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KPHLG3TTT1 Opticap® Gamma Compatible XLT30 Durapore® 0.45 µm TC/TC 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.
KPHLG3TTT1
1  
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Replacement Information
Description
Catalogue NumberKPHLG3TTT1
Trade Name
  • Opticap®
DescriptionOpticap® Gamma Compatible XLT30 Durapore® 0.45 µm TC/TC without gauge port
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange 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.
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®
SterilityNon-sterile, Gamma compatible
SterilizationGamma compatible to 40 kGy. 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
WettabilityHydrophilic
Physicochemical Information
Pore Size0.45 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Air Diffusion at 23 °C≤45 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
Non-Fiber ReleasingThis product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
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 Length34.3 in. (87.1 cm)
Length87.1 cm (34.3 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area1.86 m²
Inlet to Outlet Width87.1 cm (34.3 in.)
Device Size30 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 ≥4500 mL
Global Trade Item Number
Référence GTIN
KPHLG3TTT1 04055977275797

Documentation

Material Qualification Dossier

TitreVersion
2.0

Certificats de qualité

Titre
Opticap XLT 30 Capsule Duarpore Membrane C0BB94043
Opticap XLT 30 Capsule Durapore Membrane C8MA14829
Opticap XLT 30 Capsule Durapore Membrane C7DA08610
Opticap XLT 30 Capsule Durapore Membrane C2DB58846
Opticap XLT 30 Capsule Durapore Membrane C4JB65415
Opticap XLT 30 Capsule Durapore Membrane C8HA45924
Opticap XLT 30 Capsule Durapore Membrane - C8SA64239
Opticap XLT 30 Capsule Durapore Membrane C1HB80883
Opticap XLT 30 Capsule Durapore Membrane C1NB82685
Opticap XLT 30 Capsule Durapore Membrane C3NB35415
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 > GAMMA Durapore XLT