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KHGLA10TH1 Opticap® Autoclavable Multilayer XL10 Durapore® 0.45/0.22 µm TC/HB

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KHGLA10TH1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKHGLA10TH1
Trade Name
  • Opticap®
DescriptionOpticap® Autoclavable Multilayer XL10 Durapore® 0.45/0.22 µm TC/HB
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange/14 mm (9/16 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.
Quality LevelMQ400
Applications
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaMultilayer Durapore®
SterilityOther
Sterilization3 autoclave cycles of 60 min @ 126 °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 ConnectionHose Barb
Air Diffusion at 23 °C≤10.8 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 Diameter1-1/2 in.
Outlet Connection Diameter9/16 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
Catalog Number GTIN
KHGLA10TH1 04053252392559

Documentation

Material Qualification Dossier

TitleVersion
3.0

Operational Excellence Dossier

Title

Opticap® Autoclavable Multilayer XL10 Durapore® 0.45/0.22 µm TC/HB SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
OPTICAP XL 10 Capsule Multilayer Durapore Membrane C3MB35176
Opticap XL 10 Capsule Multilayer Durapore Cartrdige C0DB60673Z
Opticap XL 10 Capsule Multilayer Durapore Membrane C7CA81118
Opticap XL 10 Capsule Multilayer Durapore Membrane C7PA89816
Opticap XL 10 Capsule Multilayer Durapore Membrane - C9CA90069
Opticap XL 10 Capsule Multilayer Durapore Membrane -C8NA37462
Opticap XL 10 Capsule Multilayer Durapore Membrane C2BB26146
Opticap XL 10 Capsule Multilayer Durapore Membrane C2SB47285
Opticap XL 10 Capsule Multilayer Durapore Membrane C3SB73744
Opticap XL 10 Capsule Multilayer Durapore Membrane C4KB69014
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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