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KVGLA3THH1 Opticap® XLT30 Durapore® 0.22 µm 5/8 in. HB/HB

Opticap® XLT30 Durapore® 0.22 µm 5/8 in. HB/HB MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
KVGLA3THH1
1  Double Easy-Open bag
Purchase on Sigma-Aldrich

Áttekintés

Replacement Information
Description
Catalogue NumberKVGLA3THH1
Trade Name
  • Opticap®
DescriptionOpticap® XLT30 Durapore® 0.22 µm 5/8 in. HB/HB
References
Product Information
Device ConfigurationCapsule
Connections, Inlet/Outlet16 mm (5/8 in.) Hose Barb
Connections, Vent/Drain1/4 in. Hose Barb with double O-ring Seal
Housing MaterialPolypropylene (PP)
Maximum Differential Pressure, bar (psid)Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C. Reverse: 3.5 bar (50 psid) @ 25 °C, intermittent
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
Biological Information
Bacterial EndotoxinsAqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
MediaDurapore®
SterilityOther
Sterilization3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
Bacterial RetentionSamples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
WettabilityHydrophilic
Physicochemical Information
Pore Size0.22 µm
Inlet ConnectionHose Barb
Outlet ConnectionHose Barb
Air Diffusion at 23 °C≤40 mL/min @ 2.75 bar (40 psig) in water
Bubble Point at 23 °C≥3450 mbar (50 psig) air with water
Gravimetric ExtractablesThe extractables level was equal to or less than 75 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 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Dimensions
Cartridge Nominal Length30 in. (75 cm)
Length87.1 cm (34.3 in.)
Diameter10.7 cm (4.2 in.)
Filtration Area2.1 m²
Inlet to Outlet Width19.8 cm (7.8 in.)
Device Size30 in.
Inlet Connection Diameter5/8 in.
Outlet Connection Diameter5/8 in.
Materials Information
Chemistry
  • Polyvinylidene Fluoride (PVDF)
Device Material
  • Polypropylene
Seal MaterialSilicone (SI)
Support MaterialPolypropylene
Vent Cap MaterialPolypropylene (PP)
Toxicological Information
Safety Information according to GHS
Safety Information
Product Usage Statements
Storage and Shipping Information
Packaging Information
Material Size1
Material PackageDouble Easy-Open bag
Transport Information
Supplemental Information
Specifications
Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L
Global Trade Item Number
Katalógusszám GTIN
KVGLA3THH1 04053252383939

Documentation

Material Qualification Dossier

TitleVersion
1.0

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Certificates of Quality

Title
OPTICAP XLT 30 Capsule Durapore Membrane C3NB62780
Opticap XLT 30 Capsule Durapore Membrane C0HB84313Z
Opticap XLT 30 Capsule Durapore Membrane C0PB30212Z
Opticap XLT 30 Capsule Durapore Membrane C7JA39469
Opticap XLT 30 Capsule Durapore Membrane C8AA12970
Opticap XLT 30 Capsule Durapore Membrane C9NA14227
Opticap XLT 30 Capsule Durapore Membrane - C7PA89830
Opticap XLT 30 Capsule Durapore Membrane - C7SA08252
Opticap XLT 30 Capsule Durapore Membrane - C9NA05367
Opticap XLT 30 Capsule Durapore Membrane C1MB53391
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Technical Info

Title
Autoclaving Guidelines for Opticap® XL and XLT Disposable Capsule Filters
Establishing Product Specific Bubble Point Specifications For Sterilizing-Grade Filters
Simplified, efficient sizing of sterilizing-grade normal flow filters for buffer solutions

Data Sheet

Title
Durapore® Family Guide

User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules

Kapcsolódó termékek és alkalmazások

Product Families

Durapore® 0.1 µm and 0.22 µm Capsule Filters

Sterilizing-grade 0.1 µm and 0.22 µm hydrophilic polyvinylidene fluoride (PVDF) membranes are low protein binding and provide sterility assurance, high flow rates and throughputs.
További információk >>

Durapore® 0.1 µm and 0.22 µm Capsule Filters

0.1 µm and 0.22 µm hydrophilic polyvinylidene fluoride (PVDF) membranes for sterile liquid filtration
További információk >>

Kapcsolódó termékek gyártója: Brand Facete

Opticap®

Kategóriák

Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Durapore