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KPHLS10TT1 Opticap® Sterile XL10 Durapore® 0.45 µm TC/TC

  • 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.
KPHLS10TT1
1  
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Aperçu

Replacement Information
Description
Catalogue NumberKPHLS10TT1
Trade Name
  • Opticap®
DescriptionOpticap® Sterile XL10 Durapore® 0.45 µm TC/TC
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange
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 ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
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 Diameter1-1/2 in.
Outlet Connection Diameter1-1/2 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
Référence GTIN
KPHLS10TT1 04055977275827

Documentation

Material Qualification Dossier

TitreVersion
2.0

Certificats de qualité

Titre
OPTICAP XL 10 Capsule Durapore Membrane C3CB97538
OPTICAP XL 10 Capsule Durapore Membrane C3KB30033
OPTICAP XL 10 Capsule Durapore Membrane C4KB85241
Opticap XL 10 Capsule Durapore Membrane C7SA10116
Opticap XL 10 Capsule Durapore Membrane C0CB42399
Opticap XL 10 Capsule Durapore Membrane C0JB88703
Opticap XL 10 Capsule Durapore Membrane C0KB09315
Opticap XL 10 Capsule Durapore Membrane C1CB07711
Opticap XL 10 Capsule Durapore Membrane C1EB88700
Opticap XL 10 Capsule Durapore Membrane C1SB03041
Show more

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