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KWLSA04HH3 Opticap® XL4 Milligard® Low Protein Binding 0.5/0.2 µm 9/16 in. HB/HB

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KWLSA04HH3
3  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKWLSA04HH3
ReplacesKWSSL4HB3
Trade Name
  • Opticap®
DescriptionOpticap® XL4 Milligard® Low Protein Binding 0.5/0.2 µm 9/16 in. HB/HB
References
Product Information
FormatDouble Layer
Device ConfigurationCapsule
Connections, Inlet/Outlet14 mm (9/16 in.) Hose Barb
Filter GradeLow Protein Binding 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® LPB
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 90 mg per capsule after a 2 L flush and 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 Diameter9/16 in.
Nominal Pore Size0.5 / 0.2 µm
Outlet Connection Diameter9/16 in.
Materials Information
Chemistry
  • Low Protein-Binding 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
KWLSA04HH3 04053252461996

Documentation

Opticap® XL4 Milligard® Low Protein Binding 0.5/0.2 µm 9/16 in. HB/HB SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
Opticap XL 4 Capsule Milligard LPB Media C8BA41354
Opticap XL 4 Capsule Milligard LPB Media - C7KA50266
Opticap XL 4 Capsule Milligard LPB Media - C7MA61275
Opticap XL 4 Capsule Milligard LPB Media - C7SA09431
Opticap XL 4 Capsule Milligard LPB Media - C8NA38050
Opticap XL 4 Capsule Milligard LPB Media - C9DA18071
Opticap XL 4 Capsule Milligard LPB Media C1KB51489
Opticap XL 4 Capsule Milligard LPB Media C2JB84469
Opticap XL 4 Capsule Milligard LPB Media C2MB23660
Opticap XL 4 Capsule Milligard LPB Media C3EB09894
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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