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KHGES3THH1 Opticap® Sterile XLT 30 Millipore Express® SHC 0.5/0.2 µm 5/8 in. HB

Opticap® Sterile XLT 30 Millipore Express® SHC 0.5/0.2 µm 5/8 in. HB MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KHGES3THH1
1  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberKHGES3THH1
Trade Name
  • Millipore Express®
DescriptionOpticap® Sterile XLT 30 Millipore Express® SHC 0.5/0.2 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: 6.9 bar (100 psid) intermittent @ 25 °C; 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 2.1 bar (30 psid) @ 25 °C, intermittent
Maximum Inlet Pressure, bar (psi)6.9 bar (100 psi) intermittent @ 25 °C; 5.5 bar (80 psi) @ 25 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
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
MediaMillipore Express® SHC
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 Size0.5 / 0.2 µm
Inlet ConnectionHose Barb
Outlet ConnectionHose Barb
Air Diffusion at 23 °C≤93.7 mL/min @ 2.8 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 psig
Maximum Differential Pressure80 psi (5.5 bar) continuous
100 psi (6.9 bar) intermittent
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 63 L, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645> at 25 °C.
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 Length30 in. (75 cm)
Length87.1 cm (34.3 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area1.63 m²
Inlet to Outlet Width19.8 cm (7.8 in.)
Device Size30 in.
Inlet Connection Diameter5/8 in.
Outlet Connection Diameter5/8 in.
Materials Information
Chemistry
  • 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 ≥6 L
Global Trade Item Number
Numer katalogowy GTIN
KHGES3THH1 04053252562730

Documentation

Emprove Dossier

TitleVersion
1.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Certificates of Quality

Title
OPTICAP XLT 30 Capsule Millipore Express SHC Membrane C3AB59791
OPTICAP XLT 30 Capsule Millipore Express SHC Membrane C4DB03606
Opticap XLT 30 Capsule Millipore Expres SHC Membrane C3AB59388
Opticap XLT 30 Capsule Millipore Express SHC Membrane C0DB49015
Opticap XLT 30 Capsule Millipore Express SHC Membrane C0PB26222
Opticap XLT 30 Capsule Millipore Express SHC Membrane C1DB95787
Opticap XLT 30 Capsule Millipore Express SHC Membrane C1EB81121
Opticap XLT 30 Capsule Millipore Express SHC Membrane C2HB80190
Opticap XLT 30 Capsule Millipore Express SHC Membrane C7CA83892
Opticap XLT 30 Capsule Millipore Express SHC Membrane C7EA09541
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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
Opticap® XL Capsules and Opticap® XLT Capsules
User Guide - Filters with Millipore Express®Membrane
Vmax Constant Pressure

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Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Millipore Express® > Millipore Express® SHC