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KHGEG003HB3 Opticap® Gamma Compatible XL 300 Millipore Express® SHC 0.5/0.2 µm 9/16 in. HB/HB with Bell

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KHGEG003HB3
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKHGEG003HB3
Trade Name
  • Millipore Express®
DescriptionOpticap® Gamma Compatible XL 300 Millipore Express® SHC 0.5/0.2 µm 9/16 in. HB/HB with Bell
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet14 mm (9/16 in.) Hose Barb / 14 mm (9/16 in.) Hose Barb with Filling Bell
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® SHC
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 ConnectionHose Barb
Outlet ConnectionHose Barb with Bell
Air Diffusion at 23 °C≤1.9 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 2.0 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 Length4.7 in. (11.9 cm)
Length11.9 cm (4.7 in.)
Diameter5.6 cm (2.2 in.)
Filtration Area290 cm²
Inlet to Outlet Width11.9 cm (4.7 in.)
Inlet Connection Diameter9/16 in.
Outlet Connection Diameter9/16 in.
Materials Information
Chemistry
  • Polyethersulfone (PES)
Device Material
  • Gamma stable polypropylene/Polysulfone
Seal MaterialSilicone (SI)
Support MaterialPolyethylene
Vent Cap MaterialGamma stable polypropylene (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
Catalogue Number GTIN
KHGEG003HB3 04053252641749

Documentation

Material Qualification Dossier

TitleVersion
1.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Operational Excellence Dossier (Second Sterilization)

Title

Certificates of Quality

Title
Opticap XL 300 Capsule Millipore Express SHC Membrane C7NA80185
Opticap XL 300 Capsule Millipore Express SHC Membrane C0PB24224
Opticap XL 300 Capsule Millipore Express SHC Membrane C1SB00983
Opticap XL 300 Capsule Millipore Express SHC Membrane C7CA81549
Opticap XL 300 Capsule Millipore Express SHC Membrane C8AA01243
Opticap XL 300 Capsule Millipore Express SHC Membrane C8AA19344
Opticap XL 300 Capsule Millipore Express SHC Membrane C9MA95810
Opticap XL 300 Capsule Millipore Express SHC Membrane - C7CA97972
Opticap XL 300 Capsule Millipore Express SHC Membrane - C7EA12200
Opticap XL 300 Capsule Millipore Express SHC Membrane - C7KA46178
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Technical Info

Title
Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters

User Guides

Title
Vmax Constant Pressure