectionHose Barb
Outlet ConnectionHose Barb
Air Diffusion at 23 °C≤4.6 mL/min @ 2.75 bar (40 psig) in water
Bubble Point at 23 °C≥3450 mbar (50 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 Diameter1-1/2 in.
Outlet Connection Diameter1-1/2 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
Katalogové číslo GTIN
KVGLG04TT3 04053252374500

Documentation

Material Qualification Dossier

TitleVersion
3.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Certificates of Quality

Title
OPTICAP XL 4 Capsule Durapore Membrane C3JB30064
OPTICAP XL 4 Capsule Durapore Membrane C3JB47559
OPTICAP XL4 Capsule C0SB72304Z
Opticap XL 4 Capsule C1CB96391
Opticap XL 4 Capsule Durapore Membrane C0PB47118Z
Opticap XL 4 Capsule Durapore Membrane C1NB21559
Opticap XL 4 Capsule Durapore Membrane C7EA06012
Opticap XL 4 Capsule Durapore Membrane C0KB07995Z
Opticap XL 4 Capsule Durapore Membrane C7EA11654
Opticap XL 4 Capsule Durapore Membrane C8JA07307
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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

Související produkty a aplikace

Product Families

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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
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Související produkty: Brand Facete

Opticap®

Kategorie

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