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KHGLS10FF1 Opticap® Sterile Multilayer XL10 Durapore® 0.45/0.22 µm 3/4 in. TC/TC

Opticap® Sterile Multilayer XL10 Durapore® 0.45/0.22 µm 3/4 in. TC/TC: MSDS (material safety data sheet) o SDS, certificato d’analisi (CoA) e certificato di qualità (CoQ), dossier, brochure e altri documenti disponibili.
KHGLS10FF1
1  Double Easy-Open bag
Purchase on Sigma-Aldrich

Panoramica

Replacement Information
Description
Catalogue NumberKHGLS10FF1
Trade Name
  • Opticap®
DescriptionOpticap® Sterile Multilayer XL10 Durapore® 0.45/0.22 µm 3/4 in. TC/TC
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet19 mm (3/4 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; 1.05 bar (15 psid) @ 80 °C. Reverse: 3.5 bar (50 psid) @ 25 °C, intermittent
Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 23 °C; 2.75 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 ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaMultilayer Durapore®
SterilitySterile
Sterilization3 autoclave cycles of 60 min @ 123 °C; 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 Size0.45 / 0.22 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Air Diffusion at 23 °C≤15.0 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 Length10 in. (25 cm)
Length33.5 cm (13.2 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area0.55 m²
Inlet to Outlet Width33.5 cm (13.2 in.)
Device Size10 in.
Inlet Connection Diameter3/4 in.
Outlet Connection Diameter3/4 in.
Materials Information
Chemistry
  • Polyvinylidene Fluoride (PVDF)
Device Material
  • Polypropylene
Seal MaterialLead O-ring: Silicone-coated EPDM, Outer O-ring: Silicone
Support MaterialPolyester/Polyethylene
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 ≥1.5 L
Global Trade Item Number
Numero di catalogo GTIN
KHGLS10FF1 04053252260001

Documentation

Material Qualification Dossier

TitoloVersione
2.0

Operational Excellence Dossier

Title

Certificati di Qualità

Titolo
OPTICAP XL 10 Capsule Multilayer Durapore Membrane C3NB56500
Opticap XL 10 Capsule Multilayer Durapore Membrane C0DB49502Z
Opticap XL 10 Capsule Multilayer Durapore Membrane C0SB83109Z
Opticap XL 10 Capsule Multilayer Durapore Membrane C1AB03941
Opticap XL 10 Capsule Multilayer Durapore Membrane C7HA24937
Opticap XL 10 Capsule Multilayer Durapore Membrane C7KA50825
Opticap XL 10 Capsule Multilayer Durapore Membrane C9DA17652
Opticap XL 10 Capsule Multilayer Durapore Membrane - C0BB37996Z
Opticap XL 10 Capsule Multilayer Durapore Membrane - C0DB60704Z
Opticap XL 10 Capsule Multilayer Durapore Membrane - C9HA52399
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Informazioni tecniche

Titolo
Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters

Scheda tecnica

Titolo
Durapore® Family Guide

Manuali d'uso

Titolo
Opticap® XL Capsules and Opticap® XLT Capsules