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KHGEG2TTT1H Gamma Compatible High Area Opticap® XLT 20 Millipore Express® SHC 0.5  µm/0.2 µm 1-1/2 in. TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KHGEG2TTT1H
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKHGEG2TTT1H
Trade Name
  • Millipore Express®
DescriptionGamma Compatible High Area Opticap® XLT 20 Millipore Express® SHC 0.5  µm/0.2 µm 1-1/2 in. TC
References
Product Information
HS Code8421 22 00
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: 6.9 (100) intermittent @ 25 °C; 5.5 (80) @ 25 °C; 1.0 (15) @ 80 °C. Reverse: 2.1 (30) @ 25 °C, intermittent
Maximum Inlet Pressure, bar (psi)6.9 (100) intermittent @ 25 °C; 5.5 (80) @ 25 °C; 2.75 (40) @ 60 °C; 1.0 (15) @ 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
Key Applications
  • Laboratory Filtration
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
SterilityNon-sterile, Gamma compatible
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 Size0.5 / 0.2 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Air Diffusion at 23 °C≤112.8 mL/min @ 2.75 bar (40 psig) in water
Bubble Point at 23 °C≥4000 mbar (58 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
Maximum Inlet Temperature25°C
Non-Fiber ReleasingThis product was manufactured with a Millipore Express® 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 of 42 L, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 °C.
Dimensions
Cartridge Nominal Length20 in. (50 cm)
Length62.5 cm (24.6 in.)
Diameter10.7 in. (4.2 cm)
Filtration Area20000 cm2
Inlet to Outlet Width15.2 cm (6.0 in.)
Device Size20 in.
Outlet Connection Diameter1.5 in.
Materials Information
Chemistry
  • Hydrophilic Polyethersulfone (PES)
Device Material
  • Polypropylene/Polysulfone
Seal MaterialSilicone (SI)
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 ≥4 L
Global Trade Item Number
Catalogue Number GTIN
KHGEG2TTT1H 04054839167874

Documentation

Material Qualification Dossier

TitleVersion
1.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Certificates of Quality

Title
OPTICAP XLT 20 Capsule Millipore Express SHC High Area membrane C3DB11628
Opticap XL 20 Capsule Millipore Express SHC High Area Membrane C1BB10147
Opticap XLT 20 Capsule Millipore Express SHC Area Membrane C3MB53426
Opticap XLT 20 Capsule Millipore Express SHC High Area Membrane - C8BA06645
Opticap XLT 20 Capsule Millipore Express SHC High Area Membrane - C9EA98576
Opticap XLT 20 Capsule Millipore Express SHC High Area Membrane C1JB21336
Opticap XLT 20 Capsule Millipore Express SHC High Area Membrane C3EB15527
Opticap XLT 20 Capsule Millipore Express SHC High Area Membrane C3SB94736
Opticap XLT 20 Capsule Millipore Express SHC High Area Membrane C4NB89506
Opticap XLT 20 Capsule Millipore Express SHC High Area Membrane C8AA24147
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Technical Info

Title
Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters
Extended bacterial retention testing of Millipore Express® 0.2 μm filters in a continuous flow system
Simplified, efficient sizing of sterilizing-grade normal flow filters for buffer solutions

Data Sheet

Title
Millipore Express®SHC Hydrophilic Filters

User Guides

Title
User Guide - Filters with Millipore Express®Membrane