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KGEPS006FF3 Opticap® XL 600 Millipore Express® SHF Sterile 0.2 µm 3/4 in. TC/TC

Opticap® XL 600 Millipore Express® SHF Sterile 0.2 µm 3/4 in. TC/TC MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KGEPS006FF3
3  Double Easy-Open bag
Purchase on Sigma-Aldrich

Áttekintés

Replacement Information
Description
Catalogue NumberKGEPS006FF3
Trade Name
  • Millipore Express®
DescriptionOpticap® XL 600 Millipore Express® SHF Sterile 0.2 µm 3/4 in. TC/TC
OverviewSterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet19 mm (3/4 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
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 ConnectionSanitary Flange
Air Diffusion at 23 °C≤5.8 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 3.0 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 Length6.5 in. (16.5 cm)
Length16.5 cm (6.5 in.)
Diameter5.6 cm (2.2 in.)
Filtration Area970 cm²
Inlet to Outlet Width16.5 cm (6.5 in.)
Inlet Connection Diameter3/4 in.
Outlet Connection Diameter3/4 in.
Materials Information
Chemistry
  • Polyethersulfone (PES)
Device Material
  • Gamma stable polypropylene/Polysulfone
Seal MaterialSilicone (SI)
Support MaterialPolyethylene
Vent Cap MaterialPolypropylene (PP)
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Storage and Shipping Information
Packaging Information
Material Size3
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 L
Global Trade Item Number
Katalógusszám GTIN
KGEPS006FF3 04053252453700

Documentation

Material Qualification Dossier

TitleVersion
1.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Certificates of Quality

Title
OPTICAP XL 600 Capsule Millipore Express SHF C3BB79473
Opticap XL 600 Capsule Millipore Express SHF Membrane C0CB19360
Opticap XL 600 Capsule Millipore Express SHF Membrane C7EA48579
Opticap XL 600 Capsule Millipore Express SHF Membrane C7HA62096
Opticap XL 600 Capsule Millipore Express SHF Membrane C9CA03010
Opticap XL 600 Capsule Millipore Express SHF Membrane - C9DA29132
Opticap XL 600 Capsule Millipore Express SHF Membrane - C9MA86543
Opticap XL 600 Capsule Millipore Express SHF Membrane C0PB46122
Opticap XL 600 Capsule Millipore Express SHF Membrane C1HB23401
Opticap XL 600 Capsule Millipore Express SHF Membrane C1HB88831
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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