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KWLCA10FF1 Opticap® XL10 Milligard® Low Protein Binding 1.2/0.5 µm 3/4 in. TC/TC

MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
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KWLCA10FF1
1  Double Easy-Open bag
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Overview

Replacement Information
Description
Catalogue NumberKWLCA10FF1
Trade Name
  • Opticap®
DescriptionOpticap® XL10 Milligard® Low Protein Binding 1.2/0.5 µm 3/4 in. TC/TC
References
Product Information
FormatDouble Layer
Device ConfigurationCapsule
Connections, Inlet/Outlet19 mm (3/4 in.) Sanitary Flange
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 Size1.2 / 0.5 µm
Inlet ConnectionSanitary Flange
Outlet ConnectionSanitary Flange
Gravimetric ExtractablesThe extractables level was equal to or less than 355 mg per capsule after a 5 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 Length10 in. (25 cm)
Length33.5 cm (13.2 in.)
Diameter14.5 cm (5.7 in.)
Filtration Area0.69 m²
Inlet to Outlet Width33.5 cm (13.2 in.)
Device Size10 in.
Inlet Connection Diameter3/4 in.
Nominal Pore Size1.2 / 0.5 µm
Outlet Connection Diameter3/4 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 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 ≥5 L
Global Trade Item Number
Catalog Number GTIN
KWLCA10FF1 04053252486296

Documentation

Opticap® XL10 Milligard® Low Protein Binding 1.2/0.5 µm 3/4 in. TC/TC SDS

Title

Safety Data Sheet (SDS) 

Certificates of Quality

Title
Opticap XL 10 Capsule Millgard LPB Media C9DA17625
Opticap XL 10 Capsule Milligard LPB Media C7DA01339
Opticap XL 10 Capsule Milligard LPB Media - C7JA39760
Opticap XL 10 Capsule Milligard LPB Media C1HB15230
Opticap XL 10 Capsule Milligard LPB Media C2PB47156
Opticap XL 10 Capsule Milligard LPB Media C3DB05142
Opticap XL 10 Capsule Milligard LPB MediaC3HB30070

Technical Info

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

User Guides

Title
Opticap® XL Capsules and Opticap® XLT Capsules