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KPHLS2THH1 Opticap® Sterile XLT20 Durapore® 0.45 µm 5/8" HB/HB without gauge port


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

FDS (Fiches de données de sécurité), certificats d’analyse (CoA) et de qualité (CoQ), dossiers, brochures et autres documents disponibles.
KPHLS2THH1
1  
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Aperçu

Replacement Information
Description
Catalogue NumberKPHLS2THH1
Trade Name
  • Opticap®
DescriptionOpticap® Sterile XLT20 Durapore® 0.45 µm 5/8" HB/HB without gauge port
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet16 mm (5/8 in.) Hose Barb Inlet and Oulet
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.
T-line/Gauge PortT-line
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
SterilizationMinimum sterilization up to 25 kGy. 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
WettabilityHydrophilic
Physicochemical Information
Pore Size0.45 µm
Inlet ConnectionHose Barb
Outlet ConnectionHose Barb
Air Diffusion at 23 °C≤30 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 Length24.6 in. (62.5 cm)
Length62.5 cm (24.6 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area1.24 m²
Inlet to Outlet Width62.5 cm (24.6 in.)
Device Size20 in.
Inlet Connection Diameter5/8 in.
Outlet Connection Diameter5/8 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 ≥3000 mL
Global Trade Item Number
Référence GTIN
KPHLS2THH1 04055977275889

Documentation

Material Qualification Dossier

TitreVersion
2.0

Certificats de qualité

Titre
Opticap XLR 20 Capsule Durapore Membrane C3DB07622
Opticap XLT 20 Capsule Durapore Membrane C0DB33369
Opticap XLT 20 Capsule Durapore Membrane C0NB26224
Opticap XLT 20 Capsule Durapore Membrane C7EA14899
Opticap XLT 20 Capsule Durapore Membrane C8DA58188
Opticap XLT 20 Capsule Durapore Membrane C9EA37156
Opticap XLT 20 Capsule Durapore Membrane C1KB33406
Opticap XLT 20 Capsule Durapore Membrane C2EB66573
Opticap XLT 20 Capsule Durapore Membrane C3MB53404
Opticap XLT 20 Capsule Durapore Membrane- C4BB82099
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Informations techniques

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

Fiche technique

Titre
Durapore® Family Guide

Produits & Applications associés

Familles de produits

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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Produits associés classés par : Brand Facete

Opticap®

Catégories

Small Molecule Pharmaceuticals > Purification of Pharm Drugs > Sterile Filtration > Sterile Liquid > Durapore > STERILE Durapore XLT
Small Molecule Pharmaceuticals > Purification of Pharm Drugs > Sterile Filtration > Sterile Liquid > Durapore
Biopharmaceutical Manufacturing > Upstream Processing > Multi-use Processing Systems > NovAseptic > Durapore