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KVEPG10TH1 Opticap® Gamma Compatible XL 10 Millipore Express® SHR single layer 0.1 µm 1-1/2 in. TC-9/16 in. HB

Opticap® Gamma Compatible XL 10 Millipore Express® SHR single layer 0.1 µm 1-1/2 in. TC-9/16 in. HB MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KVEPG10TH1
1  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberKVEPG10TH1
Trade Name
  • Millipore Express®
DescriptionOpticap® Gamma Compatible XL 10 Millipore Express® SHR single layer 0.1 µm 1-1/2 in. TC-9/16 in. HB
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet38 mm (1-1/2 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. May be autoclaved for 3 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
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 11 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 Length10 in. (25 cm)
Length33.5 cm (13.2 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area0.69 m²
Inlet to Outlet Width33.5 cm (13.2 in.)
Device Size10 in.
Inlet Connection Diameter1-1/2 in.
Outlet Connection Diameter9/16 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 Size1
Material PackageDouble Easy-Open bag
Transport Information
Supplemental Information
Specifications
Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥1.5 L
Global Trade Item Number
Katalogové číslo GTIN
KVEPG10TH1 04053252031953

Documentation

Material Qualification Dossier

TitleVersion
6.0

Certificates of Quality

Title
OApticap XL 10 Capsule Millipore Express SHR Membrane C8NA14058Y
OPTICAP XL 10 Capsule Millipore Express SHR Membrane C4PB02407
Opticap XL 10 Capsule Express SHR Membrane C9MA92059Y
Opticap XL 10 Capsule Millipore Express SHR Membrane C8EA68648Y
Opticap XL 10 Capsule Millipore Express SHR Membrane C0HB49499
Opticap XL 10 Capsule Millipore Express SHR Membrane C1KB47040
Opticap XL 10 Capsule Millipore Express SHR Membrane C1MB64717
Opticap XL 10 Capsule Millipore Express SHR Membrane C3KB48994
Opticap XL 10 Capsule Millipore Express SHR Membrane C9AA63018Y
Opticap XL 10 Capsule Millipore Express SHR Membrane C0MB19966
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User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules