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KVEPG015FF3 Opticap® Gamma Compatible XL 150 Millipore Express® SHR single layer 0.1 µm 3/4 in. TC/TC

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KVEPG015FF3
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKVEPG015FF3
Trade Name
  • Millipore Express®
DescriptionOpticap® Gamma Compatible XL 150 Millipore Express® SHR single layer 0.1 µm 3/4 in. TC/TC
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® 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 ConnectionSanitary Flange
Air Diffusion at 23 °C≤1.4 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 2.0 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 Length3.8 in. (9.7 cm)
Length9.7 cm (3.8 in.)
Diameter5.6 cm (2.2 in.)
Filtration Area250 cm²
Inlet to Outlet Width9.7 cm (3.8 in.)
Inlet Connection Diameter3/4 in.
Outlet Connection Diameter3/4 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
KVEPG015FF3 04053252609671

Documentation

Material Qualification Dossier

TitleVersion
6.0

Operational Excellence Dossier

Title

Operational Excellence Dossier (Second Sterilization)

Title

Certificates of Quality

Title
OPTICAP XL 150 Capsule Millipore Express SHR C3PB72605
Opticap XL 150 Capsule Millipore Express SHR Membrane C0CB15402Y
Opticap XL 150 Capsule Millipore Express SHR Membrane C4EB45973
Opticap XL 150 Capsule Millipore Express SHR Membrane - C0EB58540
Opticap XL 150 Capsule Millipore Express SHR Membrane C0PB34208
Opticap XL 150 Capsule Millipore Express SHR Membrane C1DB81230
Opticap XL 150 Capsule Millipore Express SHR Membrane C1NB46538
Opticap XL 150 Capsule Millipore Express SHR Membrane C1SB02086
Opticap XL 150 Capsule Millipore Express SHR Membrane C4HB51319
Opticap XL 150 Capsule Millipore Express SHR Membrane- C4DB28493

User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules