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KVEPS03TT3 Opticap® Sterile XL 3 Millipore Express® SHR single layer 0.1 µm 1-1/2 in. TC/TC

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KVEPS03TT3
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKVEPS03TT3
Trade Name
  • Millipore Express®
DescriptionOpticap® Sterile XL 3 Millipore Express® SHR single layer 0.1 µm 1-1/2 in. TC/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
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
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 Size0.1 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
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 3.5 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 Length3 in. (7.5 cm)
Length17.3 cm (6.8 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area0.17 m²
Inlet to Outlet Width17.3 cm (6.8 in.)
Device Size3 in.
Inlet Connection Diameter1-1/2 in.
Outlet Connection Diameter1-1/2 in.
Materials Information
Chemistry
  • Polyethersulfone (PES)
Device Material
  • Polypropylene
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 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
KVEPS03TT3 04053252260230

Documentation

Material Qualification Dossier

TitleVersion
6.0

Certificates of Quality

Title
OPTICAP XL 3 Capsule Millipore Express SHR Membrane C3KB39759
Opticap XL 3 Capsule Express SHR Membrane C8PA46652Y
Opticap XL 3 Capsule Millipore Express SHR Membrane C8NA47576Y
Opticap XL 3 Capsule Millipore Express SHR Membrane C0MB04022
Opticap XL 3 Capsule Millipore Express SHR Membrane C7EA18740
Opticap XL 3 Capsule Millipore Express SHR Membrane C7KA50845
Opticap XL 3 Capsule Millipore Express SHR Membrane C7SA05602
Opticap XL 3 Capsule Millipore Express SHR Membrane C8CA35671
Opticap XL 3 Capsule Millipore Express SHR Membrane C8JA01968
Opticap XL 3 Capsule Millipore Express SHR Membrane - C7CA92032
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User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules