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KVEPG03HH3 Opticap® Gamma Compatible XL 3 Millipore Express® SHR single layer 0.1 µm 9/16 in. HB/HB

FDS (Fiches de données de sécurité), certificats d’analyse (CoA) et de qualité (CoQ), dossiers, brochures et autres documents disponibles.
KVEPG03HH3
3  Double Easy-Open bag
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Replacement Information
Description
Catalogue NumberKVEPG03HH3
Trade Name
  • Millipore Express®
DescriptionOpticap® Gamma Compatible XL 3 Millipore Express® SHR single layer 0.1 µm 9/16 in. HB/HB
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet14 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 ConnectionHose Barb
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 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 Diameter9/16 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 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
Référence GTIN
KVEPG03HH3 04053252605611

Documentation

Material Qualification Dossier

TitreVersion
6.0

Certificats de qualité

Titre
Opticap XL 3 Capsule Millipore Express SHR Membrane C0MB03245
Opticap XL 3 Capsule Millipore Express SHR Membrane C1HB90907
Opticap XL 3 Capsule Millipore Express SHR Membrane C8CA42649
Opticap XL 3 Capsule Millipore Express SHR Membrane C9PA13422Y
Opticap XL 3 Capsule Millipore Express SHR Membrane - C0AB93416Y
Opticap XL 3 Capsule Millipore Express SHR Membrane - C8BA24533
Opticap XL 3 Capsule Millipore Express SHR Membrane - C8MA14745Y
Opticap XL 3 Capsule Millipore Express SHR Membrane C3DB03161
Opticap XL 3 Capsule Millipore Express SHR Membrane C3PB62370
Opticap XL 3 Capsule Millipore Express SHR Membrane C7JA44449
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Manuels d'utilisation

Titre
Opticap® XL Capsules and Opticap® XLT Capsules