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KVVLG2TTH1 Opticap® Gamma Compatible Sterilizing Grade XLT20 Durapore® 0.1 µm 1-1/2 in. TC-5/8 in. HB

Opticap® Gamma Compatible Sterilizing Grade XLT20 Durapore® 0.1 µm 1-1/2 in. TC-5/8 in. HB MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KVVLG2TTH1
1  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberKVVLG2TTH1
Trade Name
  • Opticap®
DescriptionOpticap® Gamma Compatible Sterilizing Grade XLT20 Durapore® 0.1 µm 1-1/2 in. TC-5/8 in. HB
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange/16 mm (5/8 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.
T-line/Gauge PortT-line
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 ConnectionSanitary Flange
Outlet ConnectionHose Barb
Air Diffusion at 23 °C≤42.2 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 50 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 Length20 in. (50 cm)
Length62.5 cm (24.6 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area1.45 m²
Inlet to Outlet Width17.5 cm (6.9 in.)
Device Size20 in.
Inlet Connection Diameter1-1/2 in.
Outlet Connection Diameter5/8 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 ≥2 L
Global Trade Item Number
Katalogové číslo GTIN
KVVLG2TTH1 04053252460340

Documentation

Material Qualification Dossier

TitleVersion
2.0

Operational Excellence Dossier

Title

Certificates of Quality

Title
Opticap XL 20 Capsule Durapore Membrane C1CB54958Z
Opticap XLT 10 Capsule Durapore Membrane C1JB80638Z
Opticap XLT 20 Capsule Durapore Membrane C8AA15220
Opticap XLT 20 Capsule Durapore Membrane C2KB07751Z
Opticap XLT 20 Capsule Durapore Membrane C8NA21044
Opticap XLT 20 Capsule Durapore Membrane C9EA36289
Opticap XLT 20 Capsule Durapore Membrane - C0BB94047
Opticap XLT 20 Capsule Durapore Membrane - C7HA11849
Opticap XLT 20 Capsule Durapore Membrane - C7HA86782
Opticap XLT 20 Capsule Durapore Membrane - C7NA26403
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

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Kategorie

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