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KHGLG1THH1 Opticap® Gamma Compatible Multilayer XLT10 Durapore® 0.45/0.22 µm 5/8 in. HB

Opticap® Gamma Compatible Multilayer XLT10 Durapore® 0.45/0.22 µm 5/8 in. HB MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KHGLG1THH1
1  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberKHGLG1THH1
Trade Name
  • Opticap®
DescriptionOpticap® Gamma Compatible Multilayer XLT10 Durapore® 0.45/0.22 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; 1.05 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.
T-line/Gauge PortT-line
Quality LevelMQ400
Applications
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaMultilayer Durapore®
SterilityGamma
SterilizationGamma compatible to 45 kGy; 3 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 ConnectionHose Barb
Outlet ConnectionHose Barb
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)
Length37.6 cm (14.8 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area0.55 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
  • Polypropylene
Seal MaterialSilicone (SI)
Support MaterialPolypropylene
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
Numer katalogowy GTIN
KHGLG1THH1 04053252573262

Documentation

Emprove Dossier

TitleVersion
2.0

Certificates of Quality

Title
Opticap XLT 10 Capsule Multilayer Durapore Membrane C1HB80659
Opticap XLT 10 Capsule Multilayer Durapore Membrane C7EA07406
Opticap XLT 10 Capsule Multilayer Durapore Membrane C2EB67292
Opticap XLT 10 Capsule Multilayer Durapore Membrane C3SB68111
Opticap XLT 10 Capsule Multilayer Durapore Membrane C4AB73543
Opticap XLT 10 Capsule Multilayer Durapore Membrane C4CB03589
Opticap XLT 10 Capsule Multilayer Durapore Membrane C4DB14698
Opticap XLT 10 Capsule Multilayer Durapore Membrane C9EA85465
Opticap XLT 10 Capsule Multilayer Durapore Membrane- C4DB17293

Technical Info

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

Data Sheet

Title
Durapore® Family Guide

User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules