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KHVEA3TTT1 Opticap® Autoclavable XLT 30 Millipore Express® SHR with Prefilter 0.5/0.1 µm 1-1/2 in. TC

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KHVEA3TTT1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKHVEA3TTT1
Trade Name
  • Millipore Express®
DescriptionOpticap® Autoclavable XLT 30 Millipore Express® SHR with Prefilter 0.5/0.1 µm 1-1/2 in. TC
References
Product Information
Device ConfigurationCapsule
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 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 @ 23 °C; 5.5 bar (80 psi) @ 23 °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® SHR w/Prefilter
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 Size0.5 / 0.1 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Air Diffusion at 23 °C≤81.3 mL/min @ 3.45 bar (50 psig) in water
Bubble Point at 23 °C≥2586 mbar (37.5 psig) nitrogen with 70/30 % IPA/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 60 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 Area1.48 m²
Inlet to Outlet Width15.2 cm (6.0 in.)
Device Size30 in.
Inlet Connection Diameter1-1/2 in.
Outlet Connection Diameter1-1/2 in.
Materials Information
Chemistry
  • Polyethersulfone (PES)
Device Material
  • Polypropylene/Polysulfone
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 ≥6 L
Global Trade Item Number
Catalogue Number GTIN
KHVEA3TTT1 04053252560514

Documentation

Material Qualification Dossier

TitleVersion
5.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Certificates of Quality

Title
OPTICAP XLT 30 Capsule Millipore Express SHR w Prefilter Membrane C3KB46101
Opticap XL 3 Capsule Millipore Express SHC Membrane C5HB69194
Opticap XLT 30 Capsule Millipore Express SHR w/Prefilter Membrane C7NA76962
Opticap XLT 30 Capsule Millipore Express SHR w/Prefilter Membrane C0MB03980
Opticap XLT 30 Capsule Millipore Express SHR w/Prefilter Membrane C1BB06943
Opticap XLT 30 Capsule Millipore Express SHR w/Prefilter Membrane C3AB55047
Opticap XLT 30 Capsule Millipore Express SHR w/Prefilter Membrane C4BB93193
Opticap XLT 30 Capsule Millipore Express SHR w/Prefilter Membrane - C9BA82141Y
Opticap XLT 30 Capsule Millipore Express SHR w/Prefilter Membrane - C9MA88337Y
Opticap XLT 30 Capsule Millipore Express SHR w/Prefilter Membrane C1MB56682

Technical Info

Title
Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters
Cell Culture Media Microfiltration and Mixing: Reducing Risk with Single-use Technology
Mycoplasma clearance by Millipore Express SHR filters at pilot and production scales
Scalable Process Filtration with Millipore Express® SHR 0.1 μm Filters

Data Sheet

Title
Millipore Express®SHR Hydrophilic Filters

User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules
User Guide - Filters with Millipore Express®Membrane
Vmax Constant Pressure