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KWSSA04TT3 Opticap® XL4 Milligard® 0.5/0.2 µm 1-1/2 in. TC/TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KWSSA04TT3
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKWSSA04TT3
ReplacesKWSS04TC3
Trade Name
  • Opticap®
DescriptionOpticap® XL4 Milligard® 0.5/0.2 µm 1-1/2 in. TC/TC
References
Product Information
FormatDouble Layer
Device ConfigurationCapsule
Connections, Inlet/Outlet38 mm (1-1/2 in.) Sanitary Flange
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
European Pressure Equipment DirectiveEMD Millipore Corporation® certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.
Good Manufacturing PracticesThese products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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 ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
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 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 Length4 in. (10 cm)
Length19.6 cm (7.7 in.)
Diameter12.5 cm (4.9 in.)
Filtration Area0.16 m²
Inlet to Outlet Width19.6 cm (7.7 in.)
Device Size4 in.
Inlet Connection Diameter1-1/2 in.
Nominal Pore Size0.5 / 0.2 µm
Outlet Connection Diameter1-1/2 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 Size3
Material PackageDouble Easy-Open bag
Transport Information
Supplemental Information
Specifications
Oxidizable SubstancesWill meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L
Global Trade Item Number
Catalog Number GTIN
KWSSA04TT3 04053252572982

Documentation

Opticap® XL4 Milligard® 0.5/0.2 µm 1-1/2 in. TC/TC SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
OPTICAP XL 4 Capsule Durapore Membrane C3HB26758
Opticap XL 4 Capsule Milligaed Media C7JA39762
Opticap XL 4 Capsule Milligard Media C7PA84013
Opticap XL 4 Capsule Milligard Media C7SA05042
Opticap XL 4 Capsule Milligard Media C7HA24922
Opticap XL 4 Capsule Milligard Media C7HA24924
Opticap XL 4 Capsule Milligard Media C7NA71571
Opticap XL 4 Capsule Milligard Media C7NA76961
Opticap XL 4 Capsule Milligard Media C7NA80279
Opticap XL 4 Capsule Milligard Media C9KA69337
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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