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

KVGLG1THH1 Opticap® Gamma Compatible XLT10 Durapore® 0.22 µm 5/8 in. HB

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KVGLG1THH1
1  Double Easy-Open bag
Purchase on Sigma-Aldrich

概述

Replacement Information
Description
Catalogue NumberKVGLG1THH1
Trade Name
  • Opticap®
DescriptionOpticap® Gamma Compatible XLT10 Durapore® 0.22 µm 5/8 in. HB
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet16 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 Size0.22 µm
Inlet ConnectionHose Barb
Outlet ConnectionHose Barb
Air Diffusion at 23 °C≤14 mL/min @ 2.75 bar (40 psig) in water
Bubble Point at 23 °C≥3450 mbar (50 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 Width19.8 cm (7.8 in.)
Device Size10 in.
Inlet Connection Diameter5/8 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 ≥1 L
Global Trade Item Number
产品目录编号 GTIN
KVGLG1THH1 04053252343728

Documentation

Material Qualification Dossier

标题版本
3.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

质量证书

标题
OPTICAP XLT 10 Capsule Durapore Membrane C4BB94072
Opticap XLT 10 Capsule Durapore Membrane C7HA15346
Opticap XLT 10 Capsule Durapore Membrane C9AA80103
Opticap XLT 10 Capsule Durapore Membrane C0AB85579Z
Opticap XLT 10 Capsule Durapore Membrane C0CB31153Z
Opticap XLT 10 Capsule Durapore Membrane C1BB88110
Opticap XLT 10 Capsule Durapore Membrane C2AB08904
Opticap XLT 10 Capsule Durapore Membrane C2CB52159
Opticap XLT 10 Capsule Durapore Membrane C3CB87569
Opticap XLT 10 Capsule Durapore Membrane C3NB58419
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

相关产品和应用

产品族

Durapore® 0.1 µm and 0.22 µm Gamma Compatible Capsule Filters

Enhanced process efficiency and cost-effectiveness from reduced cleaning and validation requirements
详细了解 >>

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
详细了解 >>

相关产品，按下列排序： Brand Facete

Opticap®

种类

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