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KVEPG003FH3 Opticap® Gamma Compatible XL 300 Millipore Express® SHR single layer 0.1 µm 3/4 in TC-9/16 in. HB

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KVEPG003FH3
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKVEPG003FH3
Trade Name
  • Millipore Express®
DescriptionOpticap® Gamma Compatible XL 300 Millipore Express® SHR single layer 0.1 µm 3/4 in TC-9/16 in. HB
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet19 mm (3/4 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 @ 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® SHR
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 Size0.1 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionHose Barb
Air Diffusion at 23 °C≤2.8 mL/min @ 3.45 bar (50 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 2.5 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 Area480 cm²
Inlet to Outlet Width11.9 cm (4.7 in.)
Inlet Connection Diameter3/4 in.
Outlet Connection Diameter9/16 in.
Materials Information
Chemistry
  • Polyethersulfone (PES)
Device Material
  • Polypropylene
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 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
Catalog Number GTIN
KVEPG003FH3 04053252568206

Documentation

Material Qualification Dossier

TitleVersion
6.0

Operational Excellence Dossier

Title

Operational Excellence Dossier (Second Sterilization)

Title

Certificates of Quality

Title
Opticap XL 300 Capsule Millipore Express SHR Membrane C7SA01266
Opticap XL 300 Capsule Millipore Express SHR Membrane C8AA19347
Opticap XL 300 Capsule Millipore Express SHR Membrane C0JB85435
Opticap XL 300 Capsule Millipore Express SHR Membrane C0SB85245
Opticap XL 300 Capsule Millipore Express SHR Membrane - C0BB26857Y
Opticap XL 300 Capsule Millipore Express SHR Membrane - C7MA38284
Opticap XL 300 Capsule Millipore Express SHR Membrane - C8NA29126
Opticap XL 300 Capsule Millipore Express SHR Membrane - C8PA59140
Opticap XL 300 Capsule Millipore Express SHR Membrane - C9HA49806
Opticap XL 300 Capsule Millipore Express SHR Membrane - C9MA57106Y
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Technical Info

Title
Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters
Performance of High-Area Millipore Express®Cartridge Filters
Scalable Process Filtration with Millipore Express® SHR 0.1 μm Filters

User Guides

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