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KWSSA3THH1 Opticap® XLT30 Milligard® 0.5/0.2 µm 5/8 in. HB/HB

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KWSSA3THH1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKWSSA3THH1
Trade Name
  • Opticap®
DescriptionOpticap® XLT30 Milligard® 0.5/0.2 µm 5/8 in. HB/HB
References
Product Information
FormatDouble Layer
Device ConfigurationCapsule
Connections, Inlet/Outlet16 mm (5/8 in.) Hose Barb
Filter GradeStandard Milligard® Media
Housing MaterialPolypropylene (PP)
Maximum Differential Pressure, bar (psid)3.5 bar (50 psid) @ 25 °C
Maximum Inlet Pressure, bar (psi)5.5 bar (80 psi) @ 23 °C; 2.75 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
MediaMilligard®
Sterilization3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable
Physicochemical Information
Pore Size0.5 / 0.2 µm
Inlet ConnectionHose Barb
Outlet ConnectionHose Barb
Gravimetric ExtractablesThe extractables level was equal to or less than 165 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 media combination 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.)
Filtration Area2.07 m²
Inlet to Outlet Width19.8 cm (7.8 in.)
Device Size30 in.
Inlet Connection Diameter5/8 in.
Nominal Pore Size0.5 / 0.2 µm
Outlet Connection Diameter5/8 in.
Materials Information
Chemistry
  • Mixed Cellulose Esters (MCE)
Device Material
  • Polypropylene
Seal MaterialSilicone (SI)
Support MaterialPolyester
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 ≥15 L
Global Trade Item Number
Catalog Number GTIN
KWSSA3THH1 04053252654923

Documentation

Opticap® XLT30 Milligard® 0.5/0.2 µm 5/8 in. HB/HB SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
Opticap XLT 30 Capsule Durapore Membrane C0EB65799
Opticap XLT 30 Capsule Milligard Media C7NA80267
Opticap XLT 30 Capsule Milligard Media C8EA44456
Opticap XLT 30 Capsule Milligard Media C1DB92940
Opticap XLT 30 Capsule Milligard Media C8CA08761
Opticap XLT 30 Capsule Milligard Media C8JA58535
Opticap XLT 30 Capsule Milligard Media C8KA12186
Opticap XLT 30 Capsule Milligard Media C8KA87891
Opticap XLT 30 Capsule Milligard Media C9AA59823
Opticap XLT 30 Capsule Milligard Media C9CA70264
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Technical Info

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

User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules

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Categories

Biopharmaceutical Manufacturing > Downstream Processing > Bioburden Reduction/Particulate Control > Membrane based > Milligard