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KPHLS10HH1 Opticap® Sterile XL10 Durapore® 0.45  HB/HB

  • Prefiltration / Bioburden reduction in single use assemblies
  • Bioburden reduction before final sterilization
  • Process protection of intermediate consumables esp. in Plasma / Vaccine / r-Protein

Opticap® Sterile XL10 Durapore® 0.45  HB/HB: MSDS (material safety data sheet) o SDS, certificato d’analisi (CoA) e certificato di qualità (CoQ), dossier, brochure e altri documenti disponibili.
KPHLS10HH1
1  
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Replacement Information
Description
Catalogue NumberKPHLS10HH1
Trade Name
  • Opticap®
DescriptionOpticap® Sterile XL10 Durapore® 0.45  HB/HB
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet14 mm (9/16 in.) Hose Barb Inlet and Outlet
Connections, Vent/Drain1/4 in. Hose Barb with double O-ring Seal
Housing MaterialPolypropylene (PP)
Maximum Differential Pressure, bar (psid)Forward: 4.1 bar (60 psid) @25 ˚C. Reverse: 2.1 bar (30 psid) @ 4-40 °C
Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 23 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Quality LevelMQ400
Applications
Application
  • Prefiltration / Bioburden reduction in single use assemblies
  • Bioburden reduction before final sterilization
  • Process protection of intermediate consumables esp. in Plasma / Vaccine / r-Protein
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaDurapore®
SterilitySterile
SterilizationGamma compatible to 40 kGy. 3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
WettabilityHydrophilic
Physicochemical Information
Pore Size0.45 µm
Inlet ConnectionHose Barb
Outlet ConnectionHose Barb
Air Diffusion at 23 °C≤15 mL/min @ 3.9 bar (56 psig) in water
Bubble Point at 23 °C≥1930 mbar (28 psig) air with water
Gravimetric ExtractablesThe extractables level was equal to or less than 25 mg per capsule after 24 hours in water at controlled room temperature.
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 Inlet Temperature25 °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 Length13.2 in. (33.5 cm)
Length33.5 cm (13.2 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area0.62 m²
Inlet to Outlet Width33.5 cm (13.2 in.)
Device Size10 in.
Inlet Connection Diameter9/16 in.
Outlet Connection Diameter9/16 in.
Materials Information
Chemistry
  • Polyvinylidene Fluoride (PVDF)
Device Material
  • Polypropylene
Seal MaterialLead O-ring: Silicone-coated EPDM, Outer O-ring: Silicone
Support MaterialPolyester/Polyethylene
Vent Cap MaterialPolypropylene (PP)
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Storage and Shipping Information
Packaging Information
Material Size1
Transport Information
Supplemental Information
Specifications
Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥1500 mL
Global Trade Item Number
Numero di catalogo GTIN
KPHLS10HH1 04055977275810

Documentation

Material Qualification Dossier

TitoloVersione
2.0

Certificati di Qualità

Titolo
OPTICAP XL 10 Capsule Durapore Membrane C3KB31527
Opticap XL 10 Capsule Durapore Membrane C0JB92513
Opticap XL 10 Capsule Durapore Membrane C0NB37860
Opticap XL 10 Capsule Durapore Membrane C1EB98525
Opticap XL 10 Capsule Durapore Membrane C1KB51510
Opticap XL 10 Capsule Durapore Membrane C7EA12235
Opticap XL 10 Capsule Durapore Membrane C7HA25763
Opticap XL 10 Capsule Durapore Membrane C8JA94044
Opticap XL 10 Capsule Durapore Membrane - C9KA76748
Opticap XL 10 Capsule Durapore Membrane - C9SA81003
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Informazioni tecniche

Titolo
Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters

Scheda tecnica

Titolo
Durapore® Family Guide

Prodotti e applicazioni correlate

Linee di prodotti

Durapore® 0.45 µm Capsule Filters

Autoclavable, Gamma compatible or Presterilized bioburden reduction filters for process protection and prefiltration in single use applications
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Categorie

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