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KVVLG1TTT1 Opticap® Gamma Compatible Sterilizing Grade XLT10 Durapore® 0.1 µm 1-1/2 in. TC/TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KVVLG1TTT1
1  Double Easy-Open bag
Purchase on Sigma-Aldrich

概述

Replacement Information
Description
Catalogue NumberKVVLG1TTT1
Trade Name
  • Opticap®
DescriptionOpticap® Gamma Compatible Sterilizing Grade XLT10 Durapore® 0.1 µm 1-1/2 in. TC/TC
References
Product Information
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; 1.7 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 ConnectionSanitary Flange
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)
Length37.6 cm (14.8 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area0.73 m²
Inlet to Outlet Width15.2 cm (6.0 in.)
Device Size10 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 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
产品目录编号 GTIN
KVVLG1TTT1 04053252382703

Documentation

Material Qualification Dossier

标题版本
2.0

Operational Excellence Dossier

Title

质量证书

标题
OPTICAP XLT 10 Capsule Durapore Membrane C4AB53422
Opticap XL 10 Capsule Durapore Membrane C1BB71618
Opticap XL 10 Capsule Polysep II Media C2SB51485
Opticap XLT 10 Capsule Durapore Membrane C8DA45979
Opticap XLT 10 Capsule Durapore Membrane C0EB46874
Opticap XLT 10 Capsule Durapore Membrane C0MB01959
Opticap XLT 10 Capsule Durapore Membrane C1HB80635Z
Opticap XLT 10 Capsule Durapore Membrane C2MB15873Z
Opticap XLT 10 Capsule Durapore Membrane C3MB44663
Opticap XLT 10 Capsule Durapore Membrane C4BB10718
Show more

技术信息

标题
Establishing Product Specific Bubble Point Specifications For Sterilizing-Grade Filters
Simplified, efficient sizing of sterilizing-grade normal flow filters for buffer solutions

数据表

标题
Durapore® Family Guide

用户指南

标题
Opticap® XL Capsules and Opticap® XLT Capsules

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种类

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