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KGEPS10TH1 Opticap® XL 10 Millipore Express® SHF Sterile 0.2 µm 1-1/2 in. TC-9/16 in. HB

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KGEPS10TH1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKGEPS10TH1
Trade Name
  • Millipore Express®
DescriptionOpticap® XL 10 Millipore Express® SHF Sterile 0.2 µm 1-1/2 in. TC-9/16 in. HB
OverviewSterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.
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: 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
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
MediaMillipore Express® SHF
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 Size0.2 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionHose Barb
Air Diffusion at 23 °C≤32.7 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 11 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 Length10 in. (25 cm)
Length33.5 cm (13.2 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area0.57 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
  • Polyethersulfone (PES)
Device Material
  • Gamma stable 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 ≥1.5 L
Global Trade Item Number
Catalogue Number GTIN
KGEPS10TH1 04053252451348

Documentation

Material Qualification Dossier

TitleVersion
1.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Certificates of Quality

Title
Opticap XL 10 Capsule Millipore Express SHF Membrane C2JB86271
Opticap XL 10 Capsule Millipore Express SHF Membrane C0BB25340
Opticap XL 10 Capsule Millipore Express SHF Membrane C2PB40736
Opticap XL 10 Capsule Millipore Express SHF Membrane C3KB38379
Opticap XL 10 Capsule Millipore Express SHF Membrane C3PB62997
Opticap XL 10 Capsule Millipore Express SHF Membrane C4DB17606

Technical Info

Title
1X PBS (Phosphate Buffered Saline) Buffer Mixing Optimization
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
Scalable Process Filtration with Millipore Express® SHF 0.2 μm Filters
Scalable Process Filtration with Opticap® XL 150, 300 and 600 Capsules with Millipore Express® Membranes
Simplified, efficient sizing of sterilizing-grade normal flow filters for buffer solutions

User Guides

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