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KPHLG2TTT1 Opticap® Gamma Compatible XLT20 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

Opticap® Gamma Compatible XLT20 Durapore® 0.45 µm TC/TC without gauge port MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KPHLG2TTT1
1  
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Replacement Information
Description
Catalogue NumberKPHLG2TTT1
Trade Name
  • Opticap®
DescriptionOpticap® Gamma Compatible XLT20 Durapore® 0.45 µm TC/TC without gauge port
References
Product Information
HS Code8421 29 90
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≤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
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 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 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 ≥3000 mL
Global Trade Item Number
Katalogové číslo GTIN
KPHLG2TTT1 04055977275735

Documentation

Material Qualification Dossier

TitleVersion
2.0

Certificates of Quality

Title
Opticap XLT 20 Capsule Durapore Membrane C0KB01778
Opticap XLT 20 Capsule Durapore Membrane C0DB33368
Opticap XLT 20 Capsule Durapore Membrane C0PB30245
Opticap XLT 20 Capsule Durapore Membrane C1BB94956
Opticap XLT 20 Capsule Durapore Membrane C1EB80885
Opticap XLT 20 Capsule Durapore Membrane C4CB03598
Opticap XLT 20 Capsule Durapore Membrane C7DA08448
Opticap XLT 20 Capsule Durapore Membrane C8AA04991
Opticap XLT 20 Capsule Durapore Membrane C8DA33000
Opticap XLT 20 Capsule Durapore Membrane C9EA29458
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Technical Info

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

Data Sheet

Title
Durapore® Family Guide

Související produkty a aplikace

Product Families

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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Opticap®

Kategorie

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